Bruce F. Mackler

Dr. Mackler’s has 30 years of FDA legal and regulatory experience in biomedical products includes allergens, allergy vaccines, biologics, drugs, nutraceuticals, medical and in vitro diagnostic devices. He held a senior corporate regulatory position and served on the Board of Immunomic Therapeutics, an allergy vaccine company. He currently serves on the Board of several Biopharma companies.

Dr. Mackler has a Ph.D. and M.S. in the areas of Immunology and Microbiology and has authored more than 100 published scientific papers and abstracts in allergy, immunology, immunopathology, and various disease models, as well as numerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues. He serves on the NIH/NHLBI Small Market SBIR Phase IIB Study Section.

Dr. Mackler received his J.D. from the South Texas College of Law (magna cum laude). He received his Ph.D. in Immunology and Microbiology from the University of Oregon Medical School, his M.S. in Immunology and Microbiology from the Pennsylvania State University, and his B.A. in Biology from Temple University. He was a member of the District of Columbia Bar, and was admitted to practice before the Federal District and Appeals Court and before the U.S. Supreme Court.