The past few years has seen a migration of talent and technology from traditional biopharmaceutical manufacturing to ATMP manufacturing:
- How has this changed the CMC ecosystem, and are we overbuilding capacity again?
- Avoiding the dangers of fragmentation. How should we better communicate, collaborate, and consolidate our best ideas so we all succeed?
- Discussing the reasons to set up a new company today, and imagining how our business ecosystem will continue to grow and evolve
- Debating which production platforms will best suit the newer modalities
- Exploring the next steps for existing platforms like mAbs: How do we efficiently serve giant markets such as Alzheimer’s indications, for example?
- Striking the balance between pandemic and personalized medicine as we look to the future
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Moderator:
Chief Technology Officer
Allogene
Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as Senior Vice President, Process Development, in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).
Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.
Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.
Panelists:
Chief Operating Officer
Altos Labs
Dr. Ann Lee-Karlon is Chief Operating Officer of Altos Labs and leads scientific and business operations for the company. She was previously Senior Vice President at Genentech, leading portfolio strategy and operations with oversight for over 35 drug development teams in the pipeline. She also led the anti-CD20 immunology team, including development of Ocrevus® for multiple sclerosis. Dr. Ann Lee-Karlon holds a BS in bioengineering from UC Berkeley, MBA from Stanford, and PhD in bioengineering from UCSD, and completed her postdoc at University College London as a National Science Foundation Fellow. She serves on the Dean’s boards for UC Berkeley and UCSD schools of engineering. Dr. Lee-Karlon was elected Fellow of the American Institute of Medical and Biological Engineering and is a Fellow of the Aspen Institute.
Chief Technical Officer
Graphite Bio
Jerry Cacia is the chief technical officer at Graphite Bio. In this role, Jerry is responsible for leading the overall manufacturing strategy and technical operations in support of Graphite Bio’s gene editing programs as they advance to the clinic. He is advancing the development and implementation of a robust manufacturing strategy to ensure the advancement of Graphite Bio’s clinical programs and develop a clear and scalable path to patients.
In his most recent position, Jerry served as head of global technical development at Roche during which time he supported a pipeline that included over 80 new molecular entities and more than 100 development projects in various stages, including a number of cell, gene, and individualized neoantigen therapy programs.
Vice Chairman & Co-Founder
Resilience, Inc.
Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry.
From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company (now part of BMS) based in Seattle.
Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In this role, he was responsible for Roche’s biopharma process research and development, analytical sciences, engineering, quality, technical regulatory, supply chain and all manufacturing plants with approximately 15,000 employees around the world. From 2003 to 2009, Pat was Executive Vice President of Product Operations at Genentech. He assumed his role as Global Head of the combined technical operations of Roche and Genentech upon the acquisition of Genentech by Roche in 2009.
Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003, based in New Jersey, in various leadership positions including vice president of Asia Pacific Operations and vice president of Global Supply Chain Management. Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.
Pat holds a Bachelor of Science from the National Chiaotung University in Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in engineering from Ohio State University.
Pat is a member of the Board of Directors of three public companies, Amyris, Codexis and PharmaEssentia. In addition, he is on the board of several private companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.
BioPharma Advisor & Board Member
Michael Kamarck was the Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global biosimilars business.
Prior to joining Merck BioVentures, Dr. Kamarck held positions of increasing responsibility in Biotechnology and Vaccines Operations at Wyeth, including leading the development of the global biotechnology network with $3.5 billion of capital investment. While at Wyeth, he also was responsible for global technical operations for all of the Company’s businesses. Dr. Kamarck began his career in biotechnology and pharmaceutical research at Bayer AG.
Dr. Kamarck graduated from Oberlin College where he currently serves as a Trustee. He received his Ph.D. in biochemistry from the Massachusetts Institute of Technology and is the author of more than 50 peer-reviewed publications and 20 issued patents. He also holds an Honorary Doctorate of Science from University College Dublin.
