Regulatory Science, Drugs & Biologics
David Lucking is currently Senior Director, Regulatory Science, Drugs and Biologics at Voisin Consulting Life Sciences. As both an experienced regulatory scientist and business-oriented manager, David assists clients in the design and implementation of global regulatory strategies as well as with their core technical needs.
David holds 25+ years of experience in the regulatory field and has been a key contact with regulatory agencies for 15+ years. He has significant expertise with preparing detailed technical documents for INDs, ANDAs, NDAs, and MAAs with the FDA and European Regulatory Agencies. He has a lot of experience with pre-clinical and clinical trials, interfacing with the FDA and European regulatory agencies and participating in creating strategic plans relating to developing pharmaceutical projects from concept to FDA approval.
David has extensive experience working with strategic planning & business analysis, new product development & support, business & pharmaceutical partner alliances, venture capital due diligence, clinical trial study design, quality assurance & regulatory affairs, FDA communications and cGMPs laboratory operations & management.
Prior to VCLS, he has held several key management roles centered on regulatory affairs in various pharmaceutical companies, across several therapeutic areas. He serves as the board member of Accu-Break Pharmaceuticals Inc. since 2004. Prior to co-founding Accu-Break, David held various executive positions with Noven Pharmaceuticals, Inc. from 1987-2003 during which he obtained approval for five transdermal products.
He has occupied transversal management positions involving both technical and business development activities. His most recent position was as Executive Director of Clinical Research and Regulatory Affairs. He was the Vice President of Regulatory Affairs, Quality Assurance and Clinical Research at ProSolos Pharmaceuticals. He was Executive Director of Regulatory Affairs, QA & QC for Hercon Pharmaceuticals, LLC from 2012-2013.
From 1983 to 1987, he was employed by Key Pharmaceuticals, Inc. in Miami, Florida where he was responsible for all quality control functions before which he was employed by Gordis Dow Corporation, a manufacturer of artificial kidneys.
David has a Bachelor of Science degree in Biological Science from Florida State University.
He has co-authored an article in the European Journal of Clinical Research. David is based in Cambridge.