Consultants in Toxicology and Nonclinical Development

Curriculum Vitae

Barry S. Levine, D.Sc.
Diplomate, American
   Board of Toxicology
Levine Tox Consulting, LLC


1101 W. Armitage Ave. | Suite 210 | Chicago, IL 60614
Office: 773-697-4846 | Cell: 312-550-0100 | Fax: 312-546-6334
Email: bslevine@levinetoxconsulting.com

AREAS OF EXPERTISE

  • Strategic Planning
  • Nonclinical Drug Development
  • Toxicology/Toxicokinetics
  • Generic Drug Development
  • Product Liability
  • Scientific Program Management
  • Clinical Pathology of Laboratory Animals
  • Biosimilars Nonclinical Development
  • Forensic Aspects of Drug Intoxication

EDUCATION

  • Diplomate, American Board of Toxicology, 1980
  • D.Sc., Toxicology, Harvard School of Public Health, 1976
  • M.Sc., Toxicology, Harvard School of Public Health, 1974
  • M.S., Medicinal Chemistry, University of Illinois, 1972
  • B.S., Pharmacy, University of Illinois, 1971

CURRENT POSITION

  • Principal, Levine Tox Consulting, LLC, Chicago, IL, 2008-present.
    Consultation services are provided in Toxicology/Safety Assessment, Nonclinical Drug Development, Regulatory Submissions, Product Liability/Forensic Toxicology, Scientific Program Management, and Government Contracts.

PREVIOUS POSITIONS

  • Director, Preclinical Development, Hospira, Inc., Lake Forest, IL, 2004-2008
  • Director, Toxicology Division, PharmaMar USA, Inc., Cambridge, MA, 2003-2004
  • Associate Director, Dept. of Toxicology, Vertex Pharmaceuticals, Cambridge, MA, 2002-2003
  • Director, Toxicology Research Laboratory, and Associate Professor of Pharmacology, University of Illinois at Chicago, Chicago, IL, 1987-2002
  • Director, General Toxicology and Head, Clinical Pathology, BioReliance Corp. (formerly Microbiological Associates, Inc.), Bethesda, MD, 1985-1987
  • Senior Toxicologist and Head, Clinical Pathology Laboratory, Life Sciences Department, IIT Research Institute, Chicago, IL,1982 - 1985. Research Toxicologist, 1976-1981
  • Toxicology Group Leader, Drug Safety Evaluation Division, Ortho Pharmaceuticals, Raritan, NJ, 1981-1982

BOOK CHAPTERS

  1. Levine, B.S. Animal Clinical Pathology. In: CRC Handbook of Toxicology (M.A. Hollinger and M.J. Derelanko, eds.), CRC Press, Inc., Boca Raton, FL, second edition, 2001.
  2. Levine, B.S. Single and Repeat Dose Toxicity. In: International Pharmaceutical Product Registration (A.C. Cartwright and B. Matthews, eds.), Informa Healthcare USA, Inc., New York, NY, second edition, 2009.

PUBLICATIONS [Fifty-five (56) publications including the following recent papers]

  1. Brown, A.P., Morrissey, R.L., Faircloth, G.T., and Levine, B.S. (2002). Intravenous toxicity of Kahalalide F, a new anticancer agent, in the rat. Cancer Chemo. & Pharmacol. 50, 333-340.
  2. Brown, A.P., Kirchner, DL, Morrissey, R.L., Das, S.R., Fitzgerald, R.L., Crowell, J.A., and Levine, B.S. (2003). Endocrine effects of dehydroepiandrosterone (DHEA) and a fluorinated analogue, fluasterone, in rats. Drug Development Res. 58, 169-178.
  3. Lyubimov A.V., Smith, J.A., Rousselle, S.D., Merceica, M.D., Tomaszewski, J.E., Smith, A.C. and Levine, B.S. (2004). The effects of Tetrathiomolybdate (TTM, NSC-714598) and copper supplementation on fertility and early embryonic development in rats. Repro. Tox. 19, 223-233.
  4. Glaze, E. R., Lambert, A. L., Smith, A. C., G., Johnson, W. D., McCormick, D. L., Brown, A. P., Levine, B. S., et al. (2005). Preclinical toxicity of a geldanamycin analog, 17-(Dimethylaminoethylamino)-17-demethoxygeldanamycin, in rats and dogs: potential clinical relevance. Cancer Chemother. Pharmacol. 56, 637-647.
  5. Lyubimov, A.V., Carr, S.N., Brown, A.P., Art, J.J., Crowell, J.A., and, Levine, B.S. (2005). Evaluation of hydrogen ion concentrations in prostates from rats and dogs using fluorescent confocal microscopy. J. Photochem. Photobiol. B: Biology 80, 225-234.
  6. Crowell, J.A., Page, J.G., Levine, B.S., and Hebert, C.D. (2006). Indole-3-carbinol, but not its major digestive product 3,3’-diindolylmethane, induces reversible hepatocyte hypertrophy and cytochromes P450. Toxicol. Appl. Pharmacol. 211, 115-123.
  7. Holovics, H.J., Anderson,C.R., Levine, B.S., Ho-Wah, H., and Lunte, C.E. (2008). Investigation of drug delivery by iontophoresis in a surgical wound utilizing microdialysis. Pharm. Res. 25, 1762-1770.
  8. McGinley, C.M., Zhul, Z.J., Levine, B.S., and Bigwarfe, Jr., P.M.(2008). Managing Impurities and Degradation Products in Drug Products and Drug Substances. Pharmaceutical Canada 9, 6-10.

ABSTRACTS [Seventy-six (76) abstracts including the following recent presentations]

  1. Levine, B.S., Krishnaraj, R., Morrissey, R.L., Kapetanovic, I., Pezzuto, J.M., and Crowell, J.A. (2003). Twenty-eight day toxicity study of the cancer chemopreventive agent 4-bromoflavone in dogs. The Toxicol. 72, 210.
  2. Krishnaraj, R., Morrissey, R.L., Crowell, J.A., Pezzuto, J.M., and Levine, B.S. (2003). Twenty-eight day toxicity study of the cancer chemopreventive agent 4-bromoflavone in rats. The Toxicol. 72, 46.
  3. Levine, B.S., Lyubimov, A.V., Carr, S., Brown, A.P., and Crowell, J.A. (2003). Evaluation of hydrogen ion concentrations in prostates from rats and dogs using fluorescent confocal microscopy. Proc. Soc. Amer. Assoc. Cancer Res. 44, 189.
  4. Lyubimov, A. V., Mercieca, M.D., Tomaszewski, J.E., Smith, A.C., and Levine, B.S. (2003). Oral developmental toxicity study of ammonium tetrathiomolybdate (NSC-714598) in rabbits. Develop. and Repro. Tox. 68, 232.
  5. Krishnaraj, R, Morrissey, R.L., and Levine, B.S. (2004). A ninety day toxicological evaluation of GBR 12909 in dogs. The Toxicol. 78, 295-296.
  6. Levine, B.S., Sved, D., Harman, L., and Draganov, D. (2011). Pharmacokinetics, Excretion Balance, and Metabolite Profiling following a Single Intravenous or Oral Dose of [14C]-Forodesine in Cynomolgus Monkeys. The Toxicol. 2011.
  7. Draganov, D., Sved, D., Harman, L., and Levine, B.S. (2011). Pharmacokinetics, Tissue Distribution, Excretion Balance, and Metabolite Profiling following a Single Intravenous or Oral Dose of [14C]-Forodesine in Rats. The Toxicol. 2011.

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