With over 15 years’ experience in academia and industry developing clinical and research information systems. Joint appointment with Quantum Leap Healthcare Collaborative and UCSF Breast Care Center in overseeing efforts for process re-engineering and quality improvement of clinical care and research. Technology and data management portfolio includes: I-SPY COVID and I-SPY 2 TRIALs, the OneSource/eSource platform collaboration with the FDA, the Clinical Trials Matching platform and the Athena Breast Health Network platform.
Track Chair: - 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.