The Speaker Roundtable from BMWS23 —A Conversation About Biopharmaceutical Manufacturing Issues and Ideas
February 1, 2024
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This panel discussion, presented in memoriam of Dr. Michael Kamarck, reflects on the last few decades of the industrialization of biologics manufacturing and what the future may hold.
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Introducing Prime Medicine and its vision for the future of medicine How are we thinking about the inclusion of novel types of automation into molecular medicine workflows? Examining how we view Talent in the emergent technology space, and how do we best deploy remote and hybrid work? Historically, pharmaceutical manufacturing leaders were predominantly men; however, many important CMC leadership positions are now held by women. Why is this the case, and how do we sustain this pattern? What are the most significant learnings from having achieved success in licensing autologous cell therapies? — Ann Lee Chief Technical Officer Prime Medicine…
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Walking through how we built our Cell Therapy unit. What did we duplicate? What did we innovate? What did we adapt from others, and how did we make it our own? How are we building a sustainable pipeline, managing complexity, and keeping our focus? What are the “must haves”? What are the learnings on common threats of significant transformations? Lessons learned from the TCR² journey to provide innovative therapies for patients in need — Peter Olagunju Chief Technical Officer TCR² Therapeutics Peter Olagunju serves as the Chief Technical Officer of TCR². He brings over 20 years of experience in cell…
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Our journey from a “platform” to a “multi-product” company How we achieved the seemingly impossible What we learned along the way Where we are today and where the journey takes us next — Tara Jones SVP, North America Operations Moderna Tara is responsible for end-to-end operations for DNA, Drug Substance, and Drug Product for global clinical trial materials and commercial product for the North America region. Prior to joining Moderna she was at Amgen where she led drug substance operations at Amgen Puerto Rico and was responsible for both the mammalian and bacterial drug substance manufacturing operations for multiple commercial…
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Cell therapy, such as regenerative therapies based on iPSCs and adoptive cell therapies targeting cancer with CAR-T cells, CAR-NKs or TCRs hold enormous potential for the future of medicine, enabling for the first time curative approaches. However, the field is still in its infancy and CMC remains a critical bottleneck in bringing these therapies to patients on a global scale. This discussion will focus on the scientific, technical and cultural transformations required to drive towards true industrialization of cell therapies, including: The critical challenges in CMC for cell therapies today How more in-depth understanding of cells, their critical quality attributes…
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Industry evolution at a glance Donor Variability, the greatest source of variability for cell therapies. Thoughts on characterizing and accommodating this variability Process considerations for Autologous CAR and the importance of a good data ecosystem to provide insight and understanding to this highly complex therapeutic modality Brief introduction to Kyverna — Karen Walker Chief Technology Officer Kyverna Therapeutics Karen Walker, Chief Technology Officer, Kyverna Therapeutics. Karen brings >30 years’ experience in the biotech industry, holding positions in Technical Development, Regulatory Affairs and Quality. She has worked in a number of companies including Roche/Genentech, Seattle Genetics, Novartis, Amgen, Bayer, and several…
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Current industry challenges and opportunities related to biopharma manufacturing Internal manufacturing capability establishment challenges for biopharma Challenges related to outsourcing of technology and process throughout product lifecycle The Azzur Cleanrooms on Demand™ model Case Studies — Ravi Samavedam Chief Innovation Officer Azzur Group Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Ravi joined Azzur in 2012, and prior to his appointment as CINO of Azzur Group, Ravi was the President and COO of Azzur Cleanrooms on Demand™ and previously served as General Manager of the Boston-area consulting practice. Prior…
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