The BioCentury Show

Ep. 114 - Roivant’s Matt Gline on commercial launches and the future of the vant model

Thu, 09 Jul 2026 21:00:00 -0400

Roivant CEO Matt Gline calls the company’s move beyond spinning out subsidiary “vants” to concentrating on late-stage programs and commercial launches less a pivot than an evolution toward an original goal, which could soon be realized with the approval and launch of brepocitinib this year.
In conversation with Lindsay Martin on The BioCentury Show, Gline discussed how Roivant’s initial hub-and-spoke approach has provided the foundation needed for the company to develop and commercialize its portfolio now, including lead program JAK-1/TYK2 inhibitor brepocitinib. Gline also discussed how he views AI at Roivant and more broadly in biopharma R&D, the science behind Roivant’s next most advanced program, Phase III anti-FcRN mAb imeroprubart and the lessons he’s taking from a “graduating class” of biotechs that have launched programs, like Alnylam and Argenx S.E.

View full story: https://www.biocentury.com/article/660059

#DrugDevelopment #BiotechInnovation #Commercialization #ArtificialIntelligence #BiopharmaStrategy

00:00 - Introduction
00:42 - Roivant’s Evolution
09:19 - AI in R&D
17:48 - Lead Asset Brepocitinib
28:23 - Anti-FcRN mAb Imeroprubart
32:23 - China
37:55 - What’s Next for Roivant

Ep. 113 - Frank Jiang on Hengrui’s rise and China’s new era of biopharma dealmaking

Thu, 25 Jun 2026 19:00:00 -0400

Launched in the 1970s as a generics company, Hengrui has become China’s leading innovator in R&D and dealmaking, with more than 100 NMEs in the pipeline and broad alliances with GSK and BMS. Under the leadership of Frank Jiang, EVP and chief strategy officer, Hengrui is engaging in a range of dealmaking and using its partnerships as stepping stones toward its goal of becoming one of the top biopharma companies in the world.
In conversation with Executive Editor Jeff Cranmer on The BioCentury Show, Jiang describes the evolution of China’s biotech ecosystem — and Hengrui's — toward first-order innovation and the changing nature of deals in China, from straightforward licensing deals with “safe money” to NewCo deals and “co-co” partnerships.

View full story: https://www.biocentury.com/article/659912

#ChinaBiotech #BiopharmaInnovation #DrugDevelopment #StrategicPartnerships #GlobalBiotech

00:00 - Introduction
01:32 - Evolution of China Biotech
08:43 - China Deals
17:23 - Hengrui’s Evolution
24:43 - Shareholder Base
26:42 - Deals

Ep. 112 - Chris Arendt on rebuilding Takeda for AI

Wed, 17 Jun 2026 21:00:00 -0400

Chris Arendt, CSO of Takeda, likens the AI overhaul at the pharma to gutting and rebuilding an old house, from the plumbing and electrical up, while you’re still living there. In a Fireside Chat at Grand Rounds U.S. in Seattle, Arendt sat down with Editor in Chief Simone Fishburn to discuss how Takeda is integrating AI across R&D, in and beyond the science, while still executing on the active programs in drug development.

View full story: https://www.biocentury.com/article/659807

#ArtificialIntelligence #PharmaInnovation #DrugDevelopment #DigitalTransformation #ResearchAndDevelopment

00:00 - Introduction
02:07 - Revamping Takeda for AI
19:03 - Teams & Talent
26:43 - Alliances
32:50 - Q&A

Ep. 111 - McGill's Angela Genge on why ALS drug development is turning a corner

Fri, 12 Jun 2026 19:00:00 -0400

ALS drug development has long been hampered by heterogeneity, but Angela Genge — neurologist at McGill University and CMO of AL-S Pharma — argues the field is getting closer to making that heterogeneity tractable. On The BioCentury Show, Genge discusses progress in pathway prioritization, progression-rate prediction, and endpoint standardization with BioCentury's Selina Koch.
On the biology side, Genge expects the field to converge on a small number of high-priority pathways. SOD1 is the first validated example, and AL-S Pharma is now testing whether misfolded SOD1 marks a treatable subset of sporadic ALS. On biomarkers, she's optimistic a TDP-43 marker could arrive within two years.

View full story: https://www.biocentury.com/article/659713

#ALS #DrugDevelopment #ClinicalTrials #Biomarkers #ALSResearch

00:00 - Introduction
02:03 - ALS Mechanistic Diversity
06:13 - Trial Design Challenges
16:52 - Biomarker Toolkit Update
24:20 - ALS Pharma & SOD1

Ep. 110 - Richard Pops on Three Decades in Biotech: Drug pricing, FDA and China

Thu, 28 May 2026 18:00:00 -0400

Richard Pops has lived the biotech roller coaster over three decades as CEO of Alkermes: an IPO, M&A, near-death events for his company, FDA setbacks, battles with an activist investor, and the satisfaction of knowing that millions of patients have benefited from the company’s medicines. He has led PDUFA reauthorization negotiations for industry, chaired BIO, and advocated for the interests of mid-sized biotechs.
As Pops prepares to retire as CEO (he will remain chairman), he spoke with BioCentury Washington Editor Steve Usdin about the ways policy and economics shape the development of medicines. Pops discussed the impact of the Trump administration’s most favored nation (MFN) drug pricing policy and the Inflation Reduction Act (IRA), concerns about FDA’s loss of talent, and competition and collaboration with China’s life sciences sector.

View full story: https://www.biocentury.com/article/659601

#DrugPricing #BiotechLeadership #FDAPolicy #LifeSciencesPolicy #DrugDevelopment

00:00 - Introduction
01:40 - Alkermes’ Evolution
05:12 - PBMs, Pricing & Access
10:54 - IRA
18:14 - MFN
24:36 - PDUFA Negotiations
28:05 - FDA Staffing
31:40 - China & U.S. Policy

Ep. 109 - Mind the Gap: Karen Knudsen on Fixing Cancer Drug Development

Thu, 14 May 2026 22:00:00 -0400

Karen Knudsen, CEO of the Parker Institute for Cancer Immunotherapy, believes the central problem in cancer drug development is not discovery, but a broken “translational middle.”
In a wide-ranging interview on The BioCentury Show with BioCentury Washington Editor Steve Usdin, Knudsen discussed the Parker Institute’s focus on accelerating the path from scientific breakthrough to medical impact.
As it approaches its tenth anniversary, the institute has deployed about $400 million, catalyzing roughly $4 billion in follow-on investment across 17 companies.

View full story: https://www.biocentury.com/article/659476

#CancerImmunotherapy #TranslationalScience #DrugDevelopment #Biopharma #CancerResearch

00:00 - Introduction
01:34 - Optimizing Translation
07:42 - Training the Immune System
16:33 - China’s Opportunity
20:50 - Need for a Cancer Strategy
24:40 - Enhancing Cancer Survivorship
27:55 - Scientific Foundation Under Threat

Ep. 108 - Rethinking Discovery: Chris Hollowood on Causal Biology and Syncona’s Strategy

Thu, 30 Apr 2026 21:00:00 -0400

A paradigm shift in research tools, combined with large-scale unbiased screening, has positioned the biopharma industry not only to rethink target discovery, but also to execute more faithfully on causal biology, according to Syncona CEO Chris Hollowood.
Hollowood spoke on The BioCentury Show with Editor in Chief Simone Fishburn about how discovery is evolving, why causal biology has been stuck in a loop of circularity, and where the U.K. investor is headed. He also discussed the firm’s approach to gene therapy investments, how it is surmounting the field’s challenges and Syncona’s pivot last year, with a portfolio shift from 25% to over 85% clinical-stage companies.

View full story: https://www.biocentury.com/article/659341

#CausalBiology #GeneTherapy #BiotechInvesting #DrugDiscovery #ClinicalStage

00:00 - Introduction
01:06 - Rational Target Discovery
16:48 - Gene Therapy
23:15 - Syncona’s Strategy

Ep. 107 - Forbion’s Slootweg on Europe Biotech, NewCos From Asia and Green Investing

Fri, 17 Apr 2026 15:00:00 -0400

The European biotech ecosystem has gone through a substantial maturation process over the past 20 years, as VC funds such as Forbion have experienced exponential growth to fund the region’s innovation. But Forbion co-founder and managing director Sander Slootweg says there’s still more that can be done to fund future European innovations and improve Europe’s competitiveness globally.
“We’ve observed in Europe that although we see great science, and we’ve been able to build great companies, in terms of the absolute magnitude of the ecosystem, we’re still lagging behind the U.S., and also China is coming up quickly,” Slootweg said in conversation with BioCentury's Stephen Hansen.

