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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.
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 stage 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.
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.
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.
As Senior Vice President and Chief Medical Officer of the American Society of Clinical Oncology, Dr. Schilsky is involved in professional and patient education, quality improvement, policy and advocacy, communications, clinical research and development of CancerLinQ, ASCO’s rapid learning system for oncology. Prior to joining ASCO, Dr. Schilsky was a faculty member at the University of Chicago from 1984-2012. He served as Director of the University of Chicago Cancer Research Center (1991-99), as Associate Dean for Clinical Research (1999-2007) and as Chief of the Section of Hematology-Oncology (2009-2012). He presently serves as a member of the Board of Directors of the Reagan-Udall Foundation for the FDA, of Friends of Cancer Research and of the National Coalition for Cancer Research, and as a member of the National Cancer Policy Forum of the National Academy of Medicine. Dr. Schilsky has served as a member of the Board of Directors of ASCO and of the Conquer Cancer Foundation of ASCO and as ASCO President 2008-2009.
Dr. Ibrahim has built clinical trial management capabilities within PICI that enabled the conduct of multi-center clinical trials across PICI centers. His team is focused on supporting novel combinations that are science driven and innovative. Dr. Ibrahim is a recognized leader of clinical development in immunotherapy. He helped develop some of the first breakthrough treatments in the field during his tenure at BMS and AZ. As a member of the BMS Immuno-oncology program, he served on the Yervoy (ipilimumab) clinical team including a key role in development for PD-1, PD-L1 and CD137 antibody.Throughout his career, Dr. Ibrahim has been involved with global cancer immunotherapy societies such as the Society of Immunotherapy for Cancer (SITC), Friends of Cancer Research, the Cancer Research Institute and Cancer Support Community (CSC). He is a trained medical oncologist, who conducted bench and clinical immunotherapy research at the cancer vaccine branch of the NCI in Bethesda, MD.