Team

Dr. Hardisty

Jerry F. Hardisty, DVM, Diplomate ACVP, Fellow IATP

Chief Executive Officer / Senior Pathologist

Phone: (919) 998-9407
Email:  jhardisty@epl-inc.com

Education
Pre-Veterinary Studies, Iowa State University (1965-1967)
D.V.M., Iowa State University (1971)

Experience

Dr. Hardisty joined EPL as a staff pathologist in 1976. He has extensive expertise in nonclinical safety assessment through direct microscopic evaluation of tissues and contribution to resolution of toxicologic pathology issues related to chemical and drug development. He is a leader in developing procedures and setting standards for Pathology Peer Review, Pathology Working Groups, and Scientific Advisory Panels; these procedures were developed at EPL and utilized throughout the industry. Dr. Hardisty has worked with the NCI/NTP Carcinogenesis Testing Program closely for over 30 years and has participated in the publication and presentation of significant results of the NCI/NTP Pathology Quality Assessment Program and of several specific carcinogenesis bioassay tests. He received his pathology training in the U.S. Army Preceptorship Program.

Dr. Hardisty has been active in many industry organizations. He has served as President of the Society of Toxicologic Pathology (STP) and as a member of the STP Executive Committee, the Standard Systematized Nomenclature and Diagnostic Criteria Committee (SSNDC), the FDA Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Sciences and has served on the planning and program committees for the American College of Toxicology (ACT). He is a member of the International Academy of Toxicologic Pathologists (IATP) and has served as its North American Director. The Society of Toxicologic Pathology honored Dr. Hardisty as the recipient of its 2011 Achievement Award for his contributions to the field of toxicologic pathology. In 2010, The American College of Toxicology presented its annual Service Award to Dr. Hardisty for his contribution to the organization. In 2005, he received the highest recognition by Iowa State University, with its annual Stange Award.

He has co-authored several publications in experimental pathology, pathology quality assessment and pathology peer review. He currently serves on the Editorial Board for International Journal of Toxicology and Experimental and Toxicologic Pathology. Additionally, Dr. Hardisty is an Adjunct Assistant Professor with the North Carolina State University College of Veterinary Medicine.

Expertise and Interests

  • FDA Regulatory Concerns
  • Experimental Oncology
  • Chemical Carcinogenesis
  • Central Nervous System Pathology
  • Liver Pathology
  • Thyroid Pathology
  • Respiratory Tract Pathology
  • Pathology Peer Review
  • Pathology Working Groups (PWG)
  • Scientific Advisory and Risk Assessment Panels

Professional Memberships

  • Diplomate, American College of Veterinary Pathologists
  • Fellow, International Academy of Toxicologic Pathology
  • American College of Toxicology
  • Society of Toxicology
  • Society of Toxicologic Pathology
  • British Society of Toxicologic Pathologists
  • European Society of Toxicologic Pathology
  • American Veterinary Medical Association
  • North Carolina Society of Toxicology
  • Charles Louis Davis, D.V.M. Foundation
Dr. Funk

Kathleen A. Funk, DVM, PhD, Diplomate ACVP

President / Senior Pathologist

Phone: (703) 471-7060
Email:  kfunk@epl-inc.com

Education

B.S., College of William and Mary (1978)
D.V.M., Virginia-Maryland Regional College of Veterinary Medicine (1986)
Ph.D., University of California Davis (1993)

Experience

Dr. Kathleen Funk joined EPL in 1999. She has over 20 years of experience in toxicologic pathology. She has worked on a wide variety of toxicologic studies, including phenotypic analysis of transgenic animals and neurotoxicity studies. One area of expertise includes the evaluation of tissue reaction to biomedical devices, especially cardiovascular devices such as stents and grafts, in a variety of species.