View full story: https://www.biocentury.com/article/659150

#EuropeanBiotech #VentureCapital #BiotechFunding #Bioeconomy #GlobalInnovation

00:00 - Introduction
01:34 - Forbion’s growth
05:35 - Deal flow in Europe
10:20 - Green Investing
14:24 - Sourcing Asia Deals
22:20 - Unlocking the EU’s Capital
27:54 - Speeding Up Trials
30:13 - Building a Thriving EU Market
34:38 - Central & Eastern Europe

Ep. 106 - Can the U.K. Capture Biotech Value? Daniel Mahony on Growth, Pricing and Reform

Thu, 02 Apr 2026 20:00:00 -0400

The U.K. is excellent at invention and science, and creating institutions to further innovation, but poor at capturing their economic value, says Daniel Mahony, a problem that various forces in the U.K. are now putting serious efforts into solving.
Mahony, one of the major influential figures in U.K. biotech, is a senior partner in growth investments at Novo Holdings, and was until December chair of the U.K.’s BioIndustry Association (BIA). In conversation with BioCentury Editor in Chief Simone Fishburn on The BioCentury Show, Mahony discussed the future of U.K. and European biotech, and the intersection of reforms related to financing and clinical trials, as well as the need for a rethink on drug pricing.

View full story: https://www.biocentury.com/article/658997

#UKBiotech #BiotechInnovation #DrugPricing #HealthcareReform #LifeSciencesPolicy

00:00 - Introduction
01:40 - U.K. Clinical Trial Reform
04:23 - Funding U.K. Biotech
10:40 - Propagating Innovation
15:08 - Measuring Progress
18:22 - Drug Pricing
22:40 - Scaling Europe’s Biotechs
25:16 - AI in Biotech

Ep. 105 - Recursion’s Najat Khan: AI Will Be Judged by the Medicines It Delivers

Thu, 19 Mar 2026 20:00:00 -0400

As AI spreads across biopharma, what will matter most is not who has the flashiest tools, but who can use them to make better medicines. In this episode of The BioCentury Show, Recursion CEO Najat Khan discusses where AI is showing measurable value now, how public techbio companies are being pushed toward proof points, and what comes next — from out-of-domain prediction to stronger data foundations and precompetitive collaboration.

View full story: https://www.biocentury.com/article/658829

#ArtificialIntelligence #DrugDevelopment #AgenticAI #ClinicalProof #BiopharmaInnovation

00:00 - Introduction
01:41 - AI Hype to Proof
04:52 - Where AI Adds Value
13:30 - AI for Clinical Trials
17:01 - Agentic AI in R&D
25:34 - Out-of-Domain Prediction
28:24 - Future of Techbio
31:13 - Precompetitive Consortia
35:24 - CEO Leadership and Catalysts

Ep. 104 - SoftBank’s Jacqueline Fok on AI Drug Development, Metsera and the U.K. Biotech Opportunity

Thu, 05 Mar 2026 21:00:00 -0500

There is a real opportunity for artificial intelligence to dramatically transform the speed, cost and efficiency of drug development over the long term, but the uptake of AI tools across biopharma has been much slower relative to the broader healthcare environment, SoftBank’s Jacqueline Fok said on The BioCentury Show.
In conversation with BioCentury's Stephen Hansen, Fok, who is investment director, Life Sciences & Health Tech at SoftBank Investment Advisers, also detailed SoftBank’s investment strategy in life sciences and the opportunity the U.K. has to stand out as a globally competitive player, with SoftBank’s obesity portfolio company Metsera as a recent example of success.

View full story: https://www.biocentury.com/article/658661

#ArtificialIntelligence #DrugDevelopment #BiotechInvestment #UKBiotech #ObesityDrugDevelopment

00:00 - Introduction
01:30 - SoftBank Strategy
08:40 - Metsera
14:48 - U.K. Biotech
21:38 - AI
28:20 - Women in Leadership
32:03 - Fok’s Catalysts

Ep. 103 - Kolchinsky: FDA Conservatism, MFN and IRA Are Slowing Drug Development

Tue, 17 Feb 2026 19:00:00 -0500

Caution: This episode of The BioCentury Show contains strong language.

In a candid interview with BioCentury, RA Capital Managing Partner Peter Kolchinsky warns that staffing losses and growing conservatism at FDA are slowing drug development and pushing companies to launch early-stage trials outside the U.S.
In conversation with BioCentury Washington Editor Steve Usdin, Kolchinsky also discusses U.S. policy headwinds, including most-favored-nation (MFN) pricing proposals and the Inflation Reduction Act’s “pill penalty,” and why he’s concerned that the biopharma sector is too “genteel” in its advocacy. Kolchinsky explains his decision to speak publicly about regulatory and political issues, including immigration, and reflected on China’s expanding role in the global life sciences innovation ecosystem.

View full story: https://www.biocentury.com/article/658433

#BiotechPolicy #FDALeadership #DrugPricingPolicy #LifeSciencesInnovation #CapitalMarkets

00:00 - Introduction
00:37 - Impact of FDA Policy Changes
06:17 - MFN & Drug Pricing in Europe
20:16 - The Importance of Speaking Up
34:26 - China & Innovation

Ep. 102 - Psychiatry R&D: Steve Paul on Serendipity, Engineering and What Drives Real Breakthroughs

Thu, 05 Feb 2026 21:00:00 -0500

With disease biology still murky and trials notoriously noisy, psychiatry R&D is advancing fastest where teams can solve engineering problems. Delivery, selectivity and tolerability fixes are turning long-standing hypotheses into usable medicines, says veteran CNS drug developer Steven Paul. Few drug developers have had a closer view of the field’s false starts — and occasional breakthroughs — than Paul, who has moved from NIH to pharma R&D leadership and now to company building at Karuna, acquired by BMS for $14 billion, and Seaport.
In conversation with The BioCentury Show's Selina Koch, Paul explains why serendipity still plays a disproportionate role in psychiatric drug development and how critical it is for teams to engineer and execute their way from an unexpected signal to a usable medicine. He also discusses psychedelics, brain shuttles, Karuna’s muscarinic approach in schizophrenia, and the delivery and trial-design choices Seaport is using to revisit neuroactive steroid biology in depression.

View full story: https://www.biocentury.com/article/658314

#PsychiatryTherapeutics #CNSDrugDevelopment #BiotechEngineering #Psychedelics #NeuroScience

00:00 - Introduction
01:32 - Psychiatric Drug Discovery
06:56 - The Karuna Story
22:09 - What’s New in Depression
32:06 - Gene Therapies, Brain Shuttles
33:53 - Psychedelics

Ep. 101 - Why Science Stalls: Astellas CEO Naoki Okamura on Translation, Talent and Platforms

Thu, 22 Jan 2026 21:00:00 -0500

Why does great science so often stall before it becomes a medicine? Astellas Pharma CEO Naoki Okamura argues the bottleneck isn’t capital — it’s translation: a shortage of people, processes and platforms that can move ideas across the boundaries of biology, manufacturing, regulation and commercialization. That theme threaded through his conversation on The BioCentury Show with Executive Editor Selina Koch, surfacing most clearly in his diagnosis of what Japan’s biotech ecosystem lacks — and in his rationale for why Astellas is doubling down on cell and gene therapy as other multinational pharmas pull back. The discussion also touches on Astellas’ journey in commercializing a women’s health product, the company’s China strategy, and its plans for life after Xtandi’s patent cliff.

View full story: https://www.biocentury.com/article/658141

#BiotechTranslation #CellAndGeneTherapy #JapanBiotech #PharmaStrategy #DrugDevelopment

00:00 - Introduction
00:39 - Cell & Gene Therapy
07:22 - Women’s Health
13:00 - Japan’s Biotech Ecosystem
19:00 - Astellas’ China Strategy
22:45 - Astellas’ Near-Term Strategy

Ep. 100 - Adam Koppel on Why Private Equity Is Moving Deeper Into Biotech and What Comes Next

Thu, 08 Jan 2026 22:00:00 -0500

Private equity’s expanding role in biopharma as a growth equity investor reflects both the maturation of the life sciences sector and the rising need for large-scale capital, alongside PE firms’ increasing ability to conduct the technical diligence required for investments once considered too risky for their models.
In conversation with The BioCentury Show's Stephen Hansen, Bain Capital’s Adam Koppel discussed the evolution of private equity's interest in biotech, Bain’s prioritization scheme for scaled investments and his outlook for the capital markets in the year ahead.

