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| Name and Educational Degree: |
| Levine, Barry S., D.Sc., DABT |
| Diplomate, American Board of Toxicology |
B.S. - Pharmacy (University of Illinois) M.S. - Medicinal Chemistry (University of Illinois) D.Sc. - Toxicology (Harvard School of Public Health) |
1360 N. Sandburg Terrace
Suite 2902
Chicago, IL 60610
USA |
| Telephone: |
312-654-9550 |
| Email Address: |
bslevine@hotmail.com |
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Nonclinical Drug Development, including Toxicology/Safety Assessment, Small Molecule, Biologics and Biosimilars Drug Development; Scientific Program Management (including Contract Research Organization Interactions and Study Monitoring). Regulatory filings (FDA, EMEA, Health Canada), including Nonclinical Sections of Common Technical Documents (CTDs). Other Consultation Areas include Product Liability/Forensic Toxicology (Expert Witness Testimony); Government Contracts; and Clinical Pathology of Laboratory Animals.
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| 30+ years of experience in toxicology/nonclinical development in the pharmaceutical industry, contract research organizations, and academia, with various classes of therapeutic agents. Most recently served as Director, Preclinical Development at Hospira (Lake Forest, IL), the former Hospital Products Division of Abbott Labs. Pharmaceutical Industry Experience includes: Development, placement and monitoring of nonclinical development programs for drugs & biologics at 15+ CRO facilities (toxicology - general, DART, genotoxicity, PK; bioanalytical; safety pharmacology); Nonclinical development representative on drug development & due diligence teamsToxicology qualification of impurities in drug substances and drug products; Preparation of nonclinical sections of regulatory filings (FDA, EMEA, Health Canada); Development and oversight of a Bioethics Program on animal use in research. Director of GLP Toxicology Laboratories including: Eighteen years of experience within the pharmaceutical industry and contract research organizations: 1. General toxicology, developmental and reproductive toxicology, pharmacokinetics. 2. Rats, mice, dogs, nonhuman primates (Rhesus, Cynomolgus, Baboons, Stumptails), rabbits, goats, ferrets. Government Contracts - Principal Investigator (NCI, NIH, US Army, World Health Organization). Academic Teaching Experience - Fifteen years (Professor of Pharmacology). Lectures/courses given to graduate and medical students. Legal experience - Fifteen years including expert witness testimony. President, Society of Toxicology, Midwest Regional Chapter, 1991-1992. Chair, Animal Clinical Chemistry Division, American Association of Clinical Chemistry, 1984 -1986. 55 publications, 75 abstracts, 1 book chapter, numerous technical reports. |
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