Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Dr Shawna M Jackman

Dr Shawna M Jackman, PhD, DABT, is a Principal Research Scientist and the Scientific Lead for Charles River’s Cell & Gene Therapy Center of Excellence. With over 15 years of in vitro and in vivo experience in preclinical safety evaluation, she is the resident subject matter expert for cellular therapeutic safety regulatory studies and is recognized across the industry in that role. Dr Jackman oversees the design and execution of all studies and is involved in all client and regulatory discussions regarding study design, oversight and data interpretation. Dr. Jackman received her BS in molecular biology from Lehigh University before earning her PhD in toxicology from West Virginia University. She is an active member of the Society of Toxicology, the Drug Information Association and the International Society for Stem Cell Research. She also serves as a scientific advisor for the California Institute for Regenerative Medicine (CIRM) Translational Center which provides funding and scientific guidance to developers of stem cell-based therapeutic candidates.

Dr Lauren Black

Dr Lauren Black, PhD, Distinguished Scientist at Charles River, provides strategic consultation for drug, cellular therapy, gene therapy and vaccine development. Prior to joining Charles River, Dr. Black served as a reviewing pharmacologist at the FDA’s Center for Drug Evaluation and Research (CDER) within the Division of Antiviral Drugs where she assessed pharmacology and toxicology data for pre-INDs, initial first-in-human INDs and applications of antisense, antiviral and immunosuppressant drugs. She also served as a reviewer at the FDA’s Center for Biologics (CBER) during which time she focused on various biologics such as monoclonal antibodies, cellular therapies and vaccines/adjuvants. Over the course of her career at the FDA, she reviewed over 400 INDs and 12 BLAs and contributed to 8 guidance articles. Dr. Black received her doctorate degree in pharmacology and toxicology from the Virginia Commonwealth University Medical School and was awarded an IRTA postdoctoral fellowship at NIH/NINDS. She is an invited panelist for numerous pharmaceutical safety advisory boards and currently serves as a scientific advisor for the California Institute for Regenerative Medicine (CIRM) Translational Center which provides funding and scientific guidance to developers of stem cell-based therapeutic candidates.