• >25 years of experience at VP, SVP or “C” level” in regenerative medicine, cell therapy, combination product, specialty pharmaceutical, medical device and radiopharmaceuticals.• Experience in big pharma, mature biotechnology companies and start-up (virtual) ventures in biotechnology and medical devices. • Raised seed and late stage funds. Taken 2 companies public. • Managed global operations / clinical operations / regulatory affairs / quality assurance / CMC during periods of operational start up, rapid growth and successful repositioning. • Led high level teams of scientists and medical personnel to successfully fund and develop biopharmaceutical products from preclinical through regulatory approval and launch in diverse international markets. • Specific product expertise in intravascular medical devices, hepatology, critical care, dermatology, oncology, vaccines, drug delivery, dental pharmaceuticals and in vivo diagnostics. • Developed strategic plans, implemented international and domestic marketing plans and successfully licensed products and technology from academic and commercial sources. Out-licensed and partnered products and technology worldwide. • Hold patents with commercial value in excess of $300MM, author of numerous papers and articles. • Elected to Boards of Directors, Scientific and Business Advisory Boards.
Listed skills include Clinical Development, Fda, Medical Devices, Regulatory Affairs, and 11 others.