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 AND PREVIOUS POSITIONS
- 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
- 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
- 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.
- 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-six (56) publications including the following recent papers]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Chew, B.H., Paterson, R.F., Clinkscales, K.W., Levine, B.S., Shalaby, S.W., and Lange, D. (2013). Evaluation of a Biodegradable Ureteral Stent in a Yorkshire Pig Model. J Urol. 189,719-725.
ABSTRACTS [Seventy-six (76) abstracts including the following recent presentations]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
