Business Of Biotech

Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D.

Mon, 13 Apr 2026 06:00:00 -0400

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On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes. Dr. Niazi offers a behind the scene look at the way FDA policy gets made, and unmade, and his own role in key regulatory changes, and legislation such as the Biologics Price Competition and Innovations Act (BPCIA), and the Inflation Reduction Act (IRA). We also discuss Dr. Niazi's current company, RNA Therapeutics, and his quest to make new drug modalities accessible to patients around the world.

This episode of the Business of Biotech is brought to you by Cytiva.

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Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com

Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

Radiotherapeutics For Neuroendocrine Tumors With Perspective Therapeutics' Thijs Spoor

Mon, 06 Apr 2026 06:00:00 -0400

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On this week's episode of the Business of Biotech, Thijs Spoor, CEO at Perspective Therapeutics, a company developing Pb 212 (lead)-based therapeutics, talks about why radiopharmaceuticals are surging again and why biodistribution is the make-or-break variable when your payload is a radioactive isotope. Thijs discusses the reasons behind Perspective's investment in a proprietary generator for therapeutic production, manufacturing and delivery strategy, workforce constraints, and building a clinical strategy around receptor positivity across tumor types.

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Investing In Early-Stage Oncology With Yosemite's Dan McHugh

Mon, 30 Mar 2026 06:00:00 -0400

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On this week's episode of the Business of Biotech, Dan McHugh, head of the investment team at Yosemite, explains the San Francisco VC group's approach to investing in early-stage cancer therapeutics and funding academic research through unrestricted grants. Founded by Reed Jobs, son of Steve Jobs and Laurene Powell Jobs, Yosemite invests across drug modalities and supporting technologies in the oncology space. Dan talks about his path from bioengineering to biotech venture capital, meeting Reed Jobs on Stanford's fencing team, his CEO turn at Tune Therapeutics, and the current fundraising environment for innovative science.

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Commercializing CAR T Cell Therapy With Legend Biotech's Alan Bash

Mon, 23 Mar 2026 06:00:00 -0400

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On this week's episode of the Business of Biotech we're speaking with Alan Bash, President, Carvykti, at Legend Biotech, about how Carvykti became a blockbuster, category-leading CAR T therapy for multiple myeloma. Alan talks about manufacturing and delivering an autologous cell therapy at commercial scale, Legend Biotech's partnership with Johnson & Johnson, lessons he learned at Bristol Myers Squibb, Checkmate Pharmaceuticals, and ZielBio, and his strategy for growing Carvykti's patient footprint and facing new competitors in the market.

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Radiotherapeutics For CNS Cancers With Plus Therapeutics' Marc Hedrick, M.D.

Mon, 16 Mar 2026 06:00:00 -0400

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On this week's episode of the Business of Biotech we speak with Dr. Marc Hedrick, M.D., President and CEO at Plus Therapeutics, about the company's pivot from cell therapy to radiotherapeutics for brain cancers, and what's behind the choice of Rhenium-186 as the radioisotope for its lead development candidate, Reyobiq. We'll talk about Plus Therapeutics' diagnostic subsidiary, CNSide, and hear from Marc about recent FDA meetings and the agency's attitude toward novel radiotherapeutics.

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Developing Novel Cancer Drugs On A Budget With Iterion Therapeutics' Rahul Aras, Ph.D.

Mon, 09 Mar 2026 06:00:00 -0400

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On this week's episode of the Business of Biotech we speak with Rahul Aras, Ph.D., President and CEO at Iterion Therapeutics, about capital efficient drug development in oncology and progressing a novel therapeutic with relatively small funding amounts. Iterion is a clinical stage company developing cancer therapeutics targeting the Wnt/β-catenin pathway, a known signaling target in oncology, but one that has confounded drug development efforts for decades. Rahul talks about his path from academia to company building and early work in gene therapy, Iterion's partnership strategy, and operating a biotech in the Houston, Texas clinical hub.

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Making Biologics Orally Available With Vivtex's Thomas von Erlach, Ph.D.

Mon, 02 Mar 2026 06:00:00 -0500

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On this week's episode of the Business of Biotech, we're speaking with Thomas von Erlach, Ph.D., Cofounder and CEO at Vivtex, a company spun out of the Langer Lab at MIT that's focused on developing orally available biologics. The company announced a deal in late February '26 with Novo Nordisk for up to $2.1 billion to develop next-gen oral drugs for obesity and diabetes, bringing the total number of Vivtex's partnerships to 10. Thomas shares his experiences working in the lab with Dr. Robert Langer, Ph.D., starting up Vivtex around his co-invention (a "GI tract on a chip"), building trust externally and securing the right partnerships, and using a strategic stealth period to refine Vivtex's platform technology before scaling it out.

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An Anthropological Lens On Leadership In Life Sciences With Bunka's Monika Sumra, Ph.D.

Mon, 23 Feb 2026 06:00:00 -0500

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On this week's episode of the Business of Biotech we speak with Monika Sumra, Ph.D., about how leadership, culture, and performance emerge from the environment and conditions inside an organization. Dr. Sumra, Founder and Managing Partner at Bunka, Inc., a management consulting firm and advisor to manufacturing-based organizations globally, explains how anthropology, CPIs, and rapid ethnography make culture measurable and operations faster, safer, and more reliable. Deploying a unique lens built on biosocial anthropology, she offers guidance on creating environments for sustainable performance in the complex life sciences industry.

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Company Turnarounds And AI For Infectious Diseases With Seek Labs' Jared Bauer

Mon, 16 Feb 2026 06:00:00 -0500

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On this week's episode of the Business of Biotech, Jared Bauer, Cofounder and CEO at Seek Labs, talks about his adventures in company turnarounds, and setting up Seek Labs to improve patient diagnoses and to discover and develop new treatments for infectious diseases. Jared explains the technology convergence that was needed to build Seek Labs' AI diagnostic and CRISPR-based therapeutics platform, an African Swine Fever proof-of-concept study that reduced viremia in pigs, mapping pathogens for rapid target design, and engaging with the FDA and global regulatory agencies.

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Bringing Curative Cell Therapies To Market with Kite Pharma's Cindy Perettie

Mon, 09 Feb 2026 06:00:00 -0500

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On this week's episode of the Business of Biotech, we're speaking with Cindy Perettie, Executive Vice President and Global Head at Kite Pharma, a Gilead-owned company focused on curing cancer with cell therapies. Perettie talks about scaling cell therapies in the community setting, global manufacturing strategy, preparing for the launch of late-stage development programs in lymphoma and multiple myeloma, and working with partners like Arcellx. She also discusses cell therapy funding cycles and big pharma, the autologous versus allogeneic divide, why in vivo CAR-T therapies could be a game changer, what the FDA's focus on cell and gene therapies could mean for U.S. competition, and more.

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BoB@JPM: Brian Hilberdink, Boehringer Ingelheim

Mon, 02 Feb 2026 06:00:00 -0500

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On this week's episode of the Business of Biotech, Brian Hilberdink, President of U.S. Human Pharma at Boehringer Ingelheim, returns to the show during the J.P. Morgan Healthcare Conference, and following his departure from LEO Pharma (see episode 164). Brian talks about new opportunities in obesity, the benefits of private ownership in funding early science, Boehringer's deal strategy, using AI to improve commercialization efforts, and the FDA's selection of zongertinib (in patients with HER2-mutant NSCLC) for the Commissioner's National Priority Voucher program.

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BoB@JPM: Ron Cooper, enGene

Mon, 26 Jan 2026 06:00:00 -0500

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On this week's episode of the Business of Biotech -- on location at the J.P. Morgan Healthcare Conference -- we're speaking with Ron Cooper, CEO and Board Member at enGene, to unpack how he scaled Albireo from a small research shop to a global commercial company, and why he’s now betting on nonviral gene therapy at enGene to help patients with non-muscle invasive bladder cancer keep their bladders. Cooper talks about the importance of keeping development, financing, and hiring in sync as biotech companies grow, his experiences surviving near-death cash deficits, the importance of investing early in CMC, and what to expect in 2026.

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BoB@JPM: Marc Salzberg, M.D., Airway Therapeutics

Mon, 19 Jan 2026 06:00:00 -0500

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The Business of Biotech was back in San Francisco for the J.P. Morgan Healthcare Conference (January 12 - 15) and this week we sit down with Marc Salzberg, M.D., CEO, CMO, and Board Chair at Airway Therapeutics, a company developing a recombinant version of human surfactant protein D for several respiratory, inflammatory, and infectious diseases including bronchopulmonary dysplasia (BPD), which is currently in Phase 2b/3 trials. Brian talks about why he selected BPD as a lead clinical indication (a disease primarily affecting preterm infants), what he learned through founding and selling a CRO, how a private biotech funds a pivotal trial across continents, and offers an industry outlook for 2026.

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A Royalty Model For Value Creation With Zymeworks' Kenneth Galbraith

Mon, 12 Jan 2026 06:00:00 -0500

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On this week's episode of the Business of Biotech, we're speaking with Kenneth Galbraith, CEO and Board Chair at Zymeworks, a biotech developing multispecific therapies internally and through partnerships with companies including Jazz Pharmaceuticals and BeOne Medicines (formerly BeiGene), J&J, Merck, Daiichi Sankyo, and GSK. Ken talks about Zymeworks' shift to a royalty model for development funding and value creation, lessons learned from platform deals and cross-border R&D, the benefits of strong royalty agreements and backloaded milestone payments over headline upfronts, and industry dynamics for the coming year. Ken also shares insights from his deep experiences as a biotech investor and corporate director, and explains why scientific primacy should always drive biotech business decisions.

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Life Science Connect Editors' Roundtable: Wrapping Up 2025 And Looking Ahead

Mon, 05 Jan 2026 06:00:00 -0500

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This week's special holiday episode of the Business of Biotech brings seven chief editors from the Life Science Connect family together to talk about the life sciences industry topics, trips, and reporting that mattered most in 2025, and what each editor has planned for 2026. From the RNA, cell, and gene therapy space to small molecule manufacturing, bioprocessing, drug discovery, and outsourcing, the editors weigh in on key industry trends, new developments, and policy surprises from their respective coverage areas. Topics include biotech funding dynamics, FDA leadership, China's growing role, favorite holiday movies, and much, much more. Special thanks to Tyler Menichiello and the Better Biopharma podcast for hosting this roundtable discussion. Happy New Year!

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Building Cell Therapy Companies With Kenai Therapeutics' Nick Manusos

Mon, 29 Dec 2025 06:00:00 -0500

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On this week's episode of the Business of Biotech, Nick Manusos, CEO at Kenai Therapeutics, talks about his experiences building cell therapy spinouts from FujiFilm Cellular Dynamics, learning from big pharma decision-making processes, and dosing the first patient with Kenai's allogeneic neuron replacement cell therapy for Parkinson's disease. Nick also talks about funding an early-stage cell therapy company and forging key manufacturing and therapy administration partnerships.

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Modernizing Clinical Trial Operations With Merck's Jennifer Sheller

Mon, 22 Dec 2025 06:00:00 -0500

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On this week's episode of the Business of Biotech, Jennifer Sheller, SVP and Head of Global Clinical Trial Operations at Merck talks about simplifying trial protocols and what she likes about Merck's hybrid functional service provider model for conducting trials in over 60 countries. Jennifer shares her experiences integrating Merck's acquisitions without breaking studies or losing people, using new technology to improve trial operations, and co-designing studies with trial sites for agility and speed.

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Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D.

Mon, 15 Dec 2025 06:00:00 -0500

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On this week's episode of the Business of Biotech, Bruce Culleton, M.D., CEO at ProKidney, talks about moving from academic research to industry and the role a key mentor played in his career path. Bruce discusses his experiences as a first-time CEO at ProKidney, a late-stage autologous cell therapy biotech focused on pioneering new treatments for chronic kidney disease (CKD), the benefits of FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, how delaying or avoiding kidney dialysis would be a game-changer for CKD patients, and more.

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Engineering B Cells With Immusoft's Sean Ainsworth

Mon, 08 Dec 2025 06:00:00 -0500

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On this week's episode of the Business of Biotech, Sean Ainsworth, CEO and Chairman at Immusoft, talks about transitioning from the research bench to entrepreneurship, his M&A experiences as a biotech founder, and why engineered B cell therapies offer a better, more patient-friendly administration for lysosomal storage diseases currently treated with enzyme replacement therapies. Sean also discusses FDA pathways, incentives, and agency engagement, and offers thoughts on the regulatory outlook for cell and gene therapies.

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Building A Cancer Pipeline In A Molecule With Actuate Therapeutics' Dan Schmitt

Mon, 01 Dec 2025 06:00:00 -0500

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On this week's episode of the Business of Biotech, Dan Schmitt, President and CEO at Actuate Therapeutics, talks about building a company around elraglusib, a GSK-3β inhibitor for cancer. Dan describes his fast-fail approach to early product testing and development, using basket trials to evaluate chemotherapy combinations, and choosing pancreatic cancer as a lead program. He also talks about surviving an IPO during a brutal funding cycle for biotech, building lean teams and efficient operations, and potentially onshoring API in response to changing U.S. policy.

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Biotech Collaboration Strategy With IGI's Cyril Konto, M.D.

Mon, 24 Nov 2025 06:00:00 -0500

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On this week's episode, Cyril Konto, M.D., president, executive director, and CEO at Ichnos Glenmark Innovation (IGI) talks about the promise of multi-specific antibodies, funding the company during the 'biotech winter,' closing a $700 million upfront licensing deal with AbbVie, the impact of China's rising biotech sector, and the keys to successful collaboration. Cyril also discusses IGI's focus on developing innovative therapies for emerging markets, and the shift from animal models to in silico modeling in preclinical research.

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Biotech Funding And IPO Temperature Check With Create Medicine's Allan Shaw

Mon, 17 Nov 2025 06:00:00 -0500

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Allan Shaw, Chief Financial Officer and Chief Business Officer at Create Medicines, is back on the Business of Biotech this week, with a temperature check on biotech funding and the IPO market. We discuss the implications of recent blockbuster acquisitions, strategies for managing the current funding environment for biotech, what to look for in the IPO market in the coming months, alternative financing opportunities, and what besides lower interest rates might bring generalist investors back into the sector.

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Funding Tips And Moving From R&D To Commercial With Madrigal Pharmaceuticals' Mardi Dier

Mon, 10 Nov 2025 06:00:00 -0500

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On this week's episode of the Business of Biotech, Mardi Dier, CFO at Madrigal Pharmaceuticals, talks about building relationships in investment banking and investor relations before moving into business development and becoming a chief financial officer. Mardi describes how drug companies transition from an R&D focus to commercializing products, how to read IPO windows and manage expectations, pricing new drugs, and balancing commercial efforts with pipeline renewal and maintenance.

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Emerging From Stealth With Vima Therapeutics' Bernard Ravina, M.D.

Mon, 03 Nov 2025 06:00:00 -0500

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On this week's episode of the Business of Biotech, we're speaking with Bernard Ravina, M.D., CEO at Vima Therapeutics, a company that emerged from stealth in May with $60 million Series A financing to develop an oral candidate for dystonia, a movement disorder. Ravina talks about transitioning from government and academic medicine to industry, partnering with Atlas Ventures and defining the company's thesis, the reasons behind working in stealth mode and when to emerge, and the clinical plan and potential for VIM0423.

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BoB in South Florida: Rich Daly, Catalyst Pharmaceuticals

Mon, 27 Oct 2025 06:00:00 -0400

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On this week's episode — the last of our four-part series focused on South Florida — we catch up with Rich Daly, CEO at Catalyst Pharmaceuticals, a member of Life Science Leader's editorial advisory board and Miami-based location host for our in-person series. Rich talks about Catalyst's rare disease strategy built on operational excellence (including how to select a rare disease special pharmacy), his criteria for selecting de-risked, differentiated, and accretive products for rare diseases, partnering outside the U.S., and what new incentives Florida politicians could create to help South Florida grow even faster as a life sciences hub.

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BoB In South Florida: Anthony Japour, M.D., iTolerance

Mon, 20 Oct 2025 06:00:00 -0400

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On this week's episode of the Business of Biotech -- part three in a four part series recorded in-person at Catalyst Pharmaceuticals' Miami headquarters -- Anthony Japour, M.D., CEO at iTolerance, talks about his work as a physician treating infectious diseases, his CEO role in diagnostics at the height of the COVID-19 pandemic, what he learned working as a medical director at a large CRO, and iTolerance's work toward a cure for Type 1 diabetes that doesn't require chronic immunosuppression. Anthony also provides insights on overcoming CMC challenges and how to bypass avoidable detours, the funding climate for preclinical biotechs, and operating in South Florida.

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BoB In South Florida: Daniel Teper, NAYA Therapeutics

Mon, 13 Oct 2025 06:00:00 -0400

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In this week's episode of the Business of Biotech -- part two in a four-part series recorded in-person at Catalyst Pharmaceuticals' Miami headquarters -- we're speaking with Daniel Teper, an entrepreneur and most recently, founder and CEO at NAYA Therapeutics. Based in South Florida, NAYA is developing NK-engaging bifunctional antibodies and Astatine-211 radiopharmaceuticals targeting hepatocellular carcinoma. Daniel discusses the company's decentralized manufacturing strategy, the current funding climate for early-stage companies, his plan to conduct clinical trials in China, and what's unique about the South Florida life sciences ecosystem.

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BoB In South Florida: Raquel Cabo, Miami Biotech Collective

Mon, 06 Oct 2025 06:00:00 -0400

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The Business of Biotech is on location in Miami this week! For the first episode in this four-part series on the biotech scene in South Florida, Raquel Cabo, Founder and President of the Miami Biotech Collective, talks about her experiences as a member of the founding team at Ovid Therapeutics, why South Florida needed an organization to connect regional drug developers, what Miami offers to biotech companies and operators, and what gaps in the South Florida life sciences ecosystem still exist.

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The Business Case For Health Economics And Outcomes Research With ISPOR's Rob Abbott

Mon, 29 Sep 2025 06:00:00 -0400

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On this week's episode of the Business of Biotech, Rob Abbott, CEO of ISPOR, explains how startup and early-stage clinical drug development companies benefit from conducting health economics and outcomes research (HEOR), and not just with patients and commercial payers. HEOR, viewed as a strategic lever as opposed to a compliance exercise, can help answer investor questions about market differentiation, pricing pathways, and real world product validation. Abbott talks about the value of cost-of-illness studies, burden-of-disease analyses, and payer landscape assessments, and how AI, real world evidence, and patient-centered research can improve drug and trial design and accelerate market access.

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Cannabinoid And Psychedelic Combinations With Incannex Healthcare's Joel Latham

Mon, 22 Sep 2025 06:00:00 -0400

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On this week's episode, Joel Latham, President and CEO at Incannex Healthcare, talks about developing cannabinoid and psychedelic combination therapies for conditions as diverse as sleep apnea, rheumatoid arthritis, and generalized anxiety disorder. Joel walks through his funding strategy for the publicly-traded company, his desire to lead in a new category of medicine, and what comes next.

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Dye Drug Conjugates For Cancer With Lahjavida's Lyle Small

Mon, 15 Sep 2025 06:00:00 -0400

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On this week's episode, Lyle Small, Founder and CEO at Lahjavida, a dye drug conjugate start-up, talks about creating the famous color-changing technology that turned the mountains blue on cold Coors Light beer cans, to launching a dye-drug conjugate startup developing targeted cancer therapies. Small talks through Lahjavida's early preclinical work and the ongoing animal studies he hopes will secure an IND filing by 2027, his experience with scaling up manufacturing of new technologies, and his approach to leadership and company culture.

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Investing In The Biostack With Modi Ventures' Sahir Ali, Ph.D.

Mon, 08 Sep 2025 06:00:00 -0400

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On the Business of Biotech this week, Sahir Ali, Ph.D., founder and general partner at Modi Ventures, a family office investing at the intersection of technology and biology, talks about adapting the Markowitz model to improve returns and balance risk, his concept of the "biostack" for making direct investments into life sciences companies, and the revolutionary potential of scientific super intelligence. Ali explains why Houston, Texas is an underrated ecosystem for life sciences, and what AI will mean for medicine and the future of healthcare consumption.

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Improving Cardiovascular Outcomes With Immediate Therapeutics' Atul Deshpande, Ph.D.

Mon, 01 Sep 2025 06:00:00 -0400

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On this week's episode, Atul Deshpande, Ph.D., CEO at Immediate Therapeutics, talks about partnering with American cities to conduct clinical trials during ambulance rides to the hospital, with the goal of preserving heart function and reducing mortality related to acute cardiovascular events, including heart attacks. Deshpande reflects on his previous experience developing and commercializing Dupixent at Sanofi, describes the history and mechanism of Immediate's glucose-insulin-potassium (GIK) candidate, IMT-358, and explains why there is more to intellectual property than just patents.

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Building A Biotech Incubator And Accelerator With Swiss Rockets Founder And CEO Vladimir Cmiljanovic, Ph.D.

Mon, 25 Aug 2025 06:00:00 -0400

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On this week's episode, ex-handballer Vladimir Cmiljanovic, Ph.D., Founder and CEO at Swiss Rockets, talks about co-discovering bimiralisib with his sister Natasa Cmiljanovic, Ph.D. (and COO at Swiss Rockets), losing his company to a hostile takeover, buying the company back, and building out Swiss Rockets as an incubator with manufacturing capabilities and shared scientific expertise. Swiss Rockets' portfolio of companies is developing radioligand therapies, vaccines, and cancer treatments, including bimiralisib for actinic keratosis. Cmiljanovic also discusses U.S. expansion plans, partnering, and funding strategies for early-stage companies.

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Biotech Product Partnership with Coya Therapeutics' Arun Swaminathan, Ph.D. and Dr. Reddy's Milan Kalawadia

Mon, 18 Aug 2025 06:00:00 -0400

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On this week's episode, Milan Kalawadia, CEO, North America, Dr. Reddy's Laboratories, and Arun Swaminathan, Ph.D., CEO, Coya Therapeutics discuss their unique partnership to develop COYA 302, a novel dual-mechanism immunotherapy for the treatment of ALS. The partnership pairs Coya's scientific expertise with Dr. Reddy's manufacturing and commercialization capabilities, putting Coya in a financial position to advance development activities and commercialize COYA 302 upon FDA approval, and providing Dr. Reddy's -- a generics, biosimilars, API, and OTC manufacturer -- with an opportunity to pivot into innovative branded products. Kalawadia and Swaminathan discuss their pathways to the CEO role at each company, respectively, how the partnership came together, ongoing FDA engagement, and what COYA 302 could mean for patients with ALS.

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How To Hire And Build A Winning Executive Team With Occam Global's Bill Holodnak

Mon, 11 Aug 2025 06:00:00 -0400

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On this week's episode, Bill Holodnak, Cofounder and CEO of Occam Global, a life sciences executive recruitment firm (and occasional investor), shares insights from his decades of experience pairing executives with drug development companies, and talks about the psychology of successful biotech leadership. From building an advisory board to the sequencing of executive hires, such as CSOs, CMOs, CBOs, and CFOs, as a company grows, Holodnak offers specific tips to help founders and investors create leadership teams capable of winning the "slow motion roulette" business of biotech.

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The Generalist Biotech CEO With Seekyo's Oury Chetboun

Mon, 04 Aug 2025 06:00:00 -0400

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On this week's episode, Oury Chetboun, co-founder and CEO of Seekyo, a French biotech, talks about the range of experiences that prepared him to lead a company focused on developing innovative solid tumor treatments that target functional proteins in the tumor micro-environment. Chetboun talks about raising money for preclinical research and navigating the valley of death between research and clinical development, accessing French innovation funding and angel networks, how click chemistry can produce therapies at a lower cost compared to antibody-drug conjugates (ADCs), and the potential use of drug combinations and umbrella trials for testing multiple cancer indications.

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Innovating On The Frontier Of Radiopharmaceuticals With RadioMedix's Ebrahim Delpassand, M.D.

Mon, 28 Jul 2025 06:00:00 -0400

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On this week's episode, Ebrahim Delpassand, M.D., founder, CEO, and chairman of the board at RadioMedix talks about his personal journey standing up and growing a radiopharmaceutical company focused on oncology. Dr. Delpassand discusses the current trends in radiopharmaceutical drug development, the differences between alpha- and beta-emitting isotopes, overcoming manufacturing and supply chain challenges and restraints, and building strategic partnerships with companies like Curium, Fusion (now part of AstraZeneca), and Sanofi. He also offers specific advice to physician-entrepreneurs interested in building their own drug development companies.

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Building An Efficient Biopharma With South Rampart Pharma's Hernan Bazan, M.D.

Mon, 21 Jul 2025 06:00:00 -0400

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On this week's episode, Dr. Hernan Bazan, M.D., co-founder and CEO at New Orleans-based South Rampart Pharma, talks about building an ultra-lean drug development company to address an unmet need observed in his own patients as a surgeon: safe treatments for acute pain. Dr. Bazan explains his strategy for building value through small raises and no full-time salaried employees, co-founding the company with his father -- a scientist and director of the Neuroscience Center of Excellence at Louisiana State University Health Sciences Center -- and why the future of pain management will likely involve multimodal approached personalized to individual patients.

This episode of the Business of Biotech is brought to you by Ecolab.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Business And Science Of Obesity With Roger Cone, Ph.D., Founder Of Courage Therapeutics

Mon, 14 Jul 2025 06:00:00 -0400

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On this week's episode, Roger Cone, Ph.D., Founder and Chair of the Scientific Advisory Board at Courage Therapeutics, talks about discovering obesity-related protein receptors in the brain, how he spun his academic discoveries out into a biotech company developing new obesity drugs, the need for obesity treatments with fewer side effects than currently available GLP-1 therapies, and the value of pairing scientific leadership with a strong business partner as CEO.

