Stuart Levy, PhD, is a Principal Consultant at SGL Chemistry Consulting, focused on the advancement of small molecules from discovery into clinical trials, since May 2010. Dr. Levy has broad and signicant experience in troubleshooting and solving problems in the pharmaceutical industry related to chemical and pharmaceutical development. Previously, Dr. Levy was the Director, Chemistry at PPD Dermatology, where he was responsible for chemistry and CMC development of new candidates for topical treatment of dermatological disease. At PPD Dermatology, he led the advancement of a candidate compound from late discovery to an IND, for which he wrote the majority of the CMC section. In addition, Dr. Levy was a key participant in building a dermatology therapeutic pipeline. His responsibilities in this area included due diligence of in-licensing and partnering opportunities, and research and business development focused on identifying target mechanisms of action and in-licensing and partnering entities. Prior to PPD Dermatology, Dr. Levy was the Director of Pharmaceutics and Manufacturing at Elixir Pharmaceuticals. He led and managed three projects, two preclinical and one late-stage commercialization opportunity in-licensed from Japan. At Elixir, Dr. Levy staffed and led virtual development teams in preclinical CMC development activities and cGMP manufacture of clinical trial material for Phase I - Phase III trials. At Elixir, he also participated in due diligence and identification of new tractable target mechanisms of action in metabolic disease. Dr. Levy received a BS in biochemistry and a PhD in Chemistry from the University of Illinois.
Areas Stuart Levy is Knowledgeable in:
Chemical and pharmaceutical development, GMP manufacturing of API and drug product, troubleshooting and problem solving of analytical, chemical and formulation development efforts, stereochemistry, synthetic organic chemistry, CMC development, due diligence of in-licensing or partnering opportunities, oral and topical dosage form development, preformulation studies, small molecule physicochemical properties, chemistry R&D, application of physical organic chemistry and chemical mechanism to synthetic organic chemistry problems, outsourcing of chemistry and CMC development activities, technology transfer
Techniques Stuart Levy Uses:
Analysis of data (HPLC, NMR, DSC, TGA, MS, XRPD, yield, recovery, root cause investigations); Understanding of chemical mechanisms; Gathering information from literature and reference sources; Application of past experience; Collaboration with colleagues; Leadership; Decision-making;
Stuart Levy's Problem Solving Skills:
- due diligence for in-licensing and partnering opportunities
- technology transfer
- Leadership of CMC development programs
- synthetic organic chemistry
- GMP manufacturing
- chemical process development and troubleshooting
- chemical and pharmaceutical development
- formulation development
- analytical method development
- problem solving in chemical and pharmaceutical R&D and manufacturing
- regulatory document writing (INDs, NDAs, briefing books, amendments)
- selection, engagement and management of outsourced chemical and pharmaceutical R&D and manufacturing
Stuart Levy's Problem Solving Experience:
- I was the CMC leader for a US commercialization effort for an in-licensed drug on the market in Japan. I led the scale-up of the dosage form from 5mg (Japanese maximum dose) to 40mg (US and EU maximum dose). I led and managed the formulation development and GMP manufacture of Phase III clinical supply and registration lots.
- I led the development of an analytical method adequate for the detection of API at levels below 2.5ppm in a petrolatum-based ointment topical dosage form
- I developed a scalable multistep process for the manufacture of a chiral macrocyclic MRI imaging ligand in high optical purity at scales of up to 5kg. This work included hands-on R&D, preparation of a tech transfer package, management of outsourced scale-up, production and manufacture.
- I devised and executed the CMC strategy for the development of a small molecule vitamin D receptor modulator for treatment of inflammatory dermatological diseases. This included adaptation of the discovery synthesis of the API for scale up, production and manufacture, preformulation and in vitro skin penetration studies of topical formulation prototypes, formulation development, production and GMP manufacture of drug product, synthesis of radiolabeled API for in vitro and in vivo pharmacology and PK/ADME studies. I was also the primary author of the CMC section of the IND pertaining to drug substance and drug product process development and manufacturing. The IND was accepted by the FDA with no CMC questions.
- I led and managed the outsourced development of a multistep chemical process for a small molecule agonist of the growth hormone secretagogue (ghrelin) receptor. 10kg of material was prepared for preclinical studies, and 1kg of GMP material was manufactured for Phase I clinical supply. I also oversaw the manufacture of 10,000 dry-filled capsules for Phase I clinical supply.