View full story: https://www.biocentury.com/article/657997

#PrivateEquity #BiotechDeals #LifeSciencesInvesting #GrowthEquity #BiopharmaMarkets

00:00 - Introduction
01:57 - PE's Evolution in Biotech
06:58 - Bain's Priorities
11:24 - Structuring Deals
18:23 - Capital Market Conditions
24:03 - Environment for Private Companies
27:08 - IPO Outlook

Ep. 99 – Stelios Papadopoulos on Biotech’s Long View: Pricing Pressure, China & Big Pharma

Thu, 18 Dec 2025 20:00:00 -0500

In historical terms, this is not a bear market, says Stelios Papadopoulos. There’s volatility, which is unnerving, and major issues to reckon with, but the level of anxiety in biotech doesn’t reflect the “extraordinary science, the likes of which we’ve never seen — and it’s getting better,” said Papadopoulos on The BioCentury Show.
Papadopoulos is one of the long-term leading voices of biopharma, recognized for his influence in shaping the industry. Former chair of Biogen and current chair of Exelixis, with roles on several boards, and a background of nearly two decades as an investment banker, he brings a long view to how the industry has grown and the forces driving where it is headed. Tune in to hear his take on the financing environment for biotechs, company building, pricing pressure, innovation from China, and the future of big pharmas, in conversation with Editor in Chief Simone Fishburn.

View full story: https://www.biocentury.com/article/657910

#BiotechOutlook #DrugPricing #ChinaBiotech #BigPharma #BiopharmaStrategy

00:00 - Introduction
02:00 - Financing Environment
10:18 - Company Building
20:47 - Women in Biotech
25:38 - China, Korea & Europe
30:00 - Is Biotech Too Insular?

Ep. 98 - Inside Precision Oncology’s Next Chapter with Fore’s Bill Hinshaw

Thu, 04 Dec 2025 21:00:00 -0500

When Bill Hinshaw looks back across the arc of his career — from his early days helping to commercialize Gleevec to his present role leading Fore Biotherapeutics — he sees a precision oncology field transformed by technological ambition, yet still grappling with many of the structural challenges that defined its beginnings, now compounded by the difficulty of positioning therapies within an ever more complex treatment landscape.
Gleevec proved the power of targeting a genomic driver, but the healthcare system around it was far from ready. “We weren’t able to fulfill the promise as fast as we wanted to until that scaling happened,” Hinshaw told The BioCentury Show — a reminder that even today, precision medicines succeed or fail based not only on their biology but on the infrastructure that enables patients to access them.
Hinshaw sat down with Executive Editor Selina Koch on The BioCentury Show to discuss what’s changed in precision oncology, what’s stayed the same, and how he’s applying those lessons to steer Fore’s BRAF-focused program.

View full story: https://www.biocentury.com/article/657768

#PrecisionOncology #BRAFAlterations #NGSTesting #MasterProtocol #TargetedTherapies

00:00 – Introduction
00:47 – Precision Medicine’s Evolution
09:22 – Zeroing in on Subtypes
17:59 – Fore’s BRAF Inhibitor
26:38 – Fore’s Development Approach
32:01 – Moving from Pharma to Biotech

Popular Episode - Reimagining FDA: Steve Usdin on Designing the Drug Regulator of the Future

Wed, 26 Nov 2025 19:00:00 -0500

This is a previously recorded episode of The BioCentury Show from September 5, 2025. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

If you could redesign FDA from the ground up, what would it look like? That’s the fundamental question underlying the 2025 BioCentury Back to School essay, authored by BioCentury Washington Editor Steve Usdin, who has been a leading voice on regulation and policy for over two decades. The topic is especially meaningful in this era of FDA turmoil, when regulatory risk has piled on top of the market pullback, making biotech appear an unusually hazardous domain for investors. But while the current landscape has underscored the need, FDA reform has been on the table long before this administration came into power. On this edition of The BioCentury Show, Usdin and Editor in Chief Simone Fishburn discuss the key arguments, and some specific concepts, within Back To School, which reimagines the U.S. drugs regulator.

View full story: https://www.biocentury.com/article/656928

#FDA #DrugRegulation #Biopharma #LifeSciences #Biotech #PublicTrust

00:00 - Introduction
02:39 - Restructuring FDA
18:08 - A Learning Regulatory Agency
27:54 - Global View
31:09 - Talent
32:59 - User Fees

Ep. 97 – From NIH to Industry: Zerhouni Warns Policy & Rhetoric Threaten U.S. Science

Fri, 14 Nov 2025 18:00:00 -0500

Elias Zerhouni personifies the American dream. He arrived in the U.S. from Algeria as a young man with a couple of hundred dollars in his pocket. Talent, ambition and hard work propelled him into a successful academic career. In 2002, he was nominated and confirmed as NIH director, and later he served in senior positions in the biopharma industry. That trajectory “would be almost impossible” today, he told BioCentury Washington Editor Steve Usdin on The BioCentury Show.
Anti-immigration policies, underfunding of basic research, and attacks on philanthropy have made the U.S. an unattractive destination for anyone hoping to follow his path, Zerhouni said.
Zerhouni also discussed reasons for optimism about life sciences in the U.S., the difficulty of fixing drug pricing, and his time at Sanofi.

View full story: https://www.biocentury.com/article/657591

#NIH #BiomedicalInnovation #ImmigrationPolicy #Biopharma #LifeSciences #HealthcareReform #MedicalResearch

01:09 - The American Dream & Science
05:51 - Zerhouni at NIH
09:40 - Loss of Trust
16:53 - Vaccine Policy
20:12 - Zerhouni in Industry
23:20 - Drug Pricing

Ep. 96 – From Pharma Partnering to Biotech CEO: Sophie Kornowski on Boston Pharma’s Playbook

Thu, 30 Oct 2025 21:00:00 -0400

It took Sophie Kornowski under four years as CEO of Boston Pharma to bring it from a pipeline full of in-licensed assets to an acquisition by GSK for about $2 billion in total deal value for a single MASH program. Though her first gig as a biotech CEO, Kornowski’s success was built on her years of experience as head of partnering at Roche. She discussed that pivot and the value of rolling your sleeves up on the latest episode of The BioCentury Show.

View full story: https://www.biocentury.com/article/657446

#BiotechLeadership #DrugDevelopment #PharmaDeals #BiotechCEO #StartupSuccess #LifeSciences #MetabolicDisease #PharmaInnovation

00:00 - Introduction
01:15 - Becoming a Biotech CEO
11:40 - MASH
18:15 - First v. Best in Class
24:10 - GSK Deal

Ep. 95 - Kymera CEO Nello Mainolfi: Matching Degrader Chemistry to the Problem

Thu, 16 Oct 2025 19:00:00 -0400

Kymera Therapeutics has a clear mission: to transform immunology with targeted protein degraders that enable “oral drugs with biologics-like activity,” CEO Nello Mainolfi told The BioCentury Show. A pioneer in one of biopharma’s most closely watched new therapeutic modalities, Kymera is now over nine years into its story, with multiple pharma partnerships and a wholly owned pipeline, including a STAT6 degrader that produced promising data in June.
In conversation with BioCentury’s Selina Koch, Mainolfi discusses the appeal of degraders, the rationale for choosing glues or heterobifunctional degraders and how to prove a new modality on a new target without incurring biology risk.

View full story: https://www.biocentury.com/article/657297

#ProteinDegradation #DrugDiscovery #MolecularGlues #HeterobifunctionalDegraders #Immunology #RationalDrugDesign #BiotechInnovation

00:00 - Introduction
01:07 - Degraders' Appeal
07:22 - Glue vs. Heterobifunctional
16:12 - Translating a New Modality
24:14 - Partnerships

Ep. 94 - Frazier's James Li on China’s Rapidly Evolving Biotech Deal Landscape

Fri, 03 Oct 2025 19:00:00 -0400

The frenzy among Western companies to access China’s biotechnology innovation is remaking the landscape for cross-border dealmaking, with assets becoming more expensive and partnerships earlier and broader than ever before. That’s being driven by exceptional capital efficiency, access to patients and speed of development, said Frazier Life Sciences’ James Li on The BioCentury Show podcast.
Among multinational companies, “every company has an army on the ground hunting for assets,” said Li, who has more than 30 years of biotech experience, as an investor, company builder and executive at an MNC and a biotech.

View full story: https://www.biocentury.com/article/657156

#ChinaBiotech #Biopharma #CrossBorderDeals #LifeSciences #DrugDevelopment #HealthcareInnovation #BiotechInvesting

00:00 - Introduction
02:18 - Evolution of an Ecosystem
04:31 - NewCo Deals
10:30 - Japan, Korea
15:30 - Dealmaking

Ep. 93 – BIO’s Fritz Bittenbender on Trump 2.0, MFN Threats & Pharma’s Concessions

Thu, 18 Sep 2025 17:00:00 -0400

President Donald Trump’s demands for “most favored nation” drug pricing presents the biopharma industry with an immense public policy challenge. Drug companies are convinced that meeting the president’s demand to reduce U.S. prices to levels below those of other industrialized countries would decimate the industry. On this episode of The BioCentury Show, Fritz Bittenbender, SVP of Roche's Genentech unit and chairman of BIO, discusses the industry’s responses to the MFN challenge, and some of the under-appreciated nuances of policy options. He notes that reducing or eliminating payments to PBMs would lead to higher insurance premiums. While drug companies are scrambling to meet Trump’s Sept. 29 deadline to make voluntary pricing concessions, Bittenbender says a more comprehensive deal should be made that reduces out-of-pocket costs, preserves patient access and supports biomedical innovation. The interview touches on other hot button public policy issues, presenting the biotech industry’s views on reforming the Medicare drug pricing negotiation program, tariffs, and prospects for reviving the Biosecure Act.