This episode of the Business of Biotech is brought to you by Ecolab.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB Live At BIO: Amber Salzman, Ph.D., Epicrispr Biotechnologies

Mon, 07 Jul 2025 06:00:00 -0400

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This week's episode is one from the road, recorded in front of a live audience in Boston's Seaport neighborhood during the BIO conference (special thanks to MasterControl for making it happen). Amber Salzman, Ph.D., CEO of Epicrispr Biotechnologies (aka 'Epic Bio') explains how epigenetic editing is revolutionizing genetic medicine by controlling gene expression, without cutting DNA like traditional CRISPR technologies. Amber talks about FSHD, a progressive muscular dystrophy, how the company raised $68 million in Series B funding despite challenging market conditions, her partnership with Springbok Analytics for AI analysis of MRI images, working with a CDMO to manufacture a new treatment modality, and navigating the FDA during a time of disruption.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

How To Be A Policy Advocate For Biotech With NewYorkBIO's Jennifer Hawks Bland

Mon, 30 Jun 2025 06:00:00 -0400

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On this week's episode of the Business of Biotech, Jennifer Hawks Bland, CEO of NewYorkBIO, shares insights on New York State's life sciences ecosystem while reflecting on her journey from Capitol Hill to biotech advocacy. Her experiences in politics, law, and biopharma government affairs uniquely positions her to navigate complex policy challenges while creating opportunities for biotech upstarts across New York and beyond. Jennifer also highlights key programs, capabilities, and funding on offer to early-stage biotech companies.

This episode of the Business of Biotech is brought to you by Ecolab Life Sciences. Learn more at https://www.ecolab.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

FDA Trials And Tribulations With Connect Biopharma's Barry Quart

Mon, 23 Jun 2025 06:00:00 -0400

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On this week's episode, Barry Quart, CEO of Connect Biopharma, weighs in on the current state of engagement between drug developers and the FDA, and how that key relationship continues to evolve under new leadership. Barry also discusses moving the company from China to San Diego, why a U.S. financial reporting structure helps attract investors, and how Connect is finding the white spaces in respiratory disease -- the company's lead candidate is a biologic drug targeting acute asthma and COPD exacerbations.

This episode of the Business of Biotech is brought to you by Ecolab.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Proactive Procurement Strategies For Biotech With Tom Wells

Mon, 16 Jun 2025 06:00:00 -0400

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On this week's episode of the Business of Biotech, Tom Wells, Director of Life Sciences at 4C Associates, reveals why -- and how -- smart procurement practices can make or break emerging biotech companies during critical growth stages. Tom shares insights into procurement tools and strategies that can deliver breakthrough solutions, how poor procurement practices can damage investor confidence, and why thinking about procurement as the front end of demand flow, not the back end of supply chain, can help drug developers avoid costly mistakes.

This episode of the Business of Biotech is brought to you by Ecolab.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Discovery Of Microbes And Implications For Public Health Today, With Science Writer Thomas Levenson

Mon, 09 Jun 2025 06:00:00 -0400

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On this week's episode, Thomas Levenson, MIT professor and author of So Very Small: How Humans Discovered The Microcosmos, Defeated Germs — And May Still Lose The War Against Infectious Disease talks about what he learned in the writing of So Very Small, how cultural and political forces shape scientific progress, and what it means for drug developers, public health officials, and patients everywhere.

This episode of the Business of Biotech is brought to you by Avantor. For more information, visit avantorsciences.com

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Psychedelics For Mental Health Disorders With atai's Srinivas Rao, M.D., Ph.D.

Mon, 02 Jun 2025 06:00:00 -0400

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On this week's episode, Dr. Srinivas Rao, co-founder and CEO at atai Life Sciences, explains how his engineering background led him to the development of psychedelic compounds for treating depression, anxiety, and other mental health disorders. Internal drug development efforts at atai are focused on short-duration psychedelics that can work within existing healthcare infrastructure, with the potential to transform the treatment of mental health disorders. Rao also talks about atai's hub and spoke model for investing in other psychedelic companies, what MAPS/Lykos Therapeutics got wrong in the run-up to FDA's review of Lykos's MDMA candidate for PTSD, and whether psychedelic therapies need the "trip" to catalyze network disruption and neuroplasticity in the brain.

This episode of the Business of Biotech is brought to you by Avantor. For more information, visit avantorsciences.com

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech Angel Investing With Yaniv Sneor

Mon, 26 May 2025 06:00:00 -0400

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On this week's episode, Yaniv Sneor, founder of the Mid Atlantic Bio Angels and CEO at Native State Therapeutics, explains how life science angel investors evaluate biotech startups, and offers tips for young drug developers in search of funding. Our conversation covers how to create a successful pitch, red flags for potential investors, the importance of angel investing syndicates, the sweet spots for exit timelines and funding amounts, and why it still makes sense to invest in biotech over other industry sectors.

This episode of the Business of Biotech is brought to you by Avantor. For more information, visit avantorsciences.com

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Leading A tRNA Startup With Alltrna's Michelle Werner

Mon, 19 May 2025 06:00:00 -0400

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On this week's episode, Michelle Werner, CEO at Alltrna, talks transfer RNA (tRNA) therapy with host Ben Comer and guest co-host Anna Rose Welch, editorial and community director at Advancing RNA. Werner explains why a single engineered tRNA therapy has the potential to treat "hundreds, if not thousands," of rare genetic diseases, and how her own child's rare disease diagnosis shaped her career and approach to drug development. Werner also discusses Alltrna's use of AI and machine learning for drug optimization, the company's planned use of basket trials, and more.

This episode is brought to you by Avantor. For more information, visit avantorsciences.com

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Executing A Product Pivot With Vir Bio's Mark Eisner, MD

Mon, 12 May 2025 06:00:00 -0400

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On this week's episode of the Business of Biotech, Dr. Mark Eisner, EVP and Chief Medical Officer at Vir Bio, talks about the company's post-COVID pivot into infectious diseases (Hepatitis Delta and Hepatitis B) and oncology (solid tumors), how he reprioritized the company's development candidates and assimilated Sanofi's acquired T cell engager platform, and his own transition from healthcare provider to clinical research.

This episode is brought to you by Avantor. For more information, visit avantorsciences.com

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Commercializing RNAi Therapies With Alnylam's Tolga Tanguler

Mon, 05 May 2025 06:00:00 -0400

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On today's episode, Tolga Tanguler, EVP and Chief Commercial Officer at Alnylam Pharmaceuticals, talks about commercializing RNAi therapies, how they fit into health insurance reimbursement systems, the company's use of value-based contracts, and building therapeutic franchise "skyscrapers." Tangular also shares his thoughts on commercializing RNAi therapies for larger patient populations, compared with rare disease populations, and reflects on changes in the biopharmaceutical sales and promotion model.

This episode is brought to you by Avantor. For more information, visit avantorsciences.com

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Big Pharma Insights For Building Biotech Startups With Uniquity Bio's Brian Lortie

Mon, 28 Apr 2025 06:00:00 -0400

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On today's episode I'm speaking with Brian Lortie, President and CEO of Uniquity Bio, about his "no jerk" policy and how his experience building teams at GSK, Endo Pharmaceuticals, and Onspira Therapeutics informs his leadership at Uniquity, a clinical-stage immunology startup backed by Blackstone Life Sciences. Lortie also walks through the formation and launch of Uniquity and provides detail on the company's business model and strategy.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Implications Of China's Growing Biotech Industry With Allan Shaw

Mon, 21 Apr 2025 06:00:00 -0400

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Business of Biotech MVP Allan Shaw is back to talk about the rise of China's biotech sector, and its evolution from fast follower to global innovation powerhouse. Increased deal activity with Chinese biopharmaceutical companies is injecting new risk into traditional development models in the West, despite an uncertain policy environment in the U.S. vis-à-vis China. Will faster trial starts, cheaper asset upfronts, and a growing talent base slingshot Shanghai's biotech hub into an innovation destination on par with Boston and San Francisco?

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

How To Be A CFO With Insmed's Sara Bonstein

Mon, 14 Apr 2025 06:00:00 -0400

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On today's episode we're speaking with Sara Bonstein, Chief Financial Officer at Insmed, about what it takes to be a successful CFO. Sara provides useful insights on how to lead teams, especially when those teams have deeper subject matter expertise. Other topics discussed include when to make at-risk investments ahead of clinical data, how to balance commercial growth with pipeline investment, the importance of financial planning during early product development stages, and how to manage expectations with a potential blockbuster product in the pipeline.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Deal And Investment Trends With Investment Banker David Sans

Mon, 07 Apr 2025 06:00:00 -0400

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Today we're talking life sciences investment trends and risks with David Sans, an investment banker with an academic background in chemical engineering and molecular modeling, and a professional background that began in Big Pharma and shifted to investing over 15 years ago. Our conversation covers patent cliff implications, hot therapeutic areas and delivery mechanisms, geopolitical risks, alternative funding strategies, and private equity's move upstream to pre-clinical and pre-revenue biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Business of Biotech 2.0 with Ben Comer

Mon, 31 Mar 2025 06:00:00 -0400

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After nearly five years as host of the Business of Biotech podcast, Matt Pillar is handing the mic over to the voice of the Business of Biotech 2.0, veteran life sciences journalist Ben Comer. On this epsiode, Ben shares his nearly 20-year journey covering the pharmaceutical space, from Haymarket Media to PwC to Pharmaceutical Executive and InVivo magazines, before joining Life Science Connect as Chief Editor at Life Science Leader. He shares stories of the wild ride he's enjoyed along the way, how the stories he's covered have shaped his editorial perspective, and his plans for the next chapter of the Business of Biotech podcast.

Catch Ben's first episode as host next Monday, and every Monday after that. Subscribe to the podcast on your preferred platform and watch the videocast at lifescienceleader.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Nima Farzan, Latigo Biotherapeutics

Mon, 24 Mar 2025 06:00:00 -0400

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In this final installment of our episodes recorded and filmed on-site at the JP Morgan Healthcare Conference, Nima Farzan, CEO of Latigo Biotherapeutics, shares his company's mission to change the pain management paradigm by way of novel, non-opioid medications that target NAV 1.8 sodium channels involved in pain signal transmission. It's a timely and important conversation that explores how these selective inhibitors could provide effective pain relief without the addiction risks and side effects of traditional opioids. In addition to the social and medical implications of Latigo's work, we discuss investor perceptions about pain management as a commercial opportunity and how Latigo is differentiating from traditional approaches by focusing on safety and tolerability rather than just efficacy

The 2025 BoB@JPM series is supported by Alston & Bird, whose national health care and life sciences practice has more than 100 attorneys actively involved and integrated across the full spectrum of legal disciplines including regulatory, compliance, public policy, transactional, corporate governance, securities, FDA, biotechnology, intellectual property, government investigations, and litigation practice areas. Learn more at www.alston.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Kasper Roet, Ph.D., QurAlis

Mon, 17 Mar 2025 06:00:00 -0400

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Dr. Kasper Roet's hands-on work at the Dutch Brain Bank informed his leadership at the biotech QurAlis, where three clinical programs targeting specific genetic mechanisms in ALS are now underway. On this episode of the Business of Biotech, Life Science Leader's Ben Comer joins to co-host a conversation with Dr. Roet that goes deep on his company's genetic medicine approach to ALS, and even deeper into his opinions on, and growing influence over, the regulatory environment. Roet says that as the FDA's conservative approach to genetic medicines has pushed clinical trials overseas, he's been inspired to form and lead a consortium of 11-and-growing biotechs seeking regulatory reform through organized meetings and lobbying efforts. Join us for this latest of our BoB@JPM series from San Francisco.

The 2025 BoB@JPM series is supported by Alston & Bird, whose national health care and life sciences practice has more than 100 attorneys actively involved and integrated across the full spectrum of legal disciplines including regulatory, compliance, public policy, transactional, corporate governance, securities, FDA, biotechnology, intellectual property, government investigations, and litigation practice areas. Learn more at www.alston.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Rick Modi, Affinia Therapeutics

Mon, 10 Mar 2025 06:00:00 -0400

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The latest in our series of Business of Biotech podcasts recorded in-person at JPM in San Francisco features an inspiring conversation with Affinia Therapeutics CEO Rick Modi. Modi shares on how his upbringing in Kenya shaped his adversity-embracing worldview, and how that worldview contributes to his biotech leadership. We cover his transition from pharmaceutical work in Iowa to a career in biotech, the gene therapy advances Affinia is building on, the company's investment approach, its upcoming clinical trials, and much more.

The 2025 BoB@JPM series is supported by Alston & Bird, whose national health care and life sciences practice has more than 100 attorneys actively involved and integrated across the full spectrum of legal disciplines including regulatory, compliance, public policy, transactional, corporate governance, securities, FDA, biotechnology, intellectual property, government investigations, and litigation practice areas. Learn more at www.alston.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Owen Hughes & Brad Sitko, XOMA Royalty

Mon, 03 Mar 2025 06:00:00 -0500

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On this episode of the Business of Biotech, recorded on-site at the 2025 JP Morgan Healthcare Conference, we explore a new approach to biotech financing with XOMA Royalty's Owen Hughes and Brad Sitko. The CEO and CIO, respectively, share an innovative royalty aggregation model that mitigates risk while enabling immediate capital access to biotech firms. We learn the differences between royalty financing and equity-based funding, how the model addresses traditional risk in biotech financing, the evolution of XOMA's business model, and much more.

The 2025 BoB@JPM series is supported by Alston & Bird, whose national health care and life sciences practice has more than 100 attorneys actively involved and integrated across the full spectrum of legal disciplines including regulatory, compliance, public policy, transactional, corporate governance, securities, FDA, biotechnology, intellectual property, government investigations, and litigation practice areas. Learn more at www.alston.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Tom Chalberg, Ph.D., Genascence

Mon, 24 Feb 2025 06:00:00 -0500

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Recorded in-person at the JP Morgan Healthcare Conference in San Franscisco, this episode finds Matt Pillar and Ben Comer exploring the evolution of gene therapy with Dr. Tom Chalberg, Founder, Chairman, & CEO at Genascence. We discuss ATMPS' transition from treating rare diseases to addressing common conditions like osteoarthritis, share insights on the delivery mechanism and regulatory challenges in the space, and get into the nuts and bolts of the Genascence partnership strategy.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Ran Zheng, Landmark Bio

Mon, 17 Feb 2025 06:00:00 -0500

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Ran Zhang was hire number one at Landmark Bio back in 2021. Today, she's CEO of the 70+ employee cell and gene therapy manufacturer. We caught up with her and Life Science Leader chief editor Ben Comer at the JP Morgan Healthcare Conference in San Francisco for a discussion on Landmark's role in addressing the ATMP patient access and cost reduction challenges. Along the way, we cover innovations in distributed manufacturing, non-viral gene delivery, and the importance of collaboration with academia to make these transformative therapies widely available.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Peter Anastasiou, Capsida Biotherapeutics

Mon, 10 Feb 2025 06:00:00 -0500

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From the JP Morgan Healthcare Conference in San Francisco, Peter Anastasiou, CEO of Capsida Biotherapeutics, discusses his journey from big pharma to biotech and the challenges he's faces on the leading edge of first-gneration gene therapies. Anastasiou discusses the in-house manufacturing quality advantage, how building that capacity opened the door to important partnering opportunities, the company's preparation for clinical trials and IND submissions, and more. From mastering in-house manufacturing to forging strategic partnerships, Capsida aims to redefine genetic medicine.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Stefan Scherer, M.D., Ph.D., 3T Bioscience

Mon, 03 Feb 2025 06:00:00 -0500

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From the JP Morgan Healthcare Conference in San Francisco, Dr. Stefan Scherer shares insight from 3T Bioscience's transition from clinical medicine to drug development, and his experiences in biotech leadership along the way. Dr. Scherer discusses the balance between promising advances in T-cell therapy and the challenges associated with navigating a biotech from platform development to lead candidate status -- including staffing up for and funding the journey. Don't miss this episode, recorded in-person in San Francisco.

The 2025 BoB@JPM series is supported by Aslton & Bird, whose national health care and life sciences practice has more than 100 attorneys actively involved and integrated across the full spectrum of legal disciplines including regulatory, compliance, public policy, transactional, corporate governance, securities, FDA, biotechnology, intellectual property, government investigations, and litigation practice areas. Learn more at www.alston.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Business Of CNS with Acumen's Jim Doherty, Ph.D.

Mon, 27 Jan 2025 06:00:00 -0500

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Life Science Leader's Ben Comer and Acumen Pharmaceuticals' Dr. Jim Doherty join the Business of Biotech to discuss Dr. Doherty's lifelong, singular focus on researching therapeis for CNS diseases. We cover the historical challenges associated with the development of new therapeutics for Alzheimer’s disease, advances in the space, the controversies that have ensued on the heels of recent amlyloid-targeting drug approvals, and where Acumen Pharmaceuticals and its lead candidate, Sabirnetug, fit on the landscape. We also cover the critical and growing role of biomarkers in matching Alzheimer's therapies to specific patients, and assess the growing demand for CNS therapeutics.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

High-Throughput Discovery With Bioptic's Andrey Dobry

Mon, 20 Jan 2025 06:00:00 -0500

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Andrey Doronichev, known to many simply as Dobry, is perhaps best known for taking YouTube mobile. You heard that right. If it weren't for him and the teams he led, YouTube might still be a desktop experience. He went on to lead product strategy at Google before launching the startup Optic in 2022. What's that got to do with biotech, you ask? Well, it's Optic where he feels his greatest contributions are to come, and his sights are set squarely on disrupting the way we discover therapeutic targets. On this episode of the Business of Biotech, Dobry, Life Science Leader Chief Editor Ben Comer, and I explore the intersection of AI and biotech, discuss Bioptic's beginnings and its approach to leveraging advanced screening technologies for drug discovery, and address Bioptic's biggest challenges -- data access and industry skepticism.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

RNA Sandbox with Johns Hopkins RNA Innovation Center's Jeff Coller, Ph.D. and Michelle Kim, Ph.D.

Mon, 13 Jan 2025 06:00:00 -0500

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In close partnership woth Johns Hopkins and TriLink BioTechnologies, Jeff Coller, Ph.D. and Michelle Kim, Ph.D. have built a sandbox for RNA developers and aspirational RNA business builders to play in. On this week's episode of the Business of Biotech, we team up once again with Advancing RNA's Anna Rose Welch to learn about the venture, dubbed the Johns Hopkins University RNA Innovation Center. Anna Rose and I query Drs. Coller and Kim on how the Center came to be, what it has to offer, and how early-stage RNA explorers can benefit from the resource.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech Story Time With Tal Zaks, M.D. (Part 2, Tall Tales with Tal)

Mon, 06 Jan 2025 06:00:00 -0500

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Dr. Tal Zaks is back, along with Advancing RNA's Anna Rose Welch, for part 2 of "Story Time With Tal." On this week's episode, we turn from his time navigating medical affairs as CMO at Moderna during the COVID 19 pandemic to learn about his latest venture, an mRNA startup called Exsilio Therapeutics. We cover the foundational aspects of the company's start, from the science it's developing, who's been recruited to the team, and how Exsilio charted its way to an $82 million Series A co-led by Novartis Venture Fund and Delos Capital, with participation from OrbiMed, Insight Partners, J.P. Morgan Life Sciences Private Capital, CRISPR Therapeutics, Innovation Endeavors, Invus, Arc Ventures, and Deep Insight.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Risk Mitigation With Meira GTx's Zandy Forbes, Ph.D.

Mon, 30 Dec 2024 09:00:00 -0500

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Zandy Forbes, Ph.D. learned about business risk mitigation in the riskiest of business environments. She was a public markets healthcare investor on Wall Street for well more than a decade. Her hedge fund experience followed the Human Frontiers/Howard Hughes postdoctoral fellowship at the Skirball Institute of Biomolecular Medicine at NYU Langone Medical Center that was preceded by an Oxford Ph.D. in Molecular Genetics. Since 2015, she's been drawing from her immersion in both the business and science disciplines as President & CEO at Meira GTx. On this episode of the Business of Biotech, Dr. Forbes and I go into deep analysis mode as we examine the risks she's taken in her current role, and how she applies her experiences – both good and bad – with handling other people's money to building a biotech company.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech Story Time With Tal Zaks, M.D. (Part 1)

Mon, 23 Dec 2024 06:00:00 -0500

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Tal Zaks, M.D. was Chief Medical Officer at Moderna before, during, and immediately following the company's headline role during the COVID pandemic. If that doesn't pique your interest about the stories he can tell, this episode of the Business of Biotech surely will. Tal is now leading a new mRNA-centric startup called Exsilio Therapeutics, which Advancing RNA's Anna Rose Welch and I dig into in part two of our talk with Tal, slated for release in early January. Yep, Story Time With Tal is so good, we doubled up the episodes with him. Tune in for insight from the early days of mRNA that you probably haven't heard before, and stay for a glimpse of its future role in therapeutics at Exsilio with one of the foremost thinkers in the space.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

A $1B AI Bet With Foresite Labs' Vik Bajaj, Ph.D.

Mon, 16 Dec 2024 06:00:00 -0500

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This past spring, Xaira Therapeutics launched with $1 billion in backing, a who's-who mashup of Silicon Valley and biopharma stars led by Marc Tessier-Lavigne in the C-suite, and a mission to develop AI-generated drugs. On this week's episode of the Business of Biotech, we're digging into the company's origin story and its place on the greater techbio landscape with one of the men bearing responsibility for Xaira's launch. Vik Bajaj is Managing Director at Foresite Capital Management (which led Xaira's funding) and Cofounder and CEO at Foresite Labs (which helped incubate it, along with ARCH Venture Partners). He takes us behind the scenes, and shares his worldview on the role of advanced computing technology in drug development.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Manufacturing Partnership With Life Biosciences' Jerry McLaughlin and Forge Biologics' John Maslowski

Mon, 09 Dec 2024 06:00:00 -0500

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On this week's episode of the Business of Biotech, Jerry McLaughlin, CEO and President at Life Biosciences returns for a visit, and he brought a friend in John Maslowski, newly-appointed CEO at Forge Biologics. We revisit progress at Life Biosciences, followed by a deep look into the gears that make the company's contract development and manufacturing relationship with Forge Biologics go. From CDMO selection to contracting and execution, the episode is packed with actionable insight into building a foundation for collaborative success in advanced biologic therapy development.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Novel Peptide Delivery With Revolo's Woody Bryan, Ph.D.

Mon, 02 Dec 2024 06:00:00 -0500

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Revolo Biotherapeutics President and CEO Woody Bryan, Ph.D. is pushing the boundaries of peptide therapeutic delivery. On this episode of the Business of Biotech, we dig into Dr. Bryan’s transition to the CEO chair at the company and how that coincided with an aggressive strategic decision to alter the course of administration of its peptide candidates in allergic and autoimmune diseases. That decision didn’t come lightly and its execution wasn’t easy, but it was an important one for the future of the business. Tune in as Dr. Bryan tells us why they did it, how they did it, and the foundation that decision laid for the company’s growth.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biopolitics With Allan Shaw

Mon, 25 Nov 2024 06:00:00 -0500

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The notion that political influence has no place in biology appears poised for a test it hasn’t studied for. Trump administration nominations, from RFK, Jr. to HHS and Vivek Ramaswamy to the newly-proposed DOGE, are driving a storm of speculation over the implications for biotech and other life sciences industries. Throw in the increased probability of the Biosecure Act seeing the light of legislation day under a republican congress, and there’s no shortage of biopolitical pontificating to be done. How might this all play out, and how should biotech builders be obviating? On this episode of the Business of Biotech, we’re joined for some reflection by none other than Allan Shaw.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

T-Cells For The Win With Adaptimmune's Adrian Rawcliffe

Mon, 18 Nov 2024 06:00:00 -0500

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In August of this year, the first TCR cell therapy to be approved for use in the U.S. was greenlighted by the FDA for patients with unresectable or metastatic synovial sarcoma who have previously received chemotherapy. It marked the first new treatment for those patients in more than a decade; a win for those patients, and a win for Adrian Rawcliffe, who’s had a hand on the wheel at Adaptimmune, the therapy’s developer and manufacturer, since he joined the company as CFO in 2015. Today, Rawcliffe is CEO there, and on this episode of the Business of Biotech, we’re going to get to know him, why he’s all-in on cell therapies, and how he’s applying a solid track record in finance and business development to make good on the promise they offer.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Serving The Underserved With Gates MRI's Claire Wagner, M.D.

Mon, 11 Nov 2024 06:00:00 -0500

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On this episode of the Business of Biotech, Bill and Melinda Gates Medical Research Institute's (Gates MRI) Dr. Claire Wagner joins us to share insights into her work as head of Corporate Strategy and Market Access there. She shares the development of her North Star while working with the incomparable Dr. Paul Farmer in Rwanda, and how that experience translates to the growth of a biopharmaceutical company taking big swings for grossly underserved populations. We discuss the nuances assoiated with setting strategy and enabling product access in a unique not-for-profit setting, and how, perhaps counterintutively, the Institute's work fits synergistically into an ultra-competitive for-profit biopharma landscape.

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An Unanticipated Biotech Startup With OS Therapies' Paul Romness

Mon, 04 Nov 2024 06:00:00 -0500

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Becoming a biotech CEO wasn't on Paul Romness' bingo card. He'd forged his place in the biopharma industry as a foremost public and policy affairs expert. Thirteen years at J&J, more than 5 at Amgen, and half a dozen at Boehringer Ingelheim had earned him the right to coast into a consulting gig that would enable him to finish out his career on his terms.

