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Bruce F. Mackler, Ph.D., J.D., currently an attorney with the firm Heller Ehrman White & McAuliffe, has residences in Washington, DC and Silicon Valley/Menlo Park, CA. Dr. Mackler's 23 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. Dr. Mackler also provides effective counsel regarding certain biological vaccine, biotechnology, SNPs and other advance technology matters, as well as technology licensing, material transfer and outsourcing agreements. He has a Ph.D. in Immunology/Microbiology and has authored more than 100 scientific papers and abstracts focusing on the immunology/immunochemistry aspects of diseases, as well as numerous articles and briefing papers on FDA and FDA-related legal and regulatory issues concerning product development, FDA approval/licensure. Dr. Mackler's technical acumen better enables him to understand the nuances of clients' problems and effectively interact with governmental officials globally. He has successfully assisted clients in developing regulatory approval strategies, clinical study strategies, and applications for marketing permits for drugs, biologics (vaccines), and medical devices. Dr. Mackler has also assisted as counsel to companies in product liability lawsuits. Dr. Mackler has experience drafting and evaluating FDA regulatory documents (e.g., IDEs/PMAs, INDs/NDAs, DMFs, and BLAs), Orphan Drug Designation submissions. He has, as an agent, held IDEs/INDs and secured Treatment-INDs with substantial reimbursement, and has written Orphan Drug Development/SBIR grants. He has practical experience in clinical site, investigator, CRO, and manufacturing agreements, as well as in technology transfer and product licensing. He lectures regularly at industry conferences and workshops, and internally for companies to update or train personnel on FDA legal and regulatory matters. Dr. Mackler is also involved in the corporate aspects of commercial strategies relative to licensing, technology transfer and business agreements. He has previously served as an officer in innovative technology companies, and is familiar with the commercial and financial realities that such firms face in business and product development. The FDA regulatory strategies and advice he develops are sensitive to these commercial realities. Dr. Mackler also is a senior regulatory advisor to Techno Venture Management (TVM) a leading US/European venture capital group and on the Board of Paul Capital Royalty Fund. He currently serves on the Scientific and Business Advisory Boards of several biotech and biopharmaceutical companies. Dr. Mackler received his J.D. from the South Texas College of Law of the Texas A&M University (magna cum laude, 1979), his Ph.D. from the University of Oregon Medical School (1970), his M.S. Microbiology/Immunology) from the Pennsylvania State University (1965), and his B.A. from Temple University (1964). He is a member of the District of Columbia Bar, the Federal District and Appeals Court and admitted to practice before the U.S. Supreme Court. |
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