BIOGRAPHIES
DIRECTORS
Amy J. Reisinger
Owner, President, and Chief Science Officer
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 four U.S. Patents for the Rapid and Sensitive Method for the Detection and Quantification in Post-mortem subjects and mammals using oral fluid testing and was Granted Communication in to the EU in 27 countries. She has extensive experience and expertise working with WBENC, CLIA, CAP, DOH, OSHA, SHARP, ANAB and other regulations and guidelines governing the use of chemicals and drugs in the marketplace. Amy is a Registered Histotechnician and Histotechnologist and is published in Neuropharm, The American Journal of Forensic Medical Pathology, Journal of Analytical Toxicology, Toxicologic Pathology, and Journal of the American Association Laboratory Animal Science. Ms. Reisinger is also a member of the Society of Toxicology, Society of Forensic Toxicologists, International Association of Coroners and Medical Examiners, American College of Toxicology, American Society for Clinical Pathology, National Society for Histotechnology, and Project Management Institute.
PERSONAL EXPERIENCE
Jack Todd
Acting CEO
Mr. Jack Todd, an alumnus of Kean University, New Jersey, holds a major in Biology with a minor in Chemistry. Upon graduation, he embarked on a career trajectory as a Sales and Marketing Executive where he was instrumental in representing two globally recognized chemical organizations for a span of five years.
In his role as an entrepreneur, Mr. Todd showcased his innovative prowess by developing and introducing the concept of user-friendly sized shampoo bottles specifically tailored for the hotel industry. Concurrently, he undertook the strategic marketing of renowned shampoo brands - including Vidal Sasson, Revlon, and Gillette - aimed at hotel brands, thereby creating a unique market segment.
Continuing his entrepreneurial journey, he held esteemed positions as Chairman and CEO of his company for a decade, financially bolstering it through an initial public offering (IPO) and two additional public offerings, thereby facilitating the establishment of Guest Supply, a company wholly owned and managed by Mr. Todd.
Following his tenure at Guest Supply, Mr. Todd provided leadership for a decade as the CEO of the retail division of a publicly-traded telecom company. His post-telecom career comprises two decades of significant contributions to the laboratory industry, primarily serving as a Sales and Marketing Executive, a Strategic Advisor to Boards, and a Consultant. His expertise was particularly sought after by six independent laboratories within the United States.
PERSONAL EXPERIENCE
Gerald Harster, M.D.
LABORATORY DIRECTOR
Dr. Harster attended the University of Buffalo, New York, where he received his Bachelor of Arts in Biology; Magna Cum Laude. He then completed a Medical Technology internship at Rochester General Hospital, New York where he became a Certified Medical Technologist. He worked in the chemistry laboratory providing expertise on automation for a variety of instrumentation as well as toxicology testing utilizing Gas Chromatography. He began Medical School in 1978 at the University of Buffalo, New York where he graduated the program in 1982. He did a Medical Internship at Montefiore Hospital, Pittsburgh, Pennsylvania, for 6 months prior to starting his pathology residency at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He finished his residency (including 6 months as Chief Pathology Resident) in December 1986 while passing his pathology boards concurrently. He worked as an Associate Pathologist at Jeannette District Memorial Hospital, Jeannette, Pennsylvania from 1987-2008. He was the Director of Pathology from 1994 to 2008. Since 2008, he worked part-time as an Associate Pathologist at Jefferson Hospital, Jefferson Hills, Pennsylvania and assisted as a locum tenems at several area hospitals. He became the Laboratory Director for SteelFusion Clinical Toxicology Laboratory, LLC in 2016 to present day and continues to work as a locum tenems for two local area hospitals.
PERSONAL EXPERIENCE
Herb Layman
CHIEF OPERATING OFFICER
SteelFusion Clinical Toxicology Laboratory, LLC
Herb Layman, BS, SM, CIEC was the owner and Technical Manager of U.S. Micro-Solutions, Inc. (USMS), Environmental Microbiology Laboratory from 1996 until 2017. Mr. Layman is presently a microbial consultant for USMS, and the laboratory is currently located in Latrobe, PA. Mr. Layman held the position of Head Microbiologist at Montefiore Hospital in Pittsburgh, PA, from 1966 to 1984. He has also directed Microbiology at Med-Chek Laboratories in Pittsburgh (1984-1991), and DEYOR Laboratories in Youngstown, OH/ Pittsburgh. PA (1991 to 1993). Mr. Layman was also the Head of Microbiology at Kent General Hospital in Dover, DE from June 1994 to June 1995.