Then his daughter's best friend Olivia, a teenage girl and neighbor he'd watched grow up, was diagnosed with osteosarcoma.

The ensuing journey, now in its seventh year, put Romness in the position of CEO and Chair of OS Therapies. It's a company formed through a combination of circumstance, determination, and ingenuity that's now shepherding its HER2 and tunable ADC therapeutics through mid-late-stage clinical trials. On this episode of the Business of Biotech, we dig into the building blocks of an unanticipated biotech startup. We'll learn how Romness leaned into his personal and professional communities to build a company that's now addressing unmet patient need in osteosarcoma and cancers of the breast, esophagus, lung, and pancreas. And we'll get an update on Olivia, who's now in med school at Columbia University and serving on the OS Therapies Board of Directors.

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Building On Pandemic Progress With Barinthus Biotherapeutics' Bill Enright

Mon, 28 Oct 2024 06:00:00 -0400

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It might just be coincidence, but it sure seems like Bill Enright has a knack for making big moves at inopportune times, then turning the expected outcome on its ear. For example, he signed on as CEO at Altimmune when the company was struggling mightily. Enright had a turnaround plan in hand, but as he was in the thick of a non-deal road show to execute said plan, Lehmen Brothers collapsed. On this episode of the Business of Biotech, we'll learn in great detail how Altimmune escaped that death knell. Later, he joined his current company, Barinthus Biotherapeutics, mere months before the Covid pandemic. That was shaky for a hot minute, but it turned out fortuitous when, against his better judgment, he enabled a pivot that became foundational to the company's go-forward plan. We'll learn how he flipped the script on that crisis, too. Tune in for these, and other harrowing tales from the trenches.

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Obesity Tx End-Around With Skye Bioscience's Punit Dhillon

Mon, 21 Oct 2024 06:00:00 -0400

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While the trend toward CB1 inhibition for obesity took a small hit with the release of Novo Nordisk's small molecule oral cannabinoid receptor (CB1) inverse agonist monlunabant last month, Skye Bioscience Chairman and CEO Punit Dhillon is shaking it off. He's confident that his company's antibody-based approach to CB1 inhibition will make a moot point of the neuropsychiatric side effects that put a damper on Novo's data. On this episode of the Business of Biotech, we're digging into the uber-hot business of weight loss therapeutics and going deep with Dhillon on why Skye's blood/brain barrier-obeying antibody might turn the GLP-1 and small molecule approaches to obesity on their ears. Over the course of the conversation, we explore the ins-and-outs of the business of metabolic health, a space that's churning out one blockbuster after another.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech C-Suite Construction With Allan Shaw

Mon, 14 Oct 2024 06:00:00 -0400

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Allan Shaw is back with us this week to dig into the complexities of strategic hiring in biotech. We cover strategies for the step-wise assembly of effective executive teams, the importance of aligning key hires with clinical and regulatory milestones, managing salaries in line with cash runways, the pros and cons of fractional/consultative leadership, when it's time to turn fractional into full-time, and a whole-lot more. If you're growing a biotech in these volatile times, this episode of the Business of Biotech offers veteran insight you won't want to miss.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Peptide Promise With NervGen's Mike Kelly

Mon, 07 Oct 2024 06:00:00 -0400

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Mike Kelly faced a self-reckoning before he took the job as CEO at NervGen, a company developing peptide therapeutics targeted specifically at central nervous system repair. The veteran of life sciences business development knew the ropes of the biotech C-suite. He’d been a CEO twice before. He knew how to launch drugs, having seen commercial success several times before. He even knew how to sell them—he’d started his career carrying the bag for TAP Pharmaceuticals. But all he knew about peptides was that they were challenging to manufacture consistently and purify. And he knew that manufacturing is where a lot of biopharma companies fall down. On this episode of the Business of Biotech, we learn how Kelly reconciled that truth, and how NervGen is now leading the way for peptide therapeutics in spinal cord injury and beyond.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech Course Correction With Treehill Partners' Ali Pashazadeh

Mon, 30 Sep 2024 06:00:00 -0400

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It wouldn't be accurate to say that surgeon-turned-healthcare investment banker and consultant Dr. Ali Pashazadeh traded his scalpels for spreadsheets. In fact, he still wields a scalpel quite frequently, and on this episode of the Business of Biotech podcast, he offers a fantastic reason why. Yes, it's a bit of a departure from our normal routine of biotech founders occupying the guest chair. But, Pashazadeh's no-holds-barred reflections on and analysis of biotech breaking points, drawn from more than 2 decades of troubleshooting broken bipharmaceutical businesses and correcting courses, makes for some great programming. Whether you're a biotech builder in the throes of disruption, or feeling lucky that you've been threading scientific, clinical, capital, and regulatory needles all along, this episode offers a ton of insight from the unwritten textbooks on the business of biotech.

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An AI Awakening With Profluent Bio's Hilary Eaton, Ph.D.

Mon, 23 Sep 2024 06:00:00 -0400

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Hilary Eaton, Ph.D. was a self-described AI skeptic, particularly as it relates to using the tool in drug discovery. Then, a series of professional and deeply personal life events and medical discoveries put her in a position to confront that skepticism head-on. Today, she's Chief Business Officer at ProFluent Bio, a company that's committed to democratizing access to open-source AI gene editing tools that are custom-built for pharmaceutical development. On this episode of the Business of Biotech, Dr. Eaton shares her story and makes a pragmatic case for the transformative value of AI to biotech builders. Whether your bullish or bearish about the intersction of advanced therapeutic development and artificial intelligence, this one's a must-listen.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Picking Biotech Jockeys With SR One's Simeon George, M.D.

Mon, 16 Sep 2024 06:00:00 -0400

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SR One Capital Management CEO Simeon George, M.D. has a seemingly innate ability to pick winning biotech builders. Early on, he and his firm got behind CRISPR's Samarth Kulkarni, Ph.D., Arcellx' Rami Elghandour, and Nkarta's Paul Hastings, for example. With nearly 50 biotech leaders in SR One's portfolio, there are plenty more where those three came from. On this episode of the Business of Biotech, Dr. George, admits that despite his gifted brain he more readily follows his heart. Still, over the course of our conversation, he shares insight into the decision making processes that have contributed to his success at picking winners as an investment banker and biotech venture capitalist.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Embracing Biotech Chaos With Memo's Erik van den Berg

Mon, 09 Sep 2024 06:00:00 -0400

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Erik van den Berg is CEO and board member at Memo Therapeutics, and he's a student of biotech chaos. In fact, he's been embracing it with intention for the past 30 years. On this episode of the Business of Biotech, he walks us through the management of that chaos in specific detail. Navigating gluttonous Covid-fueled financial markets. Achieving clinical outcomes during the pandemic. Keeping development on the rails in a protracted financial drought. Creating differentiation in crowded and noisy renal and oncology antibody therapeutic spaces. We cover it all, with van den Berg offering detailed insight into the guiding principles of navigating constant change in biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Pivoting To RNA With Circio's Dr. Erik Digman Wiklund

Mon, 02 Sep 2024 06:00:00 -0400

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This week, it’s another “Business of Biotech-meets-Business-of-RNA” takeover with Circio CEO Erik Digman Wiklund, Ph.D. and guest co-host Anna Rose Welch of Advancing RNA. While Circio’s legacy is in cancer immunology (it still boasts a cancer vaccine candidate targeting KRAS driver mutations), the company made a bold pivot, of sorts, when it committed headlong to the circular RNA future. Now, it’s in the throes of fine-tuning a platform for the development of novel circRNA medicines for rare disease, vaccines, and cancer. On this episode of the Business of Biotech, we go deep inside the story behind the pivot, we explore the RNA therapeutic platform-versus-product appetite among biotech investors, and Dr. Digman Wiklund shares insights into the challenges his company overcame to enable such a dramatic shift in focus.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

mRNA Upstarts With Radar Therapeutics' Sophia Lugo and Eerik Kaseniit, Ph.D.

Mon, 26 Aug 2024 06:00:00 -0400

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Guest co-host Anna Rose Welch of Advancing RNA fame joins us on this week’s Business of Biotech podcast for a conversation with the leaders of RNA upstart Radar Therapeutics. The company’s co-founders, Eerik Kaseniit, Ph.D. (CSO & President) and Sophia Lugo (CEO), are making waves in the mRNA therapeutics space on the heels of the invention of a precision-expressed mRNA technology that laid bare the path to Radar’s inception. On this episode, we dig into that science, why it’s timely, and how it fits into today’s mRNA therapeutics landscape. We also go deep on how Kaseniit and Lugo went about navigating the complexities of biotech formation, leaning into their networks andbuilding up a team—and each other—along the way. Their work is paying off, as the fast-growing company is attracting gobs of investor and big bio attention. For more on the technology Radar is bringing to bear, read Kaseniit and Lugo’s recent byline at Cell & Gene.

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Steering Through Setbacks with AVEO Oncology's Michael Bailey

Mon, 19 Aug 2024 06:00:00 -0400

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For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone—Androderm, Augmentin, necitumumab, and Erbitux among them—Michael Bailey concedes that he's likely better known for his failures. After hearing his stories on this episode of the Business of Biotech, I tend to disagree. While he offers a transparent and instructive look at the failures themselves, I'd contend it's what he's done with those setbacks that defines his biopharma and biotech leadership legacy. Today, Bailey is CEO at Aveo Oncology, a company that saw its own set of challenges during the clinical development of now-commercial FOTIVDA (tivozanib) and ficlatuzumab. Tune in for Bailey's straight-shooting insight on how to turn biotech setbacks on their ear.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Leading From Within with ISCT & Kiji's Miguel Forte, M.D.

Mon, 12 Aug 2024 06:00:00 -0400

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He's been a big pharma executive. He's a multi-time biotech founder and current biotech CEO. He was once a regulator. He's a physician. He serves on multiple boards. And as of this summer, he's president of one of the most influential global organizations dedicated to the advance of cell and gene therapies (ISCT), and an executive member of another (ARM). Miguel Forte, M.D. simply can't stop finding places to apply his talents and energy to influence the advanced therapies landscape. The experiences he's amassed give him a unique perspective on the industry's path forward, how to navigate the regulatory gauntlet, the role of industry associations and alliances in a biotech's succes, balancing the demands of multi-point leadership, changing the ATMP accesibility paradigm, and more. On this episode of the Business of Biotech, Dr. Forte shares generously on all of it.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Allogeneic Future with Poseida's Kristin Yarema, Ph.D.

Mon, 05 Aug 2024 06:00:00 -0400

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Kristin Yarema, Ph.D. thinks the progress of CAR T therapeutics is allogeneic. In fact, she says CAR T-cell therapies have to become a one-to-many proposition, if their early autologous success can possibly live up to the promise of offering widespread accessibility to life-saving treatments. Dr. Yarema is the newly-appointed CEO at Poseida Therapeutics, a company we first covered with founding CEO Eric Ostertag, Ph.D. On this episode of the Business of Biotech, we'll learn about Dr. Yarema, how she earned the company's reins, how Poseida is positioning itself to crack the allogeneic CAR T code, and how strategic collaborations with the likes of Astellas and Roche are fueling the effort.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Expanding The Proteome with ProFound's John Lepore, M.D.

Mon, 29 Jul 2024 06:00:00 -0400

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Flagship Pioneering’s ProFound Therapeutics is on to something, and it could be something big. It began with a simple question: What if more RNAs were being translated into proteins? Answering that question took ProFound deep into the translatome, where it’s now studying the full compendium of RNA sequences that are being translated into proteins. Along the way, the young company is gaining confidence that its research will reveal important insight into potential therapeutic protein targets and medicines. On this episode of the Business of Biotech, ProFound CEO and Flagship Pioneering CEO-Partner John Lepore, M.D. shares the company’s journey—and his—as a physician scientist-turned-founder.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

From The Bench To The Boardroom with ImmunityBio's Enrique Diloné

Mon, 22 Jul 2024 06:00:00 -0400

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While organic chemistry lectures caused many of his peers at NYU to wring their hands, gnash their teeth, and question life choices, then-19-year-old Enrique Diloné ate those classes for lunch. They inspired him to earn a Seton Hall Ph.D. in chemistry, and to go to work as a big bio research scientist. Along the way, Dr. Diloné got bit by the biotech business bug. It wasn’t easy. A whole bunch of MBA and executive learning programs at Rutgers, MIT, and Harvard, and many years of experience later, he’s Chief Technology Officer at Immunity Bio, which he joined in advance of the company winning FDA approval of ANKTIVA, its IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer, in April '24. On this episode of the Business of Biotech, we follow Dr. Diloné’s path from the bench to the boardroom, and learn how valuable that rare bridge between CMC and the executive offices really is.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

First AI Antibody In Humans with Aulos' Aron Knickerbocker

Mon, 15 Jul 2024 06:00:00 -0400

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Data drives decision-making at Aulos Bioscience. It's also driven the career trajectory of its CEO. On this week's episode of the Business of Biotech podcast, we get an introspective walk through Aron Kinickerbocker's strategically-orchestrated career path, from his early days in the labs at Bristol-Myers Squibb and Genentech to his leadership of Aulos Bioscience, a company that boasts the first AI-generated antibody in human clinical trials. We explore Aulos' innovative IL-2 antibody and the role AI played in its highly-targeted and toxicity-reducing design, and we do it in pragmatic fashion — Aron's not about the AI hype, he's about the AI data — and in its Phase 1/2 clinical trial, the data is looking pretty good.

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Drug Delivery Differentiators with Syncromune's Eamonn Hobbs

Mon, 08 Jul 2024 06:00:00 -0400

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Syncromune's Sync-T solid tumor therapeutic platform is, in a word, complex. The company's three phase 1 programs combine T-cell science with a proprietary drug delivery device to target solid tumors, specifically metastatic breast, non-small-cell lung, and castrate-resistant prostate cancers. But, while orchestrating a successful drug/device combination therapy presents unique regulatory challenges and requires a diverse array of in-house skillsets, President and CEO Eamon Hobbs is confident. He's done this before, and Syncromune's lead candidate has just been fast-tracked by the FDA. On this episode of the Business of Biotech, Hobbs shares his perspectives on bringing novel drug/device combination therapies to market, and reflects on a career dedicated to the drug delivery craft and demonstrated by his leadership at Antares Pharma, Delcath Systems, AngioDynamics.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Topical Ocular Biologics with Claris Bio's Clarke Atwell

Mon, 01 Jul 2024 06:00:00 -0400

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Built on the back of hepatocyte growth factor discoveries by Harvard Drs. Reza Dana and Sunil Chauhan, ClarisBio is rewriting the ophthalmology rulebook. CEO Clark Atwell acknowledges that it's not the first to bring topically-administered biologic therapies to the front of the eye, but if successful in the clinic, its Neurotrophic Keratitis candidate will vastly improve the patient experience. It will also prove unequivocally that there's biotech business value in front-of-the-eye therapeutics, as opposed to just parenterally-administered back-of-the-eye biologics. On this episode of the Business of Biotech podcast, Atwell shares the stories of his career focus on the cornea, Claris' founding and funding progress, and why there's big, multi-indication opportunity for the company's novel HGF therapeutics in corneal diseases.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

C&G Regulatory Guidance with Lineage Therapeutics' Brian Culley

Mon, 24 Jun 2024 06:00:00 -0400

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When we last caught up with Brian Culley, CEO at Lineage Cell Therapeutics, it was January, 2021. A pandemic was raging. His company was moving mountains to keep its OpRegen dry AMD clinical trial together, and did so despite lockdowns that kept a largely aged patient population from setting foot anywhere near a healthcare clinic. Lineage emerged stronger, signing a collaboration and license agreement with Roche and Genentech later that year. In May of this year, it doubled down on the commitment with a new services agreement with Genentech to support the OpRegen program. All this, while simultaneously progressing its OPC1 spinal cord injury program into Phase 2 and laying the clinical groundwork for programs in hearing loss, vision loss, and neurologic indications. On his long-overdue return to the Business of Biotech, Culley opens up on how the company addressed struggling programs, wrestled manufacturing control issues and delivery inefficiencies in its spinal cord program to the ground, and maintained control of its regulatory progress along the way.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

True DEI Value in Biopharma with Arcellx's Rami Elghandour

Mon, 17 Jun 2024 06:00:00 -0400

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The cell therapy company Arcellx has, by any and every measure, been outperforming its peers. Its stock has rallied on the back of the strong performance of its multiple myeloma candidate, and the promise of its AML, MDS, and solid tumor pipelines is attracting the kind of interest it takes to be in it for the long run. Asked about his company’s rapid rise since taking the helm in 2021, CEO Rami Elghandour cites a few critical and risky decisions, the execution of some specific people on his all-star team, and a relentless commitment to diversity, equity, and inclusion. Before you skepticize, let me assure you: the man brings receipts.

As we head into Juneteenth celebrations, and as pride month comes to a crescendo, we’re all seeing plenty of companies putting a DEI foot forward. Much of this is hollow noise. It’s diversity-washing, the DEI equivalent to greenwashing, whereby organizations misrepresent their environmental practices to create the perception of a commitment to sustainability. Arcellx, and Rami Elghandour, are not that. On this episode of the Business of Biotech, Rami shares vivid lessons from the rise of Arcellx and gets specific on how his steadfast commitment to diversity has fueled its takeoff.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Mission-Driven Dementia Funding with DDF's Jonathan Behr

Mon, 10 Jun 2024 06:00:00 -0400

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If there's anyone qualified to analyze an early-stage therapeutic technology and place bets with other people's money, it's scientist-turned-venture capitalist Jonathan Behr, Ph.D. He built a distinguished venture capital career on the back of an MIT Ph.D. in biological engineering, having co-founded no fewer than 7 life sciences companies, served on or observed the boards of at least 17, and led investments at Pure Tech Ventures, the JDRF T1D Fund, SV Health investors, and now, the Dementia Discovery Fund, where he's a partner. Drawing from all that experience, this episode of the Business of Biotech delivers a trove of knowledge on biotech corporate finance and entrepreneurship, as well as the interplay between business strategy and influences like regulatory and scientific trends. We focus on the spirited neurodegenerative space, where case studies in investment and regulatory success and missteps abound. Tune in here and subscribe wherever you listen to podcasts!

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

ADCs Ignited with Daiichi Sankyo Inc.'s Ken Keller

Mon, 03 Jun 2024 06:00:00 -0400

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Just a few years ago, Daiichi Sankyo wasn't considered a player in the oncology therapeutics space, and it certainly wasn't a player in ADCs. But then, just a few years ago, who was? Fast forward to 2023, and we see an ADC arena that drove nearly $100 billion in M&A, licensing, and partnership deals, and a Daiichi Sankyo that can rightfully lay claim to lighting that fire. In fact, it was our guest on this episode of the Business of Biotech, Ken Keller, Chairman of the Board, President, and CEO at Daiichi Sankyo, Inc. who made the bold move to jump headlong into oncology armed with ADCs that, at the time, weren't exactly the darling of biotech. On this episode, Ken shares the story of his climb from "carrying the bag" all the way to the Big Biotech C-Suite, how and why Daiichi Sankyo pivoted from its roots in cardiovascular therapeutics into Oncology and ADCs, his reflections on the antibody-drug conjugate market, and a whole lot more.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Accelerating ADCs with Mythic Therapeutics' Brian Fiske, Ph.D.

Mon, 27 May 2024 06:00:00 -0400

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Mythic Therapeutics Chief Scientific Officer and co-founder Brian Fiske, Ph.D. broke some unwritten protocol with his rapid and multifaceted transition from academia to industry. He calls his many, and sometimes concurrent, early experiences as an MIT Ph.D. student, a Flagship Ventures Fellow, a Bain consultant, a hospital researcher, and a biopharma consultant indiciative of a young man who didn't want to make decisions. In retrospect, it looks more like the perfect preparatory mix for a guy who's leading a company with a unique approach to a white-hot ADC (antibody-drug conjugate) therapeutics market. On this epsiode of the Business of Biotech, get to know Brian as we peel back the layers to expose what's fueling the rapid rise of Mythic's ADC candidate in non-small cell lung cancer.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Anti-CDMO with CTMC's Jason Bock, Ph.D. and KSQ's Thomas Leitch

Mon, 20 May 2024 06:00:00 -0400

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This isn't your typical drug sponsor + CDMO story. In fact, CTMC's Jason Bock, Ph.D. says you shouldn't even classify his company a CDMO. He's not wrong. While some of the company's services aren't dissimilar from those offered by a contract developer, CTMC began with a more fundamental mission in mind -- to help early clinical-stage companies like KSQ Therapeutics prepare for and enter their clinical stage on the best possible footing, and with the best possible clinical partner in the MD Anderson Cancer Center. On this episode of the Business of Biotech, KSQ's Thomas Leitch and Dr. Bock join us to share the story of CTMC's evolution, KSQ's partnership need as it advanced its lead phase 1 TIL therapy for solid tumors, how the partnership unfolded and who's on the hook for what as KSQ begins its clinical journey.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

A New Prescription For PBMs with Allan Shaw

Mon, 13 May 2024 06:00:00 -0400

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Back by popular demand, biopharma industry opinionator extraordinaire Allan Shaw rejoins the Business of Biotech to expose the murky role Pharmacy Benefit Managers (PBMs) play in the last, costly mile of the drug distribution supply chain. Allan pulls no punches in his criticism of the current rebate structure and shares why the model leaves patients and manufacturers stuck with the spiraling tab. He also explains why an election year, all-time lows in public perception of the pharmaceutical industry, and inflation might create the perfect storm for real change. More than a gripe session, Allan offers up advice for biotech leaders entering the fray, shares his own ideas for systemic reform that would reward patients, not PBMs, and waxes on what, and who, it might take to change the broken paradigm.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

New Apps For AI in mRNA With Anima Biotech's Yochi Slonim

Mon, 06 May 2024 06:00:00 -0400

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From San Francisco’s Silicon Valley to Tel Aviv’s Silicon Wadi, software business entrepreneur Yochi Slonim made a name for himself in global tech hubs around the globe. Notably, he was co-founder of billion-dollar Mercury Interactive, which HP acquired for $4.5 billion, and previous to that a leader at Tecnomatix, which sold to UGS and was acquired by Siemens. Those big deals that came on the heels of several other Yochi Slonim software startups. But Slonim's not in software development anymore. Not for the software industry, anyway. He's now leveraging his tech chops to develop something with far more potential impact: drugs. On this epsiode of the Business of Biotech, we'll learn about his foray into biopharmaceuticals with Anima Biotech, a company he’s been building for the past ten years and which boasts pipeline partnerships with heavyweights Abbvie, Takeda, and Lilly.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Circular RNA with Orna Therapeutics' Tom Barnes, Ph.D. and Advancing RNA's Anna Rose Welch

Mon, 29 Apr 2024 06:00:00 -0400

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As if Orna Therapeutics' CEO Thomas Barnes, CEO isn't a enough to draw you in to the Business of Biotech, we teamed up with Advancing RNA Editorial & Community Director Anna Rose Welch to co-host this week's episode. Together, Anna Rose and I press Dr. Barnes on his transition from academia to biotech, the therapeutic proposition of circular, or "O" RNA and why it holds great potential to best linear RNA constructs, the novel, platform- and partnership-based approaches Orna is taking to address B-cell lymphomas and Duchenne Muscular Dystrophy, viral vector and lipid nanoparticle complexity, and a whole lot more.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Physician + Biotech Builder with Tome Biosciences' Rahul Kakkar, M.D.

Mon, 22 Apr 2024 06:00:00 -0400

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Novel technologies aren’t interesting to Rahul Kakkar, M.D. unless they help patients. Sounds rational, but it’s actually a unique perspective in a platform-crazed biotech industry. Dr. Kakkar’s worldview is shaped by his work as a physician—work he continues at Brigham and Women’s Hospital even as he builds Tome Biosciences, where he serves as President & CEO. Tome, which is developing programmable genomic integration technology, is the latest of Dr. Kakkar’s entrepreneurial efforts—he previously led Pandion Therapeutics to a $1.85B acquisition by Merck and Cordivia to a $2.1B acquisition by Novo Nordisk. On this episode of the Business of Biotech, Dr. Kakkar shares why he took on the brainchild of two MIT scientists under his wing, the nascent inflection point for gene editing therapy, how his work as a physician informs his biotech leadership, biopharma’s bad rap, and a whole lot more.

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Commercial Readiness with ImmunityBio's Bobby Reddy, M.D.

Mon, 15 Apr 2024 06:00:00 -0400

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This episode of the Business of Biotech begins with a personal story about my dad and the standard of care in bladder cancer, before shifting to the work that Dr. Bobby Reddy and his team at ImmunityBio are doing to change that standard of care. They're painfully close. Dr. Reddy, Chief Medical Officer at ImmunityBio, gives us a long look behind the curtain at the commercial preparations the company is making as its lead Phase 3 candidate, Anktiva, nears the goal line in non-muscle invasive bladder cancer (NMIBC). From grassroots engagement with physicians and urologists to making a global press to share clinical results, Dr. Reddy offers plenty of insight into biopharma commercial readiness, and good reason to hope for nearly a million NMIBC patients in the U.S. alone.

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Precision Drug Delivery with Ampersand Biomedicines' Jason Gardner, D.Phil.

Mon, 08 Apr 2024 06:00:00 -0400

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Ampersand Biomedicines CEO Jason Gardner, D.Phil. first took the leap from a global pharmaceutical giant to a startup at the forefront of transplant medicine innovation. Since that time, he's seen most of the ups and the downs that come with biotech leadership, and in his latest venture with the Flagship Pioneering-backed Ampersand, he's putting all those hard-fought lessons to good use. On this episode of the Business of Biotech -- the final (finally!) of several recorded at the JPM Healthcare Conference in January -- Gardner shares how and why he's applying his experience to the buildout of a precision medicine platform company, his thoughts on how big data and AI are influencing the precision medicine space and putting the "tech" in "techbio," his company's acquisition strategy, most recently demonstrated by Ampersand's acquisition of AbCheck, why "paranoid optimism" is central to his company's culture, and much, much more.

