Biography

Amy J. Reisinger, Chief Executive Officer and Toxicologist, SteelFusion Clinical Toxicology Laboratory, LLC - Ms. Reisinger studied Biology/Pre-Medicine at The University of North Carolina in Wilmington, North Carolina and completed postgraduate studies for the Cardiovascular Perfusion Program at Duquesne University in Pittsburgh, Pennsylvania. Ms. Reisinger began her professional career as an Extra Corporeal Membrane Oxygenator (ECMO) Specialist and Histologist at Children’s Hospital of Pittsburgh, Pennsylvania, where she monitored patient’s hemodynamics following critical physician orders, and administered medications. Additionally, she supported the pathology and toxicology departments by conducting toxicology interpretations and assisting in the collection of pathological specimens during autopsy procedures. She became a Research Scientist at GlaxoSmithKline, Research Triangle Park, North Carolina, where she provided regulatory support to the pharmaceutical industry. Ms. Reisinger was responsible for performing the gross and microscopic examinations of animals utilized in toxicology studies as well as evaluating the significance of the anatomic and clinical pathology, as well as organ weight data from such studies. Additional responsibilities included: generating pathology interpretations to accurately reflect the data and provide significance for drug registration and drug safety; review study protocols and contribute to the design of pathologic evaluations; train necropsy technicians to conduct Good Laboratory Practice (GLP) compliant work utilizing Standard Operating Procedures (SOPs); and keeping abreast of current scientific literature in toxicological pathology. Ms. Reisinger is a Registered Histotechnician and Registered Histologist with the American Society of Clinical Pathologists. Based on her knowledge of toxicology and pathology and understanding the logistics of performing clinical studies in accordance with GLPs, Ms. Reisinger served as a Study Director/Monitor at Bristol-Myers Squibb Company in Mt. Vernon, Indiana for GLP and non-GLP toxicology studies, including investigative and mechanistic studies. She prepared schedules for study activities; conducted data reviews; evaluated scientific data to develop conclusions derived from the studies undertaken; prepared reports and summaries of toxicology studies; prepared safety/risk assessments for human health based on preclinical study results; ensured compliance with GLPs and SOPs, Quality Assurance, safety and animal welfare guidelines, and other state and federal regulations. Ms. Reisinger maintained knowledge of worldwide testing and registration requirements and initiated and monitored Contract Research Organization (CRO) studies. Additionally, Ms. Reisinger presented at scientific meetings and published papers in journals; participated in the investigation of complex toxicity findings encountered in nonclinical toxicity studies; maintained an excellence in knowledge and evaluation group through their application in drug discovery and development; critically evaluated Human and Veterinary Pharmaceuticals; prepared Safety Data Sheets (SDSs) and prepared Chemical Hygiene Plans (CHPs) for the safe handling of chemicals including test articles and formulation components. SteelFusion Clinical Toxicology Laboratory, LLC, was established in 2014 by Ms. Reisinger as a women-owned and operated toxicology laboratory specializing in clinical and forensic toxicology services. Amy has been serving as the President and CEO of the laboratory since its inception. She is a member of Women’s Business Enterprise National Council, Society of Toxicology, American College of Toxicology, International Association of Coroners and Medical Examiners, American Society Clinical Pathology, Project Management Institute, and National Society of Histotechnology. From 2016 through 2018, Ms. Reisinger was awarded three US Patents for the rapid and sensitive method of forensic toxicology in Post-mortem subjects using oral fluid testing. She has extensive experience and expertise working with WBENC, CLIA, CAP, DOH, OSHA, SHARP, ISO, ABFT, ANAB and other regulations and guidelines governing the use of chemicals and drugs in the marketplace. Ms. Reisinger performed Graduate Studies in Perfusion Technology, Duquesne University, Pittsburgh, PA, 1993 BS, Biology, University of North Carolina, Wilmington, Wilmington, NC, 1991. She is a Registered Histotechnician and Histotechnologist and is published in Neuropharm, Toxicologic Pathology, and Journal of the American Association Laboratory Animal Science. Ms. Reisinger is also a member of the Society of Toxicology, American College of Toxicology, American Association of Laboratory Animal Science, American Society for Clinical Pathology, National Society for Histotechnology, and Project Management Institute.

Research Interest

Toxicology, Forensic Toxicology, Analytical Chemistry