Brian D. Bollwage

Biography

Brian D. Bollwage, JD is a career regulatory professional that provides strategic regulatory solutions for products at all stages of development in the product life cycle. Mr. Bollwage has more than 30 years experience in the health products industry permitting him to design regulatory strategies which expedite progress to market. Presently he serves as the Vice President of Strategic Regulatory Affairs at Theorem Clinical Research a mid-sized contract research organization. He has previously served as Regulatory Counsel at i3Research and during tenures with Johnson & Johnson, Pharmacia, Hoechst-Roussel, and Bristol-Myers Squibb he has managed the preparation, submission, research activities and associated FDA liaison activities of over 150 INDs and 25 successful NDAs or BLAs. He received the J.D. from Rutgers Law School, an M.B.A. from Fairleigh Dickinson University, an M.Sc. in Biology from Rutgers University and a B.A. in Biology from University of Bridgeport. In addition, he holds an appointment as Assistant Professor of Food and Drug Law at Temple University and speaks and publishes actively on numerous Food and Drug Law topics.  

Research Interest

drug safety