Prior to her position at EPL, she spent 10 years at Consolidated Veterinary Diagnostics/IDEXX VS as a Veterinary Pathologist, Senior Anatomic Pathologist and then Head of Contract Research Services where she was responsible for directing the growth and controlling the budget of the unit, overseeing functions of the laboratory and support staff, supporting the function of the QAU, and acting as a liaison between the laboratory, research clients, and IDEXX management. She received her PhD in Comparative Pathology while also a resident training in veterinary pathology.

Expertise and Interests

  • Biomedical Device Pathology
  • Cardiovascular Biomedical Devices
  • Diagnostic Pathology
  • Implant Irritation
  • Laboratory Animal Health
  • Non-Human Primate Pathology

Professional Memberships

  • Diplomate, American College of Veterinary Pathologists
  • Federal Accreditation in Veterinary Medicine, State of California
  • Society of Toxicologic Pathology
  • American College of Toxicology
  • American Veterinary Medical Association
Dr. Steinbach

Thomas J. Steinbach, DVM, Diplomate ACVP and ABT

Vice President / Senior Pathologist

Phone:  (919) 998-9407
Email:   tsteinbach@epl-inc.com

Education

B.S., Iowa State University (1987)
D.V.M., University of Minnesota (1999)

Experience

Dr. Tom Steinbach joined EPL as a contract staff pathologist in 2006.  He performed numerous toxicology safety studies for both commercial and government clients on products ranging from pharmaceutical products to nanoparticles.  In 2012, he joined EPL as a full-time, senior pathologist.  In 2013, Dr. Steinbach was certified by the American Board of Toxicology.

Dr. Steinbach completed a residency in anatomic pathology at the Armed Forces Institute of Pathology and was certified in the American College of Veterinary Pathologists in 2005.  He served as the Chief of Pathology at the Naval Medical Research Center from 2005 until 2008.  He performed study design and all pathology services for over 30 investigators focused on diagnostic and therapeutic remedies for undersea medicine and traumatic brain injury using swine as an animal model.   In 2008, Dr. Steinbach became the Director of Pathology at the Walter Reed Army Institute of Research.  He managed five pathologists and over 40 staff members in providing pathology services to the U.S. Army’s largest biomedical research institute, which focused on endemic infectious disease and traumatic injury.

Dr. Steinbach has made significant contributions to toxicologic pathology by being active in a number of organizations.  He has authored numerous scientific publications on pathology, including unique laboratory species such as the sand rat, and has co-authored a chapter on the human relevance of Leydig cell tumors for the upcoming sixth edition of Hamilton and Hardy’s Industrial Toxicology.

Expertise and Interests

  • Electron microscopy
  • Nanotoxicology
  • Reproductive toxicology
  • Swine pathology
  • Sand rat pathology

Professional Memberships

  • Diplomate, American College of Veterinary Pathologists
  • Diplomate, American Board of Toxicology
  • Society of Toxicologic Pathology
  • American College of Toxicology
  • Charles Louis Davis, D.V.M. Foundation
Dr. Mann

Peter C. Mann, DVM, Diplomate ACVP, Fellow IATP

Manager, EPL Northwest / Senior Pathologist

Phone: (206) 284-1900
Email:  pmann@epl-inc.com

Education

A.B., Washington University (1970)
Pre-veterinary Studies, University of Missouri (1974)
D.V.M., University of Missouri (1979)

Experience

Dr. Mann joined EPL in 1989 and is located in Seattle, WA. He has over 25 years of experience in the area of toxicologic pathology. At EPL, Dr. Mann has been involved with primary evaluation of short and long term studies, experimental carcinogenesis studies both for commercial clients and the NTP, peer review of chronic and subchronic studies, the pathology of transgenic mice, the pathology of adenoviral gene therapy and the pathology of neutral liposomes. His professional interests include siRNA and liposomes, pathology peer review, experimental carcinogenesis, respiratory pathology, and the use of alternative models in toxicology. In 2010, Dr. Mann served as President of the Society of Toxicologic Pathology (STP).

