Better Biopharma

Validation Challenges Facing Advanced Single-Use Technologies

Wed, 20 May 2026 00:00:00 -0400

In this episode of "Better Biopharma," host Tyler Menichiello is joined by BioPlan Associates’ director of research, Katrina Cordovado, as well as Joshua Nelson, Ph.D., a senior material qualification specialist at Takeda, and Paul Priebe, a consultant and single-use expert, to continue their conversation from the Bioprocess Online Live event, "Closing The Adoption Gap For Advanced Single-Use Materials."

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Aligning Upstream And Downstream Development (Part 2)

Wed, 06 May 2026 00:00:00 -0400

In Part 2 of this conversation on “Better Biopharma,” panelists from the Bioprocess Online Live event “Optimizing Process Development Through Upstream And Downstream Integration” continue their discussion about how upstream and downstream development teams can work together to accelerate timelines and reduce risk and bottlenecks in process development.

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Aligning Upstream And Downstream Development (Part 1)

Wed, 22 Apr 2026 00:00:00 -0400

In this episode of “Better Biopharma,” panelists from the Bioprocess Online Live event “Optimizing Process Development Through Upstream And Downstream Integration” continue their conversation about how upstream and downstream development teams can work together to accelerate timelines and reduce risks and bottlenecks in process development.

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Reprogramming T Cells And Reducing Manufacturing Costs With RegCell’s Michael McCullar, Ph.D.

Wed, 08 Apr 2026 00:00:00 -0400

In this episode of “Better Biopharma,” host Tyler Menichiello speaks with Michael McCullar, Ph.D., CEO at RegCell, a cell-therapy company developing regulatory T cell (Treg) therapies for autoimmune diseases. They discuss RegCell’s origins and its disease-agnostic approach to product development, as well as the ongoing efforts to improve the commercial viability of cell therapies by reducing manufacturing costs through automation and point-of-care models.

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Scaling Regenerative Medicine Production With PolarityBio’s Nikolai Sopko, MD, Ph.D.

Wed, 25 Mar 2026 00:00:00 -0400

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Nikolai Sopko, MD, Ph.D., chief operating officer, chief scientific officer, and director at PolarityBio, a biotech company developing SkinTE, an investigational autologous regenerative skin therapy for diabetic foot ulcers. The two discuss the challenges of scaling autologous therapy manufacturing, as well as the success PolarityBio has found in doing so through its parallel processing approach.

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Pursuing Quality While Maintaining Process Control With Richard Moroney, Ph.D.

Wed, 11 Mar 2026 00:00:00 -0400

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Richard Moroney, Ph.D., managing director at Stat Consulting. Moroney shares his thoughts on how organizations should think about and approach process control. His philosophy is one of continuous process improvement, as he believes there is "no ceiling" on quality control.

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Unlocking The Therapeutic Power Of Fibroblasts With Pete O’Heeron And Hamid Khoja, Ph.D.

Wed, 25 Feb 2026 00:00:00 -0500

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by FibroBiologics’ CEO and founder, Pete O’Heeron, and chief scientific officer, Hamid Khoja, Ph.D. They discuss the powerful but often overlooked fibroblast, a type of connective-tissue cell that has tremendous therapeutic potential, according to O’Heeron and Khoja. They explain the company’s mission to realize this therapeutic potential and make fibroblasts a mainstay in the cell therapy space, rivaling the prominence of stem cells.

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Supporting The Bioprocessing Workforce In The AI Era With Sanofi's Eric Doerr

Wed, 11 Feb 2026 00:00:00 -0500

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Eric Doerr, a drug substance technical lead in the manufacturing science and technology (MSAT) group at Sanofi. The two discuss how the industry can support the next generation of biomanufacturing workers in North America, comparing incentives and initiatives in both the U.S. and Canada, where Doerr is based. Doerr also shares his thoughts on the need to proactively train workers in using AI to ensure that it serves as an enabling tool, rather than a disruptive force.

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Putting Pressure On CDMOs With Herman Bozenhardt

Wed, 28 Jan 2026 00:00:00 -0500

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance. Bozenhardt outlines his concerns with the current outsourcing environment, noting a rising rate of noncompliance driven by poor facility maintenance and a shortage of reliable workers. He offers advice to sponsor companies working with CDMOs to help ensure their assets don’t fall victim to poor partnerships and operational mismanagement.

