Join us for the fifth annual Innovations in Regulatory Science Awards
December 14, 2021
6 - 7:30 pm Eastern
The Reagan-Udall Foundation for the FDA is excited to assemble our regulatory science colleagues to celebrate the leadership, scientific breakthroughs, and unwavering advocacy that safeguards America’s public health.
Register below to join us at a December 14th virtual event recognizing our 2021 honorees.
Peter Marks, MD, PhD
Director, Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration
Dr. Peter Marks is recognized for his outstanding leadership and lifelong commitment to public service. Under Dr. Marks’s guidance, CBER has approved several new treatments, including the first CAR-T cell therapy for advanced cancer and the first Ebola vaccine. He also spearheaded the unprecedented public/private partnership formerly known as Operation Warp Speed and worked to ensure the vaccines were safe, effective, and underwent a rigorous evidence-based and transparent process.
COVID-19 Research Database
This successful public-private partnership launched a large secure repository of HIPAA-compliant real-world data, which was made available at no cost to health researchers at the height of the COVID-19 pandemic. This critical innovation was an invaluable resource for COVID-19 research as well as an exemplar for other critical disease and regulatory areas. The COVID-19 Research Database provides a framework that should serve as a blueprint for future public-private collaboration, synergy and productivity that could undoubtably benefit the regulatory community.
Patrick J. Kennedy
The Kennedy Forum
Patrick J. Kennedy has demonstrated unwavering commitment to raising awareness and advocating for policies for millions who deal with mental health and substance use issues. In his work with the Kennedy Forum, he engages with advocates, business leaders, and government agencies to advance evidence-based practices, policies, and programming in mental health and addiction. As a U.S. Representative, he was the lead author of the landmark Mental Health Parity and Addiction Equity Act (Federal Parity Law), which requires insurers to cover treatment for mental health and substance use disorders no more restrictively than treatment for illnesses of the body.
2020 – Amy Abernethy, MD, PhD, Principal Deputy Commissioner, U.S. Food and Drug Administration
2019 – Theresa M. Mullin, PhD, Associate Director for Strategic Initiatives, FDA's Center for Drug Evaluation and Research
2018 – Richard Pazdur, MD, Director, FDA’s Oncology Center of Excellence
2017 – Janet Woodcock, MD, Center Director, FDA Center for Drug Evaluation and Research
2020 – Friends of Cancer Research
2019 – Compassionate Use Advisory Committee, Co-founded by Johnson & Johnson and New York University
2018 – Robert O’Neill, PhD, former Senior Statistical Adviser, Center for Drug Evaluation and Research, and Clinical Trials Transformation Initiative
2017 – Patrick Ryan, PhD, Senior Director and Head of Epidemiology Analytics, Janssen Research and Development
2020 – The Michael J. Fox Foundation for Parkinson’s Research
2019 – Cystic Fibrosis Foundation