Pierre-Louis Lezotre, PhD, MS
Dr. Lezotre joined Avanir Pharmaceuticals, Inc. in June 2015 as Vice President, Global Regulatory Affairs and Quality Assurance. In this role, Dr. Lezotre leads all aspects of the Global Regulatory Affairs function and also oversees the Quality Assurance department. Under his leadership, his group is responsible for all strategic and operational aspects of global regulatory matters and QA programs for both commercial products and R&D projects, as well as interfacing with worldwide Drug Regulatory Authorities.
Dr. Lezotre is an experienced regulatory affairs leader with over 15 years of experience in the biopharmaceutical industry, with a focus on global regulatory strategy. Prior to joining Avanir Pharmaceuticals, he worked for several multinational pharmaceutical and biotechnology companies including Allergan, Biogen and Sanofi. He successfully led many global regulatory teams in supporting global registrations of major products as well as numerous development projects in several therapeutic areas, including neurology, pain, dermatology and urology. He has been responsible for communications with numerous worldwide Drug Regulatory Authorities and has worked with external partners and companies through co-development agreements and business development programs.
Most recently, Dr. Lezotre has served as a regional and global regulatory leader at Allergan, Inc. for small molecule and biologic/biotech programs in various stages of research and development. During his tenure at Allergan, he held several regulatory positions including Global Therapeutic Area Head for Neurology and Pain, where he was responsible for 14 projects ranging from pre-development to post-marketing stages, with more than 10 active international clinical studies in six different indications. Also, as the Global lead for BOTOX®, he was responsible for international coordination of all general issues and programs. Finally, he served as one of the two Allergan representatives on the joint Development Committee with GlaxoSmithKline Japan, for BOTOX® and was the regulatory representative for strategic discussions related to the Neurotoxin franchise and global competitive defense strategy.
Dr. Lezotre has worked in different cultural environments and lived in both Europe and the United States. He holds degrees in Sciences, Drug Development and Law. He studied biology and drug development from 1992 to 1998. He then received a Master’s in Regulatory Sciences in 1999 (University of Pharmacy, Lille, France). He also earned his PhD in Law with honors from the Doctoral School of “Law, Politics and Management,” (University of Law, Lille, France). Dr. Lezotre has also published a book titled “International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations - A Global Perspective” (Elsevier Academic Press, December 2013, ISBN: 9780128000533) and teaches courses on international regulation in the Regulatory Sciences programs of the University of Southern California (USC).