Georgetown University forum to explore scientific approaches for expediting drug development

Rep. Richard Burr (R-NC), vice-chair of the House Energy & Commerce Committee, plans to join FDA officials and other drug development experts, including faculty from the CDDS, on Tuesday and Wednesday, January 15 and 16, to present Congressional views concerning the role of the FDA Modernization Act of 1997 (FDAMA) in streamlining the drug review process.

The workshop, titled "Confirmatory Evidence to Support a Single Clinical Trial (SCT) as a Basis for Drug Approval," will specifically examine Section 115a of FDAMA, which permits approval of a new drug on the basis of data from one adequate and well-controlled clinical trial, plus "confirmatory evidence." This workshop seeks to clarify the term "confirmatory evidence," an approach that makes use of scientific clinical trials to streamline drug development.

"While there have been public discussions and debate among academic, industry and regulatory experts about the meaning of 'confirmatory evidence,' there is no consensus yet," said CDDS Director Carl Peck, MD, professor of pharmacology and medicine and former director of the FDA Center for Drug Evaluation and Research (CDER). "The goal of our workshop is to develop a report that outlines scientific qualities of confirmatory evidence that can credibly support approval of new drugs--with the ultimate goal being a more efficient and rapid process that provides assurance of effectiveness and safety."

FDA participants include CDER Director Janet Woodcock, MD; Robert J. Temple, MD, director of CDER's Office of Medical Policy; and Lawrence Lesko, PhD, director of CDER's Office of Clinical Pharmacology and Biopharmaceutics. Significant contributions from academia and industry will be presented by Lewis Sheiner, MD, professor of laboratory medicine at the University of California San Francisco; Ronald Krall, MD, senior vice president for U.S. drug development for AstraZeneca; and former FDA counsel Frank Sasinowski.

Media are invited to attend the conference; anyone wishing to obtain press credentials must RSVP to Beth Porter at (202) 687-4699.

The mission of Georgetown's Center For Drug Development Science is to establish clinical drug development science as a rigorous academic discipline for advancing new scientific methodologies, to contribute to the education of scientists engaged in clinical evaluation of drugs, and to provide solutions to real-world drug development problems. For more information, visit cdds.georgetown.edu.