Kathy Giacomini, a professor at the University of California, San Francisco, is a leader in the field of membrane transporters with a focus on genetic polymorphisms. She cloned, characterized and discovered the endogenous role of the human xenobiotic transporter, OCT1 (SLC22A1), and recently de-orphaned SLC22A24 and SLC22A15, discovering physiologic and pharmacologic substrates of both transporters. Together with others, she co-founded the International Transporter Consortium, which has published highly impactful papers informing regulatory policy. She is the Co-Principal Investigator of the UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation, funded by the Food and Drug Administration. She has received numerous awards including an honorary doctorate degree from Uppsala University, and is an elected member of the National Academy of Medicine.
Use of Real World Evidence in Regulatory Sciences
I will describe the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation, which provides a forum for collaborative research between faculty and FDA scientists. I will focus on research that makes use of RWE to monitor safety and efficacy of diverse medical products including drugs and biologics.
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