FDA’s Amy Abernethy, Friends of Cancer Research, and The Michael J. Fox Foundation for Parkinson’s Research Honored with Innovations in Regulatory Science Awards

Honorees to be recognized virtually on December 8, 2020

The Reagan-Udall Foundation for the FDA will present the 2020 Innovations in Regulatory Science Awards to Amy Abernethy, MD, PhD, Principal Deputy Commissioner of the U.S. Food and Drug Administration; Friends of Cancer Research; and The Michael J. Fox Foundation for Parkinson’s Research. Honorees will be recognized at the Foundation’s annual Innovations in Regulatory Science Awards celebration on Tuesday, December 8, from 6-7:30 pm (eastern). Due to COVID-19 restrictions, the event will be held virtually.  

“We are delighted to recognize the profound contributions of these honorees,” says Garry Neil, MD, Chair of the Awards Committee, and a member of the Foundation’s Board of Directors. “They are innovators who are improving our knowledge and our scientific process while keeping patients at the forefront.”

The Innovations in Regulatory Science Awards recognize outstanding contributions to regulatory science and public health in three categories: Leadership, Innovation, and Advocacy/Policy.

The Foundation’s Leadership Award recognizes Dr. Amy Abernethy’s significant contributions, national leadership, and service in regulatory science and public health. As Principal Deputy Commissioner and Chief Information Officer at the U.S. Food and Drug Administration, Dr. Abernethy oversees the agency’s daily operations and high-priority, cross-Center initiatives as well as its data and technical vision and execution. A leader and pioneer in the use of real-world evidence (RWE), Dr. Abernethy’s conviction that patient care should be informed by reliable data is evident throughout her career. She works every day to leverage health data to inform regulatory decisions, advance medical innovation, and improve care for patients. She has built important partnerships to speed the use of RWE in our nation’s response to the COIVD-19 pandemic, imploring researchers to “learn what we can as soon as we can.”

Recognized with the Innovation Award, Friends of Cancer Research (Friends), works to accelerate policy change, support groundbreaking science, and deliver new therapies to patients quickly and safely.  Their leadership in RWE helps researchers better grasp the full potential of real-world data. Friends’ Real-World Evidence Pilot Projects 1.0 and 2.0 engage multiple data partners, international populations, and oncology disease settings to create thorough recommendations on the role of real-world data on clinical research, drug development, and regulatory processes. The projects culminated in publication of a replicable process for assembling fit-for-purpose datasets and a common real-world protocol and provides recommendations for developing a real-world evidence framework.

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) receives the Advocacy/Policy Award for changing the landscape of Parkinson’s research and patient engagement. Working to find a cure and ensure better therapies, MJFF spearheads an aggressively funded research agenda and advances understanding and treatment of the disease. MJFF leverages expert perspective and global contacts to create an open, collaborative, and replicable research environment that leads to faster results for the six million people living with Parkinson’s worldwide. A powerful patient force on Capitol Hill, MJFF regularly educates members of Congress on issues important to the Parkinson’s community and pushes for policies that spur faster knowledge.

“We are excited to celebrate the many accomplishments of our 2020 honorees,” says Susan C. Winckler, RPh, Esq., CEO of the Reagan-Udall Foundation for the FDA. “We are inspired by those accomplishments, their innovative spirit, and their impact on America’s health.”

The 2020 Innovations in Regulatory Science Awards Event is supported by presenting sponsor Alexandria Real Estate Equities, Inc./Alexandria Venture Investments and more than 40 other organizational and individual donors. Individual tickets may be purchased from the Foundation’s website.

About the Reagan-Udall Foundation for the FDA

The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and policies to keep pace with today’s rapidly evolving science.

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