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Funding Alzheimer's Tx Dev with ADDF's Karen Harris

Mon, 01 Apr 2024 06:00:00 -0400

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We've really been looking forward to dropping this episode with Karen Harris, Chief Financial Officer and Head of Mission-Related Investing at the Alzheimer's Drug Discovery Foundation. While the markets have warmed a bit since we recorded this episode, Karen's thoughtful perspective on the sometimes tumultuous Alzheimer's therapeutics space is valuable to any drug developer working in the cognitive medicines arena. In this episode of the Business of Biotech podcast, we follow Karen's journey from institutional investment banking to the incredibly gratifying work she does now, helping to fund the novel biopharma companies that are working in earnest to solve an emotionally burdensome and expensive problem. Karen shares ADDF's strategy and offers plenty of insight into the value proposition that venture philathropy offers the biotech community. Tune in!

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The AI Impact with Generate:Biomedicines' Mike Nally

Mon, 25 Mar 2024 06:00:00 -0400

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Few drug discovery and development concepts are as hyped, and as such, draw as much polarity from drug developers, as machine learning and artifical intelligence. One company on the bullish end of the spectrum is Flagship Pioneering's Generate Biomedicines, which bills itself at the "intersection of machine learning, biological engineering, and medicine." To get a grip on the "generative biology" work it's doing and the AI/ML impact it anticipates in the discovery and development of therapeutics, as well as clinical trials, we sat down with veteran biotech builder Mike Nally, CEO at Generate and CEO-Partner at Flagship Pioneering.

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Strategic Deals with CinRx's Gavin Samuels, M.D.

Mon, 18 Mar 2024 06:00:00 -0400

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Gavin Samuels, M.D. found his work as an intensive care physician boring. After earning his M.D., he did that for a few years before moving into intensive care management roles. It wasn't until he left the hospital and entered biopharma that he found his footing, cutting his teeth in business development at places like Merck, Pfizer, Quark Pharma, and Teva. He even headed growth strategy at Lonza for a while. Now, he's Chief Business Officer and General Partner at CinRx Pharma, where a deep pipeline of early- to late-stage candidates keeps him on his dealmaking toes. Within minutes of our conversation, Dr. Sameuls' introspective reflections on biotech dealmaking and negotiations planted this episode firmly on the Business of Biotech podcast highlight reel.

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Serial Success With Triumvira's Rob Williamson

Mon, 11 Mar 2024 08:00:00 -0400

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Rob Williamson's mind and hands have shaped more than 20 biotech startups, leading some to IPO and landing others firmly in Big Bio through acquisition by companies like Merck. Hanging around as many successful exits as Williamson has seen, one might become expert via osmosis. But Williamson isn't passive about honing his vision for progressive therapeutic dealmaking. He's an active leader, and for this episode of the Business of Biotech, he took a breather from a hectic agenda at the J.P. Morgan Healthcare Conference to share some introspection on the work he's done, the work he's doing at Triumvira with T-cell therapeutics in oncology, the big opportunities in cancer therapeutics, and what's coming next.

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The Innovator's Dilemma with Lumen Bioscience's Brian Finrow, J.D.

Mon, 04 Mar 2024 06:00:00 -0500

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In biotech, when "one of these things doesn't look like the other one," it can be a blessing or a curse. On one hand, scientific novelty is praised and rewarded. On the other, unfamiliarity breeds skepticism from the investment community. Brian Finrow, J.D. embraces that reality and the challenges that come with it. Despite an approach to developing antibodies and other biologics that looks decidedly different--they're developed from spirulina cell lines and, in some cases, designed for oral administration (gasp!)--Lumen Biosciences has won hard-fought funding from some nontraditional sources to continue its mission to democratize biologics. Finrow is Co-Founder & CEO at Lumen, and now a two-time guest of the Business of Biotech. He's a Harvard J.D., but don't hold that against him. He's one of the most approachable and transparent founders we've enjoyed the pleasure of hosting, and he didn't disappoint when we sat down for this talk in San Francisco.

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Precision Radiopharmaceuticals with Ratio's Jack Hoppin, Ph.D.

Mon, 26 Feb 2024 06:00:00 -0500

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Multimodal approaches to the delivery of radiologically active compounds have created a fertile environment to for players in the space to put on a precision medicine clinic, so to speak. What’s more, Radiopharmaceuticals create a unique business opportunity given the closely-related and necessary companion diagnostic arena. On today’s episode of the Business of Biotech, recorded in San Francisco, we sit down with Dr. Mark Hoppin, CEO of Ratio Therapeutics, a company that’s well-positioned in the space with a fresh Series B and the foundation of a tunable radiotherapeutic that Dr. Hoppin says addresses the delivery, safety and efficacy challenges long associated with radiopharmaceuticals in the treatment of solid cancers. We also discuss how this mathemetician-turned biotech CEO has navigated the leadership of boards, employees, and investors on his journey.

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Managing Mergers With Sail Biomedicines' Guillaume Pfefer, Ph.D.

Mon, 19 Feb 2024 06:00:00 -0500

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While you might be aware that Sail Biomedicines was just formed up in Q4 of last year, the product of Flagship Pioneering’s decision to merge Senda Biosciences and Laronde, two of its programmable medicine platform companies. What you likely haven’t heard is the inside story on how the merger was executed, how the two companies are integrating their talent, IP, and resources, and what Sail Biomedicines CEO Dr. Guillaume Pfefer and team are currently doing to take the fruits of the company’s platform into the clinic. On this episode of the Business of Biotech, Dr. Pfefer takes us under the hood of Sail Biomedicines and its mission to marry evolution and AI to develop programmable medicines based on eRNA.

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Reprogramming Human Cells With bit.bio's Mark Kotter, M.D.

Mon, 12 Feb 2024 06:00:00 -0500

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The concept of programmable biology is fueling a new breed of biotech, one that requires the marriage of computational and traditional science (and both computational and traditional scientists) on the entire journey from discovery to commercial. Bit.bio is exemplary of this new breed. Its CEO, Dr. Mark Kotter doesn’t pull any punches when addressing the complexity involved in building out the company’s capabilities. At the discovery stage alone, bit.bio has hired – and integrated – stem cell biologists, synthetic biologists, genetic engineering experts, cellular biologists, sequencing experts, data scientists, bioinformatics pros, and machine learning experts.
On this episode of the Business of Biotech, recorded in San Francisco during JPM Week, we catch up with Dr. Kotter on the work bit.bio is doing, how it’s doing it, and how he and his leadership team are recruiting and retaining a new breed of biotech talent to sustain the effort. Let’s give it a listen.

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Inhalable mRNA with Ethris' Carsten Rudolph, Ph.D.

Mon, 05 Feb 2024 06:00:00 -0500

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Without doubt, the grand and collaborative experiment that was the mRNA COVID vaccine contributed mightily to the pandemic response and continues to save lives untold. It also demonstrated the collective power of public/private partnership in biopharma. Having acknowledged that, no first iteration of a new technology is ever the best iteration of that technology. On this week's episode of the Business of Biotech, we welcome Carsten Rudolph, Ph.D., co-founder and CEO of a company that recognizes this room for improvement. Ethris is developing mRNA-based candidates for the treatment of respiratory viral infections and rare pulmonary diseases, in addition to mucosal, multivalent, and mutation-agnostic prophylactic vaccines. Dr. Rudolph explains the concept, the business case, and how he's navigating Ethris toward a better treatment and vaccine paradigm in the wake of the pandemic.

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Biotech Is Back with Allan Shaw

Mon, 29 Jan 2024 06:00:00 -0500

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The Business of Biotech took a trip to San Francisco for the JP Morgan Healthcare Conference, that most target-richest of environments for those of us who like talking shop with biotech builders. The results of that trip will feed the next several weeks of Business of Biotech podcast programming, and we're kicking things off with everyone's favorite life sciences CFO, Allan Shaw. On this episode, Allan shares what's driving the cautious optimism for biotech's return, pointing to factors like December's flurry of M&A activity, interest rate reductions, and easing inflation as just cause for the bullish sentiment that was palpable at the conference. We also discuss what could shift the tailwinds, namely the election year wildcard, and why biotech could benefit from a metered comeback. Come for the facts, stay for the Shawisms!

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Multimodal R&D Management with Incyte's Jim Lee, M.D., Ph.D.

Mon, 22 Jan 2024 06:00:00 -0500

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Success at multimodal, multi-indication, deep-pipelined Incyte—where commercial operations are as familiar as pre-discovery activity is—begins at the earliest opportunity to achieve research and discovery efficiencies. The company’s a bit larger than those we typically cover on the Business of Biotech, and that’s okay! Sometimes, the smartest approach to creating your own masterpiece is to study the masters On this episode of the podcast, we sit down with Incyte’s Group Vice President and head of its Inflammation and AutoImmunity Group, Jim Lee, M.D., Ph.D. for a dissection of the company’s approach to the comprehensive and efficient R&D that leads to repeated clinical and commercial success.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Building A Biotech Hub with Intellia Therapeutics' John Leonard, M.D.

Mon, 15 Jan 2024 06:00:00 -0500

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We spend a lot of time talking with our guests about building biotech companies. That’s true of this episode too, but today we’re taking a step further with John Leonard, M.D., longtime CEO at Intellia Therapeutics. In addition to how he’s built late-clinical stage Intellia, Dr. Leonard shares the foundational elements of a biotech community, particularly around rapidly-advancing technologies such as CRISPR, and what biotech ecosystems offer emerging biotechs in terms of resources, intellectual property, and support. Turns out that despite his proximity, Boston isn’t the prerequisite it used to be. This is an instructive conversation with an industry vet who’s happy to share the wealth of his knowledge.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Art Of The Pivot with Elevation Oncology's Joe Ferra

Mon, 08 Jan 2024 06:00:00 -0500

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Relatively new CEO Joseph Ferra has orchestrated some pretty significant change at Elevation Oncology in the two(ish) years since the Business of Biotech last hosted the company. In that short time, Ferra advance from CFO to CEO, a move that aligned very closely with the company's difficult decision to shelve the late phase 2 anti-HER3 monoclonal antibody candidate it was founded on. Those big moves set the stage for Elevations' new lead candidate, a phase 1 Claudin18.2 target in the oh-so-hot ADC (antibody drug conjugate) space. On this episode of the Business of Biotech, we go behind the scenes to learn why and how those daring moves were made, and how Elevation navigated the gauntlet of risk it assumed when it embraced disruption in a not-so-shiny biotech market.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

CDMO Collab with Scorpius BioManufacturing's Steve Lavezoli + Fina Biosolutions' Dr. Andrew Lees

Mon, 01 Jan 2024 06:00:00 -0500

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A new year marks a fresh start for biotech partnerships, and to kick off 2024, we're highlighting a good one. Fina Biosolutions' Dr. Andrew Lees recently signed on with Scorpius BioManufacturing to support his company's growth plan. On today's episode of the Business of Biotech, Lees sits down with Scorpius VP of commercial operations Steve Lavezoli for a frank conversation on the ups, downs, and expectations of a biotech + CDMO relationship. In addition to contracts and master service agreements, the pair walk us through the day-to-day execution of the partnership and responsibilities of those involved in it. If you're considering signing on with an outsourced manufacturing partner, or thinking about making a switch, you won't want to miss this episode.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech Down Under with BiomeBank's Dr. Sam Costello

Mon, 25 Dec 2023 06:00:00 -0500

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Merry Christmas, Business of Biotechers! On this Christmas Day release, we’re taking a trip to the land down under to visit with Dr. Sam Costello, a former gastroenterologist-turned managing director and co-founder at Adelaide, Australia-based BiomeBank. We covered some ground on this one, most notably the unique path BiomeBank took to chalking up the first donor-derived microbiome therapeutic approval of its kind, anywhere in the world. In a segment of biotech that’s been particularly battered of late, that’s a big, big win. We also talked about what’s behind Australia’s foray onto the global biotech scene, the public/private partnerships supporting that growth, why U.S. biotechs, in particular, are flocking there to conduct clinical trials, and whether Foster’s is really Australian for beer. Don’t miss it!

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IL-2 Program Profits with Bonum's Drs. John Mulligan and Neela Patel

Mon, 18 Dec 2023 06:00:00 -0500

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On this week's episode of the Business of Biotech, we welcome two extraordinary guests - Dr. Neela Patel, a molecular biologist-turned-Chief Business Officer, and Dr. John Mulligan, an academic-turned-founder of newly-formed Bonum Therapeutics. Together, Neela and John will pull back the curtain on Bonum's transition from its predecessor, Good Therapeutics, which was fueled by a high-profile asset sale to Roche. The asset, a PD-1-regulated IL-2 program, was a product of a platform that the new Bonum retains, and its sale to Roche was orchestrated by Dr. Patel. You've seen the terms of the deal in the news, but on this episode, you'll get the inside scoop on how the deal was done, how it set Bonum up for future paltform-driven succes, and how these two leaders retained its IP and its people through a fast, unique, and disruptive acquisition.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Public Sector Forged, Private Sector Tested with Renovaro BioSciences' Mark Dybul, M.D.

Mon, 11 Dec 2023 06:00:00 -0500

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During his leadership of the President's Emergency Plan for AIDS Relief during the George W. Bush administraion, Dr. Mark Dybul, M.D. shepherded programs credited with saving more than 25 million lives. For many years after that public service drew to a close, he continued the mission as executive director of The Global Fund to Fight AIDS, Tuberculosis and Malaria--working in lockstep with not only the world's leading scientists, but the likes of Bono and Sir Elton John along the way.
But, it wasn't all glamor and heroics. Dybul had to influence some decidedly conservative global political machines of the importance of addressing the AIDS epidemic, particularly, at the time, in Africa. He had to fight through federal and global beuracracies for every dime of funding earned. His leadership required resolve in the face of complexity and adversity.
Nothing could have better prepared him for biotech leadership, which has dealt Dr. Dybul an unfair share of unique adversity that's, quite frankly, the stuff of a Dateline NBC episode. On this epsiode of the Business of Biotech podcast, Dybul, CEO at Renovaro Biosciences, gets introspective on leadership forged in the fires of public service and battle-tested in the private sector.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

mRNA Vaccine Platforms with Combined Therapeutics' Dr. Romain Micol

Mon, 04 Dec 2023 06:00:00 -0500

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Combined Therapeutics President & CEO Dr. Romain Micol is operating his company in a very noisy space, where hundreds of new biotechs have popped up on the coattails of a COVID-driven renewal of interest in mRNA vaccines. Micol recognizes that noise and the competition it brings for capital and mindshare. He's not only aware of it — he welcomes it. On this quick episode of the Business of Biotech podcast, Micol shares the unique approach Combined Tx is taking to distinguishing itself in the mRNA infectious disease and cancer vaccine space, from the delivery, safety, efficay, and business perspectives.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech Dealmaking with Regeneron's Nouhad Husseini

Mon, 27 Nov 2023 06:00:00 -0500

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When it comes to landing and executing strategic partnerships, Regeneron puts on a clinic. Partnerships, acquisitions, licensing agreements, and other deals large and small with Intellia, Decibel Therapeutics, BARDA, Alnylam, and Sonoma Therapeutics are just a sampling of those making news this year alone. The man behind much of that dealmaking is none other than Nouhad Husseini, SVP and Head of Business Development and Corporate Strategy at Regeneron. He’s a guy who’s deftly married the art and science of biopharma dealmaking, and on this episode of the Business of Biotech podcast, we’re getting introspective with this legend in the making, who our friend Allan Shaw says “turns the deals he touches into gold.” Strategic dealmaking is central to the biotech business, and today’s episode offers a master class.

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Backpacks And Biotech with Luke Timmerman

Mon, 20 Nov 2023 06:00:00 -0500

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From his vantage point as an independent biotech journalist, Luke Timmerman has been watching the expansions and retractions of the industry for a couple of decades now. His unique perspective is hard to equal, and that perspective is, despite tough markets and tepid public sentiment, decidedly bullish. Luke's optimism is fed by sound logic gained from a career spent in observation mode, watching the development of purpose-built tools matched to address the fragility of human biology.
Luke's tireless advocacy for the industry also stretches well beyond his professional coverage and punditry. Through his Timmerman Traverse initiative, he's figured out a way to weave his personal and professional passions into a tapestery that serves some of the philanthropic initiatives our industry cares about most. On this episode of the Business of Biotech, we'll get to know Luke personally, we'll learn about his philanthropic work, and we'll give you a healthy dose of optimism as we look ahead to the next decade in biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

RNA Delivery Business with Liberate's Shawn Davis, Ph.D. & Walter Strapps, Ph.D.

Mon, 13 Nov 2023 06:00:00 -0500

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Earlier this year, Shawn Davis, Ph.D. left a pretty comfortable position at AstraZeneca (and Amgen before that, and Milliken, and others, before that) to lead Liberate Bio. He brought along another industry notable in Merck/Intellia alumnus Walter Strapps, Ph.D., who serves as CSO at Liberate. Why'd they do it? Because RNA delivery is such a crucial step toward revolutionary genetic medicine, but it's tough science. They think they can change that. On this episode of the Business of Biotech, Drs. Davis and Strapps share how they're applying automation and machine learning technologies to minimize the challenges associated with targeted delivery of genetic medicine and overcome the limitations of AAV. During our conversation, they both leaned hard into how their previous experiences have shaped the work they're doing, and the wide-open business opportunities Liberate Bio is creating.

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The Legendary Steve Gorlin's Golden Rules

Mon, 06 Nov 2023 06:00:00 -0500

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Shortly after Thalidomide became a household word—albeit a very, very bad one—a biotech investor bought it for a couple hundred grand. Who on earth would want a drug pulled from the market for causing birth defects? Steve Gorlin did.

Today, Thalidomide is the foundation of cancer drugs worth billions of dollars. Gorlin doesnt own it anymore, but the story of how he got it is just one of the experiences that contributed to the codification of his "golden rules." Following those rules has paid off. SIx of the companies he's founded acieved valuations, or sold, for more than $1 billion each. This week, the Business of Biotech sits down with the legendary biotech investor Steve Gorlin, now CEO of CoRegen, for a conversation on his golden rules for picking winners.

Gear up for an action-packed, LIVE, and INTERACTIVE Business of Biotech as we delve into the nitty-gritty of IP and legal considerations crucial for budding biotech entities. Get your queries resolved straight from a seasoned professional, minus the lawyer's fees! YOU HAVE TO REGISTER FOR THIS ONE (no cost), so head to tinyurl.com/boblive23, or secure your spot for Business of Biotech Live! Legal & IP Protection For New Biotechs here. Join us on Monday, November 13th, at 11 am Eastern. You don't want to miss this!

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UPCOMING SPECIAL: Unraveling Biotech's Legal Enigmas With Keir LoIacono

Wed, 01 Nov 2023 06:00:00 -0400

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Register for Business of Biotech Live! Legal & IP Protection For New Biotechs here. Get ready to unravel the legal enigmas of the biotech world with me and Keir LoIacono, Esq. The CEO of Blue Sphere Bio, Keir is no stranger to high-stakes decision-making and legal conundrums in the biotech industry. Having served as the general counsel and VP of Corporate Development for Oncosec, lead in-house counsel and senior director for Advaxis, and intellectual property attorney at the leading biotech law firm Lerner, David, Littenberg, Krumholz, and Mentlick, Keir is a powerhouse of knowledge ready to share his insights.

Gear up for an action-packed, LIVE, and INTERACTIVE Business of Biotech as we delve into the nitty-gritty of IP and legal considerations crucial for budding biotech entities. Get your queries resolved straight from a seasoned professional, minus the lawyer's fees! YOU HAVE TO REGISTER FOR THIS ONE (no cost), so head to tinyurl.com/boblive23, or secure your spot for Business of Biotech Live! Legal & IP Protection For New Biotechs here. Join us on Monday, November 13th, at 11 am Eastern. You don't want to miss this!

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

CDMO + Emerging Bio Partnership with Forge's John Maslowski and Ray's Jenny Holt

Mon, 30 Oct 2023 06:00:00 -0400

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What constitutes a healthy, productive, and successful relationship between an emerging biopharma company and its contract develpment and manufacturing outsourcer (CDMO)? Jenny Holt, Chief Development Officer at the biopharma company Ray Therapeutics has some opinions. So does John Maslowski, Chief Commercial Officer at the CDMO Forge Biologics. Think they align?
On this episode of the Business of Biotech, we dig into the trust, technical expertise, and project timeline considerations that required of a successful partnership. We also broach the risks associated with emerging CDMOs, the right balance among cost, quality, and time, what you should ask when evaluating outsourcing partners, and a whole lot more.

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Clinical Leadership with Cue Biopharma's Anish Suri, Ph.D. & Dan Passeri, J.D.

Mon, 23 Oct 2023 06:00:00 -0400

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On a road trip to Boston, the Business of Biotech caught up with podcast alum Dan Passeri, J.D., CEO at Cue Biopharma, and enjoyed a two-for-one with CSO & President Anish Suri, Ph.D. at Cue's headquarters just feet below the Auerbach Center. Among other things, we discussed the duo's complementary leadership approach as the company takes multiple candidates into the clinic, why Passeri leans into his biotech legal background almost every day he's at work, the successful navigation of outsourced manufacturing relationships, why Cue's discretely targeted IL-2 approach eliminates the absurdity of early IL-2 failures, and a whole lot more.

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Bio Career Moves with Codagenix's Johanna Kaufmann, Ph.D.

Mon, 16 Oct 2023 06:00:00 -0400

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Johanna Kaufmann, Ph.D.'s path to EVP, Oncology at Codagenix is part serendipity and part circumstance, but it's a much larger part hard work. On this week's episode of the Business of Biotech, Dr. Kaufmann gives us an intimate retrospective on her career to date, sharing stories about her rapid ascension from Scientist 1 to executive leadership. We dig into her wild ride through M&A, her time at GSK, and the personal professional and personal development regimens she subscribes to. We also catch up on the important work Codagenix is doing in the live vaccines and viral therapeutics arena.

***REGISTER for the first-ever, interactive Business of Biotech Live! Legal & IP Protection For New Biotechs here! https://event.on24.com/wcc/r/4376909/58114AA2A39F50879AE1B6F0CD1F5B11

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Veteran Advice From The C-Suite with Citius' Leonard Mazur

Mon, 09 Oct 2023 06:00:00 -0400

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On this episode of the Business of Biotech, Leonard Mazur, co-founder, CEO, and chairman of Citius Pharmaceuticals, shares his rollercoaster ride to success in biotech, the founding story of Citius Pharmaceuticals, his engagement with the Department of Defense, and the effort to revive an antibiotic used on the frontlines.

Leonard takes us into the complexity of investor relationships, and his personal investment that influences his leadership style. He reveals his strategies for constructing a successful biotech pipeline, underscoring the importance of a unique mechanism of action and the hurdles of resurrecting a retired product. Get ready for an intimate look at Leonard's decision-making process, and his insights into managing the financial aspects of a bio-pharma company.

As we wrap up, Leonard offers an honest look at the evolution of the biotech industry, the financial challenges faced, and his advice on navigating these turbulent waters. He brings his experience with auction processes and drug hunting to light, preparing us for unexpected hiccups in the biotech world. Leonard also credits mentorship in shaping his approach to constructing a clinical pipeline. Join us for this inspiring exploration of resilience, determination, and success in the biotech industry.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Don't Be A D**k with Ochre Bio's Quin Wills, M.D., Ph.D.

Mon, 02 Oct 2023 06:00:00 -0400

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Don't be offended by the title of today's Business of Biotech podcast. Dr. Quin Wills' application of what's become known as "Wheaton's Law" (look it up) is central to the ambitious goals his company, Ochre Bio, is pursuing: pioneering the value of computational biology in large mol discovery and development, putting an end to the global liver disease epidemic, and changing the costly, high-risk approach to clinical trials. On this week's episode, Dr. Wills and I explore how those goals are being addressed despite the challenges they present, and how the company's three guiding principles, don't be a d*** being one of them, align the Ochre team with the mission at hand.

