NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Leo Lucisano

Practice Area Focus

  • CMC
  • CMC Compliance
  • Quality Assurance
  • Regulatory Submissions

Biography

Leo Lucisano joined NDA Partners as an Expert Consultant in 2016. He is a global pharmaceutical executive with extensive experience in regulatory affairs, pharmaceutical development, and manufacturing.

Mr. Lucisano served as a Senior Director of Global Network Change & CMC Post-Approval Regulatory Affairs at GlaxoSmithKline, responsible for regulatory support to maintain supply continuity and compliance for a product portfolio containing multiple dosage forms. Most recently, he was Director, Quality Systems and Compliance, Global Manufacturing & Supply at GlaxoSmithKline, providing FDA and MHRA inspection support to a global manufacturing network.

In his early career, Mr. Lucisano served as a Development Pharmacist, Drug Delivery R&D and as Team Leader/Development Pharmacist, Pharmaceutical Manufacturing Technical Services R&D, at The Upjohn Company. During that time, he participated in the scale-up, validation, and commercialization of manufacturing processes at Upjohn’s facilities in Puerto Rico and Canada.

He is an author/co-author of twenty articles/book chapters covering a variety of topics in regulatory affairs and pharmaceutical technology and was awarded the FDA CDER Special Recognition Award for his contributions to the successful launch of the Agency’s training program that accompanied the issuance of the first FDA Guidance Document addressing CMC post-approval changes.