Leo Lucisano

A Regulatory CMC expert with experience across the product life cycle and supply chain with proven ability to successfully interact with agencies.

Leo is an accomplished global pharmaceutical executive with more than 30 years of experience leading teams of regulatory, development, and manufacturing staff as well as providing individual contributions at the senior level at several pharma companies.

Leo’s expertise ranges from strategic (developing regulatory strategies for product approval, market launch and supply continuity; leading global teams to author and submit more than 150 regulatory submissions); to reactive (directing regulatory activities for the in-licensing and divestment of multiple approved products; interfacing with regulatory bodies during inspections and for continuity of supply issues). Early in his career he gained drug development experience, including the scale-up, validation, and commercialization of pharmaceutical manufacturing processes in international settings.

He has authored a range of articles and book chapters on regulatory affairs and pharmaceutical technology, has served on industry and regulatory agency initiatives, and was awarded the FDA CDER Special Recognition Award for his part in the creation of the Agency’s training program supporting issuance of the first FDA Guidance Document on CMC post-approval changes.

Leo has baccalaureate degrees in Pharmacy and Pharmaceutics from the State University of New York at Buffalo, and lives in Cary, North Carolina.