(December 4, 2023) The Reagan-Udall Foundation for the FDA will present Innovations in Regulatory Science Awards to Francis Collins, MD, GenomeTrakr, and jointly to Representative Diana DeGette (D-CO) and former Representative Fred Upton (R-MI) on December 5, 2023. The awards recognize outstanding contributions to regulatory science and public health in three categories: Leadership, Innovation, and Advocacy/Policy.  

“The FDA Foundation is proud to recognize this year’s honorees,” said Richard L. Schilsky, MD, FASCO, chair of the Foundation’s Board of Directors. “These individuals and initiatives have all made significant contributions to advance our scientific knowledge and improve public health and safety.”  

The 2023 Leadership Award will recognize Francis Collins, MD, PhD, who has exemplified leadership and the pursuit of innovation and scientific rigor throughout his career. As the director of the National Human Genome Research Institute, he was instrumental in guiding the team that successfully carried out the Human Genome Project. While director of the National Institutes of Health, Collins worked with the larger biomedical research community to create principles and guidelines to foster rigor and reproducibility in preclinical research. During the COVID-19 pandemic, Dr. Collins spearheaded a public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. He currently serves as President Biden’s science advisor and as co-chair of the President’s Council of Advisors on Science and Technology.   

This year’s Innovation honoree is the GenomeTrakr, an FDA initiative that is transforming food safety and broader pathogen evolution. By applying whole genome sequencing to assess food safety and publicly sharing sequencing data, the GenomeTrakr network has changed how foodborne illness outbreaks are investigated, adding speed and certainty to the investigations. To date, the genomic data gathered by the GenomeTrakr network has been used in hundreds of FDA foodborne illness investigations and numerous investigations by CDC and USDA, providing expeditious leads to outbreak sources, and a means to verify the effectiveness of food safety systems in food manufacturing environments. Tapping whole genome sequencing data to advance food safety is becoming commonplace around the world, growing in part, from the vision of FDA and its GenomeTrakr partners. In addition, GenomeTrakr labs are providing information about the evolution of the SARS-CoV-2 (COVID-19) virus, which is critical to evaluating the effectiveness of FDA-regulated COVID-19 vaccines, therapeutics, and diagnostics. 

Rep. Diana DeGette (D-CO) and former Rep. Fred Upton (R-MI) are joint recipients of the 2023 Advocacy/Policy Award. Both championed and co-sponsored the 21^st Century Cures Act, bipartisan legislation passed in 2016 that has modernized the nation’s medical research system. From cancer research to precision medicine, the “Cures Act” has helped spur the development and approval of life saving drugs and devices, helping patients and families. The Act also established and helped implement a strategic plan for biomedical research.  

“We are grateful to each of this year’s honorees for their dedication and commitment to serving the public health,” said Susan C. Winckler, RPh, Esq., CEO of the Reagan-Udall Foundation for the FDA. “We look forward to celebrating their regulatory science achievements.” 

The 2023 Innovations in Regulatory Science Awards dinner will be held at the Willard InterContinental Hotel in Washington, DC, on December 5. The event is supported by presenting sponsor Alexandria Real Estate Equities, Inc./Alexandria Venture Investments along with other organizational and individual donors.