Following a residency at the National Zoological Park in Washington, DC, Dr. Mann spent three years as a Senior Lecturer at the New Bolton Center (University of Pennsylvania). In 1985, he joined ICI (now Astra-Zeneca) as a staff pathologist. As an EPL employee, he initially began in Harrogate, England then relocated to EPL North Carolina where he served as a Staff Pathologist, Laboratory Director and Special Projects Manager. From 2000-2002, Dr. Mann served as a full-time on-site contract pathologist for Dupont Pharmaceuticals. In 2002, he managed EPL Northeast in Galena, MD; in 2006, Dr. Mann moved to Seattle, WA, where he is the Manager of EPL Northwest.

Expertise and Interests

  • Pathology Peer Review
  • Non-Human Primate Pathology
  • Transgenic Phenotyping Pathology
  • Transgenic Mice Models
  • Exotic Animal Pathology
  • Diagnostic Pathology
  • Experimental Carcinogenesis
  • Mammary Gland Pathology
  • Respiratory System
  • Pathology Working Groups (PWG)
  • Experimental Oncology
  • Chemical Carcinogenesis

Professional Memberships

  • Diplomate, American College of Veterinary Pathologists
  • Fellow, International Academy of Toxicologic Pathology
  • Society of Toxicologic Pathology
  • British Society of Toxicologic Pathology
  • C.L. Davis Foundation for the Advancement of Veterinary Pathology
Dr. Snyder

Paul W. Snyder, DVM, PhD, Diplomate ACVP, Fellow IATP

Manager, EPL Midwest / Senior Pathologist

Phone:  (765) 464-0059
Email:   psnyder@epl-inc.com

Education

B.S., Iowa State University (1980)
D.V.M., Iowa State University (1985)
Ph.D., Purdue University (1992)

Experience

Dr. Paul Snyder established EPL Midwest in West Lafayette, Indiana on September 1, 2014 after retiring as a Professor at Purdue University. He received his D.V.M. degree from Iowa State University, graduate pathology training from the University of Illinois, and a Ph.D. in Immunopathology from Purdue University.  He is certified by the American College of Veterinary Pathologists and is a Fellow of the International Academy of Toxicologic Pathologists.  As Professor of Pathology at Purdue University, he taught immunology and pathology to professional D.V.M. and graduate students, performed investigative research, and was Director of the Purdue Histology and Phenotyping Laboratory.  He has mentored 25 MS and PhD students and authored or co-authored more than 125 peer reviewed publications and book chapters.  He is an internationally recognized expert in pathology of the immune and cardiovascular systems.

Dr. Snyder has more than 20 years of experience in toxicologic pathology, both as a study pathologist and expert consultant. He has studied the defect in Severe Combined Immunodeficiency Disease (SCID) in dogs and has characterized spontaneous vasculitis syndrome of purpose bred Beagle dogs, also known as Beagle Pain disease and Canine Polyarteritis Syndrome.  His areas of interests are immunology, cardiovascular, medical devices and animal model development.

Dr. Snyder has participated on numerous STP committees, working groups and panels including, the STP Executive Committee (2008-2012), editorial board for Toxicologic Pathology, Scientific and Regulatory Policy Committee, Joint Regulatory Affairs Committee, and the 2011 Annual Symposium Committee. He has also participated in the Cardiovascular INHAND Committee, Stress Effects working group, HESI panel “Toxicity Testing in the 21st Century”, and Society of Toxicology, Scientific Liaison Advisor Group/Scientific Liaison Coalition.  He was an Associate Editor for Toxicologic Pathology.  He is currently a member of the Cosmetics Ingredients Review Expert Panel.  He has also served on the FDA Non-Clinical Studies Section vasculitis expert working group.  Most recently, he co-chaired a session and presented at the 2011 STP symposium.

