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May 15, 2009 (Vol. 29, No. 10)

GEN's Spotlight on the FDA

  • Recent FDA Guidance Note

    • Q10 Pharmaceutical Quality System (April 2009) describes what FDA believes is an effective quality-management system across the entire life cycle of pharmaceuticals (drugs and biologics). This is a good predictor of the programs that FDA inspectors will be looking for, especially in the cGMP area, as well as an indicator of what FDA considers as adequate risk-based regulatory management. 
    • Somatic Cell Therapy for Cardiac Disease (March 2009) describes the level of preclinical and clinical data that will be necessary to move stem cell products into clinical development. Although, the document addresses cardiac disease, it is a harbinger of what FDA/Center for Biologics Evaluation and Research/Office of Cellular and Gene Therapies will also require for other cell regenerative therapies.

      Companies should look carefully at the FDA requirements for preclinical testing, the type of clinical study endpoints, and whether a control arm is necessary versus a “trial of sufficient size.”   

  • About the Bruce F. Mackler, Ph.D., J.D.

    Bruce F. Mackler’s, Ph.D., J.D. (bmackler@brucemackler.net), has 28 years of FDA legal and regulatory experience in biomedical products. As an FDA adviser, he assists financial groups like venture funds that are performing due diligence on biomedical opportunities prior to making an initial investment. He consults on integrated FDA, technical, and business issues by assessing portfolio companies and conducts approval risk analyses for analysts and investors.

    His business acumen stems from working in sales/manufacturing in a family business, owning several bioservice businesses, holding management roles like interim COO and regulatory affairs vp in various start-up companies, and being a university/NIH researcher for 15 years.

    Dr. Mackler has a Ph.D. from the University of Oregon Medical School (1970) in the area of immunology/microbiology and has authored more than 100 published scientific papers and abstracts. He has written/edited the Life Science Due Diligence and Regulatory Newsletter and the TVM-Capital Regulatory Bulletin.

    He also advises early- and late-stage biomedical companies, serves on several boards of directors and scientific advisory boards of biomedical companies, and is an active investor. His areas of expertise include FDA regulatory approval strategies, pre-INDs/IDEs, 510ks, PMAs/ NDAs/BLAs, manufacturing/QA/QC, and how to effectively interact with FDA.

    Dr. Mackler co-founded the Association of Biotechnology Companies (ABC) with six small biotech firms and helped it grow to over 250 members. ABC later merged to form the Biotechnology Industry Organization (BIO).


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