View full story: https://www.biocentury.com/article/657021

#DrugPricing #HealthPolicy #MFN #BIO #DrugPolicy #MedicarePartD #MedicarePartB #PBMs #Tariffs #InnovationVsAccess

00:00 - Introduction
00:48 - MFN Drug Pricing
11:06 - Tariffs
18:27 - China Policy
23:58 - Vaccines
27:03 - IRA

Ep. 92 - Reimagining FDA: Steve Usdin on Designing the Drug Regulator of the Future

Fri, 05 Sep 2025 22:00:00 -0400

If you could redesign FDA from the ground up, what would it look like? That’s the fundamental question underlying the 2025 BioCentury Back to School essay, authored by BioCentury Washington Editor Steve Usdin, who has been a leading voice on regulation and policy for over two decades. The topic is especially meaningful in this era of FDA turmoil, when regulatory risk has piled on top of the market pullback, making biotech appear an unusually hazardous domain for investors. But while the current landscape has underscored the need, FDA reform has been on the table long before this administration came into power. On this edition of The BioCentury Show, Usdin and Editor in Chief Simone Fishburn discuss the key arguments, and some specific concepts, within Back To School, which reimagines the U.S. drugs regulator.

View full story: https://www.biocentury.com/article/656928

#FDA #DrugRegulation #Biopharma #LifeSciences #Biotech #PublicTrust

00:00 - Introduction
02:38 - Restructuring FDA
18:04 - A Learning Regulatory Agency
27:48 - Global View
31:04 - Talent
32:54 - User Fees

Ep. 91 – Annalisa Jenkins: How MHRA’s Reset Could Revive U.K. Biotech

Thu, 21 Aug 2025 23:00:00 -0400

A new head at MHRA, a streamlined government life sciences strategy, and a more sophisticated innovation ecosystem have Annalisa Jenkins optimistic about the future of U.K. biotech — and its potential to carve out a stronger global role.
On The BioCentury Show, Annalisa Jenkins, chair of Gemma Biotherapeutics, discussed the evolving landscape of biotech in the U.K. and the critical hurdles it faces as it implements the latest strategy. Jenkins, who was president and CEO of Dimension Therapeutics, is a committee member on the Science Board to FDA, a board member of Genomics England and Faster Cures, and chair of the court at the London School of Hygiene and Tropical Medicine.

View full story: https://www.biocentury.com/article/656787

#UKBiotech #MHRA #BiotechStrategy #GrowthCapital #RegulatoryScience #TalentAttraction

00:00 - Introduction
02:52 - State of U.K. Biotech
13:15 - Improving U.K.’s Path to Clinic
18:50 - What’s Next for MHRA
24:53 - Changes at FDA
29:58 - Working with China

Popular Episode - Vertex’s Winning Formula: Altshuler on Choosing the Next Breakthroughs

Tue, 12 Aug 2025 20:00:00 -0400

This is a previously recorded episode of The BioCentury Show from March 19, 2025. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

Vertex’s approach to research, defined over a decade ago to beat the dismal odds of success in biotech, remains core to its strategy, even as the industry evolves and technologies expand. While that strategy, which EVP and CSO David Altshuler calls “serial innovation,” has seen the company launch eight drugs since 2011 and jump market cap tiers on the success of its cystic fibrosis portfolio, it’s now being tested in other areas as Vertex expands to pain, renal disease, Type I diabetes, and more. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Altshuler discussed the rising interest in causal biology and the role of AI, noting that the fundamentals of picking targets and programs have not changed.

View full story: https://www.biocentury.com/article/655408

#biotech #biopharma #pharma #lifescience
#RandD #DrugDevelopment #AI

00:00 - Introduction
02:17 - Causal Biology
08:54 - AI in R&D, at Vertex
16:42 - Academia-Industry Interface
22:08 - Cell Therapy for Diabetes
25:44 - Gene Therapy for DMD

Ep. 90 – Inside Biopharma Dealmaking: ProFound CEO John Lepore on Knowing What Partners Want

Thu, 24 Jul 2025 19:00:00 -0400

In an environment where everybody hurts, it helps for biotech CEOs to understand the pressures driving pharmas, investors and other key players if they want to secure deals and financings that will help them succeed. That’s how John Lepore, CEO of Profound Therapeutics and former head of research at GSK, is navigating his early stage company through this capital-constrained era as he builds it from the ground up. Speaking on The BioCentury Show in conversation with Editor in Chief Simone Fishburn, Lepore discussed how he approaches partnering, how he manages the need to both build a platform and generate products, and the science driving the company’s technology.

View full story: https://www.biocentury.com/article/656568

#biotech #biopharma #pharma #lifescience #BiotechLeadership #PartneringStrategy #TargetDiscovery

00:00 - Introduction
01:17 - From GSK to Biotech CEO
04:50 - Dealmaking
15:26 - ProFound’s Platform
24:13 - Building a Biotech: Team, AI

Ep. 89 - Delivering on the biosimilars promise, a conversation with Gillian Woollett

Thu, 10 Jul 2025 19:00:00 -0400

Gillian Woollett, head of regulatory strategy and policy at Samsung Bioepis, discusses how FDA can deliver on its promise to “massively streamline” the regulation of biosimilars. Eliminating unnecessary clinical trial requirements could halve the time and cost of developing a biosimilar, according to Woollett.
While regulators around the world are converging on ideas that will slash development times, commercial challenges, especially in the U.S., are far more challenging. The Medicare Drug Price Negotiation Program has undermined the economic rationale for investing in biosimilars. President Donald Trump’s proposals for most favored nation pricing would “kill” the industry, Woollett said.

View full story: https://www.biocentury.com/article/656445

#biotech #biopharma #pharma #lifescience #DrugDevelopment #FDA

00:00 - Introduction
02:50 - Halving the Time and Cost
10:30 - Interchangeability
15:50 - The Importance of Market Share
22:08 - Most Favored Nation

Ep. 88 – From Satiety to Muscle: Zealand CEO Steensberg on Amylin’s Edge in Obesity

Thu, 26 Jun 2025 21:00:00 -0400

Mounting clinical evidence suggests amylin agonists could supplant GLP-1 molecules as the foundational backbone of future obesity therapy, says Zealand Pharma CEO Adam Steensberg on The BioCentury Show.
One of the leading cardiometabolic biotechs, Zealand received the largest-ever upfront payment in a biotech licensing deal when it partnered its petrelintide with Roche for nearly $2 billion. The deal helped make amylin arguably the hottest target in obesity.
In conversation with BioCentury’s Stephen Hansen, Steensberg goes behind the scenes of Zealand’s deal with Roche and also shares his vision for how the obesity treatment paradigm will evolve over the next five years. This episode of The BioCentury Show was sponsored by Faron.

View full story: https://www.biocentury.com/article/656295

#biotech #biopharma #pharma #lifescience #DrugDevelopment #Amylin #GLP1

00:00 - Introduction
02:18 - The Case for Amylin
16:44 - Roche Deal
21:04 - What’s Next for Obesity Therapies

Ep. 87 – Korea’s Biotech Playbook: Orum CEO SJ Lee on Going Global and Creating Novel Therapies

Thu, 12 Jun 2025 22:00:00 -0400

Globalizing quickly and gaining a first-mover advantage are the winning strategies for South Korean biotechs as they look to compete on the world stage, says Orum Therapeutics founder and CEO SJ Lee in conversation with BioCentury Executive Editor Jeff Cranmer on The BioCentury Show.
Lee’s company, a leader in degrader-antibody conjugates, provides an example of how to run that playbook. Lee also spoke about where Korea fits in East Asia’s life sciences scene, how Western players can get to know the Korean biopharma industry, and what’s next for Orum’s pipeline. This episode of The BioCentury Show was sponsored by Faron.