Expertise and Interests

  • Immunology
  • Immunotoxicology
  • Immunopathology
  • Cardiovascular Pathology
  • Medical Device Pathology
  • Renal Pathology
  • Animal Model Development

Professional Memberships

  • Diplomate, American College of Veterinary Pathologists
  • Fellow, International Academy of Toxicologic Pathology
  • Society of Toxicologic Pathology
  • American Association of Veterinary Immunologists
  • American Veterinary Medical Association
  • C.L. Davis Comparative Pathology
  • Midwest Association of Veterinary Pathologists
Dr. Birkebak

Ted A. Birkebak, DVM, PhD, Diplomate ACVP

Manager, EPL West Coast / Senior Pathologist

Phone:  (650) 350-0831
Email:   tbirkebak@epl-inc.com

Education

D.V.M., University of Florida (1989)
Ph.D., Washington State University (1994)

Experience

Dr. Ted Birkebak established EPL West Coast in Redwood City, CA on January 1, 2015.  Dr. Birkebak has 20 years of experience as a veterinary pathologist and 15 years of experience supporting the pathology and toxicology efforts of pharmaceutical and biotech companies working in the development of small molecules and biologics.  In the pharmaceutical industry, he has functioned as a study pathologist, study director, project team toxicologist, and a manager of both toxicology and pathology groups.  He has worked on programs from discovery thru post-NDA life cycle management and has experience interacting with U.S. and E.U. regulatory agencies.  Dr. Birkebak has conducted the pathology evaluation of studies from early non-GLP thru carcinogenicity assessment and is familiar with all commonly used laboratory species.  He has experience in the evaluation and characterization of genetically modified rodents, the identification and development of appropriate animal models, and the design and conduct of pharmacology studies.  

Following veterinary training at the University of Florida and a combined PhD program/pathology residency at Washington State University, Dr. Birkebak spent five years at the University of Washington in Seattle as a postdoctoral fellow and Assistant Professor supporting research and diagnostic activities in the primate center and rodent facility.  In 1999, he joined Pharmacia & Upjohn (now Pfizer) where he served as a study pathologist, study director and project team toxicologist.  In 2006, he joined Sanofi Aventis (now Sanofi) where he initially supported pathology and toxicology functions, and then became Head of Pathology at the U.S. site in Bridgewater, NJ.

Expertise and Interests

  • Drug Development Strategies
  • Non-human Primate Pathology
  • Pathology Peer Review
  • Regulatory Interactions
  • Toxicologic Pathology

Professional Memberships

  • Diplomate, American College of Veterinary Pathologists
  • American College of Toxicology
  • Society of Toxicologic Pathology
Dr. Thomas

Heath C. Thomas, DVM, PhD, Diplomate ACVP

Manager, EPL Northeast / Senior Pathologist

Phone: (610) 283-5708
Email: hthomas@epl-inc.com

Education
B.S., North Carolina State University (1984)
D.V.M., North Carolina State University (1988)
Ph.D., University of California at Davis (1998)

Experience
Dr. Heath Thomas established EPL Northeast in Collegeville, PA on February 8, 2016 after serving as a Vice President of Safety Assessment at GlaxoSmithKline. He received his D.V.M. degree from North Carolina State University and Ph.D from the University of California at Davis in Comparative Pathology. He is certified by the American College of Veterinary Pathologists. Dr. Thomas’ research interests include pulmonary hypertension, cell cycle and apoptosis, as well as many years studying the pathogenesis and potential biomarkers of drug induced vascular injury.

After spending time as a Pathologist in Safety Assessment at DuPont and SmithKline Beecham, he was named the Director of Cellular Pathology at GlaxoSmithKline where he was active as a study pathologist, peer review pathologist and drug development scientist in the areas of oncology, cardiovascular and pulmonary diseases providing mechanistic toxicology support for drug development issues, utilizing flow cytometry, confocal microscopy, electron microscopy, quantitative image analysis and biochemical analyses. As Head of Pathology at GlaxoSmithKline, Dr. Thomas managed scientific strategy and veterinary pathologists, as well as teams across the clinical pathology, histology, and investigative laboratories. As Vice President and Site Head of Safety Assessment, he oversaw budget, strategic direction and leadership of the toxicology, pathology and investigative groups. He also had GLP site head responsibilities and led toxicology study design, reviewed study reports, and mentored numerous project team representatives on drug development.

