Sheila D. Walcoff, J.D., is a strategic and regulatory advisor to pharma, diagnostic companies and investors engaged in companion diagnostics, and other diagnostic technologies. She is the CEO and Founder of Goldbug Strategies, which provides FDA regulatory consulting for companion diagnostics and other LDTs and IVDs, quality systems/FDA compliance, NGS platforms, and digital precision medicine tools. Ms. Walcoff’s 25+ years of experience includes Associate Commissioner at FDA, the senior science and public health official in the immediate office of the Secretary at HHS, a partner in a large international law firm, and majority counsel to a congressional committee.
- Courtney McFall, UCSF
- Ben Rubin, 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.