PharmaNet

Karen L. Goldenthal, M.D. has joined PharmaNet Development Group’s consulting division as executive director, PharmaNet Consulting. “Dr. Goldenthal’s in-depth knowledge of the clinical and regulatory aspects of vaccine development will bring additional strength and leadership to PharmaNet vaccine development services,” commented James P. Burns, Jr., Ph.D, senior vice president, regulatory consulting worldwide.

Dr. Goldenthal joins the company from the FDA where she worked for more than 20 years. For the past 10 years, she was director of the division of vaccines and related products applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER). Dr. Goldenthal has been extensively involved in all aspects of vaccine development. She was responsible for providing input to senior management on regulatory policy and the review of clinical trials and clinical data to support licensure of vaccines. She has also worked with national and international committees and organizations on technical and policy issues related to vaccine development.