Gary Gamerman has over 30 years’ experience with business, legal, regulatory and scientific issues affecting the research, development and commercialization of biomedical products and ensuring their availability to patients worldwide. His expertise is in strategy and product development, audit and due diligence, outsourcing, FDA regulatory matters, distribution and commercial operations, including consulting for many of the world’s leading medical technology companies, investors and foundations. Mr. Gamerman has had direct responsibility in leading or guiding project teams, resulting in numerous INDs/IDEs and marketing approvals for biologics, drugs and medical devices/IVDs. He has experience with innovative products, including preparing some of the first commercially sponsored applications for clinical testing of gene therapy and xenotransplantation and extensive work with contraceptives. Mr. Gamerman’s broad experience in technical and regulatory matters included work as a reviewer at the FDA’s Center for Biologics Evaluation and Research. He has completed extensive work on woman’s healthcare products and created US and global public health companies that ensured affordable access.