Brian D. Bollwage is Executive Director, Regulatory Affairs, North America for Ingenix Pharmaceutical Services. He provides strategic regulatory solutions to customers at all stages of the product life cycle. Mr. Bollwage’s 25 years experience in the health products industry permits him to design regulatory strategies for clients which expedite their progress to market. Most recently, serving as FDA Counsel and the head of INC Research’s Regulatory Affairs & Quality Assurance units, he has also served as Director, FDA Liaison Group with Covance where he developed and implemented these companies’ regulatory strategies for drugs, biologics and devices. During his tenures with Johnson & Johnson, Pharmacia, and Hoechst-Roussel, Mr. Bollwage has managed the preparation, submission, and associated FDA liaison activities of over 100 INDs and 20 NDAs or BLAs. Mr. Bollwage has been the principal FDA contact regarding these submissions and has acted as the U.S. agent for numerous submissions. Mr. Bollwage received his J.D. from Rutgers Law School, his M.B.A. from Fairleigh Dickinson University, his M.Sc. in Biology from Rutgers University and his B.A. in Biology from University of Bridgeport. Mr. Bollwage 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. Mr. Bollwage is an active member of RAPS, DIA, and the American Bar Association and is admitted to the NJ Bar.

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