eLearning Seminar
Regulatory and Nonclinical Considerations for the Development of CNS/Neurology Therapeutics

Speaker Bios

Simon Authier, DVM, MSc, MBA, PhD, DSP

Dr. Simon Authier obtained a doctor in veterinary medicine degree from the University of Montreal and specialized in nonclinical studies after completing a PhD in preclinical pharmacology. He then completed an MBA in corporate finances and management. Dr. Authier is a Director of Scientific Operations at Charles River Laboratories Laval, where he overviews the work of a team of scientists and veterinarians specializing in preclinical research. He has been an invited speaker at various scientific conferences, including the American College of Toxicology, the Safety Pharmacology Society, the Japanese Society of Safety Pharmacology, the American Association of Laboratory Animal Science, and the US Food and Drug Administration. Dr. Authier is also an Associate Professor at the Faculty of Veterinary Medicine at University of Montreal, where he is involved with clinical immunology and pharmacology, and he has authored +140 peer-reviewed articles and book chapters. To date, Dr. Authier has provided scientific overview for more than 1,400 preclinical studies. He is currently an ACT Councilor and has collaborated as an elected member of the ACT Education Committee, and over the years, he has volunteered and participated in various ACT initiatives, including educational sessions.

Lorrene A. Buckley, PhD, DABT, ATS

Dr. Lorrene A. Buckley is a board-certified toxicologist with over 30 years of experience in the active practice of toxicology. In her current position as a Vice President at Eli Lilly & Company, she is responsible for the design and execution of nonclinical safety assessments and for all nonclinical aspects of global regulatory submissions and interactions for drugs in the development and commercialization phases.

Dr. Buckley’s diversity of professional experience as a toxicologist is reflected in her work spanning basic and applied toxicology research, risk assessment in the chemical & agrochemical industry, and safety assessment of pharmaceuticals. Dr. Buckley frequently lectures in various educational and professional settings and has authored numerous journal articles and book chapters concerning approaches to pharmaceutical safety assessment and the toxicologic assessment of environmental contaminants.

Dr. Buckley has served in leadership positions with the following professional toxicology organizations: American Board of Toxicology; the Academy of Toxicological Sciences; the Society of Toxicology; and the American College of Toxicology. Within the Innovation and Quality (IQ) Consortium for Pharmaceutical Development, she has actively contributed to various inter-industry initiatives as a member of the DruSafe Leadership Group.

Scott Henry, PhD, DABT

Dr. Scott Henry received a PhD in Biochemistry from North Dakota State University in 1991, studying the phosphorylation and regulation of the glycogen synthesis pathway in heart. Following his PhD, he was a post-doctoral fellow at Parke Davis in Ann Arbor Michigan in the department of toxicology until 1993. He then joined Ionis Pharmaceuticals, Inc. as a Senior Scientist in the department of toxicology. Along with a team of dedicated colleagues, he has characterized and studied the mechanisms of various toxicities that include the effects of oligonucleotide treatment on clotting time prolongation, alternative complement pathway activation, proinflammatory effects in rodents, platelet alterations and the effects related to the accumulation of oligonucleotide in kidney. Now as Vice President of Non-Clinical Development at Ionis Pharmaceuticals, Inc. he has participated in the development of approximately 8 different phosphorothioate oligodeoxynucleotides and over 30 different 2’-MOE modified phosphorothioate oligonucleotides.

Mondona McCann, PhD

Dr. Mondona McCann is a Pharmacology/Toxicology reviewer in the U.S. Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER)’s Office of Therapeutic Products. She received her PhD in neuroscience from Georgetown University; her thesis research investigated the impact of organochlorine environmental toxicants on astrocytic function and metabolism. Following her graduate studies, Dr. McCann completed her post-doctoral training at the FDA where she conducted research on the efficacy and safety of IL13Rα2 CAR T cell therapy for glioblastoma and pancreatic cancer. At the completion of her fellowship, Dr. McCann joined the Office of Pharmacology and Toxicology, where she now focuses on the review of nonclinical toxicology and pharmacology data to support the safety of a variety of products including cell and gene therapies, tissue engineered products, and tumor vaccines.

Francis Tukov, PhD, DVM, DABT

Dr. Francis Tukov is an experienced board-certified toxicologist with several years of experience in preclinical drug development spanning several therapeutic areas including Gene Therapy. Since 2019, Dr. Tukov has been leading all Preclinical safety efforts supporting the development of IV onasemnogene abeparvovec (Zolgensma®), the first replacement gene therapy product for the treatment of spinal muscular atrophy. Dr. Tukov continues to lead the preclinical safety activities related to Zolgensma post-marketing and the development of Intrathecal (IT) onasemnogene abeparvovec and other gene therapy related projects at Novartis. Dr. Tukov is currently a Director of Preclinical Safety Assessment in Novartis Institutes for Biomedical Research (NIBR). He has prior experience as a Study Director/Study Monitor for nonclinical toxicology studies in major disease areas. Francis received a DVM degree in 1995 and obtained a PhD in Pharmacology/Toxicology in 2003.