View full story: https://www.biocentury.com/article/656147

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment

02:11 - Korea's Biotech Ecosystem
09:57 - Evolution of Korean Biotech
16:08 - Orum's Degrader Antibody Conjugates

Ep. 86 – Macrophages, ASCO & Clever-1: Faron CEO Juho Jalkanen on Bexmarilimab’s Promise

Tue, 03 Jun 2025 22:00:00 -0400

The macrophage field has seen its share of setbacks, but Faron believes bexmarilimab, its humanized mAb that binds to immune checkpoint target Clever-1, has what it takes to get across the goal line at FDA.
On a special sponsored edition of The BioCentury Show, Juho Jalkanen, founder and CEO of Faron Pharmaceuticals, explains how the Finnish biotech landed on Clever-1, and why the target might more effectively repolarize macrophages than therapies against other macrophage checkpoints.
Jalkanen also discusses the Phase I/II data Faron presented for bexmarilimab in myelodysplastic syndrome at the American Society of Clinical Oncology (ASCO) in Chicago, and what’s next for the immunotherapy. This episode of The BioCentury Show was sponsored by Faron.

View full story: https://www.biocentury.com/article/656099

#biotech #biopharma #pharma #lifescience #ASCO #RandD #DrugDevelopment

Ep. 85 - Stifel’s Opler on Trump 2.0's FDA & the Capital Markets

Thu, 29 May 2025 19:00:00 -0400

Notwithstanding the bad start that the Trump administration got off to on FDA, Tim Opler is optimistic that the agency will serve drug developers well, and sees enough good signals that the direction the agency is headed will not bring the difficult regulatory era that many in the industry feared.
Opler, a managing director at Stifel, spoke to Editor in Chief Simone Fishburn on The BioCentury Show about why he’s optimistic about FDA, what he sees ahead for capital markets, competition in China, and three areas of innovation he’s focused on -- aging, women's health and the brain.

View full story: https://www.biocentury.com/article/656040

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment #FDA

00:00 - Introduction
01:30 FDA under Trump 2.0
08:07 State of Capital Markets
13:13 China Competition
17:09 Innovation: Aging, Women’s Health & the Brain

Ep. 84 – Leadership Amid Turmoil: Moonlake CEO Jorge Santos Da Silva

Tue, 20 May 2025 22:00:00 -0400

As CEO of a vintage 2021 biotech, Jorge Santos Da Silva has had his leadership mettle tested by a pandemic, rising interest rates, a bear market, and a tumultuous U.S. policy environment — all while building the case for Moonlake’s lead program to become a top therapy for hidradenitis suppurativa and, eventually, a “pipeline-in-a-product.”
The key for Santos Da Silva as founder and CEO of Moonlake Immunotherapeutics is to dial down the noise and focus on the key choices in front of you. “Moonlake has always existed in times of turmoil,” Santos Da Silva told Executive Editor Jeff Cranmer on The BioCentury Show, citing the recent M&A drought, high interest rates and political turmoil. “Understanding the situation from a cool perspective, being able to explain that to your people first, and then try to explain that to the Street and place the company in the right moment so that you have all the game in front of you" is his recipe for success as a CEO in biotech. Moonlake’s sonelokimab is expected to enter Phase III testing this year for HS; it's one of the most advanced multispecifics in the clinic for inflammation and immunology diseases.

View full story: https://www.biocentury.com/article/655903

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment

00:00 - Introduction
01:48 - Landscape for HS Therapies
09:03 - Market Opportunity
19:40 - Next Steps for Moonlake

Ep. 83 – Europe’s Biotech Moment: Jérôme van Biervliet on Turning Uncertainty into Opportunity

Thu, 01 May 2025 20:00:00 -0400

Europe did not ask for this opportunity, says VIB’s Jérôme van Biervliet, but with FDA and the U.S. research funding situation headed into uncertain territory, it needs to use this moment to capitalize on its strengths in research, and address the shortcomings of its business and regulatory systems that have made it hard for biotech to fulfill its potential there. Van Biervliet is managing director of Flanders Institute for Biotechnology (VIB), a key player in the Belgian biotech landscape that has both a research arm and an investment unit. Ahead of BioCentury’s Bio€quity Europe conference in Bruges, which will discuss how Europe can meet the complexity of this moment, he talked to BioCentury Editor in Chief Simone Fishburn on The BioCentury Show about the landscape unfolding in Europe, as well as where he sees innovation headed.

View full story: https://www.biocentury.com/article/655818

#biotech #biopharma #pharma #LifeScience #ResearchFunding #EuropeanInnovation

00:00 - Introduction
02:03 - VIB’s Mission
07:52 - Europe’s Funding Opportunity
17:37 - Belgium’s Biotech Ecosystem
25:27 - Nanobodies’ Potential

Ep. 82 – Act Now or Fall Behind: Michelle Rozo on Biotech’s National Security Stakes

Wed, 16 Apr 2025 23:00:00 -0400

The U.S. will cede its preeminence in biotechnology to China within three years unless the government acts urgently, an independent commission chartered by Congress warns. “Our window to act is closing,” the National Security Commission on Emerging Biotechnology said in a newly released report. “We need a two-track strategy: make America innovate faster, and slow China down.” BioCentury Washington Editor Steve Usdin discusses the report's recommendations and warnings with the commission’s vice chair, Michelle Rozo, on The BioCentury Show.

View full story: https://www.biocentury.com/article/655654

#biotech #biopharma #pharma #lifescience #politics #policy #law

00:00 - Introduction
03:56 - China Closing the Innovation Gap
09:20 - Slowing China Down
17:20 - Bolstering U.S. Biotech

Ep. 81 - Data-Driven Growth: Immunocore CEO Bahija Jallal on Expanding TCR Therapies

Thu, 03 Apr 2025 23:00:00 -0400

On the latest episode of The BioCentury Show, Editor in Chief Simone Fishburn speaks with Bahija Jallal, CEO of Immunocore and the former president of Medimmune. While some biotechs are circumspect about gathering data during clinical trials that might not support the product in question, Jallal sees it as part of the obligation to patients and the field to learn as much as possible, as efficiently as possible. And that strategy has informed how the company will take its TCR technology into earlier lines of treatment and new indications.

View full story: https://www.biocentury.com/article/655504

#biopharma #pharma #biotech #lifescience #RandD #DrugDevelopment #CEO

00:00 - Introduction
04:18 - Getting a New Modality to Market
17:15 - Infectious Pipeline
22:04 - Autoimmune Pipeline
27:24 - Leading in Challenging Times

Ep. 80 - Vertex’s Winning Formula: Altshuler on Choosing the Next Breakthroughs

Thu, 20 Mar 2025 13:00:00 -0400

Vertex’s approach to research, defined over a decade ago to beat the dismal odds of success in biotech, remains core to its strategy, even as the industry evolves and technologies expand. While that strategy, which EVP and CSO David Altshuler calls “serial innovation,” has seen the company launch eight drugs since 2011 and jump market cap tiers on the success of its cystic fibrosis portfolio, it’s now being tested in other areas as Vertex expands to pain, renal disease, Type I diabetes, and more. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Altshuler discussed the rising interest in causal biology and the role of AI, noting that the fundamentals of picking targets and programs have not changed.

View full story: https://www.biocentury.com/article/655408

#biotech #biopharma #pharma #lifescience
#RandD #DrugDevelopment #AI

00:00 - Introduction
02:12 - Causal Biology
08:48 - AI in R&D, at Vertex
16:35 - Academia-Industry Interface
22:00 - Cell Therapy for Diabetes
25:35 - Gene Therapy for DMD

Ep. 79 - BNP Paribas’ Moneer on Biotech’s Bull Case: M&A, PE, and Market Recovery

Fri, 07 Mar 2025 20:00:00 -0500

Since the annual J.P. Morgan Healthcare Conference in San Francisco in early January, biotech has seen a notable surge in enthusiasm, Zahid Moneer, senior managing director of investment banking at BNP Paribas, told The BioCentury Show.
Moneer, who is more upbeat than many in today’s biopharma sector, sees capital raises from million-dollar seed rounds to nine-digit series A, B, and C rounds driving significant growth alongside M&A activity. In the interview, he also also highlights the growing role of private equity firms in biopharma and the trend of pharmas engaging earlier with biotechs and investors looking to deploy capital into those companies

View full story: https://www.biocentury.com/article/655216

#biotech #biopharma #pharma #lifescience #financing #privateequity #IPO

00:00 - Introduction
00:37 - Investment Climate
05:06 - Pharma M&A Activity
15:25 - Private Equity's Role
21:44 - Biotech Financing

Ep. 78 - Biotech’s New Normal: SR One’s Simeon George on Adapting to Market Constraints

Thu, 20 Feb 2025 13:00:00 -0500

Biotechs need to get used to the new normal, says SR One CEO and Managing Partner Simeon George, and that will require significant adjustments to the business model. This new normal comes from an extended tough capital environment against a backdrop of political uncertainty, but while biotechs face a different set of factors than they have in the past, there are still first principles of value creation that should guide them.
George, who co-founded SR One management in 2020 following its spinout from GSK, spoke on The BioCentury Show with Editor in Chief Simone Fishburn about the challenges facing biotechs and how VCs are navigating through the complexity of the moment. He also discussed SR One’s strategy and philosophy of investing.