He has over 25 published manuscripts and has given more than 10 invited presentations at national and international meetings. He has served on numerous committees within the American College of Veterinary Pathology (ACVP), and also served as an Associate Editor of the journal Veterinary Pathology from 2003 to 2008. From 2012 through 2015, he also served as the Chairperson of the Institutional Animal Care and Use Committee of GlaxoSmithKline in Pennsylvania.

Expertise and Interests

  • Animal Model Development
  • Cardiovascular Pathology
  • Drug Development Strategy
  • Drug-Induced Vascular Injury
  • Gastric Pathology
  • Investigative Toxicology
  • Non-Human Primate Pathology
  • Pathology Peer Review
  • Skeletal Pathology
  • Toxicologic Pathology

Professional Memberships

  • Diplomate, American College of Veterinary Pathologists
  • Society of Toxicologic Pathology
  • Society of Toxicology
  • North American Vascular Biology Organization
  • Pulmonary Research Group
Dr. Wolf

Jeffrey C. Wolf, DVM, Diplomate ACVP

Chief Scientific Officer / Manager, Virginia Pathology

Phone: (703) 471-7060
Email:  jwolf@epl-inc.com

Education

B.S., Michigan State University (1980)
D.V.M., Michigan State University (1984)

Experience

Dr. Jeff Wolf joined EPL in 2000. Dr. Wolf’s key area of expertise is toxicologic pathology of aquatic animals, and for the past eight years, his principal focus has involved reproductive and thyroid endocrine disruption (EDC) studies that utilize various species of fish and frogs, including both native and laboratory specimens. Dr. Wolf has participated extensively in the development of guidelines for conducting EDC experiments, including the standardization of EDC diagnostic criteria and terminology. Dr. Wolf has also served as the study pathologist for carcinogenesis bioassays, target animal safety studies, environmental toxicity investigations, and basic research activities involving infectious diseases, embryology and radiation toxicity. Additionally, Dr. Wolf often designs and performs studies that incorporate image analysis and stereological techniques.

Following ten years of clinical veterinary practice, Dr. Wolf received his anatomic pathology training during residencies at the University of Florida and at Virginia Tech. During his tenure at Virginia Tech he was the lead diagnostician at the Aquatic Medicine Laboratory of the Virginia-Maryland Regional College of Veterinary Medicine, and his main research activities at VMRCVM involved investigations into the pathogenesis of mycobacteriosis in striped bass. Since 2002, Dr. Wolf has served on the faculty of Aquavet® II Comparative Pathology of Aquatic Animals, a course that is co-sponsored by the University of Pennsylvania and Cornell University, in which he teaches a two-day seminar on the “Toxicologic Pathology of Fishes.” For three consecutive years he taught the “Fish Diseases” module of the C.L. Davis Foundation course “The Gross Morbid Anatomy of Diseases of Animals.” Dr. Wolf is the curator for the “Registry of Tumors in Lower Animals”, an archival tissue and data collection that is housed at EPL.

Dr. Wolf is a Co-Editor of the Journal of Aquatic Animal Health and has been an Associate Editor and editorial board member for Toxicologic Pathology. He has authored or co-authored numerous articles that have appeared in peer-reviewed journals, including diagnostic guidelines for non-neoplastic liver disease in fish, proliferative thyroid lesions in fish, proliferative hepatic lesions in bullhead catfish, thyroid alterations in Xenopus laevis, and endocrine disruption effects in Japanese quail. He also has written or contributed to book chapters that concern the toxicologic pathology of alternative animal models.