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Pragmatic Computational Biology with Andrew Satz

Mon, 25 Sep 2023 06:00:00 -0400

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This week's guest on the Business of Biotech, EVQLV's Andrew Satz, says AI and ML in biopharma are like sex in high school. "Many of the people who say they're doing it really aren't, and the one who really are aren't talking about it," he says. So, when it comes to the computational biology buzz, what’s real? What’s hype? What’s yielding benefit and what’s merely vaporware? In our talks with the leaders of new and emerging biotechs over the past 12 to 18 months, we've seen a steep increase in the application of – or at the very least, interest in – machine learning, AI, and computational biology tools for drug discovery, development, and beyond. Even those who are using some "ultra-light" application of new computational technology are eager to talk about it, as it’s clearly become as en-vogue as tacking “bio” onto your moniker was a few years back – even among companies who aren’t actually developing biologics. On this episode, Satz offers his take on the reality of adoption and shares advice on the fundamentals of AI and ML in biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Commercial Readiness with Orca Bio's Dan Kirby

Mon, 18 Sep 2023 06:00:00 -0400

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Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing. He "carried the bag" for GSK in his early days, directed oncology marketing efforts at Amgen, and led marketing and U.S. commercial efforts at Juno, then Celgene after it acquired the former. Kirby joined Orca Bio in timely fashion back in 2020, as today the company ushers its first cell therapy into phase 3 clinical trials, with strategically-dispersed follow-up candidates spanning all phases back to R&D. On this week's episode of the Business of Biotech, we get a one-on-one commercialization preparation discussion with one of the best in the business, and the straight-talking veteran doesn't disappoint in the strategy and insight departments.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Bio & The Business Of Aging with Life Biosciences' Jerry McLaughlin

Mon, 11 Sep 2023 06:00:00 -0400

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Core to the clinical-stage biopharma Life Bisociences belief set is that, "contrary to popular belief, aging is not caused by random wear and tear, but instead is caused by a discrete set of biological mechanisms that can be targeted therapeutically.” The fountain of youth might be a fantasy, but the biology of aging, and more specifically, the science behind the manipulation of that biology, is not only real, it’s become big business. Still, the challenge for serious and legitimate biopharmaceutical companies in the anti-aging space can sometimes have less to do with biology than it does perception. Does the biotech investment community understand and embrace the concept? Equally, if not more importantly, will the FDA and other regulatory agencies lean into the idea that aging itself might be viewed as an indication that warrants therapeutic review? And from a commercial perspective, how does a legitimate biopharmaceutical company, focused on combatting the physical deterioration marked by the advance in our years, separate and differentiate itself from the billions of dollars being poured into the consumer packaged anti-aging and cosmetic medical procedures markets? On this episode of the Business of Biotech, Matt sits down with Life Biosciences' CEO Jerry McLaughlin to address these questions and more.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Fiscal Turnarounds with Protalix's Eyal Rubin

Mon, 04 Sep 2023 06:00:00 -0400

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Within about five minutes of conversation with Protalix CFO Eyal Rubin, I learned that he doesn’t bite his tongue about the rigors of biotech business and finance management, which is precisely why I’m eager to talk with him on today’s episode of the podcast. From commercialization deals with big pharma to being about $50 million underwater to swatting away the day trading armchair quarterbacks on Stocktwits, Rubin’s seen a few things and he’s developed more than a few opinions.

On this episode of the Business of Biotech, you'll get a front-row seat to a discussion with a biotech CFO who knows how to put on the blinders, shut out distractions, right the ship and set the course to favorable financial waters. Bringing his years of experience in the CFO role at Teva Pharmaceuticals, Brainstorm Cell Therapeutics, and now, Protalix Biotherapeutics, we bring you Eyal Rubin for a story on big biopharma fiscal recoveries.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Building LEO Pharma's U.S. Presence with Brian Hilberdink

Mon, 28 Aug 2023 06:00:00 -0400

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In many respects, bringing an established foreign biopharma company to the U.S. market is not unlike starting one up from scratch. In other respects, it's even harder; long-held cultural norms and management styles, region-specific market dynamics, payer system nuance, and political influence must all be re-navigated and re-negotiated without encumbrance. The job's not for the faint of heart, which might be why the Danish company LEO Pharma tapped veteran biopharma leader Brian Hilberdink to lead its U.S. operations. On this episode of the Business of Biotech, Hilberdink shares loads of biopharma-specific leadership intel and advice as we discuss the task he faces and the course he's charting.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Managing Momentum With Rezolute Bio's Nevan Charles Elam, JD

Mon, 21 Aug 2023 06:00:00 -0400

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Since we last spoke in the Spring of 2021, Nevan Charles Elam, JD has managed to advance both of small-but-mighty Rezolute Bio's candidates onto the next phases of their journey. This year, on the back of a $130 million investment, Rezolute Bio is prepping its RZ358 candidate, a monoclonal antibody for congenital hyperinsulinism, for a pivotal phase 3 trial. On this week's epsiode of the Business of Biotech, we're settling in for an interrogation of Elam on the management principles of maintaining multi-candidate clinical momentum among highly disparate candidates and raising big dollars as a small biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Facing NASH Therapeutic Skepticism with 89bio's Rohan Palekar

Mon, 14 Aug 2023 06:00:00 -0400

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The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics has yet reached the finish line. On this episode of the Business of Biotech, 89bio CEO Rohan Palekar gives us the insider's perspective on the the challenges that heave beset the field, from a rigorous FDA approval process to poorly designed clinical trials and a wary investor base. Palekar also expresses optimism in his explanation of how, through a focus on safety, convenience, and cutting-edge testing technology to aid patient recruitment, 89bio is positioning itself to break the tape.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech Cash Management with Allan Shaw

Mon, 07 Aug 2023 06:00:00 -0400

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It’s been said that clinical trials are where emerging biotechs go to die. If the science doesn't kill quickly, poor cash management will slowly. And, even when good data opens the cash floodgates, post-round cash management savvy isn't necessarily intuitive to academic and scientific founders. Cash runway preservation is, however, ingrained in the cerebral cortex of one of our favorite mavens of biotech finance markets and management, Mr. Allan Shaw. He joins us on this week’s episode of the Business of Biotech for a conversation on post-financing fundamentals for new and emerging biopharmas.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Establishing Research With Horizon Therapeutics' Robert Stoffel, Ph.D.

Mon, 31 Jul 2023 06:00:00 -0400

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While Horizon Therapeutics has made plenty of waves in the biotech news cycle of late. While perhaps not as flashy as a perilous multibillion dollar acquisition deal or potential blockbuster readout, its formal establishment of a research team – comparatively pragmatic as that may be – could have long-term consequences that are just impactful. On this week's episode of the Business of Biotech, we dig into why the company chose to establish a research function, learn why it chose Dr. Robert Stoffel, Ph.D. to run it, and get a step-by-step explainer on how Stoffel went about establishing the department, setting its goals and strategy, staffing it, and integrating it across teams at the fast-rising biopharmaceutical company.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Surviving The Microbiome Market with MaaT Pharma's Hervé Affagard

Mon, 24 Jul 2023 06:00:00 -0400

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The microbiome therapeutics market has been taking a beating, with several clinical-stage companies failing or flailing at the hands of tough financial markets and regulatory scrutiny. MaaT Pharma Founder & CEO Hervé Affagard knows these perils well. Affagard recently navigated his company through a protracted FDA clinical hold, emerging on the other side with a promising Phase 3 candidate in Graft versus Host Disease. On this episode of the Business of Biotech, Affagard offers a transparent look at how MaaT is beating the odds with a redundant clinical strategy and scrupulous cash management.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

COO Liftoff With Rocket Pharmaceuticals' Kinnari Patel, PharmD

Mon, 17 Jul 2023 06:00:00 -0400

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Chief Operating Officer is arguably the toughest job in the emerging biopharma C-suite. HR, CMC, regulatory affairs, legal, PR, you name it, the COO touches it, and practically everything rolls up to her. This week's episode of the Business of Biotech brings us to a president and COO who's also a mom, a volunteer, and an advocate for diversity and equality in biopharma. That advocacy isn't just lip service, by the way. Here, Rocket Pharmaceuticals' Kinnari Patel, PharmD, shares on the real, practical, replicable steps Rocket takes to build a diverse and equitable work environment, how the fruits of that effort have proven important to the company's success, and where Rocket is taking its high-flying gene therapy act next.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

ML-Enabled Drug Discovery With LabGenius' James Field, Ph.D.

Mon, 10 Jul 2023 06:00:00 -0400

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Will machine learning revolutionize biopharma drug discovery? Has it already? This week on the Business of Biotech, we explore the intersection of tech and bio with Dr. James Field, founder and CEO of LabGenius. We'll get an insider's look at the formation of a company bridging the divide between computational and biological sciences, we'll learn why this ML-intensive leader applies a scientist's skepticism to the tech he's building, and we'll address fundamental data considerations along the way. We'll also learn about the challenges and opportunities that come with balancing a company that's building both a high-tech drug discovery platform and drugs themselves. If you're concerned with what ML will do to — or for — your biopharma business, don't miss this episode.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biopharma Comebacks With Vincerx's Ahmed Hamdy, MD

Mon, 03 Jul 2023 06:00:00 -0400

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Ahmed Hamdy, MD didn’t ask to be the subject of Nathan Vardi's new book For
Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug. In fact, that particular chapter of Dr. Hamdy’s career is one he’d rather not relive. But, in display of the resilience required of biotech leadership, Hamdy made a raging comeback. On this week’s episode of the Business of Biotech, we dive into Hamdy’s resurrection; how he shepherded Acerta Pharma all the way to a multibillion dollar blockbuster exit with Astra Zeneca and his plans to recreate that success in his new post as CEO and Founder at cancer therapeutics-focused Vincerx Pharma.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Origins Of A Biopharma VC Deal With Bernat Olle, Ph.D. and Parag Shah

Mon, 26 Jun 2023 06:00:00 -0400

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Last October, we dropped an episode dissecting the relationship between Ray Therapeutics and one of its lead funders, 4BIO, and it quickly rocketed to an all-time Business of Biotech fan favorite. This week, we’re doing it again with a candid, behind-the-scenes breakdown of how Vedanta Biosciences secured the support of K2 Health Ventures in its recent $100 million+ financing to fund a pivotal Phase 3 study. Join us as we dissect a story that started when Vedanta CEO Bernat Olle, Ph.D. met K2HV’s Founding Managing Director & CEO Parag Shah on a mountain during the Timmerman Traverse. Their story serves as a guide to ensuring the cultural and strategic alignment of science and finance.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Population-Level Health Impact With Vaxxinity's John Krayacich

Mon, 19 Jun 2023 06:00:00 -0400

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Vaxxinity’s John Krayacich likes taking big swings at big indications. He’s played key roles on the teams that launched Lipitor, Lyrica, and Neurontin, which have had measurable impacts on global populations of people suffering from cardiovascular disease, CNS disorders, and pain. He found those opportunities at companies like LEO, Novartis, Parke Davis, and Pfizer. Now, Krayacich is taking big swings at a new set of incredibly challenging candidates—immunotherapeutic vaccines for neurodegenerative and chronic diseases like Alzheimer’s, Dementia with Lewy Bodies, Multiple System Atrophy, Parkinson’s, Migraine, and Hypercholesterolemia. On this episode of the Business of Biotech, the Chief Business Officer shares his inspiration and strategy for seeing therapeutics for big, global patient populations through the commercial finish line.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Face Of African Biotech with Adrienne Leussa, Ph.D.

Mon, 12 Jun 2023 06:00:00 -0400

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Dr. Adrienne Leussa is one of my favorite follows. If the booming biotech scene on an incredibly diverse continent of 1.2 billion people interests you, she should be one of your faves, too. Dr. Leussa's intellect, energy, and glowing spirit contribute to her ambassadorship of the African biotech scene. She's an entrepreneur, a visionary, a communicator, and a tireless advocate for African biotech opportunity. On today's epsiode of the Business of Biotech, we share a lot of laughs as we learn how Adrienne's entrepreneurial beginnings selling nuts and lollies on the streets of Yaounde, Cameroon set the foundation for an accelerated academic career and a passion for bio business development. We also dive into Africa's growing biotech scene, discussing the support infrastructure available for budding entrepreneurs and the importance of technology transfer and commercial research innovations from local universities.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Innovation Reduction Act with Allan Shaw

Mon, 05 Jun 2023 06:00:00 -0400

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Allan Shaw isn't the only insider who's preemptively critical of the impact the IRA (Inflation Reduction Act) will have on the biopharma industry. Allan's back this week with analysis of what he and others are tongue-in-cheek calling the "innovation reduction act." He posits that the act's removal of certain protections will stifle momentum by disincentivizing the pursuit of novel discoveries in molecules small and large. He also suggests that the impact of the IRA will ultimately cost patients and payers more. Tune in to learn why.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Propagating Peptides With Peptilogics' Jonathan Steckbeck, Ph.D.

Mon, 29 May 2023 06:00:00 -0400

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The Business of Biotech took a road trip to Pittsburgh to visit with Peptilogics CEO and founder Dr. Jonathan Steckbeck, whose Ph.D. work was inspired by the loss of his father-in-law to a hospital-borne infection. That work subsequently led to the formation of a company committed to leveraging peptide therapeutics to address PJI (prosthetic joint infection), cystic fibrosis infection, as well as rare genetic disease and oncological indications. Dr. Steckbeck walks us through the transition of his academic work into a clinical-stage company, how he's sustaining the company in a lean capital market, and the virtues of doing biotech business in Pittsburgh.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Resilient Biopharma Leadership With Ambrx's Dan O'Connor

Mon, 22 May 2023 06:00:00 -0400

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Since Dan O'Connor stepped in as CEO at Ambrx late last year, the company's stock has rallied on the revival of a previously-shelved anti-HER2 ADC. It also raised $78 million and completed its ATM (at-the-market) offering. O'Connor is no stranger to overcoming adversity. A former marine captain, he was among the first deployed to the Persian Gulf to fight in Operation Desert Shield. While his leadership at Ambrx is anything but militaristic, he ascribes much of his style, and certainly his approach to adverse conditions, to his military time. On this episode of the Business of Biotech, we welcome back Dan O'Connor to discuss the resuregence of Ambrx and leadership resilience in an industry that demands it.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Funding A Neurodegeneration Startup With Coya Therapeutics' Howard Berman

Mon, 15 May 2023 06:00:00 -0400

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Like many of us, Howard Berman, Ph.D. has personal experience with the tragedy of cognitive decline. Neurodegenerative disorders are on the rise, and when one afflicted his father — a triple board-certified physician — he saw firsthand that they don't discriminate. Berman has dedicated his career to addressing neuro, autoimmune, and metabolic diseases, having founded Nicoya Health in 2020 and overseeing its merger with Coya Therapeutics the following year. The company came out of the gates this year fueled by an 11th-hour 2022 IPO, one of just a dozen on the year. Berman joined the Business of Biotech to share his strategy during a stingy stretch in biotech capital markets.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

A More NIIMBL Biotech Workforce With John Balchunas

Mon, 08 May 2023 06:00:00 -0400

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What are biopharma's greatest skilled manufacturing labor needs, and what's the industry doing to fill them? John Balchunas is on the front lines in his position as Workforce Director at NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals, and he says advanced degrees and pedigrees aren't the answer. The breadth and depth of NIIMBL's efforts to influence the next generation of the biopharma workforce — from high school vocational programs to community colleges and on-the-job development—might surprise you. Listen in as Balchunas brings the Business of Biotech up to speed on a training and development agenda that plants seeds early and often.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Building Flagship Pioneering With Avak Kahvejian, Ph.D.

Mon, 01 May 2023 06:00:00 -0400

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Flagship Pioneering is fertile ground for a bevy of blossoming biotechs, and one of its most prolific sowers is General Partner Avak Kahvejian, Ph.D. Dr. Kahvejian counts Seres Therapeutics, Rubius Therapeutics, Codiak BioSciences, Cygnal Therapeutics, Ring Therapeutics, Cellarity, Laronde, and Generate Biomedicines among the companies he's played a leading hand in launching. On this episode of the Business of Biotech, Kahvejian takes us under the hood of one of the most burgeoning businesses in biotech, sharing details on the people, processes, and technologies fueling its rapid growth.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Therapeutic Molecules From Moss with eleva's Andreas Schaaf and Björn Cochlovius, Ph.D.

Mon, 24 Apr 2023 06:00:00 -0400

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We kick this conversation off with the writer Elizabeth Gilbert's take on moss, which she so eloquenlty dubs a "resurrection engine." Gilbert almost certianly didn't realize the potential of moss to play a resurrectional role in human health, but Eleva Biotech's Andreas Schaaf and Bjorn Cochlovius do. On this episode of the Business of Biotech, we learn about a company that's developing proteins to fuel its own pipeline — and its partners' — from a most ubiquitous plant that grows virtually everywhere. It grows particularly well in bioreactors outfitted with custom grow lights, and presents some significant advantages over CHO cell line development.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Gene Tx For Hearing Loss with Sensorion's Nawal Ouzren

Mon, 17 Apr 2023 06:00:00 -0400

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We often talk about biotechs taking "big swings." This week's guest is swinging for the fences with a lineup of gene therapies designed to address multiple forms of hearing loss, which affect multiple millions (if not, billions) of people worldwide. Adding to the challenge she's accepted, Sensorion CEO Nawal Ouzren is architecting an approach that seeks to restore hearing that's been lost due to genetic factors, treat sudden hearing disorders, and proactively prevent hearing loss due to common causes such as cisplatin induced ototoxicity or cochlear implantation. Listen in as Ouzren shares her holistic and aggressive plans with the Business of Biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Functional Ectopic Organs with LyGenesis' Michael Hufford, Ph.D.

Mon, 10 Apr 2023 06:00:00 -0400

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LyGenesis is developing a pipeline of allogeneic cell therapies using the lymph node as an in vivo bioreactor to grow functioning ectopic organs. What sounds like science fiction to some is starting to look like a life changing therapy for millions of liver, kidney, pancreas, and thymus disease sufferers. The science behind it is being developed not in Boston, not in Philadelphia, nor in San Franciso, but right in the heart of the rust belt in Pittsburgh, PA. This week's episode of the Business of Biotech takes us there for a conversation with LyGenesis CEO Dr. Michael Hufford, Ph.D.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Approvals & Mergers: Inside Enzyvant with Bill Symonds, Pharm.D.

Mon, 03 Apr 2023 06:00:00 -0400

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Today's episode of the Business of Biotech covers a lot of ground with Enzyvant CEO Bill Symonds, Pharm.D. Among other things, we discuss the career moves Dr. Symonds has made within the "vant" environment since his involvement in the launch of the original Roivant, the approval of Rethymic, the merger of Altavant and Enzyvant, and the company's intentions for a brand new regenerative medicine manufacturing facility in Research Triangle Park. From drug approvals to mergers, from internal manufacturing capacity to founders-turned-presidential candidates, this one's got it all.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Next-Gen Nanobodies With MoonLake's Jorge Santos Da Silva, Ph.D.

Mon, 27 Mar 2023 06:00:00 -0400

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The more we learn about inflammation and the complex cause/contributor/symptom roles it plays in various disease states, the more business activity we see in the inflammation therapeutics space. But to date, commercial pharmaceutical and biologic efforts have fallen short for patients, says Moonlake Immunotherapeutics CEO Jorge Santos Da Silva, Ph.D. What's the problem, and why does he think his camelid-derived nanobody candidates are poised to outperform big-pharma standards from the likes of UCB and Novartis? Find out on this week's episode of the Business of Biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Lessons From The Bone Therapeutics/Medsenic Merger With BioSenic's François Rieger, Ph.D.

Mon, 20 Mar 2023 06:00:00 -0400

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On the surface, the merger of Medsenic (a developer of arsenic salt formulations for therapeutic application in inflammatory conditions) and Bone Therapeutics (which develops allogeneic cell therapies for complicated bone fractures) doesn't look obviously synergistic. But Francois Rieger, Ph.D. says that on the scientific level, it's a perfect union, and the veteran biotech founder says the business should always follow the science. The union of the two companies formed BioSenic, which Dr. Regier now serves as CEO. On this week's episode of the Business of Biotech, Dr. Regier shows us the good, the bad, and the ugly of the merger process and shares his philosophy on letting science lead the way, regardless of the analysts' takes.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

TCRs In Personalized Oncology With BlueSphere Bio's Keir Loiacono

Mon, 13 Mar 2023 06:00:00 -0400

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Among a growing cluster of Pittsburgh biotechs, you'll find BlueSphere Bio, an early-stage company discovering T-cell receptors to leverage against tumor-specific antigens in individual cancer patients. Its leader, CEO Keir Loiacono, Esq., works with a sense of urgency inspired by his own cancer journey. Business of Biotech host Matt Pillar and guest co-host Jon O'Connell, executive editor at Bioprocess Online, toured Bluesphere's state-of-the-art facility perched on the bank of the Monongahela River. Then, we sat down with Loiacono to learn his story and discuss the company's vision for the future of personalized, adoptive cell therapy.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Self-Replicating RNA With Elixirgen's Akihiro Ko

Mon, 06 Mar 2023 06:00:00 -0500

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SPECIAL EDITION: BoB@JPM
Elixirgen Therapeutics CEO Akihiro Ko joins the Business of Biotech for the final episode in our special series recorded at JPM Week in San Francico. Life Science Leader Chief Editor Ben Comer joined us for the conversation. We dive deep into Elixirgen's unique, temperature-controlled in-vivo gene expression technology designed to address common cell therapy administration challenges and unwanted, off-target immunogenicity effects. Ko also shares progress on the company's ex-vivo candidate EXG-34217, an autologous cell therapy for telomere biology disorders, offers his take on the ever-crowded RNA therapeutics space and how the company is separating itself from the crowd, and much more!

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Gene Writing With Tessera's Michael Severino, M.D.

Mon, 27 Feb 2023 06:00:00 -0500

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SPECIAL EDITION: BOB@JPM
Flagship Pioneering plucked Michael Severino, M.D. away from AbbVie to run point at Tessera, a startup it's backed to pioneer a new category of genetic medicine it calls gene writing. The Business of Biotech caught up with Severino at the JP Morgan Healthcare Conference in San Francisco last month. We learned what lured him away from leadership positions at Merck, Amgen, and AbbVie, how gene writing differs from gene therapy and gene editing, why the team at Tessera believes its technologies can write and rewrite DNA at the scales necessary to cure most genetic diseases, and where he plans to take the company from here.

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BoB@JPM: Post-IPO With Bolt Biotherapeutics' Drs. Randall Schatzman and Edith Perez

Mon, 20 Feb 2023 06:00:00 -0500

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SPECIAL EDITION: BOB@JPM
Bolt Biotherapeutics CEO Randall Schatzman, Ph.D. and CMO Edith Perez, M.D. are no strangers to the Business of Biotech, having previously joined us on episodes 14 and 18, respectively. The last time we spoke with Dr. Schatzman, he was preparing the company for its initial public offering. We caught up with him and Dr. Perez at the JP Morgan Healthcare Conference in San Francisco last month for a conversation on the IPO process, the impacts it's had on the go-forward plan at Bolt Bio, the company's clinical progress, and its collaboration strategy moving forward.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

BoB@JPM: Academia To Industry With Oncolytics' Matt Coffey, Ph.D.

Mon, 13 Feb 2023 06:00:00 -0500

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SPECIAL EDITION: BoB@JPM
The JP Morgan Healthcare Conference is a target-rich environment for conversations with the leaders of up-and-coming biopharma companies, so we took the Business of Biotech on the road. On today's episode, we sat down with Matt Coffey, Ph.D., who earned his Ph.D. in 1998 and turned his doctoral thesis into a biopharma company called Oncolytics in 1999. Dr. Coffey shares on his abrupt transition from academia to industry, tells tales of the company's backstory, and updates us on its aggressive clinical activity spanning 7 wide-ranging oncology programs.

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BoB@JPM: Support Of A Blossoming Pipeline With Sangamo's Sandy Macrae, Ph.D.

Mon, 06 Feb 2023 06:00:00 -0500

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SPECIAL EDITION: BoB@JPM
The Business of Biotech podcast took to the streets of San Francisco during the 41st Annual J.P. Morgan Healthcare Conference. This week's episode features a conversation with Sangamo Therapeutics CEO Sandy Macrae, Ph.D., who rationalizes the company's aggressive pipeline development and its decision to invest in multinational AAV and cell therapy manufacturing facilities in France and California. Dr. Macrae zeroes in on the relationship between people and processes that's enabled the company to grow to more than 500 associates working on nearly 20 cell therapy, gene therapy, and genome engineering programs.

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Building A Better COVID Vaccine With Ocugen's Shankar Musunuri, Ph.D.

Mon, 30 Jan 2023 06:00:00 -0500

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Is it past time for a new approach to the COVID vaccine? Ocugen Chairman of the Board, Founder & CEO Shankar Musunuri, Ph.D. says yes, and his ideals would mark significant improvements: fewer shots, better durability, less post-vaccination transmission, and safety proven by time-tested technology. How would such a vaccine be produced? Dr. Musunuri lays out the manufacturing science— and why the improved COVID vaccine his company is currently putting through Phase 2/3 trials makes good business sense—on this week's episode of the Business of Biotech.

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Modality-Agnostic Drug Discovery With Cullinan Oncology's Nadim Ahmed

Mon, 23 Jan 2023 06:00:00 -0500

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Call it fortuitous, good planning, instinct, or a combination of all three, but Nadim Ahmed's educational foundation— earned before the IT/Biology combination was cool— is serving him well as CEO at Cullinan Oncology. On this episode of the Business of Biotech, Ahmed shares his story and that of Cullinan Oncology's drug discovery efforts, which have yielded a wide range of multi-modal candidates spanning a range of cancer indications. Our discussion digs into the company's transition from R&D to the clinic, how its built an uncommonly comfortable cash position through partnership, and its ambition to become a fully-integrated commercial-stage biotech.

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Women In Biotech With Bill & Melinda Gates MRI's Piper Trelstad, Ph.D.

Mon, 16 Jan 2023 06:00:00 -0500

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After more than 21 years leading process, product, and technical development efforts at Merck and Takeda, Piper Trelstad, Ph.D. joined the Bill & Melinda Gates Medical Research Institute (MRI) in January, 2022. On this episode of the Business of Biotech, we'll dive into how the MRI, a full-fledged clinical-stage biopharmaceutical company, is tackling health problems that challenge some of the world's most vulnerable populations. Dr. Trelstad also shares her minority perspective as a woman working in a highly technical capacity in biopharma, and how the industry can proactively support and advance women in technical roles.

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Computational Drug Discovery With Gain Therapeutics' Matthias Alder

Mon, 09 Jan 2023 06:00:00 -0500

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Gain Therapeutics' newly-appointed CEO Matthias Alder offers up a deep, yet abundantly clear explanation of how his company is applying compute power to speed up drug discovery. At Gain, computational models help researchers winnow down not just which molecules might have therapeutic effect, but also how adept those molecules will be at binding--and staying bound--to their target. It's not just theory, either. On this episode of the Business of Biotech, Alder shares on how the virtual successes seen on Gain's servers have translated in the wet lab, and how they've contributed to the company's fast-growing preclinical pipeline.

