Session Chair Profile
RPh, Esq, CEO, Reagan-Udall Foundation for the FDA.
Biography
Susan C. Winckler, RPh, Esq, has 30 years of experience in the FDA and healthcare community and has worked with members of regulated industry across FDAs portfolio; with healthcare professionals, associations, patient organizations, consultants in this community; and other governmental and quasigovernmental organizations. She has served as chief of staff at the agency and in helping the commissioner and FDA navigate routine and emergent situations both domestic and international; leading the Food and Drug Law Institute to speak, write, and convene discussions of food and drug law issues; driving the policy, regulatory, and communications agenda of the American Pharmacists Association, and advising regulated industry (drug, device, biologic, and food companies) and others in the health care sector while at Leavitt Partners, the health care consulting firm founded by former HHS Secretary Michael O. Leavitt. She can be reached at swincklerreaganudall.org
Session Abstract – PMWC 2024 Silicon Valley
Track Chair:
- William Oh, Mount Sinai
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.
Sessions:
- PMWC 2024 Award Ceremony
Pioneer Honoree: Atul Butte, UCSF
- Fostering Collaboration: Strategies to Enhance Data Sharing in Medical Research (PANEL)
Chair: Craig Eagle, Guardant Health
- Paul Boutros, UCLA
- Atul Butte, UCSF
- George Sledge, Caris Life Sciences
- Erica Galvez, Manifest MedEx - Regulatory Challenges in Collecting and Using Race and Ethnicity Data in Real-World Evidence
Chair: Susan Winkler, Reagan-Udall Center
- Multi-Modal Datasets & RWE/D: Pioneering Tools for Accelerated Biomedical Research
Chair: TBA
- Data Privacy and Security in RWE/D
Chair: Deven McGraw, Invitae
- Christopher Boone, AbbVie
- Susan Stayn, Stanford
- Alexa Berk King, CVS
- Accelerating Drug Development Approvals Using RWE/D (PANEL)
Chair: Maria Karasarides, BMS
- Leo Russo, Pfizer
- Eric Schadt, Ethos AI
- Ashley Brenton, Optum
