ADVISORY/Experts Available to Discuss Reduction of Time, Cost in Drug Development.

Business Editors

ADVISORY...

--(BUSINESS WIRE)--Jan. 31, 2003

TOPIC: The Food and Drug Administration (FDA) plans to reduce the time and cost of introducing new drugs, vaccines and medical devices to the U.S. market, according to an article by Reuters. The FDA will take measures to avoid multiple review cycles for products, which has caused delays, by making sure companies are aware of the scientific standards the agency requires for approval. In 2002, the FDA approved 17 novel chemical-based drugs, which is down from 24 in 2001. The average approval time for novel "priority" drugs was 16.3 months in 2002, up from six months in 2001, the article says. EXPERTS: ExpertSource can offer several highly qualified experts to comment on this story:

Dr. Kenneth I. Kaitin is the director of the Tufts Center for the Study of Drug Development at Tufts University, where he studies national and worldwide trends in pharmaceutical innovation, regulation, and public policy. He is also Assistant Professor of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine. Dr. Kaitin has written extensively on factors that contribute to the slow pace and high cost of pharmaceutical R&D, and the impact of regulatory and legislative initiatives to speed drug development and approval. His articles have been published widely in medical and policy journals. Dr. Kaitin has provided testimony before the U.S. Congress in hearings on FDA reform, and he has worked closely with the U.S. Council on Competitiveness in the preparation of their report on the pharmaceutical industry. He is a former President of the Drug Information Association, and he serves on the faculty of the European Center for Pharmaceutical Medicine. PR: Peter Lowy, 781-326-9980, [e-mail]

Dr. Joyce O'Shaughnessy is currently a breast cancer researcher and practitioner at Texas Oncology, P.A. in Dallas and is Associate Director for clinical research for US Oncology. She is also Director, Chemoprevention Research and Co-Director, Breast Cancer Research for US Oncology. Dr. O'Shaughnessy's major area of research interest is the development of breast cancer, and she is involved in several ongoing chemoprevention studies. She served as special assistant to the National Cancer Institute (NCI) director from 1988 to 1990 and coordinated the development of new cancer drug approval guidelines for the NCI and Food and Drug Administration. Dr. O'Shaughnessy then served as a Senior Investigator in the Medical Breast Cancer Section of the NCI from 1990 through 1995. In this role, she conducted many breast cancer treatment clinical trials, including evaluation of high-dose chemotherapies and hematopoietic growth factors, new cytotoxic drug combinations, novel hormonal treatments, monoclonal antibody and gene therapies for breast cancer. 214-370-1000, [e-mail]

Dr. Bert Spilker, of George Washington University School of Public Health, is an expert regarding health sciences, medicine, drug development, regulatory affairs and the Food and Drug Administration. 301-718-5150

ExpertSource cannot guarantee the immediate availability of these experts or their familiarity with this specific issue.

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