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Dissecting Spesolimab's Approval With Boehringer Ingelheim's Carine Boustany

Mon, 02 Jan 2023 06:00:00 -0500

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Join Matt Pillar for a conversation with Carine Boustany, PharmD and SVP, US Research Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. On this episode of the Business of Biotech, we walk through the story leading up to the recent approval of spesolimab. In September 2022, spesolimab was approved in the USA for the treatment of generalized pustular psoriasis (GPP) flares in adults. Dr. Boustany shares the antibody's fortuitous discovery, the challenges her team faced on the path to approval, and how those challenges were overcome.

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AI & Computational Biology With Recursion's Chris Gibson, Ph.D.

Mon, 26 Dec 2022 06:00:00 -0500

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Recursion's unique, technology-aided approach to drug discovery has yielded one of the deepest, fastest-growing pipelines in emerging biotech. It starts with a 20-petabyte-and-growing database designed to create comprehensive "maps of biology" that enable insight into the relationships between molecules and cell types. On this episode of the Business of Biotech, we take a deep dive into the approach—and what Recursion intends to do with all that data—with the company's co-founder and CEO, Chris Gibson, Ph.D. Don't miss this window into the world of a true pioneer in computational biology.

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Allan Shaw On Financing Biopharma Innovation

Mon, 19 Dec 2022 06:00:00 -0500

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Friend and frequent guest Allan Shaw rejoins the Business of Biotech to reflect on his recent presentation on innovative biotech financing at the BioFuture event in NYC. We also dig into Bruce Booth's "Atlas Venture Year In Review," revisiting and unpacking some quoteworthy material and metrics from both sources. Allan offers up plenty of prognostication and professional insight in a preview of what's to come in 2023, complete with his signature "Allanisms" and colorful analogies. A can't-miss episode as we round the turn to a new year!

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Gene Therapy For Chronic Inflammation With Xalud's Howard Rutman, M.D.

Mon, 12 Dec 2022 06:00:00 -0500

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While many gene therapy development efforts focus on rare disease, Xalud Therapeutics is taking a swing that, measured in addressable patient market terms, is considerably bigger. Osteoarthritis, or OA, is a chronic, progressive joint disease that affects over 30 million people in the United States. On this episode of the Business of Biotech, we catch up with Xalud Chief Medical Officer Howard Rutman, M.D., MBA for a discussion on the company's late-stage plasmid DNA gene therapy that's showing promise in OA and other chronic inflammatory conditions.

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The Antibody Engine With Abpro's Chan Brothers

Mon, 05 Dec 2022 06:00:00 -0500

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In an industry that takes new business naming conventions to extremes, Abpro is a refreshingly clear exception. Brothers Ian Chan (CEO & Co-Founder) and Eugene Chan, M.D., (Chairman & Co-Founder) are antibody pros. The company's pipeline spans no fewer than 8 antibody candidates aimed at COVID-19, cancers including breast, gastric, and liver, and ophthalmologic indications DME and wet AMD. With a scientific advisory board led by Bob Langer, Ph.D. of Moderna fame and a new partnership with global powerhouse Celltrion worth a potential $1.75 billion, the company's on the move. On this episode of the Business of Biotech, the Chan brothers take us behind the scenes of Abpro's progress.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

In-Vivo CAR T Update With Umoja Biopharma's David Fontana, Ph.D.

Mon, 28 Nov 2022 06:00:00 -0500

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2023 is just around the corner, and it's shaping up to be a big year for Umoja Biopharma. The company is on the leading edge of the effort to break the solid tumor barrier with in vivo CAR T-cell therapies, with one such effort currently enrolling patients for a phase 1 trial. It's planning two more INDs in the coming year. This episode of the Business of Biotech finds us getting the inside story from Umoja Chief Operating Officer David Fontana, whose storied career includes leadership positions at heavyweights including Sanofi, SeaGen, Pfizer, Juno, and BMS. Fontana shares on how he applies his experience playing a lead role in the success of Breyanzi, Adcetris, Bavencio, and Relatlimab in his new role at Umoja, the outsourcing battle scars that motivated the company to build its own 146,000 square foot development and manufacturing facility, and much more.

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RNA-Based Therapeutics With Nutcracker Therapeutics' Dr. Geoff Nosrati

Mon, 21 Nov 2022 06:00:00 -0500

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Nutcracker Therapeutics is a preclinical biopharma company developing multimodal RNA-based therapeutics for HPV-driven tumors, T-cell lymphoma, and Genitourinary tumors. On this episode of the Business of Biotech, Chief Business Officer Geoff Nosrati, Ph.D. offers a comprehensive view of the RNA-based therapeutics landscape and sheds light on what he perceives as an advantageous position at Nutcracker— the capacity to manufacture RNA in-house. If you're curious about the expanding science behind RNA-based therapeutics and their application in biotech, this conversation with a scientist-turned-chief business officer (Nosrati earned his Ph.D. in Biochemistry and Molecular Biology) is a can't-miss episode.

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Tick-Derived Therapeutic Molecules With Akari Therapeutics' Rachelle Jacques

Mon, 14 Nov 2022 06:00:00 -0500

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Ticks are a scourge. They're vectors of multiple serious an debilitating diseases, and evolution has made them perfectly adept at attaching to their hosts—and potentially spreading those diseases virtually undetected— that ability owing to anti-inflammatory and anesthetic proteins in their saliva. But the emerging biotech Akari Therapeutics thinks there's a broad range of medicinal value in those proteins. They've painstakingly developed a recombinant version of one such tick saliva-derived protein, called nomacopan, and put it to work in phase 3 trials to treat rare but deadly severe hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). On this week's episode of the Business of Biotech, Akari President & CEO Rachelle Jacques tells us about the redeeming qualities of tick saliva and how her company is putting it to work.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Product vs. Platform With Surface's Vito Palombella, Ph.D. and Robert Ross, M.D.

Mon, 07 Nov 2022 06:00:00 -0500

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Earlier this month, Surface Oncology shared that it will open a second stage of its monotherapy trial of SRF388, an antibody targeting IL-27, on the heels of a promising phase 2 data readout. Shortly before that release, the Business of Biotech caught up with Surface's CSO Vito Palombella, Ph.D. and CEO Rob Ross, M.D. in the company's Cambridge, MA HQ. We discussed the first-of-its-kind target, the company's "product versus platform" strategy and how it fits in the industry's current "platform" vibe, the finer points of building and maintaining a startup bio culture, the difference between that Bob Ross and the Rob Ross, M.D., and whole lot more.

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Leveraging Lymph Nodes With Elicio's Dr. Peter DeMuth

Mon, 31 Oct 2022 06:00:00 -0400

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MIT-born startup Elicio Therapeutics' novel Amphiphile Technology Platform is designed to directly engage the lymphatic system in the deployment and delivery of therapeutic payloads. We caught up with Chief Scientific Officer Peter DeMuth, Ph.D. at Elicio HQ in Boston to learn how the platform works, and how it's driving rapid clinical progress for the company's robust pipeline of therapeutic vaccines in oncology, as a cell therapy amplifier in liquid and solid tumor indications, and in prophylactic vaccines for infectious diseases like COVID-19. Dr. DeMuth also shares his journey as a young scientific founder, how he's managed the transition from academic scientist to the C-suite, and how he leans into his scientific training to make a killer home brew.

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Engineering Proteins For Food Allergies With Ukko's Dr. Anat Binur

Mon, 24 Oct 2022 06:00:00 -0400

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Anat Binur, Ph.D. is CEO and Co-Founder at Ukko, where she's leading an effort to create new allergy therapeutics by engineering the proteins that induce immune response in people who suffer from food allergies. The effort at Ukko is deeply rooted in computational biology. The company leverages artificial intelligence to analyze how the allergen proteins interact with patients' blood in an effort to determine the specific attributes of the proteins that trigger immune response. Then, it applies a unique combination of compute power and biology to identify and understand the changes it wants to engineer and predict the best possible designs. Learn how Ukko is fostering a culture of IT and biology collaboration and what lured this dynamic entrepreneur into biopharma on this episode of the Business of Biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Anatomy Of A VC Deal With 4BIO's Dima Kuzmin & Ray Therapeutics' Paul Bresge

Mon, 17 Oct 2022 06:00:00 -0400

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In a particularly candid conversation, 4BIO Managing Partner Dmitry ‘Dima’ Kuzmin and Ray Therapeutics Co-Founder & CEO Paul Bresge share the recipe for a successful relationship between biotech VC firm and startup. Bresge offers insight into VC engagement strategy and pitch, Kuzmin dishes on what investors look for in terms of "fundability" and what throws red flags, such as— perhaps ironically— a CEO like Bresge who has a deep and incredibly personal connection to the indication he's pursuing. The pair also discuss, in real and tangible terms, what constitutes a material, cultural match.

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Oncology Discovery Advances With AbbVie's Steve Davidsen, Ph.D.

Mon, 10 Oct 2022 06:00:00 -0400

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AbbVie VP of Oncology Discovery Research Steve Davidsen, Ph.D. is a living, breathing timeline of the company's cancer research and development efforts. He got his start with the company— Abbott at the time— way back in 1986. As such, he's charted the adoption of multiple advanced technologies that have contributed to the realization of dozens of molecular weapons in the fight against cancer. On this episode of the Business of Biotech, Dr. Davidsen shares the latest on AbbVie's adoption of computational biology and how it's contributing to discovery and development efficiencies, why he's an AbbVie "lifer," how he manages and motivates a large team of research scientists, and a whole lot more.

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IND For TIL Therapy With Obsidian Therapeutics' Paul Wotton, Ph.D.

Mon, 03 Oct 2022 06:00:00 -0400

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On this episode of The Business of Biotech, Obsidian Therapeutics CEO Paul Wotton, Ph.D. takes us behind the scenes to reveal what precipitated the FDA's clearance of its IND application for a novel, engineered tumor-infiltrating lymphocyte therapy called OBX-115. Learn how the company navigated the regulatory path for a first-of-its-kind biologic therapy developed in partnership with the University of Texas MD Anderson Cancer Center that Dr. Wotton says, should it succeed, will eliminate the patient risk associated with concomitant IL2 therapy and improve clinical outcomes for certain patients with metastatic melanoma. We also get an update on outcomes from Obsidian's unique approach to solving COVID-19 challenges covered on episode 9 of the Business of Biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Regenerative Wound Care With BioStem Technologies' Jason Matuszewski & Andrew VanVurst

Mon, 26 Sep 2022 06:00:00 -0400

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Here's the story of BioStem, it's young founders, and how they reached commercial status in short order with a portfolio of proprietary regenerative wound care products developed from perinatal tissue. Fueled by a personal story of resilience and inspiration, Jason Matuszewski (CEO) and Andrew VanVurst (COO) built a company that's developed a local microenvironment activation platform drawing on a combination of small molecules, cytokines, and growth factors to promote tissue repair and regrowth. The company's internal development and cGMP manufacturing facilities have already yielded three approved products poised to change the paradigm for diabetic, traumatic, and other wound care.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Epigenomic Programming With Omega Therapeutics' Mahesh Karande

Mon, 19 Sep 2022 06:00:00 -0400

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Using computational biology to hasten the effort, Omega Therapeutics' plan is to "coopt nature's universal biological operating system for gene control and cell differentiation." On this episode of the Business of Biotech, we dig into exactly what that means. We also explore the company's preclinical ambitions, which are diverse, targeting regenerative, multigenic/immunologic, oncologic, and monogenic indications. Omega is leaning heavily into computational biology along the way, having mapped what CEO Mahesh Karande characterizes as 95% of the IGD landscape. Learn how Karande intends to maintain momentum on this episode of the Business of Biotech.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

IDO Target Perseverence With IO Biotech's Mai-Britt Zocca, Ph.D.

Mon, 12 Sep 2022 06:00:00 -0400

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Under the leadership of Mai-Britt Zocca, Ph.D., IO Biotech is advancing novel, immune-modulating cancer therapies targeting IDO (indoleamine 2,3-dioxygenase). Though promising, the target fell out of favor after some high-profile misses – most notably Merck's Phase 3 failure with pembrolizumab in 2018. But Immunome's dual mechanism of action is renewing interest in the target, and Dr. Zocca is gaining confidence as the company's data grows. On this episode of the Business of Biotech, she shares the approach, how it differs from previous attempts, and how her company is working to advance its programs in the wake of IDO's fall from grace.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Pursuit Of A Universal Flu Vaccine With Longhorn Vaccines & Diagnostics' Jeff Fischer

Mon, 05 Sep 2022 06:00:00 -0400

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With a unique multi-target approach, what it considers the world's best adjuvant, and a host of learnings from the successes and failures of COVID-19 vaccine efforts, Longhorn Therapeutics is gaining steam in its pursuit of a universal influenza vaccine. On this episode of the Business of Biotech, Longhorn Vaccines & Diagnostics Co-Founder and President Jeff Fischer gives us a transparent look at the science and the partnerships that are giving him cause to believe his company will succeed where so many have failed.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Genetic Testing & Neurodegenerative Disorders With AviadoBio's Lisa Deschamps

Mon, 29 Aug 2022 06:00:00 -0400

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Lisa Deschamps' story is one of determination and fortitude. She got her start in the life sciences where it begins and ends for many— "carrying the bag" in big pharma sales—then proceeded to crush the odds on her way to the C-suite at Novartis. Today, she's CEO at AviadoBio, a disruptive gene therapy startup prepping an intra-thalamic Frontotemporal Dementia candidate for the clinic with a heavy Series A in its hip pocket. On this episode of the Business of Biotech we get to know Lisa, her company and its therapeutic approach, her advocacy for genetic testing, and how she's applying her determination and fortitude to enabling more women to become life science leaders.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech M&A Anomalies With Allan Shaw

Mon, 22 Aug 2022 06:00:00 -0400

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While many clinical-stage biopharmas are contracting or holding the line through the current market slump, Portage Biotech leaders Ian Walters, Allan Shaw, and company are making moves. The company recently acquired Tarus Therapeutics and iOx Therapeutics Ltd., extending its pipeline and positioning itself to meet some aggressive investor expectations. On this episode of the Business of Biotech, Shaw dissects the deals, digging into the M&A strategy at Portage and offering advice from the batter's box to leaders of early-stage biotechs.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Observations On Outsourcing With Molecule to Market's Raman Sehgal

Mon, 15 Aug 2022 06:00:00 -0400

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Raman Sehgal has made a career out of putting his energy— and he's got a lot of it— into building biotech outsourcing companies and the people who make them run. After years spent supporting several from within, he launched ramarketing, a firm dedicated to helping CROs, CDMOs, CPOs, and other providers to the biotech ecosystem build their businesses, in 2009. He's also an international best-selling author (The Floundering Founder), co-founder of life sciences recruitment firm Lead Candidate, and founder & host of the Molecule to Market podcast. On this week's episode of the Business of Biotech, Raman brings us his unique and multifaceted perspectives on the biopharma outsourcing space, the bear biotech markets, and how both are impacting the work of early- and clinical-stage biopharma leaders.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

What's A Biologic Revolution? With Vaxxinity's Mei Mei Hu, J.D.

Mon, 08 Aug 2022 06:00:00 -0400

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Vaxxinity CEO Mei Mei Hu, J.D. leads a company with some lofty ambitions. The democratization of healthcare, interplanetary colonization, and development of accessible therapeutic vaccines to serve and enable both. Those big-picture visions have helped the company establish itself as a pioneer of the "third biologics revolution." On this week's Business of Biotech podcast, Mei Mei joins me to share Vaxxinity's strategy, what "democratization" and "revolution" really mean, why traditional vaccines and biologic therapies are converging to form the "third biologic revolution," and a whole lot more.

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Creative Capital Generation With James Thomas Coates, Ph.D.

Mon, 01 Aug 2022 06:00:00 -0400

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As biotech capital markets continue to restrict access to funding for emerging biopharmas, you might be surprised by how many federal dollars get left on the negotiating table. To that end, James Thomas Coates, Ph.D. and his team at Decisive Point have carved out a niche in the venture capital space. The firm specializes in helping biotech startups realize direct routes to millions of dollars in federal funding from a host of not-so-intuitive federal institutions—NASA, and the US Navy, Air Force, and Army, for instance—and helping them optimize funding from more obvious federal agencies such as DARPA and the NIH. On this episode of the Business of Biotech, Dr. Coates shares strategies and resources for tapping into biopharma capital that's ripe for the taking.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Oligonucleotide Opportunities in DMD with PepGen's James McArthur, Ph.D.

Mon, 25 Jul 2022 06:00:00 -0400

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Among the more prevalent genetic conditions, Duchenne muscular dystrophy affects an estimated one in 3,500 male births worldwide. It's caused by mutations of the DMD gene, which regulates the production of a protein called dystrophin. Approved DMD treatments haven't demonstrated strong clinical outcomes, but James McArthur, Ph.D. and his team at PepGen are seeking to change that with a pipeline of disease-modifying peptide-conjugated oligonucleotide candidates derived from the company's Enhanced Delivery Oligonucleotide platform. The Business of Biotech caught up with Dr. McArthur at PepGen's Cambridge headquarters to learn more.

Catch up on more gene therapy development advances on bioprocessonline.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Changing The Diabetes Care Paradigm With Arecor's Dr. Sarah Howell

Mon, 18 Jul 2022 06:00:00 -0400

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While renal disease treatment technologies have seen moderate incremental improvements, there hasn't been a step-change advance in diabetes care since the discovery of insulin more than 100 years ago. Working with manufacturers of existing diabetes therapeutics in addition to advancing its own pipeline, Arecor is developing enhanced reformulations of tried-and-true therapeutics like insulin to improve a long-static standard of care. Arecor CEO Sarah Howell, Ph.D. joins the Business of Biotech for a discussion on the company's approach to improving the quality of life for some 200 million insulin-dependent patients worldwide.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Innate Immunity & Mouse Models With LIfT Biosciences' Alex Blyth

Mon, 11 Jul 2022 06:00:00 -0400

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Serial inventor and entrepreneur Alex Blyth had long held interests in health and science, but losing his mom to pancreatic cancer was the inflection point that launched LIfT Biosciences in 2016. Now, the preclinical company is on a mission to develop the world's first 'off-the-shelf' cell therapy to destroy all solid tumors, irrespective of strain or mutation, beginning with pancreatic cancer. On this episode of the Business of Biotech, Blyth shares the company's scientific approach and progress, and we explore the shortcomings of legacy clinical protocols including the inherent problems and limitations of mouse models.

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Antibody Cocktails With Immunome's Dr. Purnanand Sarma

Mon, 04 Jul 2022 06:00:00 -0400

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Immunome CEO Purnanand Sarma, Ph.D. joins the Business of Biotech for a discussion on precision antibodies and his company's discovery platform, which identifies novel therapeutic antibodies and their antigen targets by leveraging highly educated memory B cells from patients who have learned to fight off their disease. It’s kind of like picking an all-star team of players who have been in the game, and who are well-trained to win. On today's episode we'll learn how they’re discovered, how they’re developed, and how they’re applied in cancer and coronavirus.

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Antibody-Cytokine Combinations With Philogen's Dr. Dario Neri

Mon, 27 Jun 2022 06:00:00 -0400

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Swiss-Italian biopharma company Philogen was co-founded in 1996 by three brothers, all of them PhDs. This unique family affair has fueled the development of an incredibly deep and advanced pipeline of no fewer than ten therapeutic products, most of them in oncology, contributing to 16 active clinical trials, three of them at Phase 3. On this episode of the Business of Biotech, co-founder, CEO, and CSO Prof. Dario Neri shares the incredible story of the company's progress and explains Philogen's approach to delivering bioactive agents to the site of disease using antibodies or small organic ligands, thus increasing therapeutic activity and helping spare normal tissues.

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Fibroblasts In Regenerative Medicine with FibroBiologics' Pete O'Heeron & Dr. Hamid Khoja

Mon, 20 Jun 2022 06:00:00 -0400

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FibroBiologics Chairman, CEO, & Founder Pete O'Heeron shares the journey that led him from clinical care to biopharma entrepreneurship, and he's joined by Chief Scientific Officer Hamid Khoja, Ph.D., who explains the manufacturing technology that's driving the company's exploitation of fibroblasts to develop regenerative therapies for indications ranging from degenerative disk disease and multiple sclerosis to cancer immunotherapies and therapeutics.

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Pyxis Oncology's Lara Sullivan, M.D. On Site-Specific ADCs And Change Management

Mon, 13 Jun 2022 06:00:00 -0400

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To fully appreciate the work Pyxis Oncology is doing in its development of site-specific ADCs for a number of oncological indications under the leadership of Lara Sullivan, M.D., you need to understand the work that shaped her leadership style. On this episode of the Business of Biotech, Dr. Sullivan shares the science and technology driving progress at Pyxis, but she also serves up a master class on change management, honed during her tenure managing high-stakes product portfolios at Pfizer. If you want to be a better leader, don't miss this one. And for more on Dr. Sullivan's journey, read this recent feature story at Life Science Leader magazine.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Biotech Beatdown With Allan Shaw

Mon, 06 Jun 2022 06:00:00 -0400

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On this, the 100th episode of the Business of Biotech podcast, our dear friend, frequent guest, and business of biotech brainiac Allan Shaw joins us to dissect the beleaguered biotech capital markets. We pick apart what's driving sentiment, whether the industry is over-inventoried, what's getting funded , what's not, and why, and what biotech leaders should be doing in an investment landscape marked by hyper-discernment. We also reflect on the podcast journey and celebrate the 100-episode milestone!

The Business of Biotech is produced by Bioprocess Online in partnership with Cytiva.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Inflammation & Antibodies with Ampio Pharmaceuticals' Mike Martino, CEO

Mon, 30 May 2022 06:00:00 -0400

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Ampio Pharmaceuticals is currently weaving the gauntlet of a clinical hold triggered by COVID's disruption to clinical studies of its lead candidate Ampion, and recently launched an independent investigation into that trial and others. On this episode, Ampio Pharmaceuticals chairman and CEO Mike Martino joins the Business of Biotech for a candid discussion on the company, the candidate, the disruption, and the go-forward plan.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

What's Next For COVID Vaccines With Tonix Pharmaceuticals' Seth Lederman, M.D.

Mon, 23 May 2022 06:00:00 -0400

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As COVID-19 cases climb yet again, the Business of Biotech catches up with Tonix Pharmaceuticals CEO Seth Lederman, M.D. for a conversation on his company's multi-pronged strategy to advance vaccine and therapeutic candidates to address the disease and its variants. In addition to sharing on his journey from academia to industry, Dr. Lederman discusses his company's approach to grabbing its share of the highly competitive, and highly lucrative, vaccine market.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Running Interference: RNAi with Silence Therapeutics' Craig Tooman

Mon, 16 May 2022 06:00:00 -0400

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Fresh on the heels of his appointment as President & CEO at Silence Therapeutics, Craig Tooman joins the Business of Biotech to share how he applies his finance-minded leadership to steward the advance of the company's deepening pipeline of gene silencing candidates. Tooman also shares insight into the IP and the people responsible for managing that deep pipeline, which spans indications from hematology to cardiovascular disease to rare diseases.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Live Biologics & The Microbiome With 4D pharma's Duncan Peyton

Mon, 09 May 2022 06:00:00 -0400

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4D pharma's flagship early-stage clinical candidates are live biotherapeutics, a relatively new class of biologics that seek to impact disease state by modulating the microbiome. CEO Duncan Peyton is leading the effort to understand how the health of the microbiome relates to a wide range of diseases, including immuno-oncology, central nervous system disorders, respiratory disease, auto immune indications, and gastro intestinal disease. 4D pharma is even working on a live biotherapeutic vaccine platform. Join Duncan on this episode of the Business of Biotech as we discuss this new frontier of therapeutic exploration.

Learn more about gut microbiome therapeutic up-and-comers at bioprocessonline.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Gene Tx For Renal Disease With Purespring CEO Richard Francis

Mon, 02 May 2022 06:00:00 -0400

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Purespring Therapeutics launched in 2020 on the back of IP developed by renowned kidney researcher Prof. Moin Saleem, who spent decades working on podocytes when podocytes weren’t cool. Just two years later, the company boasts three gene therapy assets and a platform developed expressly to identify new therapeutic targets to address kidney disease. These assets promise to change the "dialysis or transplant" ultimatums associated with kidney disease, where therapeutic innovation has been scarce. Under the leadership of CEO Richard Francis, the young company is operating with the audacious goal to take its therapeutics all the way to the commercial finish line. On this episode of the Business of Biotech, Francis offers a transparent look at the company’s growth strategy and the progress it’s achieved to date.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Fighting Blindness & Funding The Fight With Opus Genetics' CEO Ben Yerxa, Ph.D.

Mon, 25 Apr 2022 06:00:00 -0400

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Opus Genetics is an early-stage gene therapy company launched just last year and in unique fashion on the back of the patient advocacy group the Retinal Degeneration Fund. Already, its pipeline has developed into three candidates, the lead among them addressing Leber congenital amaurosis. Opus CEO Ben Yerxa, Ph.D. serves in triplicate as CEO at the RD Fund, Foundation Fighting Blindness, and Opus Genetics. His plate is full, but he's a man on a mission. On this episode of the Business of Biotech, Dr. Yerxa shares his story, that of Opus Genetics' unique approach to addressing inherited retinal diseases, and how the company is addressing current development and capacity challenges in the cell & gene manufacturing space.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Gynecological Cancer Therapies with Context Therapeutics' Martin Lehr

Mon, 18 Apr 2022 06:00:00 -0400

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Context Therapeutics Co-Founder & CEO Martin Lehr shares stories from his self-described "recovery from venture capital," the work his company is doing in gynecological cancers, and how his small company manages a modality-agnostic approach and investigator-sponsored trials across multiple clinical candidates, four of which are in phase 2 clinical trials. We also discuss his "extracurricular" work with BioBreak, Life Science Leader, and Life Science Cares, and why those organizations are important to him personally and professionally.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Commensal Viral Vectors with Ring Therapeutics' Tuyen Ong, M.D.

