Reagan-Udall Foundation for the FDA Appoints Steering Committee for Innovation in Medical Evidence Development and Surveillance Program

WASHINGTON, June 11, 2013 /PRNewswire-USNewswire/ -- The Reagan-Udall Foundation for the FDA (RUF) is pleased to announce the appointment of the Steering Committee for its Innovation in Medical Evidence Development and Surveillance (IMEDS) program. IMEDS is a public-private partnership within RUF launched in April 2013 to advance the science and tools necessary to support post-market evidence generation on regulated products, including safety surveillance and evaluations, and to facilitate utilization of a robust electronic healthcare data platform for generating better evidence on regulated products in the post-market settings. IMEDS will build upon the significant progress made on research methodology by FDA's Sentinel Initiative, including its Mini-Sentinel pilot and the Observational Medical Outcomes Partnership (OMOP).

The newly formed IMEDS Steering Committee is comprised of top leadership of the healthcare and scientific communities, with representation across a diverse set of stakeholder groups. It will play a critical role in governing IMEDS's research and operations.

"The selection process was quite robust, as our Board of Directors reviewed 66 nominations for seven of the Steering Committee positions," noted Jane Reese-Coulbourne, Executive Director for the Reagan-Udall Foundation. "We are honored to have such a well-respected group of individuals with proven leadership skills serve on the IMEDS Steering Committee. These individuals will provide IMEDS with the guidance and vision necessary to ensure IMEDS' methods research has sustainable impact and value for all stakeholder groups: the FDA, patients, consumers, pharmaceutical companies, data partners, healthcare providers, and clinicians."

"The IMEDS program will play a critical role in broadening the impact of the Sentinel Initiative and strengthening the regulatory tools and capabilities of the FDA," said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA. "The FDA is excited to serve on this Steering Committee to help advance the collection of useful product safety information to protect the public's health."

The IMEDS Steering Committee will be chaired by Marcus Wilson, PharmD who is President of HealthCore. Its members are as follows, along with the positions they will assume on the Steering Committee:

• Marcus D. Wilson, PharmD: President, HealthCore [Data Partner Representative, and IMEDS Steering Committee Chair]
• Elizabeth B. Andrews, PhD: Vice President of Pharmacoepidemiology and Risk Management, RTI [Research / Academic Institute Representative, and IMEDS Steering Committee Vice-Chair]
• Robert M. Califf, MD: Vice Chancellor for Clinical and Translational Research, Duke University [Provider / Clinician Representative]
• Patrizia A. Cavazzoni, MD: Senior Vice President for Worldwide Safety and Established Products Regulatory, Pfizer [Pharmaceutical Industry Representative]
• Karen Midthun, MD: Director, Center for Biologics Evaluation and Research, FDA [FDA Representative (non-voting member)]
• Jane Perlmutter, PhD: Founder, Gemini Group [Patient Advocate Representative]
• Michael Rosenblatt, MD: Executive Vice President and Chief Medical Officer, Merck [Pharmaceutical Industry Representative]
• John S. Santa, MD, MPH: Director, Health Ratings Center, Consumer Reports [Consumer Advocate Representative]
• Janet Woodcock, MD: Director, Center for Drug Evaluation and Research, FDA [FDA Representative (non-voting member)]
• The Reagan-Udall Board will select a Liaison to serve as a non-voting member on the IMEDS Steering Committee

The IMEDS Steering Committee will be convened this July. More information about the roles and responsibilities for this Committee can be found in the IMEDS Charter.

About the Reagan-Udall Foundation

The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDA by advancing regulatory science and research. With the ultimate goal of improving public health, the Foundation provides a unique opportunity to bring all parties to the table (FDA, patient groups, academia, other government entities, and industry) to work together in a transparent way to create exciting new regulatory science.

http://www.reaganudall.org/

SOURCE Reagan-Udall Foundation for the FDA