(October 27, 2022) The Reagan-Udall Foundation for the FDA will present 2022 Innovations in Regulatory Science Awards to Robert Temple, MD; Medidata; and George Vradenburg on December 6 at the Mayflower Hotel in Washington, DC. The awards recognize outstanding contributions to regulatory science and public health in three categories: Leadership, Innovation, and Advocacy/Policy.  

“The Innovations in Regulatory Science Awards recognize those individuals and organizations that have made a profound impact on regulatory science and public health,” said Ellen V. Sigal, PhD, chair of the Foundation’s Board of Directors. “We hope raising awareness about these champions of public health can inspire the next generation of researchers, innovators, and regulators to address emerging challenges.”  

The Leadership Award will be presented to Robert Temple, MD, who serves as Senior Advisor for Clinical Science in FDA’s Center for Drug Evaluation and Research (CDER) as well as Senior Advisor in the Immediate Office of the Office of New Drugs. Dr. Temple’s lifetime commitment to FDA's public health mission is evident from his influential career at FDA and the tremendous impact he has had on advancing thinking on clinical trials.  He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation and active control trials, trials to evaluate dose-response, and trials using enrichment designs.   

This year’s Innovation honoree is Medidata Link, a product from Medidata, a Dassault Systèmes company. The program allows sponsors and regulators to connect and analyze once-disparate data sources to bridge the gap between the clinical trial and the real world, ultimately advancing regulatory science and improving public health. Medidata Link offers an opportunity to better understand a patient population and therapeutic outcomes before, during, and after a clinical trial. It provides sponsors and regulators with a centralized and privacy-preserving way to link clinical trial data with real-world data at the patient-level, which can help to monitor long-term safety and improve trial diversity. 

George Vradenburg, this year’s recipient of the Advocacy/Policy award, has been a tireless advocate for raising awareness and increasing engagement for Alzheimer’s and dementia.  He was named by then-U.S. Health and Human Services Secretary Kathleen Sebelius to serve on the Advisory Council on Research, Care, and Services established by the National Alzheimer's Project Act and is co-founder and chair of UsAgainstAlzheimer’s. Vradenburg has spearheaded an effort to work across sectors to secure $10 billion in annual public funding for Alzheimer’s and dementia research and drug development.   

“This year’s awardees have each made significant contributions to the field of regulatory science,” said Susan C. Winckler, RPh, Esq., CEO of the Reagan-Udall Foundation for the FDA. “We are grateful for their dedication and pleased to celebrate their achievements toward improving public health.”  

The 2022 Innovations in Regulatory Science Awards event is supported by presenting sponsor Alexandria Real Estate Equities, Inc./Alexandria Venture Investments along with other organizational and individual donors.

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