He was an assistant professor in Schools of Medical Technology and Dental Medicine at the University of Pittsburgh teaching Medical Mycology to Medical Technology students (1974 – 1987) and Microbiology to student nurses (1983 – 1994) in the School of Nursing.
Mr. Layman holds memberships with The Arican Society for Microbiology from 1968-2018, The American Society of Clinical Pathology with a Specialist in Microbiology (SM) since 1983, The American Council for Accredited Certification as a Certified Indoor Environmental Consultant (CIEC) and is a member of the local American Industrial Hygiene Association (AIHA).
A graduate of Juniata College (1957) in Huntingdon, PA, Mr. Layman has had to opportunity to perform graduate work in genetics and microbiology at West Virginia University and the University of Pittsburgh.
PERSONAL EXPERIENCE
Jana L Champion
FORENSIC DIRECTOR
SteelFusion Clinical Toxicology Laboratory, LLC
Ms. Champion studied Chemistry at Mount Mary University-Milwaukee WI and graduated with a BS in Chemistry. Ms. Champion began her professional career as a drug chemist at the Drug Enforcement Administration in Chicago, IL. She then became employed by the Wisconsin Department of Justice, State Crime Laboratory-Milwaukee, where she was a drug analyst and then trained as a forensic toxicologist. Ms. Champion was responsible for analyzing biological evidence (including post-mortem) in forensic toxicology and controlled substances cases involving operating while under the influence, homicide by intoxicated use, great bodily injury by intoxicated use, homicides and sexual assaults. She has testified as an expert in the area of drug identification and forensic toxicology in Federal, State and municipal courts over 300 times. Working as a toxicologist, she presented a poster at the Society of Forensic Toxicologist (SOFT) meeting and she was trained on the maintenance and repair of laboratory instrumentation, including gas chromatographs (GC), gas chromatographs/mass spectrometers (GC/MS), Fourier transfer infra-red spectrometers (FTIR), and high-pressure liquid chromatographs (HPLC). Ms. Champion provided technical expertise to law enforcement agencies, provided court training to newer analysts and participated in clandestine laboratory investigations.
Based on her knowledge of toxicology and leadership skills, Ms. Champion was promoted to Chemistry Supervisor where she became the Quality Assurance Coordinator for the Crime Lab Bureau. Her duties included supervision of the toxicology unit, the controlled substances unit and the trace identification unit and monitoring the Bureau’s compliance with national accreditation standards. During this time, Ms. Champion became a Certified Public Manager from the University of Wisconsin-Madison, a Certified Grant Manager and a Technical Assessor in forensic toxicology. She also wrote and implemented a Wisconsin DOJ Affirmative Action Plan through cooperative education.
Ms. Champion was then promoted to Laboratory Director of the Wisconsin State Crime Laboratory-Milwaukee where she directed all activities related to the technical and administrative operations of the laboratory including hiring, dismissing, disciplining employees, and evaluating performance expectations and goals. Ms. Champion conducted public relations with all crime laboratory clients which included District Attorneys, State Attorneys, Law Enforcement Agencies, Public Defenders, Judges and the news media. During her time as Laboratory Director she performed external technical assessments of other forensic crime laboratories and was active in the Association of Forensic Quality Assurance Managers (AFQAM), becoming President of that organization and helped to shape quality policies and procedures for the forensic community. During this tenure, Ms. Champion received the Madonna Award for professionalism from Mount Mary University. This is the highest award given to an alumna.
Ms. Champion was then promoted to Deputy Bureau Director where she assisted the Crime Laboratory Bureau Director with the daily operations of the three crime laboratories. She directly supervised the laboratory managers and was responsible for the statewide Bureau budget and management of both the Coverdell and DNA backlog Reduction grants from the Federal Government. Soon after that she was promoted to Bureau Director of the State Crime Laboratory System. She was responsible for the daily activities of all three crime laboratories with staff of over 175 employees. Ms. Champion worked closely with the Wisconsin Attorney General to formulate legislative initiatives that would move the Crime Laboratories forward. During her tenure as Deputy and Bureau Director, she became a Lead Assessor with American National Standard Institute Laboratory Accreditation Board (ANAB). She was trained to lead teams of over 40 technical assessors to go out and audit other forensic laboratories across the country to ensure compliance with the ISO/IEC 17025 and ANAB standards.
