Session Abstract – PMWC 2020 Silicon Valley
Session Synopsis: Recent articles questioned the validity of the current FDA programs for rapid cancer drugs approval, suggesting they may be flawed. This panel will review the FDA Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review programs, why the programs were created, how they address the needs and wishes of patients and families, and some of the points that the authors failed taking into consideration.
Session Chair Profile
Ph.D., Vice President, Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy
Biography
Theresa LaVallee has over 25 years of research and industry experience with a broad knowledge in the discovery and development of drug candidates. Theresa is Vice President, Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy and previously served as Senior Vice President, Celldex Therapeutics and Kolltan Pharmaceuticals. She also was Senior Director Translational Medicine at MedImmune and EntreMed. In these roles, she has advanced drugs in oncology, immunology and inflammatory diseases from discovery through late state development. Theresa has a depth of expertise in Translational Medicine enabling science driven development decisions and implementing effective use of biomarker assays in clinical studies. She is author or co-author of more than 50 publications and abstracts with a focus on Translational Medicine approaches in clinical development. She received her Ph.D. degree from University of California, Los Angeles and her B.A. degree from the University of California, Santa Barbara.
Speaker Profile
M.D., Ph.D., Director, Center for Biologics Evaluation and Research, FDA
Biography
Peter Marks received his graduate and medical degrees from New York University. Following this, he completed an Internal Medicine residency and Hematology/Medical Oncology fellowship at Brigham and Women’s Hospital in Boston, where he subsequently joined the attending staff as a clinician-scientist and eventually served as Clinical Director of Hematology. He then moved on to work for several years in the pharmaceutical industry prior to returning to academic medicine at Yale University where he served as Chief Clinical Officer of Smilow Cancer Hospital. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016. Dr. Marks and center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle.
Talk
Immuno-Oncology Products At CBER
The Center for Biologics Evaluation and Research (CBER) regulates complex biologic products including genetically modified T cells (e.g., CAR-T cells), therapeutic cancer vaccines, and microbiome products. All of these are increasingly being used in the treatment of cancer. CBER aims to take a risk-based approach to ensuring that safe and effective IO products are available as quickly as possible to benefit cancer patients in need.
