- Is talent and workforce development in our industry changing? If so how and why?
- What are the most important new technologies in biomanufacturing today?
- What current factors are affecting speed of development and efficient manufacturing?
- What Regulatory progress has been made and what future opportunities exist?
- How can we improve the access of biologic medicines?
—
Moderator:
Alison Moore
CMC Executive
Dr. Alison Moore is a CMC Executive who most recently served as the 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:
Tim Moore
EVP, Chief Technical Officer
Allogene Therapeutics
Tim Moore is Executive Vice President, Chief Technical Officer for Allogene, overseeing product sciences, supply chain, manufacturing, quality and technical operations. Tim has more than three decades of leadership experience in biopharmaceutical manufacturing and operations and was responsible for the global development of two of the most successful autologous CAR T manufacturing processes in the industry. Prior to roles as Chief Operating Officer of Instil Bio, and President and Chief Operating Officer of PACT Pharma, Tim was Executive Vice President, Technical Operations at Kite Pharma (now a Gilead company) from 2016 to 2019, where he was responsible for the process development, manufacturing, quality and supply chain for Yescarta®, the first FDA approved CAR T therapy for the treatment of non-Hodgkin lymphoma. He and his team also developed the manufacturing process for Kite’s second FDA approved autologous CAR T therapy, Tecartus®. Tim previously served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee where he oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Tim serves as a Board member for Cerus and BioLife Solutions. He received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.
Wolfram Carius
EVP Pharmaceuticals
Bayer AG
Prof. Wolfram Carius is the EVP Pharmaceuticals at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for nearly three years. Before that, he worked for Boehringer Ingelheim from 1987 to the end of 2013, eventually becoming responsible for that company’s worldwide chemical, pharmaceutical, and biopharma production network. In his over 30 years in the pharmaceutical industry he has worked in Asia, South America and Europe. In 2009, the Biberach University of Applied Sciences awarded him the title of honorary professor in recognition for his long and exceptional service. He also holds a PhD in pharmaceutical biology and analytical phytochemistry from the University of Saarland, Germany.
Dr. Pascal Bécotte
Managing Director
Russell Reynolds Associates
Pascal leads operations for Russell Reynolds Associates in New York and Canada. He works closely with top healthcare clients around the globe, advising them on their talent strategy, including leadership assessment, succession planning, and the recruitment of directors, CEOs, and other senior executives. Within the healthcare industry, Pascal specializes in biotech and pharma technical operations, including process development, manufacturing, quality, engineering, and supply chain leadership. Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and trained as an aerospace engineer with the Royal Canadian Air Force. He also earned master’s and doctorate degrees in business administration from Athabasca University in Canada, where he focused his research and dissertation on CEO succession. Pascal speaks fluent French and English.
Snehal Patel
SVP, Head Technical Operations
Sana Biotechnology
Snehal Patel is the Head of Technical Operations at Sana Biotechnology. He has oversight of Manufacturing, Process and Analytical Development, Supply Chain, CMC Regulatory, and Technical Quality for Cell and Gene Therapy. Snehal has a breadth of knowledge and experience in leading roles in Technical Operations, Manufacturing, Technology, and Quality Assurance in Biologics, Small Molecules, and most recently in Cell Therapy.
Prior to Sana, Snehal was the Global Head and Vice President for Cell Therapy Manufacturing at Bristol Myers Squibb (BMS). He led the growing global manufacturing network to produce Clinical and Commercial Cell Therapy Products, including two cell therapies recently commercially launched in 2021 by BMS. Prior to this role he served as Site Head for Cell Therapy Manufacturing in Bothell, Washington. Prior to BMS, Snehal worked at Genentech/Roche for 18 years, holding a variety of different roles with increasing responsibility, including Head of Global External Drug Product Manufacturing, Head of Drug Product Operations, and Head of Quality Operations.
