Susan G. Emeigh Hart, VMD, Ph.D., DACVP, DABT, ERT
Scientific Advisory Board Member
Principal Consultant, Integrated ToxPath Consulting Services, LLC
Dr. Susan Emeigh Hart is an experienced toxicologist, clinical and anatomic pathologist with over 35 years’ experience in all aspects of preclinical pharmaceutical development for both large and small molecules. She received her BS in Animal Science from the Pennsylvania State University and her VMD from the University of Pennsylvania School of Veterinary Medicine. After a short tenure in private practice, she enrolled in a combined veterinary pathology residency and PhD program in Pathobiology at the University of Connecticut, which she completed while also serving as a postdoctoral fellow in mechanistic toxicology in the laboratory of Dr. Steven D. Cohen.
Dr. Emeigh Hart started her career in the chemical industry with CIBA Crop Protection before transitioning to pharmaceutical development. At Pfizer Central Research and DuPont Pharmaceuticals, she served primarily as a Contributing Scientist or Principal Investigator, providing direct support to toxicology studies either as a study director, clinical pathologist, study pathologist or peer review pathologist for studies supporting all phases of pharmaceutical development, from exploratory studies through chronic toxicity and carcinogenicity studies, and serving as the non-clinical safety project team lead. Since 2002, she has held multiple leadership and executive level positions, Director through Vice President, both in established global pharmaceutical companies (AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc) and small biopharmaceutical companies (Genaera Corporation, Auxilium Pharmaceuticals, Intrexon Corporation and Venatorx Pharmaceuticals), where she has been responsible for the strategic direction, oversight and management of non-clinical drug development programs and regulatory submissions (IND through NDA/BLA and post-marketing) across a number of therapeutic areas. Compound types she has supported include unusual biopharmaceuticals (peptides, aminosterols, non-antibody, non-recombinant proteins and gene therapy products) in addition to traditional small molecules and monoclonal antibodies.
Currently, Dr. Emeigh Hart is the owner and Principal Consultant for Integrated ToxPath Consulting, LLC, headquartered in Oxford, PA (USA). She provides support for non-clinical development programs at all stages (pre-IND through registration) as well as support for CMC-related toxicology assessments: impurity qualification, ICH M7 assessment of potentially genotoxic impurities, and generation of risk assessments and PDE calculations for extractables and leachables.