Mon, 11 Apr 2022 06:00:00 -0400

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When Tuyen Ong was a child, he and his family escaped Vietnam by boat in the dead of the night, bound for an Indonesian refugee camp. They spent a year in that camp before emigrating to the U.K., where Ong’s underprivileged adolescence found him growing up in the projects of London. Against the odds, Ong worked his way to UCL for an education that culminated with an M.D. Today, he’s CEO of Ring Therapeutics, a promising emerging biotech backed by Flagship Pioneering, the kingmaker behind the rise of Moderna. On this episode of the Business of Biotech, Ong shares on his challenging formative years, the unspoken love between a father and son, facing down racism as a poor Chinese kid in Vietnam and London, and how those experiences shape his leadership at Ring. Oh, and we talk about some really great science, too.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Antibodies For Severe Allergies With IgGenix's Jessica Grossman, M.D.

Mon, 04 Apr 2022 06:00:00 -0400

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In this wide-ranging discussion, IgGenix CEO Jessica Grossman, M.D. discusses the application of and market opportunity for antibody therapy for severe allergies, the gender gap in the biopharma c-suite, why women work harder than men, what it means to be a female biopharma leader, and IgGenix's approach at isolating and re-engineering allergen-specific IgE antibodies into IgG antibodies designed to alleviate — and possibly prevent — allergic cascade.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Gene Therapies For Ocular Disease With Sparing Vision's Stéphane Boissel

Mon, 28 Mar 2022 06:00:00 -0400

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Since assuming the President and CEO role at Sparingvision in August, 2020, Stéphane Boissel has been making big moves in the arenas of talent acquisition and IP expansion. Those efforts are securing the company's development of a number of genomic medicines to address inherited retinal disease. On this episode of the Business of Biotech, Boissel shares the company's foundation story and the role venture philanthropy played in it, his strategy for attracting and retaining big-league talent, and the why behind his vigorous allegiance to internal development.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech M&A Trends With Allan Shaw

Mon, 21 Mar 2022 06:00:00 -0400

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On this episode of the Business of Biotech, Allan Shaw waxes on his expectations for mergers, acquisitions, and collaborative partnership opportunities for new and emerging biotechs in 2022 and beyond. We tackle questions biotech leaders should be asking about intentionality, what's attractive to potential suitors, and why startups that aren't prepared to take a candidate to the finish line have already conceded a major factor in partnership or buyout negotiations. Don't miss Shaw's advice for startup success in a suddenly tumultuous market.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Lipid Nanoparticle Gene Coding With SalioGen Therapeutics' Ray Tabibiazar, M.D.

Mon, 14 Mar 2022 06:00:00 -0400

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This episode of the Business of Biotech is fire. In fact, it's an interview with SalioGen Therapeutics Chairman and CEO Ray Tabibiazar, M.D., whose last name literally translates to "Dr. Fire." Learn how he got that name, what's shaped his technology-agnostic philosophy on therapeutic development, the advantages of a genome engineering technology that leverages proprietary mammal-derived enzymes, rather than viruses, and how SalioGen is possibly carrying forth a pipeline that's 15 candidates deep and addressing eye, liver, heart, lung, bone marrow, and kidney diseases.

Learn more about gene therapy validation strategies at bioprocessonline.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

CAR T-cells For Ovarian Cancer with Anixa Biosciences' Amit Kumar, Ph.D.

Mon, 07 Mar 2022 06:00:00 -0500

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While success has been seen in animal models, solid tumors have proved a vexing challenge for CAR T-cell therapies. On this week's episode of the Business of Biotech, we're joined by Anixa Biosciences Chairman, President, & CEO Amit Kumar, Ph.D. Dr. Kumar shares on the company's progress with a CAR T-cell therapy that aims to attack both tumor cells and the tumor vasculature, in hopes that it might be the first to destroy solid ovarian cancers.

Discover more on recent developments in autologous and allogeneic CAR T-cell therapies in this column from Mustang Bio at BioProcessOnline.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

AI-Driven Biologics With Fountain Therapeutics' William Greene, M.D

Mon, 28 Feb 2022 06:00:00 -0500

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With its hypothesis-free, target-free, AI-driven drug discovery platform, Fountain Therapeutics is turning the traditional drug discovery pathway on its ear to address a variety of age-related disease. On this week's episode of the Business of Biotech, Fountain CEO William Greene, M.D. joins us to discuss the approach, its rationale, and how the company is applying substantial support from the likes of Eli Lilly, Alexandria Venture Investments, R42 Group, Khosla Ventures, and Nan Fung Life Sciences.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Regulatory Harmonization With Aurion Biotech's Dr. Daniela Drago

Mon, 21 Feb 2022 06:00:00 -0500

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If you're taking a candidate into clinical trials that will be monitored by multiple international regulatory bodies, this episode is an absolute must-listen. Dr. Daniela Drago , Chief Regulatory Officer at Aurion Biotech, shares her encyclopedic knowledge of the dynamic regulatory harmonization landscape. Along the way, she offers concrete advice on creating multijurisdictional regulatory efficiencies that will smooth your journey through the clinic and beyond. Don't miss this one.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Plant-Based Biologics With iBio's Randy Maddux

Mon, 14 Feb 2022 06:00:00 -0500

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iBio COO Randy Maddux walks us through the Bryan, Texas-based biopharma's attempt to turn the CHO cell biologic development paradigm on its ear with hydroponically-grown N. benthamiana. His company's FastPharming approach to protein production, he says, could be modularized to speed cycle times and dramatically reduce upstream costs at scales large and small. For its part, iBio is proving out the approach on a host of therapeutic and vaccine candidates for oncological, infectious, and fibrotic diseases.

Learn more about iBio's COVID-19 vaccine candidate from CEO Tom Isett and Head of Vaccine Development Melissa Berquist, Ph.D. in this feature story at bioprocessonline.com.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

NK Cell Therapy Accessibility With Shoreline Biosciences' Dr. Kleanthis Xanthopoulos

Mon, 07 Feb 2022 06:00:00 -0500

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Shoreline Biosciences CEO Kleanthis Xanthopoulos, Ph.D. joins the Business of Biotech to share the company's strategy for the development, manufacture, and commercialization of off-the-shelf NK (natural killer) cell therapy. On this episode, Dr. Xanthopoulos shares why the cell and gene immunotherapeutic market has underperformed to date, why he believes autologous is not the long-term path forward, and the safety and accessibility advantages he sees in his allogeneic-based, pluripotent stem cell approach.

Visit www.bioprocessonline.com to learn how another emerging biopharma is leveraging allogeneic NK cells in oncology.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

A Hybrid mAb Manufacturing Model With John Glasspool

Mon, 31 Jan 2022 06:00:00 -0500

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Post-operative venous thromboembolism (VTE) is a serious and prevalent post-operative risk that has several contributing factors. John Glasspool, CEO at Anthos therapeutics, is on a mission to address the issue—and a host of other cardiovascular and metabolic conditions—with monoclonal antibodies that inhibit coagulation Factor XI and its activated form XIa. On this episode of the Business of Biotech, Glasspool discusses the advantages and challenges of the hybrid manufacturing approach at Anthos, and how its strategy has enabled phase 1 and 2 clinical studies that have demonstrated an 80% reduction of the rate of VTE in post-operative total knee arthroplasty patients compared to the standard of care (enoxaparin).

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Biotech Capital Markets Forecast With Allan Shaw

Mon, 24 Jan 2022 06:00:00 -0500

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As Allan Shaw likes to say, "there have never been so many people with their hands out, and there has never been so much money to go around." But how sustainable is this seemingly perennial boom in the biotech capital markets? Will the road go on forever and the party never end, or are there signs of a slowdown on the horizon? Shaw once again joins us to break down the market activity he's seeing, and what he anticipates for early-stage biotech leaders in 2022.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Venture Philanthropy For Type 1 Diabetes With T1D Fund's Katie Ellias

Mon, 17 Jan 2022 06:00:00 -0500

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The JDRF's T1D Fund is exemplary of an indication-specific advocacy group's aggressive pursuit of a cure through venture philanthropy. Put simply, unlike traditional VC firms who entertain myriad and often diverse pitches from biotech startups, the T1D fund creates financial and advisory incentives for the biotechs in its portfolio to pursue candidates and formalize programs around Type 1 Diabetes therapies. A growing number of the programs the T1D fund is supporting are cell and gene therapies and biologics. Katie Ellias, a managing director at the fund, joins the Business of Biotech to explain the JDRF T1D fund's unique approach, why Type 1 Diabetes is an important and potentially lucrative indication, and how the venture philanthropy model applies to the life sciences startup community.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Precision Approach To Infectious Disease With Locus Biosciences' Paul Garofolo

Mon, 10 Jan 2022 06:00:00 -0500

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Locus Biosciences CEO Paul Garofolo built his biotech leadership career on the back of an MIS degree, having learned the business from the inside out via the tentacles of the IT networks at companies including Genentech, The Broadlane Group, Valeant Pharmaceuticals and Patheon. On today's episode of the Business of Biotech, Garofolo shares how a technologist's approach has helped shape the effort to develop precision therapeutics for infectious diseases at Locus, the company's decision to build its own cGMP manufacturing facility in Research Triangle, and the massive business opportunity the field addresses in the effort to overcome antibiotic resistance.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Bioengineering Human Tissue With Humacyte's Dr. Heather Prichard

Mon, 03 Jan 2022 06:00:00 -0500

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Humacyte COO Dr. Heather Prichard joins the Business of Biotech for a discussion on the company's pipeline of candidates for the repair, replacement, and reconstruction of human vascular vessels. The company recently scaled the production of its implantable bioengineered human tissues from 10 to 200 per day to meet Phase 3 vascular trauma and arteriovenous access trials. On today's episode, Dr. Prichard shares the company's scale-up story and the science and engineering behind a unique approach to regenerative medicine using human tissue.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Top Stories Of 2021 With Allan Shaw

Mon, 27 Dec 2021 06:00:00 -0500

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Join your host Matt Pillar and guest Allan Shaw for a no-hold-barred retrospective on the year's top stories and trends. From the frontlines of the COVID-19 pandemic to the questionable approval of Aduhelm to leadership instability at the FDA and more, Shaw dissects the year past and predicts how those stories will influence the biotech industry in 2022 and beyond.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Complete CAR T Manufacturing Control with Cellectis' Steve Doares

Mon, 20 Dec 2021 06:00:00 -0500

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Cellectis' decision to build and operate its own trans-Atlantic manufacturing facilities was a strategic one. On this week's episode of the Business of Biotech, SVP of U.S. Manufacturing Steve Doares talks internal manufacturing rationale, discusses interoperability between its Paris and Raleigh, N.C. plants, and shares how the company keeps meeting the challenges presented by COVID-fueled supply chain disruptions head-on.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Genomically-Guided Medicine with Elevation Oncology's Shawn Leland, PharmD, RPh

Mon, 13 Dec 2021 06:00:00 -0500

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Elevation Oncology is taking a new approach to leveraging the genome to guide development of its precision therapeutic development efforts. Its first step is improving both the accuracy of and accessibility to genomic testing for cancer patients, In tandem, the company is in the clinic with its lead candidate seribantumab for cancer patients with a solid tumor of any origin that expresses a genomic change called an NRG1 fusion. On this episode of the Business of Biotech, Founder & CEO Shawn Leland, PharmD, RPh takes us inside the company's unique approach.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Inhalable mAbs & Vaccines with TFF's Glenn Mattes

Mon, 06 Dec 2021 06:00:00 -0500

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Glenn Mattes' TFF Pharmaceuticals is looking to break the parenteral barrier by manufacturing biologics — mAbs and vaccines, more specifically — that can be inhaled, rather than injected. It's a timely endeavor, and TFF's business model is a collaborative one that seeks to explore dry powder biologic options through partnership, in addition to its own pipeline. On this episode of the Business of Biotech, the veteran biopharma CEO shares the company's vision and the technology that's bringing it into focus.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Democratizing Biologics With Lumen Bioscience's Brian Finrow, J.D. & Craig Behnke, Ph.D.

Mon, 29 Nov 2021 00:00:00 -0500

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Making powerful and curative biologic therapies accessible to patients from all walks of life, and all corners of the globe, requires radically innovative thinking. On this episode of the Business of Biotech, Lumen Bioscience's Co-Founder and CEO Brian Finrow, J.D. and EVP of Production/Development Craig Behnke, Ph.D. discuss a novel approach: developing therapeutic proteins from readily-available food algae spirulina. It's driving a diverse pipeline of candidates into the clinic, for indications reaching from the gut to the heart and lungs.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Cornering The Antibody Market With Akesobio CEO Dr. Michelle Xia, Ph.D.

Mon, 22 Nov 2021 06:00:00 -0500

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In business for just a decade, Akesobio's stats are mindboggling: 20 drug development programs, including 12 antibodies in clinical-stage development, six bi-specific antibodies (two at clinical stage), four antibodies with IND approvals from the FDA, and 22 clinical trials initiated. The company's CEO, Michelle Xia, Ph.D., sat down with the Business of Biotech for a conversation about how the company has managed such supercharged growth.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Turning The Liver Into A mAb Factory With Homology's Arthur Tzianabos, Ph.D.

Mon, 15 Nov 2021 06:00:00 -0500

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Homology Medicines' approaches to gene therapy and gene editing have the potential to seriously disrupt both the cell/gene therapy space and the mAb manufacturing and administration paradigms as we know them. On this episode of the Business of Biotech, Homology President & CEO Arthur Tzianabos, Ph.D. shares the company's approach and supports its rationale for investing in its own development and manufacturing capacity.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Maximizing mRNA With Precision Nanosystems' James Taylor, Ph.D.

Mon, 08 Nov 2021 00:00:00 -0500

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Dr. James Taylor believes that genomic medicine will prove the most revolutionary thing the life sciences industries have ever seen, and that it will ultimately become the largest therapeutic class. Dr. Taylor is president an CEO at Precision Nanosystems. He chalks up the genomic nature of biology, the fact that genomes are information-based, the breadth and validation of the genomic medicine toolbox, and the democratization of genomic medicine development as reasons to be bullish. Join Dr. Taylor and me for a conversation on why RNA and DNA delivery are game-changers, and what Precision Nanosystems is doing to push the ball downfield.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Foundations Of Flexible Manufacturing With Sarepta Therapeutics' Brian Winstead

Mon, 01 Nov 2021 06:00:00 -0400

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Is "flexible manufacturing" just another empty buzz concept concocted by the biopharma equipment marketing community, or does it demonstrate real benefit to bioprocess pros and their companies? On this episode, we sit down with Sarepta Therapeutics Director of Pharmaceutical Engineering Brian Winstead and Project Farma VP Tony Khoury to discuss what flexible manufacturing means, where it works, and where it doesn't. Listen in as Winstead shares the flexible manufacturing philosophy at Sarepta.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The CDMO Capacity Crunch With Discovery Labs' Audrey Greenberg and Iovance Biotherapeutics' Sumit Verma

Mon, 25 Oct 2021 06:00:00 -0400

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While nary a day goes by without a shovel breaking ground on a new CDMO buildout, biopharmas remain hard-pressed to secure the outsourced manufacturing space and expertise needed to meet timelines, satisfy investors, and drive competitive advantage. On this episode of the Business of Biotech, we're tackling the CDMO capacity crunch from every angle in a spirited discussion with Discovery Labs & Center for Breakthrough Medicines Co-Founder Audrey Greenberg, Iovance SVP of Commercial Manufacturing Sumit Verma, and Project Farma CEO Anshul Mangal.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

The Clinical Trials Conundrum with Allan Shaw

Mon, 18 Oct 2021 06:00:00 -0400

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The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're expensive. On this episode of the Business of Biotech, friend and frequent guest Allan Shaw shares some strong opinions on what's wrong with clinical trials, and what the industry (read: you) and the FDA need to do to make them right.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

CMC Developability Assessments For Rapid Ph.1 Entry with AltruBio's Gene Lee, Ph.D.

Mon, 11 Oct 2021 06:00:00 -0400

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Fresh on the heels of an outstanding talk with AltruBio President & CEO Judy Chou, Ph.D., the company's VP of Technology Development, Gene Lee, Ph.D., joins the Business of Biotech for a deep dive into the importance of CMC developability assessments. On this episode we cover the key points CMC developability assessments must address, when to begin them, how to go about them efficiently, and why they're integral to early milestones and rapid entry into Phase 1 clinical trials.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

CDMO With A Pipeline with Forge Biologics President & CEO Dr. Timothy J. Miller

Mon, 04 Oct 2021 06:00:00 -0400

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Inspired to develop a treatment for Infantile Krabbe Disease, the founders of Forge Biologics picked a unique but strategic approach to funding the initiative. They built a CDMO that aims to become one of the largest on the planet in the cell and gene therapy space. On this week's episode of the Business of Biotech podcast, co-founder, President, & CEO Timothy J. Miller, Ph.D. joins us to discuss the strategy, why it was a no-brainer given the white-hot market for contract development and manufacturing space, the state of the biologics manufacturing capacity crunch, and what companies like Forge are doing about it.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Building A DNA Delivery System With Poseida Tx CEO Eric Ostertag, M.D., Ph.D.

Mon, 27 Sep 2021 06:00:00 -0400

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Eric Ostertag, M.D., Ph.D., wanted to launch a biotech. When University of Pennsylvania department heads said no to a licensing deal for lack of a CEO, Dr. Ostertag convinced them he could run the company. Many bold moves later, Dr. Ostertag is founder and CEO at Poseida Therapeutics, a company that's doing things never seen before in the field of CAR T-cell and gene therapies for multiple myeloma and prostate cancer. On this week's episode of The Business of Biotech, Dr. Ostertag gives us a tour of the architecture supporting Poseida's unique 3-tiered development and manufacturing platform.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

From Bayer To Startup Bio With AltruBio's Dr. Judy Chou

Mon, 20 Sep 2021 06:00:00 -0400

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Judy Chou, Ph.D. was a big-pharma MVP. She earned her academic stripes in the hallowed halls of Yale, the Max Planck Institute, and Harvard Medical School before taking on principal scientist roles at AbbVie, Pfizer, and Genentech. That experience parlayed into SVP positions at Tanvex, Medvation, back to Pfizer, and on to Bayer, where she was most recently SVP and Global Head of Biotech before taking the leap into the startup scene as President & CEO at AltruBio in 2020. On today's episode of the Business of Biotech, Dr. Chou shares personal and professional insight into how she's applied what she learned in Big Bio to transform a clinical-stage developer of mAbs designed to treat a broad range of immunological diseases.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Creating Competitive Differentiation With Allan Shaw

Mon, 13 Sep 2021 06:00:00 -0400

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The biologic therapy market is crowded, and judging by the recent parade of IPOs, competition for investment, mindshare, talent, and ultimately share of market is only getting stiffer. On this week's episode of the Business of Biotech, our friend and biotech business guru Allan Shaw joins us for a foundational conversation on creating competitive differentiation at every stage of biopharma growth. We cover the connections between developmental strategy and the competitive commercial landscape, the moral obligation to differentiate between promise and plausibility, the commoditization of brilliant science, and the necessity to align balanced plans with wild dreams.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Gene Therapy Manufacturing Advances With Aruvant CTO Dr. Palani Palaniappan

Mon, 06 Sep 2021 06:00:00 -0400

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Aruvant Chief Technology Officer Palani Palaniappan, Ph.D. joins the Business of Biotech with special guest Tony Khoury, EVP at Project Farma to discuss recent advances in gene therapy manufacturing. We cover the role of artificial intelligence in the discovery of AAV capsids that can avoid the immune system, the growth of non-viral vectors, the scale up advantages of suspension technologies versus adherence, the evolution of the regulatory environment, manufacturing capacity and talent constraints, and much, much more.

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iNK T-Cell Immuno-oncology For Solid Tumors With Dr. Ian Walters

Mon, 30 Aug 2021 06:00:00 -0400

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Dr. Ian Walters' company, Portage Biotech, is focused on addressing the 75% of cancer patients who show no, or limited, response to existing therapies such as checkpoint inhibitors. Leading that charge are the company's invariant natural killer T cell agonists, designed to activate the innate and adaptive immune system, as well as a growing portfolio of proteins, antibodies, and small molecules. On this episode of the Business of Biotech, Dr. Walters shares what's fueling the company's progress, including its unique financing strategy and its approach to de-risking platform development for novel immuno oncology therapies.

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How to Apply For BTD And Win It With Drs. Ira Gupta & Shanthi Ganeshan

Mon, 23 Aug 2021 06:00:00 -0400

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Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK has a few BTDs under its belt. Dr. Gupta is VP of Medicine Development at GSK and Dr. Ganeshan is formerly VP of Global Regulatory Affairs there, having recently joined Gilead as Head of Regulatory for Oncology. On this episode, we go deep on how to apply for--and win--breakthrough therapy designation with two women who couldn't be more qualified for the discussion.

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Cold Chain Integrity & Sustainability With Celyad Oncology's Thomas Lequertier

Mon, 16 Aug 2021 06:00:00 -0400

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Maintaining therapeutic integrity through cryopreservation and super cold supply chains have challenged, and continue to vex, biologics producers. On this episode of the Business of Biotech, Celyad Oncology Head of Cell Therapy Manufacturing Thomas Lequertier shares best practices for the cryopreservation of cell therapies while minimizing cell degradation, maintaining their integrity on the journey from the lab to the patient, and what the future holds for cold chain biologic therapy logistics.

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Peptides & Proteins: Resetting The Immune System With Revolo CEO Jonathan Rigby

Mon, 09 Aug 2021 06:00:00 -0400

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Revolo Biotherapeutics has entered phase 2 clinical studies of two molecules for autoimmune or allergic diseases that act to reset the immune system “upstream,” or ahead of the inflammatory cascade. On this episode of the Business of Biotech, Revolo CEO Jonathan Rigby shares the outsourced manufacturing strategy behind the endeavor, why it's so important to avoid immune suppression and how the therapies work to avoid it, and how the company managed to raise a $53 million Series B to fund development in the midst of a raging global pandemic.

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Intranasal Prophylactics For Flu & Coronavirus With Leyden Labs' Koenraad Weidhaup

Mon, 02 Aug 2021 06:00:00 -0400

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As Leyden Labs Founder & CEO Koenraad Wiedhaup puts it, we breathe in galaxies of viruses on a daily basis. As those viruses multiply and mutate, our approach to mitigating their risks is largely reactive. That's why his new company is busy developing a prophylactic approach to protecting populations from a host of influenza and coronaviruses via a self-administered intranasal spray. Learn how the company came to be, how its development efforts were buoyed by a recent $40 million series A investment, and why Wiedhaup believes intranasal prophylactics are ready to play a role in prevention of the next pandemic on this episode of the Business of Biotech podcast.

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Unpacking the SPAC With Allan Shaw

Mon, 26 Jul 2021 06:00:00 -0400

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Special-purpose acquisition companies, or SPACs, are all the rage as start-up financing vehicles go, and they're particularly well-suited for emerging biopharma companies. On this episode of the Business of Biotech, we dig deep into the advantages, limitations, and potential pitfalls of the SPAC with a man who was executing SPAC deals before SPAC deals were cool. Whether you're a biotech investor or a biopharma leader looking to acquire or be acquired, you'll want to tune in to this episode for insight into the special-purpose acquisition company strategy.

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A Vaccine For Type 1 Diabetes With Diamyd Medical's Dr. Ulf Hannelius

Mon, 19 Jul 2021 06:00:00 -0400

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As leaders at Diamyd Medical made plans to manufacture clinical supply of therapies aimed at preserving and restoring insulin production in Type 1 diabetes patients, outsourced production was on the table. Then, the company doubled down on its intentions and built out its own manufacturing facility. On this week's episode of The Business of Biotech, Diamyd Medical President & CEO Dr. Ulf Hannelius tells us all about the therapies his company is developing, plus the why and the how behind the company's choice to manufacture them in-house.

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CAR T Process Automation With Kite Pharma's Charles Calderaro III

Mon, 12 Jul 2021 06:00:00 -0400

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Kite Pharma Global Head of Technical Operations Chuck Calderaro joins the Business of Biotech for a conversation on a dichotomy in the CAR T-cell supply chain: the inherent source material advantages and subsequent logistical challenges associated with the distribution of cell therapies. Calderaro discusses the implementation of manufacturing automation at Kite, the manufacturing hurdles that remain, and reflects on the company's autologous and allogeneic roadmaps.

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Biopharma PR 101 with Matt Middleman, M.D.

Mon, 05 Jul 2021 06:00:00 -0400

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When is the appropriate time for a new life sciences company to wind up the PR machine? What's the difference between public and investor relations, and how do they complement each other? What's newsworthy? What's not? What are the latest tools of the trade in an increasingly social-driven PR practice? What results should you expect, and how are those results measured? On this episode of the Business of Biotech, we address these questions with physician and professor-turned public relations practitioner extraordinaire Matt Middleman, M.D. , founding partner and CEO at LifeSci Communications, LLC.

