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Advancing a New Policy Framework for Regenerative Cell Therapy

KEYWORDS: FOOD AND DRUG ADMINISTRATION, 114TH CONGRESS, SENATE HELP COMMITTEE, 21ST CENTURY CURES

WHEN: Tuesday, April 12, 2016 5:30 a.m. to 8:00 a.m. ET

WHERE: Bipartisan Policy Center, 1225 Eye St. NW, Suite 1000, Washington, DC

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Cell therapies represent one of the most promising areas for the next generation of groundbreaking treatments in the areas of cardiology, neurology, ophthalmology, and orthopedics. New studies for those with Alzheimers’ disease, Parkinson’s disease, heart disease, diabetes, and cancer are encouraging.

Despite the benefits of these treatments, cell therapies are generally not accessible to patients in the United States. Europe and Japan have outpaced the United States in modernizing their regulatory policies to grant patient access to safe cell therapies. As a result, patients are forced to seek treatment overseas and U.S. companies are increasingly making investments in other parts of the world.

A significant amount of policy activity is now underway to address this problem. Earlier this month, bipartisan, bicameral legislation was introduced to create a new regulatory pathway to bring safe and effective treatments to patients in the United States. The REGROW Act was also discussed during the Senate Health, Education, Labor, and Pensions (HELP) Committee’s third and final mark-up of medical innovation legislation.

The Bipartisan Policy Center and the Regenerative Medicine Foundation hosted policymakers, scientific and academic experts, practitioners, and patients to discuss the science and benefits of cell therapy and new policies needed to modernize the U.S. regulatory approach for bringing safe and effective treatments to Americans.


Panel discussions featuring:

Julie G. Allickson, PhD
Director, Regenerative Medicine Clinical Center
Wake Forest Institute for Regenerative Medicine, Wake Forest University School of Medicine

Sandy Barker
President and Co-Founder, Gold Rush Cure Foundation

Arnold Caplan, PhD
Professor, Case-Western Reserve University
Director, Skeletal Research Center

Kate Cassling
Office of Sen. Joe Manchin (D-WV)

Steven A. Davis, MD
Co-Founder and Chief Medical Officer, StemBioSys, Inc.

Deborah L. Dean
Executive Vice President and Chief Compliance Officer, MiMedx

Timothy Ganey, PhD
Chief Scientific Officer, Vivex

Joshua M. Hare, MD
Founding Director, Interdisciplinary Stem Cell Institute
Leonard M. Miller School of Medicine at the University of Miami

Joanne Kurtzberg, MD
Professor of Pediatrics and Professor of Pathology, Duke University of Medicine
Chief Scientific Officer, Robertson Clinical and Translational Cell Therapy Program

Leslie Miller, MD, FAHA, FACC
Chairman, Alliance for the Advancement of Cellular Therapies

C. Randal Mills, PhD
President and CEO, California Institute for Regenerative Medicine
View presentation slides

Shelley Ross
President, The Cure Alliance

Marc J. Scheineson, Esq.
Partner, Alston & Bird LLP

Andrew Vogt
Office of Sen. Mark Kirk (R-IL)

Moderated by:

Janet Marchibroda
Director of Health Innovation, BPC

Bernard Siegel
Executive Director, Regenerative Medicine Foundation

Our Partners for This Event

Logo: The Regenerative Medicine Foundation