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.

While in the FDA Office of the Chief Counsel, Mike also advised on medical countermeasures. He served on the FDA’s Pandemic Influenza Planning and Preparedness Team, and helped draft guidance on pandemic and seasonal flu vaccines and a regulation on Strategic National Stockpile product labeling. In his years at the firm, Mike has advised on Emergency Use Authorizations, select agents and toxins and Dual Use Research of Concern (DURC), and various issues involving vaccines and other products.