Expertise and Interests

  • Fish and Aquatic Animal Pathology
  • Reproductive and Thyroid Endocrine Disruption
  • Environmental Toxicology
  • Diagnostic Pathology
  • Image Analysis
  • Stereology

Professional Memberships

  • Diplomate, American College of Veterinary Pathologists
  • Society of Environmental Toxicology and Chemistry
  • International Association for Aquatic Animal Medicine
  • American Fisheries Society. Fish Health Section
  • European Association of Fish Pathologists
  • Charles Louis Davis, D.V.M. Foundation
  • Society of Toxicologic Pathology
Mr. Helms

Jadrian Helms

Client Services Business Development Associate

Phone: (703) 471-7060
Email:  jhelms@epl-inc.com

Experience

Jadrian Helms  joined the EPL staff in 2016 and has over 12 years of client services and business development experience in the preclinical CRO industry.  Jadrian’s previous roles served the Safety Assessment group at Charles River Laboratories.  Jadrian’s broad knowledge of preclinical toxicology testing including the specialty toxicology areas of developmental, reproductive and juvenile toxicology, photobiology, and cellular therapeutic safety testing will be a valuable resource to EPL’s clients.

Mr. Deninger

Joseph V. Deninger

Executive Vice President

Phone:   (703) 471-7060
Email:    jdeninger@epl-inc.com

Experience

Mr. Deninger joined EPL in 1989 as Controller and was promoted to his current position in 1994. He has also served as a member of the EPL Board of Directors since 1996. As Executive Vice President and Chief Financial Officer, he is responsible for all of the financial and administrative functions of the company including finance and accounting, human resources, and contract administration as well as information technology.

Prior to joining EPL, Mr. Deninger was an auditing manager with Arthur Young & Company, an international accounting and auditing firm and served in various financial and administrative capacities for companies in manufacturing, toy distribution and home construction.

Mr. Deninger earned his bachelor’s degree in Accounting from Canisius College and his MBA from the State University of New York at Buffalo where he was a member of the international honor society, Beta Gamma Sigma. He is a certified public accountant.

Dr. Hamlin

Melvin H. Hamlin, II, DVM

Consultant

Phone: (919) 998-9407
Email:  mhamlin@epl-inc.com

Education

B.S., Kansas State University (1970)
D.V.M., Kansas State University (1972)

Experience

Dr. Melvin H. Hamlin II, is a consultant to EPL with extensive experience and expertise with operations management of toxicologic pathology laboratories and biorepository facilities.  Previously, Dr. Hamlin served as Vice President at EPL where he managed operations in support of government and commercial clients which also required the management of off-site activities. He is also experienced in the monitoring and coordination of numerous activities and personnel which provide critical support to governmental agencies.

He has over 35 years of experience in experimental pathology and has served as the Principal Investigator for EPL’s contract to provide the facilities and staff necessary to operate and manage the NTP Archives, NTP Frozen Tissue Bank and the NIEHS Repository.  He has over 25 years of experience managing the storage and safe handling of frozen specimens and has had extensive experience with the support and management of government contracts.  Dr. Hamlin has worked closely with scientists and Project Officers at the EPA, NCI Bioassay Program and the NIEHS/NTP.  He also has extensive experience coordinating all mandated support for EPL’s NTP Quality Assessment contract.  Prior to joining EPL In 1978 as a staff pathologist, Dr. Hamlin was a research pathologist at the Biomedical Laboratory, Chemical Systems Laboratory, Aberdeen Proving Ground, Maryland.

Expertise and Interests

  • Retrospective Pathology Data Audits
  • Pathology Data Analysis
  • Biorepository Operation and Management
  • Experimental Oncology
  • Chemical Carcinogenesis

Professional Memberships

  • Society of Toxicologic Pathology
  • North Carolina Society of Toxicology
  • International Association of Records Managers and Administrators (ARMA)
  • International Society for Biological & Environmental Repositories (ISBER)
  • Charles Louis Davis, D.V.M. Foundation
  • American Veterinary Medical Association
  • Kansas Veterinary Medical Association