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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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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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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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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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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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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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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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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