Michael N. Druckman | Washington, D.C. | Hogan Lovells
Mike Druckman leverages his prior experience at the FDA – and what he has learned since then while extricating companies from regulatory problems – to anticipate and prevent life science clients from getting into trouble in the first place.
Mike understands the business challenges that companies face in a highly regulated environment. He actively works with other Hogan Lovells lawyers experienced with government reimbursement, anti-kickback limits, product liability, and a full range of other regulatory areas to craft approaches that will maximize clients’ opportunities and minimize their risks.
Mike chairs the firm’s Cell, Tissue, and Gene Therapies Working Group, a cross-disciplinary team that advises companies in this emerging space on the evolving regulatory and business challenges they face. Mike and the team work closely with companies developing stem cells, cord blood, placental tissues, gene therapies, proteins, and other cellular products to help people with serious health problems.
Mike also advises companies with a full range of regulatory challenges involved in investigating new drugs, biologics, and combination products, obtaining FDA approval for those products, and in promoting, selling, and distributing them. His experience also includes the Drug Supply Chain Security Act, pharmacy compounding, expanded access/compassionate use clinical trials, orphan drug exclusivity, and precision medicine and companion diagnostics.