View full story: https://www.biocentury.com/article/655142

00:00 - Introduction
01:31 - Meeting the Moment
04:45 - Company Valuations
13:54 - China Strategy, NewCos
22:08 - Building Successful Biotechs

#biotech #biopharma #pharma #lifescience #CEO #financing #newco

Ep. 77 - AI’s Next Leap: Foresite Labs’ Vik Bajaj on Predictive Biology

Thu, 06 Feb 2025 19:00:00 -0500

Clinical trials will be launched in the next year or two to test predictions about causal biology made by artificial intelligence models, Vik Bajaj, co-founder and CEO of Foresite Labs and managing director of Foresite Capital Management, believes. Foresite teamed up with Arch Venture Partners last year on a $1 billion venture round to fund Xaira Therapeutics, which aims to reinvent the R&D process via AI-driven protein design and biological discovery technologies.
Bajaj, who serves as interim president of Xaira, discussed the potential for artificial intelligence to accelerate biomedical progress in an interview with Washington Editor Steve Usdin on The BioCentury Show.

View full story: https://www.biocentury.com/article/654977

#biotech #biopharma #pharma #lifescience #AI #RandD #drugdiscovery

00:00 - Introduction
01:18 - AI & Biotech
12:19 - Getting the Data Right
19:06 - Healthcare Delivery
30:47 - Making It Real

Ep. 76 - FDA Inflection Point: Steve Usdin on Biopharma during Trump 2.0

Thu, 23 Jan 2025 19:00:00 -0500

All presidential transitions with a change of party come with disruption and threats as well as opportunities. But this one, in particular with regard to the implications for FDA, is different from all those Steve Usdin has been covering in his 30-year tenure as Washington editor at BioCentury.
In particular, this is an inflection point for the agency that currently serves as the global gold standard for drug regulation, said Usdin on a special edition of The BioCentury Show covering the ramifications for the biopharma industry of the second Trump administration. Usdin has recently outlined the threats and opportunities that the new era presents, and he elaborated further on those in a discussion with Editor in Chief Simone Fishburn.

View full story: https://www.biocentury.com/article/654798

#biotech #biopharma #pharma #lifescience #politics #policy #fda #ftc #biosecure #ira

00:00 - Introduction
05:06 - Inflection Point at FDA
14:10 - Changes at the FTC
16:43 - China, Biosecure
21:30 - The IRA

Ep. 75 - PBMs, IRA, RFK Jr: A Conversation With Rep. Jake Auchincloss

Sun, 12 Jan 2025 21:00:00 -0500

Rep. Jake Auchincloss (D-Mass.), an influential voice in Congress on life sciences issues, gained stature last week when he was appointed to serve on the Energy & Commerce Committee, giving him a seat at the table for debates over legislation affecting FDA, CMS and NIH and a host of issues of critical importance to the biopharma industry.
In an interview with Washington Editor Steve Usdin on The BioCentury Show, Auchincloss outlined his priorities for the 119th Congress, from pushing “muscular” PBM reform over the congressional finish line to finding bipartisan support for refining the IRA's orphan drug exemption and advancing methods to evaluate the social value of medicines.

View full story: https://www.biocentury.com/article/654659

#biotech #biopharma #pharma #lifescience #politics #policy #law

00:00 - Introduction
01:08 - New Congress & RFK Jr.
10:09 - China & Biotech
16:36 - Assessing Drugs’ Value

Ep. 74 - Chris Bardon on Biotech’s Recovery: Valuations, Obesity Drugs, and M&A

Thu, 09 Jan 2025 20:00:00 -0500

Specialist public investors are doing their best to hold up the sector, but biotech still has to wash out many of the lower quality companies that were funded during the boom and ended up driving the generalists away, said MPM Bioimpact's Chris Bardon on The BioCentury Show. Bardon said the market hasn’t yet found the footing that will see an opening of the IPO window and a swing of positive sentiment. But although markets aren’t yet out of the woods, she said M&A will remain robust for years, fueled by obesity drug revenues.

View full story: https://www.biocentury.com/article/654649

#biotech #biopharma #pharma #lifescience #financing #investing

00:00 - Introduction
01:30 - Market Sentiment
06:19 - IPO Window
12:04 - M&A Outlook
19:51 - The Obesity Landscape

Ep. 73 - Resilience and the CEO’s Paradox: Aoife Brennan on Leading in Biotech

Thu, 12 Dec 2024 20:00:00 -0500

Leading biotech companies through the turbulence of the past few years and the uncertainty of the next ones takes not just resilience, but an ability to grapple with the CEO’s paradox, according to Climb Bio CEO Aoife Brennan. This paradox requires preparing for repeated setbacks while planning optimistically, a duality that has been the story of biotech since the outbreak of the pandemic, said Brennan. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Brennan discusses how CEOs are managing through uncertainty, and why "boring" naked mAbs are the smart move in one field.

View full story: https://www.biocentury.com/article/654451

#biotech #biopharma #pharma #lifescience

00:00 - Introduction
00:59 - State of Play for Biotech
04:34 - How to Choose a CEO Job
18:49 - New Era of Discipline
26:51 - Building a Team

Ep. 72 - Outlook for Biotech M&A and Financing: Sidley's Robert Darwin

Thu, 14 Nov 2024 17:00:00 -0500

With new governments both side of the pond, capital markets picking up, and some geopolitical overhang, there’s a mixed feast for biotech, with a net trend to the positive, says Sidley Austin’s Robert Darwin, who specializes in global M&A and private equity for life sciences and healthcare companies and investors. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Darwin, who is based in London, discussed the consequences for biotech of the changing forces as we enter 2025: the new Labour government’s recently announced budget, the incoming Trump administration, the improving outlook for the markets, and the ongoing — if not mounting — tensions between the U.S. and China. Across each of these is a considerable amount of uncertainty, but the pluses and minuses add up to net positive outlook, he believes.
This episode of The BioCentury Show was sponsored by Cytiva.

View full story: https://www.biocentury.com/article/654182

#biotech #biopharma #pharma #lifescience #deals

00:00 – Introduction
01:49 – U.K.’s Place in Global Biotech
09:41 – Trump & Biotech
17:32 – Deals in 2025
31:57 – Private Equity in Biotech

Ep. 71 - Pazdur Unplugged: FDA Director Richard Pazdur on the Past, Future of Cancer Treatments

Thu, 31 Oct 2024 17:00:00 -0400

Richard Pazdur, director of FDA’s Oncology Center of Excellence, joined FDA in 1999. Looking back on his 25th anniversary, he draws a line between unpopular decisions at the start of his tenure and a surge in cancer drug development over the last 20 years. He believes this and other lessons from the regulation of oncology can be applied broadly across FDA. The BioCentury Show discussed these lessons, as well as Pazdur’s views about advisory committees, pragmatic trials, dose optimization and more.
This episode of The BioCentury Show was sponsored by Cytiva.

View full story: https://www.biocentury.com/article/654032

#biotech #biopharma #pharma #lifescience #RandD #drugapproval #regulation

00:00 - Introduction
01:55 - Rejecting the ineffective
10:56 - Creating Consensus
16:43 - Fire From the Dragon’s Mouth
24:30 - Three Reasons for Trial Equity
29:28 - Dose Optimization

Ep. 70 - Trends in Global Biopharma Deals: Lazard’s Kingston and Raine

Thu, 17 Oct 2024 21:00:00 -0400

With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape.

View full story: https://www.biocentury.com/article/653858

#biotech #biopharma #pharma #lifescience #IPO #capitalmarkets #deals

00:00 - Introduction
02:17 - Capital Markets Outlook
05:18 - M&A
14:37 - Breaking Down Deals
23:44 - Asia

Ep. 69 - Lee Fleisher: An Insider’s Account of CMS’s Alzheimer’s Coverage Decisions

Thu, 03 Oct 2024 20:00:00 -0400

CMS’s controversial decision to restrict access to Alzheimer’s mAb treatments, including Aduhelm, approved under FDA’s accelerated pathway was a unique case that is unlikely to set a precedent, former CMS CMO Lee Fleisher told BioCentury. “I do not think this will be repeated,” he said. In an interview with The BioCentury Show's Steve Usdin, Fleisher gives a behind-the-scenes account of the decision-making process, including the role of accelerated approval. He also discusses the opportunities and risks for healthcare posed by AI, and the scientific and legislative steps that will be needed to make real the promise of blood-based multicancer detection technologies.