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Data Governance And Regulations For AI Use In GMP With Peter Baker

Sat, 17 Jan 2026 11:00:00 -0500

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Peter Baker, former FDA investigator and president of Live Oak Quality Assurance. They discuss Annex 22, the EMA’s GMP annex addressing the use of artificial intelligence (AI) in regulated manufacturing, including where it is sufficient and where it is lacking. Baker reflects on his time at the FDA and offers his own advice on AI and technology adoption and validation in GXP.

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The Editors’ Roundtable: A 2025 Retrospective Of The Life Science Industry

Wed, 31 Dec 2025 00:00:00 -0500

In this special edition of “Better Biopharma,” host Tyler Menichiello is joined by fellow chief editors from across the Life Science Connect ecosystem to reflect on the year and share their industry outlooks for 2026. This editorial roundtable features Katie Anderson, chief editor at Pharmaceutical Online; Jeff Buguliskis, Ph.D., deputy chief editor at Outsourced Pharma; Ben Comer, chief editor at Life Science Leader and host of The Business Of Biotech podcast; Ray Dogum, chief editor at Drug Discovery Online; Erin Harris, chief editor at Cell & Gene and host of Cell & Gene: The Podcast; and Anna Rose Welch, chief editor at Advancing RNA.

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Combining AI With Operations Research To Advance Biomanufacturing With Tinglong Dai, Ph.D., and Tugce Martagan, Ph.D.

Wed, 17 Dec 2025 00:00:00 -0500

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tinglong Dai, Ph.D., Bernard T. Ferrari Professor of Business at Johns Hopkins University, and Tugce Martagan, Ph.D., associate professor at Northeastern University, to talk about the potential advancements that can be made in biomanufacturing by combining AI with operations research (OR). You can check out their recent paper on the subject, “Synergizing Artificial Intelligence And Operations Research For Advancements In Biomanufacturing,” here: https://link.springer.com/epdf/10.1007/s10729-025-09725-7?sharing_token=RsWPImKggnLuwsztf7Y1S_e4RwlQNchNByi7wbcMAY7x0AE_Vqj5xOwaldIl63JrPLRzcTIZn-7Iu6LEV-lGtfKrE2ZoADSYlnvcNAipmXCnruKMpDaS19yEPXSw9A0rbab6H57jkCX1EJOGdqO_VeCnwP3qw80LUT-QFcDzr58%3D

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Building An Oral Vaccine Platform With Vaxart's Sean Tucker, Ph.D.

Wed, 03 Dec 2025 00:00:00 -0500

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Sean Tucker, Ph.D., founder and chief scientific officer at Vaxart, a company developing oral recombinant pill vaccines. They discuss Vaxart’s manufacturing process and how it differs from traditional biopharmaceutical production, as well as the regulatory considerations around its oral vaccines.

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Lessons In Scaling Regenerative Medicine Manufacturing With Organogenesis's Patrick Bilbo

Tue, 18 Nov 2025 15:00:00 -0500

In this episode of "Better Biopharma," Tyler Menichiello is joined by Patrick Bilbo, chief operating officer at Organogenesis, a regenerative medicine company developing and manufacturing advanced wound care products. They discuss the construction of Organogenesis's new facility in Rhode Island, as well as how the industry has changed in the company's 40-year history.

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Navigating The Complexity of Conditionally Active Biologics With Bonum Therapeutics' Diane Hollenbaugh, Ph.D., and Neela Patel, Ph.D.

Wed, 05 Nov 2025 00:00:00 -0500

In this episode of "Better Biopharma," host Tyler Menichiello is joined by Bonum Therapeutics' chief scientific officer, Diane Hollenbaugh, Ph.D., and chief business officer, Neela Patel, Ph.D. They talk about the inherent challenges of developing complex molecules like conditionally active biologics, sharing advice on CMC strategy, analytical methodology, and working with contract manufacturing and development partners.

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Developing Antibodies To Block Neuroinflammation With MindImmune's Stevin Zorn, Ph.D.

