Joseph F. Holson, PhD, DABFE
Summary
Joseph Holson has more than 35 years of experience as a scientist, business executive, and educator in the disciplines of toxicology and product development. His internationally recognized expertise in developmental and reproductive toxicology, pharmacokinetics, and risk assessment, including extensive experience with study design, data interpretation, and interspecies extrapolation of health effects data, strengthened his executive leadership of WIL Research Laboratories through two decades of continuous growth. Dr. Holson has functioned as a key advisor to numerous product development programs (INDs, NDAs, TCSA consent orders, FIFRA registrations and international product registrations) and has served as principle investigator in more than 600 safety assessment studies. These projects involved diverse test agents using a variety of experimental animal models and human studies. He has served in numerous U.S. EPA/FDA advisory committees and as an expert toxicology witness for these agencies and in 27 civil lawsuits. He was elected to two National Academy of Sciences toxicology committees. He has been a long-standing member of numerous national and international professional societies, serving in a variety of roles. Throughout his career, including his tenure as President of WIL Research, Dr. Holson has lectured and published extensively in the fields of toxicology and human health risk assessment. At each phase of his career, he has complemented his research and executive responsibilities with regular adjunct teaching activities in toxicology programs of nearby universities.
Professional and Academic Experience
Joseph Holson received his Doctorate in Physiology in 1973 from the University of Cincinnati College of Medicine, having studied under the direction of Dr. James G. Wilson in the disciplines of developmental toxicology and research pediatrics. His doctoral research investigated the relative transport capabilities of chorioallantoic and yolk sac placentae during organogenesis in the rat. Prior to his doctoral training, he earned a B.S. (1967) and M.S. (1969) in Biology from East Carolina University (receiving the Poteat Award for his research on the teratogenicity of LSD). He also completed a Traineeship in Reproductive Physiology at Louisiana State University in Baton Rouge, Louisiana, in 1970.
Dr. Holson began his professional career in 1973 with the U.S. FDA/EPA-sponsored National Center for Toxicological Research (NCTR) in Little Rock, Arkansas, as a reproductive toxicologist. He became the Division Director in 1975 and organized a multidisciplinary research program, which became one of the nation’s major federally sponsored research groups in reproductive toxicology. For the next five years, he directed the teratology and developmental toxicology research programs of the National Toxicology Program (NTP), which focused on biochemical and physiological causes of birth defects, pharmacokinetics, postnatal functional evaluations, and mechanistic studies. During his tenure at NCTR, he also served as Assistant Professor of Physiology in the Interdisciplinary Toxicology Training Program at the University of Arkansas School of Medicine in Little Rock, Arkansas. In this capacity, he developed and taught the first graduate-level regulatory toxicology course in the country, served on PhD student committees, and was a member of the admissions committee and policy council.
Dr. Holson joined Science Applications International Corporation (SAIC) in La Jolla, California during March of 1980 to establish research and development and chemical testing programs in toxicology. For the next five years, he directed SAIC’s toxicology division, which included an active reproductive toxicology research emphasis. In 1983, he was elected to SAIC’s Executive Science and Technology Council. During his time at SAIC, he served as an adjunct lecturer in toxicology for the Toxicology Training Program at the University of Arizona and the Graduate Program in Public Health at San Diego State University. From 1985 through 1986, he served as President of Biomedical Research Institute of America in La Jolla, California and as an independent consultant in toxicology. From 1980-1986, he also served as a member of the Board of Directors and Secretary for the San Diego Biomedical Research Institute.
In March 1987, Dr. Holson was appointed Vice President and Director of Developmental and Reproductive Toxicology at WIL Research Laboratories, Inc., in Ashland, Ohio. In August of 1988, he was promoted to President and Director of WIL Research. During the next 20 years, he was responsible for all fiduciary and scientific aspects of the company’s operations. He remained scientifically active by serving as a study director upon special request, selectively reviewing data and reports, advising sponsors regarding toxicologic and product development issues, serving as a consultant to federal agencies, publishing scientific papers, giving presentations to various community and scientific organizations, and lecturing at Ashland University. He also served on Ashland University’s Science Advisory Board (1990-2008) and Board of Trustees (1993-1998).
Under his leadership, WIL Research grew from approximately 30 employees and negative profitability into a dynamic contract research organization employing more than 600 individuals, boasting an 18% compound annual growth rate and nearly $40 million annual EBITDA. This success was due to the scientific prowess of Dr. Holson and his team and their emphasis on a study director-centric business model. This model viewed each study director as an individual business unit comprising scientific, project management, and marketing responsibilities.