View full story: https://www.biocentury.com/article/653749

#biotech #biopharma #pharma #lifescience #policy

00:00 - Introduction
01:31 - Behind the Aduhelm Decision
08:01 - Questioning CMS
17:19 - Accelerated Approval
26:34 - AI in Medicine

Ep. 68 - Inside BeiGene: CEO John Oyler on Owning the Drug Development Process

Thu, 19 Sep 2024 18:00:00 -0400

Few CEOs have built a $20 billion biotech in under 15 years, as John Oyler has with BeiGene, managing to stay in that market cap band even through the downmarket. His strategy, to own clinical trials and manufacturing early on, looks particularly prescient in light of the cost and supply constraints threatening many biotechs today. On this episode of The BioCentury Show, Editor in Chief Simone Fishburn sits down with Oyler to discuss the early strategies that are now paying off for the global oncology company.

View full story: https://www.biocentury.com/article/653597

#biotech #biopharma #pharma #lifescience #drugdevelopment

00:00 - Introduction
11:20 – In-house Manufacturing
15:51 – BeiGene’s Pipeline
23:45 – Partnering Plans
27:00 – Building a High Value Biotech

Ep 67 - AAM's Craig Burton on Opportunities, Challenges of U.S. Biosimilars Market

Thu, 05 Sep 2024 13:00:00 -0400

There is good news in this year’s Association for Accessible Medicines report on savings from biosimilars, including a 30% increase over the last year in savings attributed to biosimilars. The report also explores the economic, policy and regulatory headwinds that are preventing the industry from generating savings at a level that would have a dramatic effect on the U.S. healthcare system.
In an interview with Washington Editor Steve Usdin on The BioCentury Show, Craig Burton, executive director of AAM’s Biosimilars Council, calls out business practices and government policies that are holding the industry back and discusses the ways a robust biosimilars market could promote biomedical innovation.

View full story: https://www.biocentury.com/article/653459

#biotech #biopharma #pharma #lifescience #biosimilars #politics #policy #law

00:00 - Introduction
03:45 - IRA
13:38 - Humira
20:44 - Biosimilars Pipeline

Popular Episode - Bob Nelsen on AI, China and the IRA

Thu, 22 Aug 2024 17:00:00 -0400

This is a previously recorded episode of The BioCentury Show from February 22, 2024. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

In a wide-ranging conversation with BioCentury, Bob Nelsen, co-founder and managing director of Arch Venture Partners, said he is excited by the potential for AI to “create a language of biology,” is cautious about investing in China given increasing geopolitical tensions, and is convinced that the U.S. healthcare system could do a far better job of delivering on the promise of rapidly progressing science.
Nelsen, who has helped finance and create more than 150 companies, including 47 that have reached valuations exceeding $1 billion, discussed his conviction that focusing on creating transformational medicines, rather than looking for short-term gains, is a key to success in the life sciences.

View full story: https://www.biocentury.com/article/651502

#biotech #pharma #biopharma #TheBioCenturyShow

0:00 - Introduction
01:59 - The Promise of AI
08:35 - The Inflation Reduction Act
15:38 - China
25:58 - Building Companies Around Big challenges

Ep. 66 - Jane Grogan on Building Biogen’s Growth Engine

Thu, 08 Aug 2024 13:00:00 -0400

As Jane Grogan anticipates the unmet needs in patients five years from now, she’s harnessing a wave of interest in targeting B cells as a key driver of an immunology expansion at Biogen. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Grogan, who became EVP and head of research of Biogen in October, discusses how she’s approaching the mission to build diversity and balance the risk in the company’s portfolio, extending further into disease areas beyond neurology.

View full story: https://www.biocentury.com/article/653208

#RandD #DrugDevelopment #neurology #immunology #nephrology #celltherapy #bcells #CD28 #CD38

00:00 - Intro
01:05 – Expanding Research
08:22 – Integrating Hi-Bio
11:30 – Targeting B Cells
16:35 – Growing the Modality Toolbox

Ep. 65 - Astellas' Claus Zieler: Global Launches with Local Impact

Thu, 25 Jul 2024 15:00:00 -0400

As Astellas prepares to launch four products in parallel, Chief Commercial Officer Claus Zieler is balancing the complexity of this multi-faceted enterprise with a simple guiding principle: it has to work at a local level, and that will change with geography, circumstance and time. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Zieler discusses how to factor local differences in patient behavior, payer systems and regulatory environments into a global launch strategy. He also advocates for a seamless integration of R&D and commercial efforts throughout the lifecycle of each product, from early development to loss of exclusivity, and he discusses what small companies need to know when deciding whether to commercialize a therapy on their own.

View full story: https://www.biocentury.com/article/653047

#biotech #biopharma #pharma #lifescience #RandD #deals #licensing #partnerships

00:00 - Intro
01:26 - Focus Area Approach
04:55 - Continuous Teams
09:00 - Building Partnerships
15:24 - Omni Channel Launches
28:40 - Future Pipeline

Ep. 64 - NPC CEO John O’Brien: Why America Needs an Honest Conversation About Drug Pricing

Thu, 11 Jul 2024 12:00:00 -0400

Ignorance about the path from scientific discovery to approved drugs, high out-of-pocket costs, and a byzantine healthcare system that obscures net prices while inflating list prices have fueled policies that threaten biomedical progress, John O’Brien, CEO of think tank National Pharmaceutical Council, told BioCentury.
In an interview with The BioCentury Show's Steve Usdin, O’Brien, who led efforts to reduce drug prices as an HHS official during the Trump administration, said that whoever wins the White House in November will step into a political atmosphere that is hostile to biopharma companies. While it is difficult to predict what drug pricing policies Trump would pursue if he is re-elected, “Beltway chatter” suggests he would undercut the Inflation Reduction Act’s Medicare drug price negotiation program and attempt to revive international reference pricing proposals, O’Brien said.

View full story: https://www.biocentury.com/article/652931

#biotech #biopharma #pharma #lifescience #politics #policy #law #IRA #healthcare

00:00 - Intro
01:15 - Drug Pricing Policy Overview
09:30 - Inflation Reduction Act
16:20 - A Byzantine Healthcare System

Ep. 63 - Day One's Jeremy Bender: Building Pediatric Oncology from the Ground Up

Thu, 27 Jun 2024 10:00:00 -0400

Pediatric cancer drug development is difficult: it requires high levels of safety, involves parents as well as the patients, and has small populations that can make it difficult to achieve the revenues that reward the investment. Squaring that circle, according to Day One Biopharmaceuticals CEO Jeremy Bender, is not impossible, but takes a dedicated strategy that considers both pediatric and adult development paths from the get-go, and pursues them with equal intensity. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Bender discussed the rapid rise of Day One, and how it is building a pipeline and evolving a strategy that allows it to keep pediatric drug development central to its philosophy.

View full story: https://www.biocentury.com/article/652807

#RandD #DrugDevelopment #pediatriccancer #biopharma #pharma #biotech #lifescience

00:00 - Intro
02:25 - Origins & What’s Next
07:57 - Commercialization & Capital
15:28 - Precision Pediatric Strategy
21:00 - First v. Best, ADCs
30:00 - Life as a CEO

Ep. 62 - Rick Bright: Navigating the Avian Flu Threat

Thu, 13 Jun 2024 10:00:00 -0400

The U.S. is experiencing events that are either the first stages of a widespread avian influenza outbreak or a fire drill that will show how well the nation is prepared for an outbreak. The U.S. has not stepped up to meet the challenge, Rick Bright, the former director of BARDA, told BioCentury.
In an interview with The BioCentury Show's Steve Usdin, Bright said there are opportunities for biotech companies to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics. The federal government must provide leadership and funding to unleash industry, but it has acted slowly and hasn’t taken the necessary initiative, Bright said.

View full story: https://www.biocentury.com/article/652676

#biotech #biopharma #pharma #lifescience #politics #policy #law

00:00 - Intro
01:56 - H5N1: State of Play
10:14 - Rebuilding Trust, Vaccines
20:50 - Creating Better Therapeutics
25:34 - BARDA, Barriers to Preparedness
32:50 – Urgent Next Steps

Ep. 61 - Vas Narasimhan: How New Data Fit Novartis’ Growth Plan

Fri, 31 May 2024 11:00:00 -0400

Differentiating on tolerability, raising the bar for efficacy and concentrating small molecule development on indications with minimal IRA exposure are all pieces of Novartis CEO Vasant Narasimhan’s strategy to break into the top pharmas by U.S. sales. Two data readouts this week — one for CML drug Scemblix at ASCO and one for inflammatory disease therapy remibrutinib at the EAACI Congress — may tee up two launches to advance that goal through a strategy focused on prioritizing blockbuster-bound programs. Narasimhan discusses the readouts with Editor in Chief Simone Fishburn on a Special Edition of The BioCentury Show.

