News | July 13, 2006

FDA And Industry Veteran To Provide High-Level Regulatory And Clinical Guidance To Biotechnology And Pharmaceutical Companies

Rockville, MD - RRD International, LLC (RRD), a product development company supporting the regulatory and clinical needs of pharmaceutical and biotechnology companies, announced today the appointment of Curtis L. Scribner, M.D., as Senior Vice President of Medical and Regulatory Affairs. In this newly created position, Dr. Scribner will provide strategic leadership of product development programs for the expanding number of RRD partners which include both start-up biotechnology and larger pharmaceutical companies. He will be based in the San Francisco Bay Area and report directly to Charles W. Finn, Ph.D., Chief Executive Officer of RRD.

"Dr. Scribner brings to RRD more than 20 years of experience in clinical trial design and management and a proven track record in worldwide regulatory drug development," said Dr. Finn. "His background as a clinician, his decade-long tenure at FDA, and his hands-on industry experience make him an important asset to RRD and will greatly benefit our partner companies."

"I am excited to be joining RRD and look forward to continuing the success that the firm has had to date in providing companies with high-level regulatory and clinical guidance as well as operational support for regulatory submissions and clinical trials," commented Dr. Scribner.

Dr. Scribner is a board-certified physician in internal medicine and has direct experience running large clinical programs. Before joining RRD, Dr. Scribner was Vice President of Regulatory and Quality Affairs and Chief Regulatory Officer at Intarcia Therapeutics, a privately held drug and biologics development company. In this role, Dr. Scribner had overall responsibility for developing, planning, directing, and implementing global regulatory and quality strategy. Previously, Dr. Scribner was Chief Regulatory Consultant for Quintiles Consulting, where he developed and wrote numerous NDA, BLA, IND, IDE, 510(k), PMA, and MAA applications. Prior to Quintiles Consulting, Dr. Scribner spent ten years at the US Food and Drug Administration, where he held a variety of positions and was involved in reviewing products regulated by the Center for Biological Evaluation and Research. Most recently, he held the title of Deputy Director and Supervisory Medical Officer at the Office of Blood and Research Review, Center for Biological Evaluation and Research. Dr. Scribner holds an M.D. from the University of Colorado College of Medicine, an M.B.A. from the University of Maryland College of Business and Management, and a B.A. from Grinnell College.

SOURCE: RRD International, LLC