DrBarry Levine

Barry S. Levine, DSc, Diplomate, American Board of Toxicology, is Principal, Levine Tox Consulting, and is a consultant in toxicology/nonclinical drug development with 44 years of experience. His experience spans the pharmaceutical industry, contract research organizations, and academia. He has 56 publications, 76 abstracts, and 2 book chapters, and has served as Principal Investigator on several NCI, NIH, US Army, and WHO preclinical toxicology contracts as subsequently described. His current consulting activities include the design and oversight of nonclinical drug development programs for pharmaceutical and biotechnology clients.

From 2004 – 2008, Dr. Levine served as Director, Preclinical Development at Hospira, Inc., the former Hospital Products Division of Abbott Laboratories. In that role, he directed the activities of the Preclinical Development Dept. in support of products under development. This included providing preclinical expertise and consultation for products and medical devices throughout all phases of preclinical and clinical development. He also represented preclinical issues to worldwide regulatory agencies, e.g., FDA, EMA, etc., served as preclinical representative on drug development project teams, oversaw Hospira’s Bioethics Program related to animal research, and prepared and/or oversaw the preparation of non-clinical sections of regulatory filings (such as INDs and NDAs in CTD format), Investigator’s Brochures, etc.

Prior to Hospira, he held director level positions at PharmaMar and Vertex Pharmaceuticals. In those positions, he functioned as dept. director, provided toxicologic expertise to support the development of drug candidates, served as Study Sponsor for non-clinical contracts with CROs, served as toxicology department representative and preclinical sub-team leader on several drug development project teams, and prepared position papers and non-clinical sections of INDs and NDAs.

From 1987 - 2002, Dr. Levine was Director of the Toxicology Research Laboratory (TRL) and Associate Professor of Pharmacology at the University of Illinois at Chicago (UIC). The UIC/TRL is a contract research organization focused on preclinical development testing services for the pharmaceutical industry and government agencies, and was established in 1987 by Dr. Levine. As Director of UIC/TRL, his responsibilities included administration and conduct of regulatory toxicology studies for industry and government Sponsors in accordance with FDA GLP regulations, served as Principal Investigator on several US government contracts (NCI, NIDA, US Army) and contracts for the WHO, developed preclinical toxicology programs for industrial clients, and assisted clients in the preparation of IND and NDA toxicology sections. As Associate Professor of Pharmacology, he presented lectures to medical and graduate students, including serving as Course Director for “Principles of Toxicology.”

Prior to his position at UIC, he held senior scientist/director level positions of increasing responsibility at Microbiological Associates (currently BioReliance Corp.), Ortho Pharmaceuticals, and IIT Research Institute.

Dr. Levine’s research experience includes numerous acute, subchronic and chronic toxicology/carcinogenicity studies in mice, rats, dogs, non-human primates, and rabbits; reproductive and developmental toxicity studies in rats and rabbits; pharmacokinetics studies in rodents, dogs and non-human primates; and in vivo cytogenetic studies in rats. Routes of administration included oral, intravenous bolus, intravenous infusion, subcutaneous and intramuscular. These studies were conducted for government and industry Sponsors, and included therapeutic agents such as antimalarials, chemical antidotes, antivirals, anticancer agents, cancer chemoprevention drugs, oral contraceptives, tranquilizers, diuretics, monoclonal antibodies, recombinant DNA products, and proteins. He also studied the toxicity of munitions compounds (under contract to DOD), pesticides, biomaterials, and environmental pollutants. Sponsors have included NCI, NIH, the U.S. Army, pharmaceutical and chemical companies, EPA, and the National Toxicology Program. The majority of these studies were utilized by Sponsors in support of regulatory submissions.

In addition to his extensive experience in toxicology, Dr. Levine has 12+ years of experience directing clinical pathology laboratories. This included functioning as the Clinical Pathologist (and Toxicologist) at Microbiological Associates for studies conducted for the National Toxicology Program. He has supervised clinical pathology measurements for a variety of species including rodents, monkeys, dogs, and rabbits. Dr. Levine's clinical pathology expertise also includes serving as past chairman of the American Association for Clinical Chemistry's (AACC) Division of Animal Clinical Chemistry (DACC), and past Member of the AACC/DACC Regulatory Affairs Committee. As a member of the AACC/DACC Regulatory Affairs Committee, he co-authored a position paper by Weingand et al. entitled "Clinical Pathology Testing Recommendations for Nonclinical Toxicity and Safety Studies (Toxicol. Pathol. 20, 539-543, 1992). This publication was the initial manuscript from which the clinical pathology harmonization guidelines (Weingand et al., Fund. Appl. Tox. 29, 198-201, 1996) were derived. Dr. Levine also wrote a book chapter entitled "Animal Clinical Pathology" which appeared in the 1995 and 2001 editions of the CRC Handbook of Toxicology.

Dr. Levine received his D.Sc. in Toxicology from the Harvard School of Public Health (1976), and a Master's degree in Medicinal Chemistry (1972) and a Bachelor's degree in Pharmacy (1971) from the University of Illinois. Dr. Levine is board-certified by the American Board of Toxicology (1980) and is a member of the Society of Toxicology, the American College of Toxicology, the Society of Toxicologic Pathology, and several other scientific organizations. He is past President of the Midwest Regional Chapter/Society of Toxicology, in addition to having held several other scientific advisory appointments. In 1993, Dr. Levine traveled to Beijing, China on behalf of the World Health Organization to present lectures on GLP implementation procedures to the Academy of Military Medical Sciences (China's equivalent of the US Army's Walter Reed Army Institute of Research). In addition to his current consulting activities, Dr. Levine recently wrote a book chapter entitled “Single and Repeat Dose Toxicity” for International Pharmaceutical Product Registration (2009).