After two decades of sustained organic growth, he led WIL Research through a period of private capital-financed expansion, beginning with a management buyout (with Behrman Capital) and formation of WIL Research Holding Company (WRH) in 2004. The expansion continued with acquisitions in the U.S. and Europe, culminating in the $500 million sale of WRH to American Capital, Ltd. (NASDAQ:ACAS) in 2007. After the sale to ACAS, he served as Vice President and Chief Scientific Officer of the global entity while continuing to serve as President and Director of WIL Research Laboratories until his retirement from active management duties in November 2008. He served on the Board of Directors of WRH from its inception in 2004 until February 2009.
Throughout his career, including during his tenure as chief executive officer of WIL Research Laboratories, Dr. Holson has published extensively in the discipline of toxicology. He is an editor and author of the textbook Regulatory Toxicology and an author of two significant chapters in the textbook Developmental and Reproductive Toxicology: A Practical Approach, Second Edition. Two of his peer-reviewed articles were recognized by the Risk Assessment Specialty Section of the Society of Toxicology as the Outstanding Published Papers Demonstrating an Application of Risk Assessment. He has frequently contributed to continuing education courses and symposia at national and international scientific meetings that dealt with toxicology and human health risk assessment.
Academic Credentials
PhD, Physiology, University of Cincinnati College of Medicine and Children’s Hospital Research Foundation, 1973
Traineeship in Reproductive Physiology, Louisiana State University, 1970
M.A., Biology, East Carolina University, 1969
B.S., Biology, East Carolina University, 1967
Certifications
Diplomate, American Board of Forensic Examiners (DABFE), March 1997
Awards and Professional Recognition
Poteat Award (for research on teratogenicity of LSD), North Carolina Academy of Sciences, 1969.
Sigma Xi Senior Research Award, East Carolina University, 1969.
Panel member, 2,4,5-T Scientific Conference, U.S. Department of Agriculture/Dow Chemical Co., Washington, D.C., March 1974.
Expert witness, Report on Teratogenicity of 2,4,5-T, Office of Pesticide Programs, U.S. Environmental Protection Agency, June 1974.
Invited member, Dioxin Planning Conference, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC, July 25-26, 1974.
Expert witness, Hearing on Red Dye No. 2 (FD&C) Toxicology (testified on findings of the collaborative teratology study of FD&C Red No. 2), U.S. Food and Drug Administration, Washington, DC, 1974.
Commendable Service Award, U.S. Food and Drug Administration, 1974.
Committee member, Dioxins Toxicology Meeting, U.S. Environmental Protection Agency, Health Effects Research Laboratory, Research Triangle Park, NC, October 1975.
Expert witness, Open Hearing on FD&C Red No. 2 (reported on review of reproduction and teratology studies of FD&C Red No. 2), National Toxicology Advisory Committee, Washington, DC, November 1975.
Invited member, Institute de la Vie International Conference, Birth Defects – Detection and Prevention, Fort-de-France, Martinique, January 1976.
Listed in 13th Edition of American Men and Women of Science, 1976.
Invited member, Committee for Development of Toxicology Testing Guidelines, National Toxicology Advisory Committee, U.S. Food and Drug Administration, 1977.
Invited member, Food Additive Review Task Force, U.S. Food Drug Administration, 1977.
Panel member, Short-Term Tests for Carcinogenicity, Toxicology Forum, Hunt Valley, MD, February 1977.
Session organizer and chairman, Teratologic Testing, Second Annual NCI/NCTR Conference, Status of Predictive Tools in Application to Safety Evaluation, Little Rock, AR, October 1977.
Invited member, Reproductive Toxicology Risk Assessment Group, U.S. Environmental Protection Agency, 1978.
Invited member, Reproductive Risks Assessment Committee, Interagency Research Liaison Group, 1978-80.
Director, Developmental and Reproductive Toxicology Section, National Toxicology Program, 1978-80.
Committee member, Workshop on “Evaluation of the Toxic Substances Control Act Interagency Testing Committee’s Chemical Scoring System”, U.S. Environmental Protection Agency, San Antonio, TX, February 1979.
Invited member, Commissioner’s Search Committee for Director of National Center for Toxicological Research, U.S. Food and Drug Administration, 1979.
Invited member, Expert Committee on Extrapolation of Toxicological Findings, International Life Sciences, Hannover, Germany, November 17-19, 1980.
Secretary, Third International Congress of Toxicology, 1981-1983.
Expert witness, Testimony Concerning New York State Department of Health’s Reproductive Risk Assessment of Ethylene Dibromide, New York State Department of Health, Albany, NY, May 14, 1984.
Group leader, Workshop on Risk Assessment in Reproductive and Developmental Toxicology, Little Rock, AR, September 21-23, 1987.
Invited member, Risk Assessment Panel, Developmental Neurotoxicity Workshop, U.S. Environmental Protection Agency, Williamsburg, VA, 1989.
Invited member, Workshop on Benchmark Dose Methodology, ILSI Risk Science Institute, U.S. Environmental Protection Agency, American Industrial Health Council, Handon, VA, September 27-30, 1993.
