Stuart Levy

Stuart G. Levy, PhD, has provided chemistry consulting services to the pharmaceutical industry as an independent consultant since 2010. Dr. Levy has more than 18 years of experience in the pharmaceutical industry, primarily at start-up and medium size biotech pharmaceutical companies. Stuart’s consulting practice is focused on the transition and advancement of small molecule leads from discovery into preclinical and clinical development. Within this focus, Stuart performs evaluation of synthetic routes to discovery hits and leads, troubleshooting of difficult chemistries, conception of operationally simple and scalable syntheses, guidance and leadership in initial scale-up efforts, strategy, planning and execution for production and manufacture of API and dosage form for preclinicaland clinical studies, guidance and leadership for API salt screening and selection and drafting and finalization of the necessary CMC regulatory documents to support IND filing. Stuart has overseen and led the overall effort for the development of small molecules for numerous preclinical and clinical drug candidates. Given that all of Stuart’s employers were at least partially virtual in chemistry capabilities, part of his professional role has been management of outsourced chemistry R&D, production and manufacturing for the last 15 years. Stuart also has significant experience in due diligence evaluations of therapeutic assets offered for consideration for in-licensing for employers and client companies, from the point of view of chemistry and CMC viability.

Previously, Stuart held two positions at the director level, at PPD Dermatology (formerly MagenBiosciences) as Director of Chemistry, and as Director, Pharmaceutics and Manufacturing at Elixir Pharmaceuticals. He had full responsibility for all CMC activities at both positions, as well as roles in supporting discovery and medicinal chemistry activities at both employers. Stuart’s career as a bench chemist includes positions as Senior Staff

Scientist in chemistry R&D at EPIX Pharmaceuticals, project leader at the CDMO/CRO Ricerca, process chemist at the biotech SUGEN, and Scientist at the CDMO SERES Laboratories. . Stuart’s employment at two vendors providing chemistry services has afforded him a full perspective on the process and dynamic between vendors and their customers, and the ability to create and maintain optimally productive, respectful relationships between vendors and his employers/clients.

Expertise
Chemistry-GMP, Chemistry-Medicinal, Chemistry-Synthetic, CMC, CNS, CVMD, Dermatology, Formulation, Oncology, Regulatory, Small Molecule, USA, Stereochemistry, Route scouting, Route selection, API manufacturing, GMP, IND, NDA, Preformulation, Solid state chemistry, Salt screen, Polymorphism, Characterization, Troubleshooting, Metabolic disease, Injectable dosage, Oral dosage, Due diligence, Process development, Process discovery, Chemical mechanism, Enabling synthetic route, Asymmetric synthesis, Classical resolution – HPLC and SMB, Chiral separation, Starting material and raw material sourcing, Radiosynthesis, Stable isotopic label synthesis.