Dr. Bruce F. Mackler
Bruce has 27 years of FDA legal/regulatory experience in biomedical products includes biologics, drugs, medical and in vitro diagnostic devices, food and cosmetics manufactured by traditional and biotechnology processes (recombinant proteins, genomics, cell and gene therapy). He has counseled clients on agreements relative contract manufacturing (outsourcing), contract animal studies and contract monitoring of clinical studies. He has also taught workshops on outsourcing agreement development, clinical development, FDA inspections, negotiating with FDA for 510(k)/PMA approvals, preparing investigational (IND/IDE) and marketing permits (NDAs/ANDAs) and many other important regulatory issues. His various activities have included actually serving as agent and holding INDs and IDEs for clients and assistance in organizing clinical studies and troubleshooting regulatory problems. Bruce has represented and counseled a number of traditional and biopharmaceutical companies developing drug products. Bruce is an Advisor with various major US and European venture capital groups/banks, performing in depth FDA due diligence evaluations prior to investing, and assisting portfolio companies with FDA strategy. He is a member of the Scientific Advisory Boards of several biopharmaceutical companies. He has lectured extensively on performing FDA due diligences. He has also served as interim operational management in several companies undergoing management transitions. Bruce recently retired as Chairman of the FDA Legal Group at Heller and Ehrman. He is consultant in FDA topics. more >>
Bruce has a Ph.D. and M.S. in the area of Immunology/Microbiology and has authored more than 100 published scientific papers and abstracts in immunology, immunopathology, mucosal diseases and cancer as well as numerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues. He received his J.D. from the South Texas College of Law (magna cum laude, 1979), his Ph.D. (Immunology/Microbiology) from the University of Oregon Medical School (1970), his M.S. (Immunology/Microbiology) from the Pennsylvania State University (1965), and his B.A.(Biology) from Temple University (1964). As an attorney, he is a member of the District of Columbia Bar, and admitted to practice before the Federal District and Appeals Court and before the U.S. Supreme Court. Bruce founded the Association of Biotechnology Companies (ABC) and helped grow it to over 250 members and organize the annual ABC biotech conference, before it merged to form the current Biotechnology Industry Organization (BIO). He has also been an investor and founder of several businesses in the biotech industry space.
E-mail or phone: +1-301-529-6984