Invited member, Proposition 65 Safe Use Determination Workshop for Methyl Bromide, Review and Analysis of Reproductive Toxicology of Methyl Bromide, Air Resources Board, Sacramento, CA, November 30 – December 1, 1993.
Invited member, Committee on Developmental Toxicology, National Research Council, National Academy of Sciences and Institute of Medicine, 1997-2000.
Invited member, Subcommittee on Reproductive and Developmental Toxicology, National Research Council, National Academy of Sciences and Institute of Medicine, 1997-2001.
Peer reviewer, U.S. Environmental Protection Agency, Research Triangle Park, NC, 2001.
Outstanding Published Paper Demonstrating an Application of Risk Assessment, Society of Toxicology, Risk Assessment Specialty Section, 2002.
J.F. Holson, J. M. DeSesso, C. F. Jacobson, C. H. Farr, Appropriate use of animal models in the assessment of risk during prenatal development: an illustration using inorganic arsenic. Teratology 62, 51-71 (2000).
Outstanding Published Paper Demonstrating an Application of Risk Assessment, Society of Toxicology, Risk Assessment Specialty Section, 2003.
L.M. Sweeney, T. R. Tyler, C. R. Kirman, R. A. Corley, R. H. Reitz, D. J. Paustenbach, J. F. Holson, M. D. Whorton, K. M. Thompson, M. L. Gargas, Proposed occupational exposure limits for select ethylene glycol ethers using PBPK models and Monte Carlo simulations. Toxicological Sciences 62, 124-139 (2001).
Invited Presentations
Publications (complete list)
Continuing Education
Workshop in Basic Pharmacokinetics and Pharmaceutics. Dr. D. Garrett, St. Augustine, Florida, 1975.
Microsurgery Training Program. Dr. Rhoton, Department of Neurosurgery, College of Medicine, University of Florida, 1975.
Workshop in Communication Skills, National Center for Toxicological Research, Jefferson, AR, 1976.
Management Training Workshop, National Center for Toxicological Research, Jefferson, AR, 1976.
Motivation of Behavior Workshop, Little Rock, AR, November 1978.
Standards of Performance Workshop, Little Rock, AR, November 1978.
Monoclonal Antibodies: Application to Toxicology, The Society of Toxicology, San Diego, CA, March 18, 1985.
Methods in Male Reproductive Toxicology: The Evaluation of Spermatogenic Impairment, The Society of Toxicology, Dallas, TX, February 15, 1988.
Concepts in Molecular Biology, The Society of Toxicology, Atlanta, GA, February 27, 1989.
Toxicity of Agents: Pesticides, The Society of Toxicology, Miami Beach, FL, February 12, 1990.
Concepts in Cell Biology, The Society of Toxicology, Miami Beach, FL, February 12, 1990.
Advanced Topics in Risk Assessment, The Society of Toxicology, New Orleans, LA, March 14, 1993.
Embryology for Teratologists, The Teratology Society, Las Croabas, Puerto Rico, June 25, 1994.
New Endpoints in Developmental and Reproductive Regulatory Studies: Methods for Success, The Society of Toxicology, Baltimore, MD, March 5, 1995.
The Female Reproductive System – How to Assess Potential Toxicity, The Society of Toxicology, Anaheim, CA, March 10, 1996.
Endocrine Control of Reproductive Development – Normal and Abnormal Aspects, The Society of Toxicology, Cincinnati, OH, March 9, 1997.
International Harmonization of Non-Clinical Toxicology Requirements: Regulation vs. Practice, The Society of Toxicology, Seattle, WA, March 1, 1998.
Development and Function of Endocrine and Immune Systems in Teratology, The Teratology Society, San Diego, CA, June 20, 1998.
Evaluation of Male Reproductive Toxicity: Sperm Markers and Epididymal Mechanisms of Toxicity, The Society of Toxicology, New Orleans, LA, March 14, 1999.
Genomic Technologies and New Screening Strategies for Toxicology, The Society of Toxicology, New Orleans, LA, March 14, 1999.
Organ System Maturation and Functional Postnatal Development, The Teratology Society, Keystone, CO, June 29, 1999.
Metabonomics – A New Approach to Drug Toxicity Screening Using NMR Spectroscopy, Pattern Recognition and Expert Systems, The Society of Toxicology, Philadelphia, PA, March 19, 2000.
Safety Pharmacology and Risk Assessment, The Society of Toxicology, Philadelphia, PA, March 19, 2000.
Signal Transduction: Pathways to Growth, Differentiation, and Morphogenesis, The Teratology Society, Palm Beach, FL, June 24, 2000.
Improving Risk Assessment for Human Developmental Defects: The Promise of Recent Advances in Developmental Biology and Genomics, The Society of Toxicology, San Francisco, CA, March 25, 2001.
CNS Functional Teratology, The Teratology Society, Monterey, CA, June 28, 2008.
