Bruce Mackler
Member Board of Directors
Vastora, Inc.
Dr. Mackler’s 35 years of FDA legal/regulatory experience in biomedical products includes biologics, drugs, nutraceuticals, medical and in vitro diagnostic devices, food and cosmetics manufactured by traditional and biotechnology processes (recombinant proteins, genomics, cell and gene therapy). Dr. Mackler has advised financial groups, performed due diligence assessments prior to their initial and bridging investments. He integrates his business acumen gained by working in sales/manufacturing, owning and managing several bioservice businesses and being a university/NIH researcher for 15 years, followed by 35 years in an FDA legal/regulatory practice, and venture partner. He continues to serves on biomedical company Boards of Directors and Scientific Advisory Boards and is an active angel investor. He has served as CEO/Pres., COO and Regulatory Affairs Vice-President in several start-up biomedical companies.
Dr Mackler has a Ph.D. and M.S. in the area of Immunology/Microbiology and authored 100+ published scientific papers and abstracts in immunology, immunopathology, and various disease models, as well as numerous articles on FDA and FDA-related legal and regulatory issues. Dr. Mackler continues to advise biomedical companies and venture capital groups on FDA regulatory approval strategies, pre-INDs, problems regarding manufacturing/QA/QC facilities and how to effectively interact with FDA.
Dr. Mackler has advised and counseled a number of traditional and biopharmaceutical companies developing drug products to treat various diseases including multiple sclerosis, ALS, stroke, spinal cord injuries as well as endocrine hormones, ophthalmics, anti-infectives, pulmonary delivery, to name a few of the clinical areas, using traditional organic (new chemical entities & generic) compounds, and biotech-derived therapeutics (monoclonal antibodies, cytokines, fusion proteins), classic and new technology-driven vaccines, and cellular and gene therapy. Dr. Mackler has served as CEO/President of pharma drug development company and guided companies through FDA; as well as raised over $2 million from angels, foundations and investors for one company.
Dr. Mackler has previously been an Advisor with TVM-Capital in Boston/Montreal & Munich, Paul Capital Royalty Fund (Advisor) in New York City and other venture capital groups, performing in depth FDA due diligence evaluations prior to investing, and assisting portfolio companies with FDA strategy. He has written/edited the Life Science Due Diligence and Regulatory Newsletter and the TVM-Capital Regulatory Bulletin (copies available upon request). Dr. Mackler serves as author of the Spotlight on FDA, a column published in Genetic Engineering News.
Dr. Mackler received a J.D. from the South Texas College of Law (magna cum laude, 1979), Ph.D. (Immunology/Microbiology) the University of Oregon Medical School (1970), a M.S. (Immunology/Microbiology) the Pennsylvania State University (1965), and his B.A. (Biology) Temple University (1964). He was a member of the District of Columbia Bar, and was admitted to practice before the Federal District. Appeals Court
and before the U.S. Supreme Court. Dr. Mackler founded and grew the Association of Biotechnology Companies (ABC) into over 250 members, before it merged to form the current Biotechnology Industry Organization (BIO). He established the
annual ABC BioConference, now the annual BIO Conference. He also was a partner and organizer with Genetic Engineering News [GEN] of BioEast, BioWest & BioEurope, workshops and focus groups. After his practice of FDA law activities, he has organized an advisory group to assist financial groups with FDA due diligence assessments, provide regulatory assistance to their portfolio companies, and been an active investor and organizer of biomedical startups.