Trained as an internist and epidemiologist, Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP) at the Center for Drug Evaluation and Research (CDER), US Food and Drug Administration. In seeking to enhance policies related to drug development and regulatory review in CDER, his responsibilities include a focus on real-world evidence (RWE) and involve work developing internal Agency processes, interacting with external stakeholders, supporting RWE demonstration projects and guidance development, and serving as the Chair of the RWE Subcommittee. Prior to joining FDA, his career focused on generating research as an independent investigator and research center director at Yale University School of Medicine and the U.S. Department of Veterans Affairs (VA), including serving as one of two founding principal investigators of the VA Million Veteran Program genomic mega-biobank. He received M.D. and M.S. degrees from New York University and an M.P.H. degree from Yale University.
Keith Yamamoto, UCSF
Patient-centric data – Real-World Evidence (RWE) and Real-World Data (RWD) - is becoming instrumental in the drug development process and for health care decisions in general. This data is not only informative for the process from discovery to new indications, clinical trial design, and drug development, it also can be of value to monitor post-marketing drug safety and for decision support in clinical practice. As the data becomes a decision driver, science companies and medical organizations are increasingly focused on leveraging RWD and RWE to not only better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support. This session will focus on the various aspects of integrating RWE and RWD to support drug development and clinical decision support