Events

This seminar will involve a lecture and discussion on current and ongoing policy and ethical, legal, and social implications in 21st Century Cures Act biomedical innovation, with a specific focus on the generation and use of real-world data (RWD) in medical product development and health research. Areas and topics that will be covered include individual perspectives on RWD sharing with researchers pre-and post-mortem, privacy concerns about sharing sensitive RWD, and the use of generative artificial intelligence to create synthetic data for medical product research and development. This seminar will also involve a discussion about health system trustworthiness in 21st century medicine and beyond, including but not limited to a discussion on informed consent practices intended to drive clinical research and real-world evidence development at the point of care.

Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute’s RWE Collaborative and RWE policy research portfolio and education. As an engagement expert, biomedical researcher, bioethicist, and policy practitioner with over 18 years of experience, her work centers on addressing implementation, regulatory, and ethical, legal, and social implications (ELSI) at the intersection of health policy and innovation. She presently partners with Duke University faculty, scholars, students, and external practicing experts to advance the Institute’s biomedical innovation work.