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Dr. Jens Vogel is SVP & Global Head of Biotech, Bayer Pharmaceuticals Product Supply, leading biologics operations, development and strategy across five sites, including cell & gene therapy industrialization. Jens has more than 20 years of professional and leadership experience in biologics development, operations, program management and regulatory affairs.
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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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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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Given the experiences of Covid 19 Pandemic Response, we are even more aware of the need to be ready for what lies ahead with emerging and existing infectious diseases. Covid 19 continues to be a problem with evolving variants, Flu season ahead is anticipated to be worst in years, and we’re learning about new or resurfacing infectious disease outbreaks around the world on a daily basis. Therefore, Pandemic Preparedness is more important now than ever. This presentation will share the key CMC lessons learned from the past two years that can be applied to Pandemic Preparedness – with focus on…
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