Wed, 22 Oct 2025 00:00:00 -0400

In this episode of "Better Biopharma," host Tyler Menichiello is joined by MindImmune's president and CEO, Stevin Zorn, Ph.D. They discuss the development of the company's lead candidate, MITI-101, a monoclonal antibody designed to prevent peripheral immune cells from entering the brain and driving neuroinflammation linked to Alzheimer's disease.

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Engineering Bacterial Vector-Based Immunotherapies With OS Therapies’ Paul Romness and Robert Petit, Ph.D.

Wed, 08 Oct 2025 00:00:00 -0400

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by OS Therapies’ CEO, Paul Romness, and chief medical and scientific officer, Robert Petit, Ph.D. The three discuss the development and manufacturing of the company’s lead asset, OST-HER2, a Listeria-based immunotherapy for osteosarcoma. They also explain the unique CMC challenges around developing a safe bacterial vector.

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How J&J Is Tackling Alzheimer's Disease With Fiona Elwood, Ph.D.

Wed, 24 Sep 2025 00:00:00 -0400

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Fiona Elwood, Ph.D., VP and Neurodegeneration Disease Area Stronghold Leader at Johnson & Johnson. The two talk about J&J’s end-to-end organizational structure and its modality-agnostic approach to treating Alzheimer’s disease.

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CDMO Hunger Games And The State Of Biotech With Siren Biotechnology's Nicole Paulk, Ph.D.

Wed, 10 Sep 2025 00:00:00 -0400

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Nicole Paulk, Ph.D., CEO and founder of Siren Biotechnology, a company developing a universal AAV immuno-gene therapy for cancer. They discuss the company’s decision to switch from plasmids to producer cell lines (PCLs) in production, the current funding environment for cell and gene therapies (CGTs), how companies are innovating and doing more with less, and the unconventional head-to-head competition that determined which CDMO won Siren’s business.

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Delivering Biologics To The Brain With Adaptin Bio's Michael Roberts, Ph.D., and Duke University's Mustafa Khasraw, MD

Wed, 27 Aug 2025 00:00:00 -0400

In this episode of "Better Biopharma," host Tyler Menichiello is joined by Adaptin Bio's CEO, co-founder, and president, Michael Roberts, Ph.D., and Duke University's Mustafa Khasraw, MD. They discuss Adaptin's Brain Bispecific T-cell Engager (BRiTE) platform, its clinical potential to deliver therapeutic T cells across the blood-brain barrier, and the development and manufacturing challenges behind the company's lead asset, APTN-101.

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Developing An In Vivo CAR-T With Interius BioTherapeutics' Sianny Christanti and Babu Medi, Ph.D.

Wed, 13 Aug 2025 00:00:00 -0400

On this episode of Better Biopharma, Interius BioTherapeutics’ Sianny Christanti and Babu Medi, Ph.D., explain how the company is re-engineering a lentiviral vector to enable INT2104, its off-the-shelf, in vivo CAR T-cell therapy. They discuss the vector's design and its manufacturability, as well as the analytical and regulatory challenges of bringing this first-in-human therapy to the clinic.

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Functional Antibody Screening With Abalone Bio's Richard Yu, Ph.D.

Wed, 30 Jul 2025 00:00:00 -0400

In this episode of Better Biopharma, Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains how the company's functional antibody selection technology (FAST) platform differs from traditional affinity screening.

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Using Algae To Manufacture Oral Biologics With Lumen Bioscience's Craig Behnke, Ph.D.

Wed, 16 Jul 2025 06:00:00 -0400

Lumen Bioscience is putting the farm in biopharma — literally! In this episode of Better Biopharma, Lumen's EVP of production and development, Craig Behnke, Ph.D., explains the company's chlorophyll-powered approach to bioprocessing using photosynthetic cyanobacteria.

Check out Behnke's past appearance on Business Of Biotech: https: //www.lifescienceleader.com/doc/democratizing-biologics-with-lumen-bioscience-s-brian-finrow-j-d-craig-behnke-ph-d-0002

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PILOT: Introducing Better Biopharma

Wed, 16 Jul 2025 06:00:00 -0400

How can the biopharmaceutical industry improve? Join Bioprocess Online's Tyler Menichiello as he explores this question through a series of interviews with experts and leaders from across the space. Subscribe for biweekly, in-depth conversations with the brightest minds in biotech to learn how they're moving the needle to make better medicines and optimize manufacturing.

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