In 2017, Ms. Champion retired from the State of Wisconsin after 33 years of service in the forensic arena. She was then recruited by SteelFusion Clinical Toxicology Laboratory, LLC to become the Forensic Director. Ms. Champion was competency tested on the LC/MS/MS instrumentation, she is responsible for the operation of the forensic laboratory components which include, compliance with all established rules and accreditation requirements, proper performance of the forensic testing operations, reviewing quality assurance data and forensic proficiency testing. Ms. Champion is also providing testimony in the area of forensic toxicology when requested. She is published in the Journal of Analytical Toxicology and is an active member in the American Society of Crime Laboratory Directors (ASCLD). Ms. Champion continues to perform duties as a Lead Assessor for ANAB and is now training others to become technical assessor and internal auditors for ANAB.
PERSONAL EXPERIENCE
Autumn C. Miller
TECHNICAL SUPERVISOR
SteelFusion Clinical Toxicology Laboratory, LLC
Ms. Miller is a Senior Laboratory Manager with 10 years of clinical and forensic laboratory experience. Ms. Miller studied Chemistry at Seton Hill University in Greensburg, Pennsylvania and completed the Medical Technology Program at Saint Vincent School of Medical Technology in Erie, Pennsylvania.
Ms. Miller began her professional career as a Laboratory Technician at The Institute of Transfusion Medicine (ITXM), Pittsburgh, Pennsylvania, where she distributed safe, compatible blood products for hospitals, research institutions and outside patient facilities. Ms. Miller was responsible for performing blood type confirmations, preparing blood components in deadline- driven environments. She showed a talent for quickly mastering automated technology and new operating procedures.
Ms. Miller joined Universal Oral Fluid Lab of PA, LLC in 2011 as a Laboratory Technician. The company was a moderately-complex clinical toxicology laboratory. She prepared patient samples for drug screening utilizing the TECAN Freedom EVO instrument; prepared final reports; laboratory inventory; ensured compliance with Standard Operating Procedures (SOPs) and Quality Assurance. Ms. Miller also participated in the transition to a high-complexity laboratory; she assisted with method development for the Liquid Chromatography Tandem Mass Spectrometry instrument utilized for the confirmation testing of patient samples and assisted with analytical test methods to support method validation. In 2013 Ms. Miller was promoted to Laboratory Manager. She provided training to new staff members; performance reviews; managed the people in safe and fair environment; approves QC, vacation time, monthly quality assessments, searching for and hiring new employees, oversee all purchases and inventories, direct communication between senior management and employees.
She currently provides her expertise in toxicological assessment to SteelFusion Clinical Toxicology Laboratory, LLC as a Technical Supervisor. She has experience 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. She has assisted clients with understanding drug screen and confirmatory results, interpreting chromatography data including quality control. She is custom to compliance, strategy development and implementation, results interpretation and ultimately how to establish compliance with various regulatory requirements. Additionally, Ms. Miller is an author and custodian of the SOPs for the operation of laboratory equipment and for executing established analytical methods to support GLP compliance according to the International Standardization Organization (ISO); ISO 15189 and ISO 17025; College of American Pathology (CAP), participates in investigative laboratory projects, and contributes to design, execution, and/or analysis of data; and critically evaluates SDS’s and Certificate of Analysis (COAs), prepares CHPs for safe handling of chemicals including test articles and formulation components.
Ms. Miller attended Saint Vincent School of Medical Technology, Erie, Pennsylvania 2009 and received a B.S Chemistry from Seton Hill University, Greensburg, Pennsylvania in 2008. She has SHARP Training, GLP/GCP Training, Health and Safety Assessments, and ISO 15189 and 10725 Compliance training.
PERSONAL EXPERIENCE
ADVISORS
Barbara Munch
Principal
SteelFusion Clinical Toxicology Laboratory, LLC
Ms. Barbara Munch is Principal, at Munch GLP Consulting, LLC. Ms. Munch was formerly Director, R&D Pharma GLP Risk Coordinator, at GlaxoSmithKline (US, UK), retiring in May 2019. Ms. Munch held positions with increasing levels of responsibilities, and has worked in pathology, management of a laboratory animal facility, Quality Assurance, and for the past two decades, focused on risk management, and compliance. This included leading global cross-functional teams to develop and implement effective process changes arising from emerging business or regulatory changes (US, UK, OECD), as well as supporting many FDA and MHRA inspections. Based on her 41-year career and knowledge of toxicology processes, GLP regulations, and data integrity, she continues to provide interpretation of difficult regulatory issues.
Ms. Munch has been a member of the Society of Quality Assurance (SQA) since 1991, is currently a member of the Board of Directors, and is past chair of the GLP Specialty Section. She also is a Distinguished Speaker, and teaches at SQA meetings, including Basic GLP, the History Behind the FDA GLPs, and SOPs. Ms. Munch earned her Bachelor of Science degree in Animal Science from the University of Maryland, College Park.