Pam leads Adaptive’s efforts to engage across the precision medicine community to drive policy solutions that support immune-driven medicine. Adaptive is a commercial-stage biotech company that aims to translate the genetics of adaptive immune systems into clinical products to transform the diagnosis and treatment of disease. Pam brings scientific and policy expertise from her work across FDA, U.S. Congress, NIH, biotech industry and the non-profit sector, specializing in personalized medicine, oncology and regulation of in vitro diagnostic devices. Pam received her Ph.D. in developmental biology and genetics from Johns Hopkins School of Medicine and completed postdoctoral research at Harvard Medical School.
New federal rules are driving significant shifts in development and marketing of “follow-on” CDx and “Co-CDx”/novel therapeutics and immuno-therapies. The panel will discuss the rapidly evolving regulatory and reimbursement landscape and the impact of new FDA and CMS policies on investor/company approaches to managing companion diagnostic development risk.