Michael M. Gaba
Life Science Partner
Holland & Knight LLP, USA
Michael M. Gaba is a partner in the Washington, D.C., office of Holland & Knight where he is the federal policy leader of the firm’s national Healthcare & Life Sciences Team. His regulatory and legislative life sciences practice includes counseling and representing medical device and biotech companies before the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the U.S. Congress. Mr. Gaba advises clients on the complex intersection of FDA regulatory issues and CMS coverage and payment issues, including federal health policy matters created by these sister agencies. He also provides pre-market strategic counseling and post-market surveillance and enforcement advice, with a particular focus on combination product approval, labeling and promotion.
Founder and CEO
SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland
Shayesteh Fürst-Ladani leads the team at SFL and provides global strategic support for the development of healthcare products. Shayesteh has longstanding experience in formulating global regulatory strategy for drugs, orphan drugs, drug & device combination products, borderline products, medical devices, in vitro diagnostics (IVDs) and advanced therapy medicinal products (ATMPs). Shayesteh has been involved in reviewing and assessing the impact of European and US legislation, such as the Cell & Tissue Directive, the Advanced Therapy Medicinal Products Regulation, the Orphan Medicinal Product Regulation, and reviewing requirements impacting Drug & Device Combination Products, Personalized Medicine and HTA.