Stuart G. Levy PhD, SGL Chemistry Consulting, LLC
92 Fairmont St Arlington, MA 02474
(617) 504-3519
Primary Area of Expertise
Medicinal Chemistry
Expert Witness Profile
Expert witness in all aspects of chemical and pharmaceutical development, including:
• Late lead optimization and discovery activities bridging medicinal chemistry and early development, including:
⚬ Transitioning of multiple lead molecules into early development
⚬ Optimization/discovery of practical synthetic routes
⚬ Process R&D, full chemical and physical characterization (pre-formulation)
⚬ Development of discovery PK/ADME and preclinical formulations
• Strategic, logistical, and technical leadership of entire CMC programs, from preclinical studies through commercialization
• Regulatory CMC support - strategy/pathl, documentation, interactions (written and real time) with global regulatory agencies
• Hatch-Waxman litigation, concerning all of the above subject areas and topics
• Late lead optimization and discovery activities bridging medicinal chemistry and early development, including:
⚬ Transitioning of multiple lead molecules into early development
⚬ Optimization/discovery of practical synthetic routes
⚬ Process R&D, full chemical and physical characterization (pre-formulation)
⚬ Development of discovery PK/ADME and preclinical formulations
• Strategic, logistical, and technical leadership of entire CMC programs, from preclinical studies through commercialization
• Regulatory CMC support - strategy/pathl, documentation, interactions (written and real time) with global regulatory agencies
• Hatch-Waxman litigation, concerning all of the above subject areas and topics
Education & Licenses
BS, Biochemistry, University of Illinois-Chicago, 1987
PhD, Chemistry (area of concentration - Organic Chemistry, 1992
NIH Post-Doctoral Fellow, University of California, San Diego School of Medicine, La Jolla, CA, 1992-1995
PhD, Chemistry (area of concentration - Organic Chemistry, 1992
NIH Post-Doctoral Fellow, University of California, San Diego School of Medicine, La Jolla, CA, 1992-1995
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