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Bruce F. Mackler is a senior advisor in FDA matters and FDA due diligence issues to financial/investment groups and companies. He is effective in developing and implementing FDA strategies for product approval of biologics, drugs and medical devices in the US and the global market place. Bruce couples his scientific knowledge (M.S., Ph.D. Immunology) with practical, hands-on regulatory experience of 27 years of FDA legal work on traditional and biotechnology derived products. He continues to provide FDA advice to US and European financial (venture capital and royal fund investment groups and stock analyst) groups, directly to biomedical product companies and is available to assist you. His grasp of the technical and FDA issues is augmented by his understanding of the commercial realities facing biomedical companies and products in the marketplace including the intended use claims, reimbursement and cost of goods. His business acumen is on his work experience including that in a family business in the packaging field, operationally in organizing and managing multidiscipline research laboratories and as management of several biomedical commercial entities. He has a proven record of accomplishments in moving technology from the laboratory into animal and human testing and FDA marketing submissions.

His accomplishments include:

  • Organizing and obtaining federal and state agency grants for
    research, managing research laboratories, as well as being on NIH Study Section evaluating grant & contract proposal and publishing over 100 published scientific papers/articles.

  • Organizing and managing an independent FDA/patent law firm,
    being FDA Legal Practice Group Chairman in an international law firm and generating substantial clients in the biologic, drug, medical devices, nutraceutical and food industries.

  • Organizer and founder of the Association of Biotechnology
    Companies (ABC), which became the largest biotechnology organization and merged to form BIO.

  • Founder, senior management and commercial driving force for
    several biotechnology service and product companies, for example, BioConferences International (BioEast, BioWest & BioEurope), Human Auto Cell, Life Sciences Management Group, for which he generated and raised operating capital.

  • Editor and writer for TVM Life Science Bulletin and FDA
    Regulatory & Due Diligence newsletters, as well as an author and contributor to numerous other FDA and Life Sciences publications.

  • Works as a Due Diligence Advisor on FDA matters to financial
    groups (US and Europe) and their portfolio companies, providing FDA strategies and their implementation.

His hands-on, practical FDA work experiences includes developing of product development strategies, organizing numerous pre-IND/IDE meetings, acting as an Agent for submissions to FDA, implementing pre-clinical and clinical programs, negotiating with FDA to resolve issues and with vendors for analytical, animal, clinical (CRO, investigators and institutions) and for product manufacturing during his 27 years of FDA legal practice and now as an Advisor; This work included developing the first bio-similar drug (505(b)(2) NDA application; and as an Arbitrator in conflicts regarding FDA matters, i.e., in disputes involving compliance with current Good Manufacturing (cGMPs) and Clinical (GCP) Practices regulations and meeting product specifications.

Bruce currently serves on the Board of Directors of several biomedical companies and is also an active investor in biomedical start-up companies through venture groups. He is also an angel investor with cash and services in several biomedical startup companies.
You are invited to download copies of the newsletters and presentations available in this web site. For more information on Bruce's FDA experience, please click on his Biosketch tab to view or download his biosketch.

Bruce welcomes your enquires concerning providing FDA product approval strategy development and implementation, due diligence assessments and FDA problem solving. You are invited to contact him through the CONTACT tab to directly send him an e-mail regarding your matter or, if urgent, through his cellphone 1-301-529-6984.

TVM FDA Bulletins
Oct 2002 - Mar 2007
Life Sciences Files
Oct 2006, Mar 2007
FDA Alerts
Nov 2003, Mar 2005


BioTech 2007
Stem Cells 2003
Research Products
NDA Strategies


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