Applied clinical trials: Integrium launches dermatology practice
APPLIED CLINICAL TRIALS: INTEGRIUM LAUNCHES DERMATOLOGY PRACTICE
July 14, 2010 – Early last month, Integrium launched its expansion into the dermatology therapeutic area. Dr. Mary Spellman, dermatology drug development expert, will lead Integrium’s Dermatology Clinical Research Group.
The company’s new Dermatology Clinical Research Group will help its clients design studies, leverage its relationships with investigators to help identify and recruit study patients, and effectively manage their studies.
“Selecting the right CRO partner is critical to our success,” said Dr. Sharon Levy, Senior Vice President of Product Development for Graceway Pharmaceuticals, a firm focused on developing branded prescription products for the dermatology and women’s health therapeutic areas. “We selected Integrium not only for their scientific and clinical trial expertise, but for their experience in studies of topical therapies. They have helped us complete enrollment and lock the study database ahead of schedule for a multi-center Phase 2 trial.”
Dr. Spellman is a board-certified dermatologist with 20 years of experience in clinical research and drug and medical device development. Dr. Spellman has helped to achieve US FDA and ex-US approvals for multiple topical, systemic, and biological drugs, as well as dermatological devices and vaccines, and has served as a medical and safety officer, and nonclinical and clinical development and regulatory strategist to biopharmaceutical and device companies. In addition to working with Integrium, Dr. Spellman maintains a pharmaceutical and medical device consulting practice.
Before Integrium, Dr. Spellman served as Chief Medical Officer at Revance Therapeutics, where she was responsible for the development of novel topical therapies for aesthetic and medical dermatology indications. Before that she held senior roles at Biogen Idec, Inc., Connetics Corporation (now Stiefel Laboratories, Inc., a GlaxoSmithKline company) and Novartis Pharmaceuticals. Before entering the biopharmaceutical industry, Dr. Spellman was an Assistant Professor of Medicine (Dermatology) and Director of Dermatology Clinical Research at the University of California, San Diego School of Medicine and Medical Center, and an attending physician at the Veterans Affairs Medical Center in San Diego. After earning her medical degree from the Medical College of Wisconsin, she completed an internship in Internal Medicine Residency at Northwestern University McGaw Medical Center and a Dermatology Residency at the Medical College of Wisconsin Affiliated Hospitals. She is a member of the Board of Directors of the Women’s Dermatologic Society and the Editorial Board of the Journal of the American Academy of Dermatology.