Fred Kamal is a biotechnology veteran, scientist, and technical operations leader in development and commercialization of biotechnology-derived products including cell and viral vector therapies. He is the Chief Technical Officer (CTO) and Head of Regulatory and Quality at 4D Molecular Therapeutics Inc. (4DMT). Fred has spent over thirty years developing and commercializing products to advance human health worldwide. Fred’s experience encompasses domestic and international product development, registration and commercialization.
Over the last 20 years, Fred has helped develop and commercialize target-specific monoclonal antibodies, viral vector gene therapies, and engineered cell immunotherapies for treatment of cancer, inflammatory diseases, and rare genetic disorders. He has aided in the development and commercialization of 8 therapeutic biotechnology-derived products including cell and gene therapy products, in addition to multiple small molecule targets, from pre-clinical stages through commercialization.
Prior to joining 4DMT, Fred served as the Senior Vice President of Quality and Regulatory CMC for AveXis Inc. (now a Novartis company); Vice President of Quality Operations for Juno Therapeutics (now a Celgene company); Vice President of Global Quality for InterMune Inc. (now a Roche company); Vice President of Global Quality and Head of Quality for the Vaccine Franchise for MedImmune (now an AstraZeneca company); and Head of Quality and Scientific Affairs for Otsuka America Pharmaceutical Inc.
Fred’s expertise and oversight in various executive roles over the last 10 years has encompassed analytical and process development, technical operations, quality compliance, and regulatory functions, ushering human therapeutics from concept through product registration and commercialization. In addition, Fred has had extensive experience directly interacting with domestic and international regulatory competent authorities (FDA, EMA, PMDA, etc.).
In addition to his role with 4DMT, Fred is also an entrepreneur as the Founder and CEO of Tollaris LLC, a pioneer in software application design to enable the Healthcare Industry in data digitization and e-System workflow automation.
Fred completed his Ph.D. and M.Sc. in Chemistry from The American University, Washington DC.