Tiernan's work in biotechnology gives her a unique perspective on combination products.
The staff of MD&DI is pleased to announce that Diane C. Tiernan, MS, RAC, has become a member of its Editorial Advisory Board. With more than 20 years of experience in medical device reg ulatory affairs, her professional expertise complements the existing board and makes her an asset to the magazine.
Tiernan currently serves as associate director of regulatory affairs for Alkermes Inc., based in Cambridge, MA. Her responsibilities at Alkermes include all device-related functions for the company's inhaled and injectable drug-delivery products. “Taking a leap from medical device development into the biotechnology arena has provided me with a unique opportunity to view combination products from an entirely new vantage point,” Tiernan says. “There are nuances to each regulatory process that must be considered when identifying a regulatory strategy for a combination product. In addition, this current exposure gives me the experience that is critical to the identification of best practices with respect to worldwide regulatory strategies for these types of products.”
Before joining Alkermes, Tiernan was senior regulatory affairs associate for Beltsville, MD–based Bio-Reg Associates, a consulting firm specializing in medical devices. Prior to Bio-Reg, she held regulatory affairs positions with Synthes Spine (Paoli, PA), MedChem Products Inc. (Woburn, MA), CR Bard (Billerica, MA), and Symbion Inc. (Salt Lake City, UT). In those positions, she oversaw U.S. and European device regulatory filings, liaised with regulatory agencies, and monitored clinical trials.
Tiernan began her career as a certified audiologist, working extensively with cochlear implants. She received her BA in speech pathology from the University of Connecticut and her MS in audiology from Ithaca College. In addition to being a member of the Regulatory Affairs Professionals Society (RAPS), she leads the Boston chapter of RAPS.