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.
Immunotherapy drugs have resulted in multiple firsts including a large number of accelerated approvals and new ways of classifying biomarkers. Recent articles questioned the validity of current FDA programs for rapid cancer drug approval, suggesting that they may be flawed. This panel will review FDA’s 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 FDA failed to consider.