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Tuesday, June 28 • 4:00pm - 5:15pm
#267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The historic structure of FDA is oriented around the products it regulates. Today, the treatment of many diseases involves numerous different technologies and interventions centered on providing optimal care for the patient, and a patient-centered orientation to reflect the current multimodal approach to patient care is being proposed. Cross-center Institutes of Excellence could help FDA to further advance the promotion of human health. These institutes could foster increased intellectual collaboration and a consistent FDA approach by forming teams of Agency staff with cutting-edge expertise in the treatment and prevention of specific types of diseases. Consolidating disease-oriented activities at FDA may help reduce redundancies within the current FDA Centers and better consolidate core competencies to focus on scientific advancement within the Agency and streamline processes for the review of products to treat high impact disease areas. The benefits of such a restructuring will be explored and discussed by a panel of experts.

Learning Objectives

Describe how the proposed reorganization could affect drug development and review by FDA; Discuss whether the proposed reorganization could benefit patients; Explain path forward and potential challenges associated with the proposed reorganization.

Chair

Margaret A. Anderson, MA

Speaker

Panelist
Wade Ackerman, JD

Panelist
Steven K. Galson

Panelist
Eric H. Rubin, MD

Panelist
Ellen Sigal, PhD



Chair
avatar for Margaret Anderson

Margaret Anderson

Executive Director, FasterCures, A Center of the Milken Institute
Margaret Anderson is the executive director of FasterCures, a Washington, DC-based center of the Milken Institute, which is driven by a singular goal – to save lives by speeding up and improving the medical research system. FasterCures focuses on spurring cross-sector collaboration, cultivating a culture of innovation and engaging patients as partners. She is also acting president and CEO of the Melanoma Research Alliance, the largest private... Read More →

Speakers
avatar for Wade Ackerman

Wade Ackerman

Former Senior FDA Counsel for the Senate HELP Committee, NA
Wade Ackerman recently served as Senior FDA Counsel for Ranking Member Patty Murray on the US Senate Committee on Health, Education, Labor and Pensions (HELP) where he handled issues related to pharmaceuticals, medical devices, animal products, cosmetics, and other FDA-related areas. Prior to working in the Senate, Wade was agency counsel for the FDA. In his role as Associate Chief Counsel, he advised officials at FDA and the US Department of... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug Evaluation and Research and held other senior government positions. Galson holds a B.S. from Stony Brook University, an M.D. from Mt. Sinai School of Medicine, and... Read More →
ER

Eric Rubin

Vice President and Therapeutic Area Head, Merck Research Laboratories
ES

Ellen Sigal

Chairperson and Founder, Friends of Cancer Research
Dr. Ellen Sigal has been a devoted patient advocate and stanch supporter of cancer research. She founded Friends of Cancer Research in 1996 to mark the anniversary of the National Cancer Act. Friends is a cancer research think tank and advocacy organization based in the Washington, D.C. area.


Tuesday June 28, 2016 4:00pm - 5:15pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA