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Dr. Macklerís 28 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 on integrated FDA, technical and business issues, when performing due diligence assessments on biomedical opportunities prior to their making initial investments and during bridging. These due diligence activities integrate his business acumen from working in sales/manufacturing in a family business, owning and managing several bioservice businesses and being a researcher for 15 years (graduate, fellow, NIH and University), followed by 28 years in a FDA legal / regulatory practice with premier law firms, and now as a resource for numerous financial groups.

He also serves on several Boards of Directors and Scientific Advisory Boards of biomedical companies, and is an active investor through financial groups and as an angel investor. He has served as interim 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 has authored more than 100 published scientific papers and abstracts in immunology, immunopathology, and various disease models, as well as numerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues. Dr. Mackler still advises biomedical companies and venture capital groups on FDA regulatory approval strategies, pre-INDs, on problems regarding manufacturing / QA/QC facilities, and how to effectively interact with FDA. He has assisted companies in developing regulatory approval strategies for US and global markets, pre-clinical and clinical study strategies to facilitate clinical studies and market entry.

He has assisted companies in the integration of new technologies into FDA product development strategies and achieved the approval of a number of biologics, drugs and medical/diagnostic devices. These activities have included actually serving as agent and holding INDs and IDEs for clients and assistance in organizing clinical studies and troubleshooting regulatory problems. During his regulatory activities, he meets regularly with FDA staff and maintains a dialogue with them in the biologic, drug and devices areas and has a hands-on approach to solving regulatory problems ranging from pre-clinical, clinical and marketing submissions, as well as pre-and post-marketing promotion and advertising.

Dr. Mackler has advised and counseled a number of traditional and biopharmaceutical companies developing drug products to treat 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 assisted venture funded US biomedical companies in initiating early stage safety and proof of concept clinical studies of drugs, biologics and devices in Europe, Eastern Europe and India, along with manufacturing strategies to export investigational products.

Dr. Mackler has experience drafting and evaluating numerous FDA regulatory documents (e.g., IDEs/PMAs, INDs/NDAs, DMFs, and BLAs, 510(k)s), Accelerated and Fast Track Approvals, Orphan Drug Designation applications, and USDA submissions. He has, as a U.S. agent, held IDEs/INDs and secured Treatment-INDs with substantial reimbursement, and has written Orphan Drug Development/SBIR grants and Designation applications; therefore, he is familiar with the nuances of these regulatory procedures. He lectures regularly at industry conferences and workshops, and internally for companies and financial groups to update or train personnel on FDA legal and regulatory matters.

Dr. Mackler is an Advisor with TVM-Capital in Boston & Munich, Paul Capital Royalty Fund (Advisor) in New York City, Apax Partners (London & Israel), Index Ventures (Geneva), ABN AMRO Capital/Life Sciences (Amsterdam), UNUS Ventures (Birmingham, AL), D.E. Shaw Group (New York & Houston), NGN Capital (Heidelberg), Gilde Healthcare Partners (Utrecht) CANACOORD ADAMS (Toronto & New York) 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 FDA ALERT (HellerEhrman), Life Science Due Diligence and Regulatory Newsletter and the TVM-Capital Regulatory Bulletin (copies available on this website for downloading).

Dr. Mackler 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).

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. 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 was the organizer of the annual ABC BioConference, which is now the annual BIO Conference.

He also was a founder of BioConferences International, Inc., which partnered with Genetic Engineering News [GEN] to run BioEast, BioWest & BioEurope, regulatory workshops and focus groups. Since his retirement from the active practice of FDA law, he has organized an advisory group to assist financial groups with due diligence assessments, provide regulatory assistance to their portfolio companies and to other biomedical companies where he also accepts fees and/or equity.

Contact information:
Dr. Bruce F. Mackler (Ph.D., J.D.)
Private Office Tel.: 858-459-0236
Cellphone: 301-529-6984
 

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