SGL Chemistry Consulting, LLC
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BiographyStuart 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.
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 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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