2024 Innovations in Regulatory Science Awards

Leadership Award - Jeff Shuren, MD, JD 

Jeff Shuren, MD, JD, recently was Center Director Emeritus at the U.S. Food and Drug Administration. For 15 years, Dr. Shuren was the Director of the Center for Devices and Radiological Health (CDRH) which is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation. Under Shuren's leadership, FDA achieved significant milestones, including a five-fold increase in annual authorizations of innovative medical devices, establishment of key programs like the Breakthrough Devices Program, CDRH’s Patient Engagement Program and the Digital Health Center of Excellence, and co-founded the Medical Device Innovation Consortium and the International Medical Device Regulators Forum.

Innovation Award - Real-World Evidence Collaborative

The Real-World Evidence (RWE) Collaborative, convened by Duke-Margolis Institute for Health Policy, engages medical product developers, data companies, payers, research groups, providers, patient networks, as well as experts on regulatory affairs, law, health and data science, and policy, with a shared goal and interest to advance RWE policy. In late 2023, the Collaborative launched the International Harmonization of RWE Standards Dashboard, addressing a critical need for global alignment on real-world data and real-world evidence standards. This groundbreaking tool provides up-to-date summaries of international regulatory guidance and simplifies access to essential regulatory definitions, data quality standards, and relevant literature.

Advocacy/Policy Award - Steven A. Grossman, JD

Steven A. Grossman, JD, co-founded and led the Alliance for a Stronger FDA, a multi-stakeholder organization with 150+ members devoted to advocating for increased appropriations for the FDA and educating policymakers and the public about the FDA's mission and responsibilities. Established 18 years ago in response to FDA's underfunding, the Alliance came out of Grossman’s background in public service which includes strong ties with the patient and research advocacy communities and nearly three decades of work in the Senate, HHS, and as a consultant. The Alliance’s advocacy efforts have contributed to significant growth in the FDA budget and its programs have increased understanding of the FDA's expanding mission, growing responsibilities, and budget process.

Thank you to our 2024 sponsors