Stuart Levy Email & Phone Number

SGL Chemistry Consulting, LLC is focused on acceleration of the advancement of discovery chemistry leads to the development candidate stage, and the transition of candidates into preclinical and clinical development.SERVICES OFFERED:• EXPERTISE IN CHEMICAL DEVELOPMENTo Evaluation / optimization of synthetic routes to drug candidateso Adaptation of discovery chemistry routes for scale-upo Chemical process development / optimizationo Creation and execution of fit for purpose R&D, production and cGMP manufacturing strategies and planso Design of syntheses of stable isotope and radiolabeled molecules for in vivo studieso Solid state chemistry – polymorphism, salt screening and selectiono Sourcing of raw materials, excipients, standards• VENDOR SELECTION, ENGAGEMENT AND MANAGEMENTo API, drug product, analytical, custom synthesis, QA and regulatory supporto Creation of requests for proposalo Definition of scope of work, deliverables / timelineso Facilitation of performance, completion of worko Technology transfer - tech transfer packages, performance of tech transfer to / between vendors and organizations• PROBLEM SOLVINGo Troubleshooting of chemical process development / API manufacture, drug product process development / manufacture, analytical method developmento Leadership of expert teams in the solution of complex technical problemso Broad, multidisciplinary consultant network• ASSISTANCE WITH STRATEGY AND MANAGEMENT OF DRUG DEVELOPMENT PROGRAMSo Coordination of CMC activities• TECHNICAL AND REGULATORY DOCUMENTATIONo Drafting, review, editing of development reportso Authorship, review, editing of CMC regulatory documents, including INDs, NDAs, amendments, biowaivers• REGULATORY/QA SUPPORTo Interpretation / application of FDA and ICH guidances pertaining to CMC development activitieso Practical experience in quality audits / mock PAIs in North America, EU, India, Japan

Leader, PPD Dermatology New Product Sourcing Team- Established a process for researching and evaluating new approaches to topical small molecule therapies for dermatologic diseases- Identified biological mechanisms of action relevant to dermatology and determined tractability, based on medicinal chemistry hits and leads in the literature- Sought scientific collaborators and partners in industry and at academic and private research institutionsDevised and executed a strategy for the CMC development of a small molecule vitamin D receptor modulator for the treatment of inflammatory skin disease-Resulted in the filing of an IND, which was accepted by the FDA with no CMC questions-Required development and manufacture of a very low dosage (2-10ppm active concentration in vehicle) petrolatum-based ointment as the clinical dosage form- Transferred a gram-scale API synthesis to a vendor for scale up to a 1.5kg GMP manufacturing lot- Managed/led process optimization efforts at vendor to prepare for manufacture of Phase 2a clinical supply- Devised and executed a strategy for the radiosynthesis of a 14C labeled version of the development candidate. Specific activities of the lots produced were 60 and 330 mCi/mmolWrote the manufacturing sections of the IND for both API and drug product for the candidate INDSupervised two PhD chemistsEvaluated potential in-licensing and partnering opportunities from a chemistry and CMC perspective

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Managed and led the CMC effort for the preclinical development of EX-1350, an Elixir internal discovery lead for the growth hormone secretagogue receptor (GHSR, ghrelin) antagonist program- Achieved the production of > 1kg EX-1350 suitable for GLP studies at an external vendor within 5 months of candidate nomination- Managed two salt screening and selection studies-Identified and addressed issues relevant to formulation development for EX-1350, including physicochemical properties and stabilityLed/Managed outsourcing and performed technology transfer for all CMC activities and NDA preparation for an in-licensed late stage US/EU commercialization opportunity for Mitiglinide, a type II diabetes treatement approved in Asia- Key author and reviewer of Mitglinide pre-NDA meeting briefing book CMC section- Led and managed the manufacture of Mitiglinide Phase III clinical trial material and registration lots- Led and managed the development of a fixed combination drug containing mitiglinide and another known Type II diabetes drug; activities included analytical method development and validation, dosage prototype production and evaluation, feasibility manufacturing, and preparation for manufacture of registration lotsProject Leader, Ghrelin Agonist Preclinical Development Program- Identified, engaged and managed all resources necessary for undertaking all activities related to the development of a small molecule ghrelin agonist, EX-1314- Personally managed all activities related to CMC for EX-1314- Created and refined a detailed plan for the development of EX-1314- Staffed, led and managed a virtual development team composed of experts in areas other than API (drug product, PK/ADME, toxicology, QA) tasked with development of EX-1314- Managed the production of > 10kg EX-1314 API for IND-enabling toxicology studies- Oversaw the GMP manufacture of 800g API and 10,000 dry-filled capsules for Phase I clinical supply

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Concord, Oh, Us

Post-Doc, Organic Chemistry, Medicinal Chemistry

Phd, Chemistry

Bs, Biochemistry

Education record