SGL Chemistry Consulting, LLC

Biography

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Stuart G Levy, PhD is Principal Consultant at SGL Chemistry Consulting, LLC, a sole-proprietor practice focused on the advancement of small molecules from the late discovery lead stage into preclinical and clinical development. 

  • 29-year career in industry, primarily involved the practical solution of problems related to chemical and pharmaceutical R&D and manufacturing.  Worked at the bench for 10 years on multistep syntheses of many classes of biologically active small molecules, in addition to chemical process R&D, scale-up, production and cGMP manufacture up to the multi-kg scale.  During the last 19 years, responsibilities have expanded to include all aspects of CMC development, including the development of analytical methods and development, production and cGMP manufacture of suitable dosage forms for both toxicology studies and clinical trials. 
  • Prior to launching SGL Chemistry Consulting, LLC permanent employee at organizations involved in outsourcing of CMC activities, either as clients (SUGEN, EPIX, Elixir and PPD Dermatology) or vendors (SERES Laboratories, Ricerca Biosciences).   Expertise in the selection, engagement and management of vendors involved in all aspects of CMC development and manufacturing to provide preclinical and clinical dosage form supply 
  • Experience leading and managing work at every phase of development, from late discovery through process validation lots.  Hands-on experience in laboratories at biotech pharmaceutical companies and as a scientist and project leader at API vendors afforded a unique perspective on how to maximize productivity in CMC development efforts and create constructive, enduring client-vendor relationships. 
  • Developed numerous processes that have been implemented in cGMP manufacture of drug candidate APIs.  Project leader for the process development and cGMP manufacture of a drug candidate that is now an FDA-approved drug, fospropofol disodium (Lusedra). 
  • Thorough understanding of the practical application of GMP to the manufacture of APIs and clinical dosage supply.  Expertise in the preparation and assembly of technology transfer packages for outsourced work, and demonstration of repeated success in the timely and efficient implementation and execution of chemical technology transferred to API and dosage form manufacturing vendors. 

​Stuart obtained a BS in biochemistry and a PhD in chemistry from the University of Illinois at Chicago, and was a postdoctoral fellow in the School of Medicine at the University of California, San Diego.

Please see my interview in the June issue of Lawyer Monthly, discussing expert witnessing in chemical and pharmaceutical development

www.lawyer-monthly.com/2024/06/chemical-and-pharmaceutical-expert-witness-stuart-g-levy-phd/

Please see my article in American Pharmaceutical Review May-June 2020 on the transition between drug discovery and drug development

www.americanpharmaceuticalreview.com/Featured-Articles/565508-Fluidity-Versus-Certainty-in-Early-Small-Molecule-CMC-Development/

Please see my article in American Pharmaceutical Review January-February 2020 on the role of API manufacturing within integrated CMC development

www.americanpharmaceuticalreview.com/Featured-Articles/561480-The-Role-of-Chemical-Development-and-Drug-Substance-Manufacturing-in-Early-Integrated-CMC-Development-at-Emerging-and-Virtual-Pharma/

Please see my article in American Pharmaceutical Review March 2019 on Form Selection in API Manufacturing

www.americanpharmaceuticalreview.com/Featured-Articles/359472-Form-Selection-in-API-Development-and-Manufacturing-In-the-Context-of-Phase-Appropriateness/

Please see my article in Pharmaceutical Outsourcing Jan-Feb 2017 on non-GMP material sourcing for API manufacturing

www.pharmoutsourcing.com/Featured-Articles/333766-Establishing-Successful-Non-GMP-Material-Supply-Chains-for-Outsourced-API-Development-and-Manufacturing-Evolution-of-a-Phase-Dependent-Strategy/

Please see my article in Pharmaceutical Outsourcing Jan-Feb 2016 on Technical Packages in API Development

http://www.pharmoutsourcing.com/Featured-Articles/182576-Technology-Transfer-Packages-for-Contract-Manufacturing-Iterations-During-the-Development-Cycle/


Please see my article in Pharmaceutical Outsourcing Jan-Feb 2015 on expediency vs. QbD in API manufacturing:

http://www.pharmoutsourcing.com/Featured-Articles/171807-Expediency-vs-QbD-Resolving-the-Conflict-in-Early-and-Mid-Stage-API-Development-for-Virtual-Pharmaceutical-Companies/

Please see my article in Pharmaceutical Outsourcing Jan-Feb 2014 on effective API vendor management for emerging, virtual pharmaceutical companies

http://www.pharmoutsourcing.com/Specialty/API/Featured-Articles/153810-Effective-Outsourcing-of-Small-Molecule-Chemistry-R-D-and-API-Manufacturing-for-Emerging-Pharmaceutical-Companies-A-Stepwise-Approach-to-Risk-Management/


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