View full story: https://www.biocentury.com/article/652562

#biotech #biopharma #pharma #lifescience

00:00 - Intro
01:12 - CML Data
09:34 - Endpoints, Approval Pathway
13:00 – Remibrutinib
24:07 – IRA, Radioligands

Ep. 60 - JMM John Maraganore: A higher bar for investment is a credit to biotech

Thu, 30 May 2024 17:00:00 -0400

“The bar has gotten higher because science has gotten so much better,” John Maraganore says on the latest BioCentury Show. Reflecting on the capital markets and the state of innovation, the founder and former CEO of Alnylam painted a picture of a robust ecosystem fueled by sprawling innovation, where the higher scrutiny by investors will serve the industry well. In a broad-ranging conversation with Editor in Chief Simone Fishburn, Maraganore gives his views on the innovation and funding landscape, geopolitical issues facing the industry and the outlook for the next generation of leaders.

View full story: https://www.biocentury.com/article/652517

#biotech #biopharma #pharma #lifescience #investment #innovation

00:00 Intro
01:50 Innovation Today
09:00 Obesity
12:23 Building, Mentoring Biotechs
16:38 Capital & Competition
24:10 Industry Overhangs

Ep. 59 - Derek Lowe Unplugged: AI; Biosecure; FDA, Abortion & SCOTUS; and more

Thu, 16 May 2024 12:00:00 -0400

“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about why he hopes and believes the Supreme Court will rule for FDA in litigation over the abortion drug mifepristone; and explained his view that approval of Aduhelm to treat Alzheimer’s disease was one of FDA’s worst decisions

View full story: https://www.biocentury.com/article/652427

#biotech #biopharma #pharma #lifescience #DrugDiscovery

00:00 - Intro
01:04 - Lowe’s Blog
04:42 - Biosecure Act
09:04 - AI & Drug Discovery
16:46 - FDA, The Abortion Drug, & Aduhelm

Ep. 58 - Ysios' Karen Wagner: How Europe's Biotechs Can Rise Above the Noise

Thu, 02 May 2024 12:00:00 -0400

It sounds obvious, but still needs saying, says Ysios Capital's Karen Wagner. “How do you rise above the noise? By having the most spectacular data.” In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Wagner discussed the theme of the upcoming Bio€quity Europe conference — rising above the noise: in a sea of competition where companies vie for attention among investors and pharmas, what are the characteristics that allow them to differentiate? Wagner explains what she and her team looks for in a biotech before investing, and also discusses the role of ESG policies, including diversity, in companies. “We have absolute certainty that ESG is important."

View full story: https://www.biocentury.com/article/652294

#biotech #biopharma #pharma #lifescience #finance

00:00 - Intro
01:36 - Spain’s Biotech Ecosystem
09:30 - Investment Criteria
14:27 - ESG, Diversity
27:53 - AI in Drug Development

Ep. 57 - BMS's Robert Plenge: Causal biology is the North Star of R&D

Thu, 02 May 2024 12:00:00 -0400

This is a previously recorded episode of The BioCentury Show. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

Within the framework of target, modality and path to clinic, causal biology is the axis along which Head of Research Robert Plenge is building and prosecuting research at Bristol Myers. It maps from late-stage decisions the company has made, such as the Karuna acquisition, to strategies in early R&D, such as how to innovate in ADCs and extend the modality to new applications.
In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Plenge outlined his view of causal biology as a principal axiom for building an R&D engine to maximize probability of success. It is the foundation for step one — picking the right target — and sets the basis for the second and third tenets of his framework, finding the right therapeutic modality for a mechanism of action, and establishing a clear path to clinical proof of concept.

View full story: https://www.biocentury.com/article/652135

#biotech #biopharma #pharma #lifescience

00:00 - Intro
01:53 - BMS's Framework for Research
12:38 - First vs. Best in Class
16:09 - Modalities & Manufacturing
19:48 - CAR Ts & Autoimmunity
24:34 - ADCs

Ep. 56 - BIO’s John Crowley on the Biosecure Act

Wed, 17 Apr 2024 17:00:00 -0400

This is a previously recorded episode of The BioCentury Show. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

BIO CEO John Crowley believes that biotech is part of a “great global rivalry” between the U.S. and China. The role of biotech in determining the outcome of this rivalry, and a belief in the need for reducing U.S. reliance on Chinese biotech companies, led BIO to reverse its opposition to the Biosecure Act. Crowley acknowledges concerns that the enactment of the bill in its current form would create serious disruptions in drug development. By accepting its overall goals and engaging with Congress, BIO will have opportunities to persuade negotiate changes that will mitigate its negative consequences for biopharma companies and patients, Crowley told BioCentury Washington Editor Steve Usdin in this episode of #TheBioCenturyShow.

View full story: https://www.biocentury.com/article/651990

#biotech #biopharma #pharma #biosecureact #lifescience

00:00 - Intro
03:57 - Decoupling from China
11:33 - Biosecure Act
15:48 - Rare Diseases at FDA
25:02 - Fly-outs and Big Ideas
28:05 - Changing the Narrative

Ep. 55 - Bruce Booth: Biotech Benefiting from Belt-Tightening

Wed, 17 Apr 2024 17:00:00 -0400

This is a previously recorded episode of The BioCentury Show. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

Atlas Venture’s Bruce Booth believes the belt-tightening by biotechs in the past few years will presage a better financing outlook for companies, but the ripple effects will be felt for some time to come. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, the longtime biotech VC said that there are clear positive signs for biotech, with the XBI ETF bouncing back from its lows in the 60s, February’s robust follow-on financing market and a stream of M&A deals. “Everybody did belt-tightening the last few years,” said Booth. “So, you’re coming from a good place in terms of overall burn rates, and companies, I think, are in a good place to be financed by the next wave of investors.”

View full story: https://www.biocentury.com/article/651821

#biotech #pharma #biopharma #lifescience #TheBioCenturyShow

00:00 - Intro
01:54 - Capital Markets
07:19 - How to Pitch a VC
12:12 - Obesity
16:30 - New Modalities
22:28 - Industry Efficiency, AI

Ep. 54 - Arthur Caplan: Lessons From a Compassionate Use Firestorm

Wed, 17 Apr 2024 17:00:00 -0400

This is a previously recorded episode of The BioCentury Show. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

On the tenth anniversary of a viral media campaign for access to an unapproved drug that extended a boy’s life, bioethicist Arthur Caplan reflected in an interview with The BioCentury Show on how the experience reshaped public views, corporate policies and legal requirements associated with providing access to unapproved therapies.
The wide-ranging conversation also touched on the need for scientists to receive communications training that could help reduce the impacts of medical disinformation, Caplan’s concerns about the lack of transparency about Neuralink Corp.’s experimental implantable brain chip, and the benefits of teaching biopharma CEOs about ethics.

View full story: https://www.biocentury.com/article/651502

#biotech #pharma #biopharma #TheBioCenturyShow

00:00 - Intro
01:12 - Josh Hardy & Compassionate Use
13:27 - Ethics Training for the C-suite
16:16 - FDA
23:44 - Neuralink & Transparency

Ep. 53 - Bob Nelsen on AI, China and the IRA

Wed, 17 Apr 2024 17:00:00 -0400

This is a previously recorded episode of The BioCentury Show. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

In a wide-ranging conversation with BioCentury, Bob Nelsen, co-founder and managing director of Arch Venture Partners, said he is excited by the potential for AI to “create a language of biology,” is cautious about investing in China given increasing geopolitical tensions, and is convinced that the U.S. healthcare system could do a far better job of delivering on the promise of rapidly progressing science.
Nelsen, who has helped finance and create more than 150 companies, including 47 that have reached valuations exceeding $1 billion, discussed his conviction that focusing on creating transformational medicines, rather than looking for short-term gains, is a key to success in the life sciences.

View full story: https://www.biocentury.com/article/651502

#biotech #pharma #biopharma #TheBioCenturyShow

00:00 - Intro
02:00 - The Promise of AI
08:37 - The Inflation Reduction Act
15:50 - China
26:04 - Building Companies Around Big challenges

Ep. 52 - Khoo Shih on Scaling Singapore Biotech

Wed, 17 Apr 2024 17:00:00 -0400

This is a previously recorded episode of The BioCentury Show. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

Success for the Singapore biotech project will take a global network, one which Khoo Shih and other prominent drivers of the local ecosystem are keen to leverage to bring the right combination of talent, experience and capital to the growing hub. Speaking on The BioCentury Show, Khoo Shih, CEO of investment firm ClavystBio, laid out the strategy for capitalizing on the ascendant energy and attention being devoted to Singapore biotech. While the goal continues to be to create companies that solve global problems and have a global outreach, she said the path involves bringing in international life science investors from day one.

View full story: https://www.biocentury.com/article/651376

#biotech #biopharma #pharma #TheBioCenturyShow

00:00 – Intro
04:48 – ClavystBio
08:18 – Why Singapore
19:07 – 65Labs Incubator
23:20 – Growing the Ecosystem