Personal Statement:
John M. Wetzel, Ph.D. has served full time as Principal of Wetzel Chemistry Consulting, LLC since 2006. For clients engaged in drug development, he has managed synthetic route scouting, process optimization, analytical method development/qualification, structure elucidation, impurity qualification, salt screening, polymorph characterization, and API manufacturing under cGMP. He has managed the development and manufacturing of parenteral, dermal and oral clinical trial materials. He has authored Chemistry, Manufacturing and Controls (CMC) documents in support of >15 Investigational New Drug Application (IND), New Drug Application (NDA) and post-approval filings. These filings resulted in two drugs receiving U.S. marketing approval, and several more entering Phase 1 and Phase 2 clinical trials. He is currently Director of Chemistry, Manufacturing and Controls for BioMimetix JV, LLC and South Rampart Pharma, Inc. His achievements on behalf of clients engaged in anticancer, immunomodulatory, antibacterial and antiviral drug discovery include prioritizing chemical series; elucidating binding modes, structure-activity relationships and off-target binding sites; designing lead optimization strategies; identifying new compounds with improved target selectivity; and helping to obtain patent claims. He provided trial and deposition testimony in the pharmaceutical Hatch-Waxman litigation case, Hospira v Sandoz, District of New Jersey.
Prior to becoming an independent consultant, Dr. Wetzel was Director, Chemistry Support Services at Lundbeck Research USA, where he led project teams for MCH1 antagonist discovery and Chemistry Technology Platform development. As Director, Department of Chemistry at Synaptic Pharmaceutical Corporation, he led a 40-member team in the discovery and clinical development of drug candidates targeting G-protein coupled receptors for indications that included pain, mood disorders, obesity, and urinary disorders. Discoveries made under his supervision included the first subtype-selective alpha-1a adrenoceptor antagonist, SNAP 5089, and tool compounds selective for the alpha-1d adrenoceptor. He managed the CMC efforts for preclinical and clinical development of a novel anti-depressant, including chemical process development, GMP-compliant synthesis, GLP-compliant analysis and bioanalysis, and formulation, and authoring of the CMC sections of the IND.
He is an inventor on 21 issued US patents and co-author of 26 peer-reviewed publications.