There has always been a special concern that products approved for pediatric use should be safe. In a recent analysis published in the July 2010Regulatory Focus --the journal for the Regulatory Affairs Professionals Society, Quintiles experts, Dr. Edward Tabor and Jeff Ventimiglia, set-out to determine whether recent regulation would lead FDA to require a REMS more often for drugs and biologics indicated for pediatric use than products indicated only for use in adults.
About the Authors:
Edward Tabor, MD Vice President, Head of Global Regulatory Strategy
Dr. Tabor heads up our work in regulatory strategy, drawing on years of experience with the FDA. He joined Quintiles after serving as Associate Director for Medical Affairs in the Office of Blood Research and Review at the FDA. He was also a Division Director in the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation & Research (CBER). Here he led the review and approval of products including the first treatment for human immunodeficiency virus. He also led the development of the antiviral regulatory policy and created an antiviral review group that formed the basis of the FDA’s Division of Antiviral Drug Products. Dr. Tabor also participated in the development of many FDA policies and policy documents. In addition, he managed an active laboratory-based research program.
At the National Institutes of Health (NIH), he was Associate Director for Biological Carcinogenesis for the National Cancer Institute, supervising six large intramural research laboratories. Dr. Tabor is an internationally known expert on the hepatitis viruses and liver cancer. He is an author of more than 300 publications on viral hepatitis and other infections transmitted by blood transfusion, has written or edited six scientific books, and holds seven US patents (on behalf of the US government).
Dr. Tabor earned his undergraduate degree from Harvard University and his MD from Columbia University, where he did a residency in pediatrics at Columbia-Presbyterian Medical Center.
Jeff Ventimiglia Analyst, Global Strategy & Solutions
For nearly five years, Jeff has worked in the pharmaceutical industry conducting competitive intelligence analyses, market research, and strategic consultation. Jeff holds a degree in Biomedical Engineering from Tulane University. Prior to joining Quintiles, Jeff worked in management consultancy specializing in strategic planning, market analyses, and competitive war gaming with pharmaceutical clients in both the US and EU.