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A Scale-Up Story with Solis BioDyne Drs. Kadri Artma and Angela Vaasa

Mon, 28 Jun 2021 06:00:00 -0400

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When the pandemic hit, Solis Biodyne found its manufacturing capacity stretched to its limit. In short order, it doubled, and then tripled, its manufacturing capacity. Then it doubled, and then tripled, its workforce. Meanwhile, it adopted a host of new platforms to serve the demand of its clients. Drs. Kadri Artma and Angela Vassa join this episode of the Business of Biotech to take us behind the scenes and tell us the scale up story that's allowing the renowned producer of reagents to the life sciences industry to meet market demands.

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Academia + Industry with BridgeBio's Dr. Michael Henderson

Mon, 21 Jun 2021 05:00:00 -0400

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BridgeBio has a whopping 18+ pre-clinical to clinical-stage candidates in its pipeline representing an impressive array of modalities and targets. It boasts a couple of commercial wins under its belt. The company is no stranger to developing business strategies for success. Central to that success are partnerships with scientists and researchers to fuel pipeline expansion. On this episode of The Business of Biotech, BridgeBio Chief Business Officer Michael Henderson, M.D. walks us through the formula behind the company's academia-led growth strategy.

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GSK's Michael Mehler On The Cell & Gene Talent Crunch

Mon, 14 Jun 2021 06:00:00 -0400

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Michael Mehler honed his cell therapy chops at Adaptimmune before joining GSK as Senior Clinical Development Manager, Cell Therapy Oncology in 2017. He and Cell & Gene chief editor Erin Harris joined the Business of Biotech podcast for a candid and detailed discussion on finding, hiring, and retaining cell and gene therapy professionals, facilitating their on-going training, bridging the gap between academia and industry, why clinical feedback is an underappreciated source of intelligence, and the resources available to cell and gene developers to further their "pipelines" of bench-level talent.

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RNA-Engineered Cell Therapy with Cartesian's Dr. Murat Kalayoglu

Mon, 07 Jun 2021 06:00:00 -0400

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Cartesian President & CEO Murat Kalayoglu, M.D., Ph.D. has led three of his company's six autoimmune, oncology, and respiratory candidates through Phase I/II clinical trials and two more of them are on the cusp of entering Phase I this year. With so many programs in and entering the clinic, he's a great choice for a conversation on GMP expectations for phase I first-in-human trials. Glean insight from Cartesian's experiences and learn about the company's novel approach to RNA-engineered cell therapies for oncology and beyond on this episode of The Business of Biotech.

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Real-Time Clinical Analysis with Glympse Bio's Dr. Caroline Loew

Mon, 31 May 2021 06:00:00 -0400

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On this episode of the Business of Biotech, we're going deep with Glympse Bio President & CEO Dr. Caroline Loew to explore the possibilities and implications of the in-vivo, bioengineered, tunable sensors the company is developing for diagnostic and prognostic purposes in protease-mediates diseases. Currently in the clinic with applications for Non-Alcoholic Steatohepatitis and other fibrotic diseases as well as Non-Small Cell Lung Cancer and other solid tumors, Glympse is unlocking an unprecedented view of near-real-time therapeutic response and therapeutic efficacy that could have big implications on the way biologics are developed, refined, and studied in the clinic.

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AAV & Lentivirus Gene Therapies with Sio Gene Therapeutics' Dr. Pavan Cheruvu

Mon, 24 May 2021 05:00:00 -0400

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Fresh on the heels of a significant data readout on its AXO-AAV-GM1 candidate at the recent ASGCT meeting, Sio Gene Therapies CEO Pavan Cheruvu, M.D. joins the Business of Biotech podcast. We discuss Dr. Cheruvu's formative years and inspiration, his company's origins, its progress developing AAV and lentiviral gene therapies to treat GM1 gangliosidosis, Tay-Sachs / Sandhoff disease, and Parkinson's disease, and the challenges the company has overcome in a hybrid manufacturing environment that will ultimately transfer entirely in-house.

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Med Device Meets Biopharma with OncoSec's Dan O'Connor, J.D.

Mon, 17 May 2021 06:00:00 -0400

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OncoSec CEO & Director Dan O'Connor, J.D. joins the Business of Biotech to discuss his company's development of proprietary application and injection technologies for direct delivery of its pipeline of immunotherapeutic candidates and combination therapies into the tumor environment. O'Connor shares leadership lessons gleaned from his service as a Captain in the United States Marine Corps during Operation Desert Shield, and how he's applied those lessons as his company charts the manufacturing and regulatory challenges along its unique development timeline.

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Drug Development: From Bench To Bedside With Allan Shaw

Mon, 10 May 2021 05:00:00 -0400

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CFO to the biopharma stars and frequent Business of Biotech guest Allan Shaw joins us for a candid discussion on the keys to efficiency as you move your candidate from the bench to the bedside. Shaw shares the common perils of insular thinking in biopharma and offers practical advice for avoiding those pitfalls. We discuss the value of being early in the context of the current biopharma market — early to study, early to differentiate, early to kill if necessary, and early to fund your project on its journey to the clinic.

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Digital Transformation In Cell Therapy with Organicell Drs. Mari Mitrani & Michael Bellio

Mon, 03 May 2021 05:00:00 -0400

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Drs. Mari Mitrani, CSO and Michael Bellio, Laboratory Director are young pioneers in the study of the therapeutic potential of exosomes. Their research leans heavily into the digital realm, leveraging computational biology, bioinformatics, large-scale sequencing, proteomics, and mass spectrometry to analyze perinatal tissue-secreted exosomes and their impact on a host of indications the company is exploring. On this episode of The Business Of Biotech, Drs. Mitrani and Bellio offer insight into the digital discovery and manufacturing automation technologies in use at Organicell.

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Biopharma Regulatory Requirements with bluebird bio's Scott Cleve

Mon, 26 Apr 2021 05:00:00 -0400

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Scott Cleve brings an entire career dedicated to the mastery of global biopharma regulatory standards to his role as Vice President of Regulatory Operations and Compliance at bluebird bio. Join Cleve, host Matt Pillar, and Erin Harris, chief editor at Cell & Gene, for a candid discussion on the regulatory trends shaping the advance of bluebird's pipeline of gene therapies for the treatment of serious, life-altering diseases including Cerebral Adrenoleukodystrophy, Multiple Myeloma, Transfusion-Dependent β-Thalassemia, and Sickle Cell Disease.

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Filling A Vaccine Void with Cue Biopharma's Dan Passeri, J.D.

Mon, 19 Apr 2021 06:00:00 -0400

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CUE Biopharma CEO Dan Passeri, J.D. joins us for a discussion on the development of the company's Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares the rationale behind his belief in the company's immunotherapeutic approach, and how the CUE-100 series of candidates in its pipeline are being developed to address the scourge of HPV-related head, neck, and other cancers expected in pre-HPV vaccine populations.

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Supercharging An ADC Program With SOTIO CEO Dr. Radek Špíšek

Mon, 12 Apr 2021 06:00:00 -0400

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SOTIO isn't your typical single-molecule, single-platform biopharma. Since its inception, the company has supported 14 clinical trials of oncology therapeutics developed leveraging multiple platform technologies. On this episode of The Business of Biotech, SOTIO Global CEO Radek Špíšek takes a deep dive into the development, HR, and funding strategies the company has deployed to build its IL-15, immune cell therapy, and antibody-drug conjugate candidates.

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mAb Manufacturing with Rezolute Bio CEO Nevan Charles Elam, JD

Sun, 04 Apr 2021 06:00:00 -0400

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Nevan Charles Elam, JD founded Rezolute Bio ten years ago on the heels of a complex career intersecting law, high tech, and life sciences. On this episode of the Business of Biotech, Elam shares the company's rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses Rezolute's approach to process development and manufacturing.

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Cell Therapy Platforms With Precigen CEO Dr. Helen Sabzevari

Sun, 28 Mar 2021 06:00:00 -0400

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Learn how Precigen is advancing a deep pipeline of immuno-oncology, infectious disease, and autoimmune disorder candidates through the clinic on the back of its UltraCAR-T platform. CEO Dr. Helen Sabzevari describes the promise of the platform to change the CAR T complexity paradigm with an overnight manufacturing process to affect patients in urgent need of timely therapy.

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A CFO's Prescription For Biopharma Success With Allan Shaw

Sun, 21 Mar 2021 06:00:00 -0400

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Friend of the show and life sciences CFO extraordinaire Allan Shaw joins us for a discussion on the steps to biopharma success from an insider's perspective. We discuss the incremental steps that are necessary and common to success in the biologic therapy space, and the mistakes Shaw has seen in his many engagements with new and emerging biotech firms. From capital resource allocation to personnel decision making to preparing for the bubble to burst, listen in as Shaw shares his unfiltered advice.

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A Biopharma Pivot with Compugen's Dr. Anat Cohen-Dayag

Mon, 15 Mar 2021 05:00:00 -0400

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Dr. Anat Cohen-Dayag transformed her company from a computational biology service provider to a clinical-stage biopharma with multiple cancer immunotherapy candidates, and she did it in a remarkably short period of time. Listen in as she discusses the human resources, financial, and capital strategies she deployed to build a biotech on the back of computational science, and shares her vision for the future of drug discovery.

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Preparing For The Clinic With Amolyt Pharma CEO Dr. Thierry Abribat

Mon, 08 Mar 2021 06:00:00 -0500

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Amolyt Pharma is developing a therapeutic peptide program targeting rare endocrine and metabolic diseases including hypoparathyroidism and acromegaly. Fresh on the heels of its lead candidate's foray into phase 1 clinical trials, we're joined by the company's founder and CEO, Thierry Abribat, Ph.D., for a deep dive into Amolyt Pharma's pre-clinical preparation, including his financing, talent acquisition, and clinical study strategies.

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Pioneering Antiviral Conjugates with Cidara's Dr. Jeff Stein

Mon, 01 Mar 2021 04:00:00 -0500

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Cidara Therapeutics President and CEO Dr. Jeff Stein joins the Business of Biotech to discuss his career mission to battle microbial organisms and his company's development of a novel approach to producing immunotherapeutic antivirals that couple potent antivirals to a human antibody fragment. We discuss the company's manufacturing approach, which Dr. Stein anticipates yielding a low-cost alternative to standards of care in multiple antiviral indications.

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AI & The Human Genome With Dr. Dietrich Stephan

Mon, 22 Feb 2021 05:00:00 -0500

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From his Fellowship at the NIH Human Genome Research Institute to his leadership as CEO at NeuBase Therapeutics, Dr. Dietrich Stephan is recognized as a pioneer in the field of genomic precision medicine. On this episode of The Business of Biotech, Dr. Stephan shares how artificial intelligence is shaping the acceleration of genomic medicine discovery at NeuBase and beyond, with plenty of practical insight on how to adopt and leverage the technology.

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The FDA's Progressive Appeal ft. Allan Shaw

Mon, 15 Feb 2021 06:00:00 -0500

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Allan Shaw rejoins the Business of Biotech with candid and deep commentary on the unprecedented pace of biopharma innovation, and how the FDA is doing in its equally unprecedented effort to keep pace. In particular, Shaw shares his take on the advance of cell and gene therapies, his observation on the outsized approval rate for orphan disease and oncology therapies, and much, much more. *Editor's note: the review of Biogen's Aducanumab, referenced here as taking place in the March timeframe, was extended shortly after this episode was recorded.

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Celyad CEO Filippo Petti On In-House Allogeneic Cell Therapy Manufacturing

Mon, 08 Feb 2021 05:00:00 -0500

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Join Matt Pillar and Erin Harris as we catch up with Celyad Oncology chief Filippo Petti on his company's differentiated approach to the discovery and development of allogeneic CAR-T cell therapy candidates for the treatment of cancer. Petti shares the technology and how the company intends to scale in-house manufacturing in its Belgium-based manufacturing facility.

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Keeping Cell Therapy Clinicals On The Rails With Brian Culley

Mon, 01 Feb 2021 06:00:00 -0500

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Like most biotechs, Lineage Cell Therapeutics faced some significant challenges as it navigated multiple clinical trials, one of them in an aging, at-risk population, during a global pandemic. On this episode, CEO Brian Culley tells Erin Harris and Matt Pillar how he kept the company's programs for OpRegen® (dry AMD with GA) and OPC1 (acute spinal cord injury) running on time despite the disruptions.

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Orchard Tx's Bobby Gaspar On Manufacturing Hematopoietic Stem Cells

Sun, 24 Jan 2021 06:00:00 -0500

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In this third installment of our cell & gene therapy manufacturing miniseries, Erin Harris and Matt Pillar sit down with Orchard Therapeutics CEO Dr. Bobby Gaspar. An update on the company's pipeline progress gives way to an in-depth discussion on the process challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders.

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Acepodia's Approach To ACC & CAR Manufacturing Scalability

Mon, 18 Jan 2021 06:00:00 -0500

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Acepodia CEO, President, & Co-founder Dr. Sonny Hsiao and Dr. Mark Gilbert, VP of R&D, join Erin Harris and Matt Pillar for a discussion on the company's approach to dramatically reducing the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates.

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The AAV Vector Challenge With Selecta's Dr. Carsten Brunn

Mon, 11 Jan 2021 01:00:00 -0500

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The Business of Biotech kicks off our Cell & Gene Miniseries with Dr. Carsten Brunn, President & CEO at Selecta Biosciences. Guest host Erin Harris, chief editor at cellandgene.com, joins us for a discussion on Selecta's ImmTOR platform and how the company is addressing the immunogenicity of adeno-associated virus (AAV) vectors challenge faced by gene therapy companies.

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A Look Behind, A Look Ahead With Allan Shaw

Mon, 04 Jan 2021 07:00:00 -0500

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The Business Of Biotech kicks off the new year with an up-close-and-personal talk with biotech investor and CFO extraordinaire Allan Shaw. We talk through last year's ups and downs and do a little prognosticating on what we're feeling bullish about--from unprecedented regulatory action to exciting progress on the cell and gene front--as we head into the new year.

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Manipulating Milestones In Pandemic Times With AGTC's Sue Washer

Mon, 21 Dec 2020 08:00:00 -0500

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The COVID-19 pandemic continues to disrupt biopharma clinical trials, especially those conducted with at-risk patient populations. From patient recruitment to data collection, clinical trials execution became considerably more challenging in 2020. On this episode of The Business Of Biotech, AGTC CEO Sue Washer gives us a behind-the-scenes look at the creative measures her company took to serve a geographically dispersed clinical patient population and ensure her company met clinical milestones.

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Gene Therapy Manufacturing At-Scale With Geoff MacKay

Mon, 07 Dec 2020 09:00:00 -0500

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Listen in as AVROBIO President & CEO Geoff MacKay tells the Business Of Biotech about the technology his company is using to drive at-scale gene therapy production for lysosomal disorders, replete with the story of how the company overcame a major manufacturing investment that didn't quite work as planned.

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Bacterial Therapy: Modulation of the Microbiome With Dr. Bernat Olle

Mon, 23 Nov 2020 09:00:00 -0500

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Dr. Bernat Olle discusses the pioneering work his company, Vedanta Biosciences, is doing to modulate the immune system and provide colonization resistance against infectious pathogens—particularly those contracted during hospital stays. Learn about a company pioneering the exploration of immune-regulating and immune-potentiating bacteria.

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Foundations Of Biopharma Finance With Smital Shah

Mon, 09 Nov 2020 09:00:00 -0500

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Smital Shah brings a trifecta of chemical engineering, consulting, and finance experience earned at heavyweight companies like JP Morgan, Leerink, and Gilead to her role at clinical-stage RNA therapy biotech ProQR Therapeutics. We sat down for a deep conversation on the recipe for successful business and finance operations in an emerging biopharma organization.

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Off-The-Shelf CAR T-Cell Therapy with John McKearn, Ph.D.

Mon, 26 Oct 2020 13:00:00 -0400

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Find out what drove John McKearn, Ph.D. & CEO at Wugen, out of the lab at Pfizer and on to his quest to develop off-the-shelf cell therapies for T-Cell leukemias and lymphomas, Acute Myeloid Leukemia, and Multiple Myeloma.

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CAR T Therapy Cost Control With Laurence Cooper, M.D., Ph.D.

Tue, 13 Oct 2020 08:00:00 -0400

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Controlling the cost of personalized medicine: We go behind the scenes of the effort to build a system that simplifies production and reduces the cost of non-viral T cell therapies with Ziopharm Oncology CEO Laurence Cooper, M.D., Ph.D.

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010: Gap Analysis With Dr. Pablo Valenzuela & Cristián Hernández-Cuevas

Mon, 28 Sep 2020 07:00:00 -0400

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We're joined by biopharma pioneer Dr. Pablo Valenzuela and rising star Cristián Hernández-Cuevas for a candid discussion on biopharma's compute power revolution, the influence of technology on gap analyses and next steps for emerging biopharma, and what's driving biotech growth in South America.

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009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle

Mon, 21 Sep 2020 07:00:00 -0400

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Bolt Biotherapeutics CMO Dr. Edith Perez and VP of CMC & Quality Dr. Nathan Ihle bring a unique combination of patient and production process expertise to the table for an enlightening conversation on preparing chemistry, manufacturing, and controls for an IND and ensuing first in-human studies.

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008: Commitment To GMP With Dr. Shabbir Anik

Mon, 14 Sep 2020 08:00:00 -0400

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Sutro Biopharma Chief Technical Operations Officer Shabbir Anik has contributed to 15 INDs and 10 NDA’s over the course of his distinguished career, making him a great choice to sit down for a chat about the mechanics of GMP and CMC strategy in new and emerging biopharma enterprises. Here, Dr. Anik shares stories from the front lines of Sutro's effort to move its antibody conjugate, bispecific antibody, and cytokine derivative candidates forward.

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007: Quality Data For FDA Submissions With Dr. Robert Hariri

Tue, 08 Sep 2020 07:00:00 -0400

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If ever a biotech unwittingly begged for FDA scrutiny by virtue of its business model, it was Celularity. The company is working on a host of biologic therapies, the development of which is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. That's an approach that simply begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent discussion on the importance of data quality and complete master files for FDA submissions.

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Summer Sessions 8: Dr. Gaurav Shah, Rocket's Chief Gene Therapist & Virtuoso

Mon, 31 Aug 2020 07:00:00 -0400

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Rocket Pharmaceuticals CEO Dr. Gaurav Shah shares the parallels between his leadership in the gene therapy space and his successes as a Grammy®-nominated recording artist with the Business of Biotech podcast. This episode is full of actionable insight on the inspiration behind how Dr. Shah manages the science and process side of the business, his employees, financing, and stakeholder expectations by drawing from has passion for—and understanding of—music.

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Summer Sessions 7: Dr. Randall Schatzman & The New Fundraising Norm

Mon, 24 Aug 2020 07:00:00 -0400

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Dr. Randy Schatzman, CEO at Bolt Biotherapeutics, discusses his company's adjustment to pandemic disruption on the fundraising trail. He walks us through the remote-fundraising strategy that landed Bolt's recent $93.5 million Series C financing round, and how the company is moving towards an IPO in spite of market, civil, and political tumult.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Summer Sessions 6: Alexis Peyroles On Myeloid Cells, Transplants, & Immuno-Oncology Inspiration

Mon, 17 Aug 2020 07:00:00 -0400

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OSE Immunotherapeutics CEO Alexis Peyroles joins The Business Of Biotech: Summer Executive Sessions to discuss myeloid cells' role in immunology, why a team of transplant specialists is key to his company's therapeutic development approach, and creating differentiation as a clinical-stage immunotherapy company in an ever-growing sea of competitors.

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Summer Sessions 5: Dr. Christopher Anzalone Takes RNAi Beyond The Liver

Mon, 10 Aug 2020 07:00:00 -0400

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Arrowhead Pharma CEO Christopher Anzalone, Ph.D. gives us the inside story on the stake his company claimed on the now re-burgeoning RNAi space, the indications his company is targeting beyond liver disease, and how it's addressing the development and process challenges that must be overcome to further progress RNAi beyond the liver.

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Summer Sessions 4: Dr. Loretta Itri On Taking ADCs Across The Finish Line

Mon, 03 Aug 2020 07:00:00 -0400

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While Immunomedics CMO Loretta Itri, M.D. is no stranger to taking drugs across the commercial finish line in big pharma, her most recent win with TRODELVY was very, very different. Here, Dr. Itri shares insight on her small biopharma's first commercial launch, the manufacturing and regulatory challenges overcome to get there, and why ADCs are coming of age.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

Summer Sessions 3: Jeff Wolf Builds Heat Bio On Its Therapeutic Platform

Mon, 27 Jul 2020 07:00:00 -0400

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Heat Biologics founder and CEO Jeff Wolf took a creative approach to building his organization. With the science behind his company's platform to activate immune responses against pathogenic or cancer antigens in place, he proceeded to structure the organization and its people in a strategic fashion to support that platform. Learn how he did it–and how Heat's management philosophy is driving innovation and efficiency there–on this episode of The Business Of Biotech: Summer Executive Sessions.

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Summer Sessions 2: Dr. Paul Wotton Solves A COVID-19 Workforce Crisis

Mon, 20 Jul 2020 07:00:00 -0400

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Obsidian Therapeutics CEO Dr. Paul Wotton didn't let pandemic-induced workforce restrictions impede his biopharma's progress. Instead, his team developed a software system purpose-built for biotechs to manage personnel and equipment per ever-changing guidelines. On this episode of The Business Of Biotech: Summer Executive Sessions, Wotton tells us how the application, dubbed SWFT, was built, how it's working, and why Obsidian has made it available to more than 30 (and growing) other biotechs, free of charge.

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Summer Sessions 1: Ivor Macleod brings big-league finance experience to an emerging biotech

Mon, 13 Jul 2020 06:00:00 -0400

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The Business Of Biotech "Summer Executive Sessions" kick off with a candid conversation with Athersys CFO Ivor Macleod, who brings years of finance leadership at Roche, Merck, and other big pharmas to Athersys as the company readies its lead candidate for life beyond clinical trials. Join us for a discussion on how Macleod is applying big-league finance principles to an emerging biopharma company, and what he's learned about managing funds in a pre-commercial biotech environment. Produced by bioprocessonline.com with the support of Cytiva.

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006: Leaving The Incubator With Kavitha Iyer Rodrigues

Mon, 29 Jun 2020 07:00:00 -0400

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A strategic departure from the biotech incubator requires the coordination of moving parts aplenty. Development timelines, seed funding, facilities development, and team dynamics are just a sampling of the critical aspects discussed here with multi-time founder and Zumutor Biologics CEO Kavitha Iyer Rodrigues.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

005: Building A Biotech All-Star Team With Vivek Ramaswamy

Mon, 15 Jun 2020 08:00:00 -0400

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On this episode of The Business Of Biotech, we're talking with Vivek Ramaswamy, who launched Roivant Sciences—parent company to a full 20 biopharma companies with dozens of pre-clinical through phase 3 candidates in their collective pipelines—back in 2014. Spinning them all up so quickly has required a skillful approach to recruiting—and maintaining—the company’s talent pool.Listen in as Ramaswamy walks through the art, science, and nuance of building an all-star biotech team.

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004: Finding Funding In Volatile Times With Dr. Ben Zeskind

Mon, 01 Jun 2020 07:00:00 -0400

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This week's Business Of Biotech pod features Immuneering CEO Dr. Ben Zeskind, who launched his biotech on the back of creative financing in the throes of the Great Recession. A pivot into biopharma landed Immuneering a $20 million series A round to develop its pipeline--at the outset of the COVID-19 pandemic. Dr. Zeskind joins us for a candid and instructive discussion on getting creative when the economy isn't exactly booming.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.

003: Building The Biopharma Pitch With Leslie Williams

Mon, 18 May 2020 07:00:00 -0400

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Leslie Williams is a multi-time biotech founder and board member who's honed her pitch-building skills to a fine point. On this episode of The Business Of Biotech, Williams shares best practices for building your pitch deck, how to draw out the nuance that makes your story unique, what to expect in your initial pitch session and follow-on meetings, and why the human element trumps everything else in an otherwise formulaic pitch process.

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002: The Biopharma Exit Strategy With Dr. Francois Nader

Mon, 04 May 2020 08:00:00 -0400

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Every emerging biopharma company shares a common goal: creating value for its employees, its board, its investors, and ultimately, patients. Along the way, that value creation might get a boost from an IPO, a merger, an acquisition, or steady growth as a private entity. On this episode of The Business Of Biotech, we talk with Dr. Francois Nader—a man who's orchestrated several wildly successful biotech exits—about why it's imperative to begin with the end in mind, and how to navigate your options when the time is right.

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001: The Business Of Biotech: Allan Shaw

Mon, 20 Apr 2020 15:00:00 -0400

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There are few better suited to advise the leaders of new and emerging biopharma companies on the building blocks of a biotech startup than Allan Shaw. That's why we chose Shaw to help us kick off our Business of Biotech podcast series with an overview of the episodes to come. In addition to his work on the financial front lines of several biotechs, Shaw holds multiple board of director roles with startup biopharma firms, and he advises dozens more in his role as special adviser. On this episode, we'll preview the series and absorb Shaw's to-the-point, practical advice on winning finances, building a pitch, assembling a biotech all-star team, leaving the incubator, navigating early regulatory considerations, and a whole lot more.

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Business Of Biotech Trailer

Tue, 14 Apr 2020 14:00:00 -0400

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Produced by BioProcess Online, the Business Of Biotech serves as a resource for the leaders of new and emerging biopharmas. We've lined up an incredible group of guests to join us—all of them founders who have taken biotherapy ideas and successfully turned them into clinical realities. Here’s a preview of how the series, which is focused on the financial, organizational, HR, and regulatory aspects of launching a biopharma company, will play out.

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.