John Wetzel Email & Phone Number

How clients have benefited:In Drug Development:Novel active pharmaceutical ingredient (API) manufacturing processes were developedAPI and impurity structures were elucidated and impurities qualifiedAPI polymorphs were characterizedAnalytical and bioanalytical methods were developed and validatedNovel oral, dermal and parenteral formulations were developedAPIs and drug products were manufactured under cGMP, enabling clinical trialsChemistry, Manufacturing and Controls (CMC) documents were provided in support of >15 Investigational New Drug Application (IND), New Drug Application (NDA) and post-approval filings Two drugs received U.S. marketing approval Process and formulation patent applications were filed on behalf of clientsIn Drug Discovery:Several chemical series were prioritized according to their potential to yield drug-like leads for an anti-cancer targetThe binding mode, structure-activity relationships and likely sites of off-target binding were elucidated for two leading chemical seriesPredicted off-target binding was experimentally verified for several key cross-reactivity sitesTesting strategies were designed and implemented for efficient prioritization of new compounds and minimization of off-target interactionsNew analogs with improved selectivity for the desired target were identifiedPatent applications were carefully written, Examiner concerns were addressed and patents were issuedIn Litigation:Trial and deposition testimony was provided on behalf of defendant in the Hatch-Waxman Act litigation case, Hospira v Sandoz, District of New Jersey For more information, please visit http://www.wetzelconsulting.com.

Greenwood Village, Colorado, Us

Athens, Ohio, Us

Valby, Copenhagen, Dk

Led project teams for MCH1 antagonist discovery and Chemistry Technology Platform development.Co-led the selection of an automated storage / retrieval strategy for the Lundbeck screening collection worldwide.

Managed 40 FTEs, including Medicinal, Computational, Analytical and Bioanalytical Chemists.Managed the outsourcing of Chemistry, Manufacturing and Controls (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. Contributed CMC section to IND filing and annual update.Designed and synthesized alpha-1a adrenoceptor antagonists for treatment of benign prostatic hyperplasia.Discovered the first subtype-selective alpha-1a antagonist, SNAP 5089.Discovered highly selective alpha-1d adrenoceptor antagonists exemplified by SNAP 8493.Designed and implemented a novel strategy for the efficient characterization, purification and formatting of combinatorial libraries culminating in neat solid archive samples.Developed a novel LCMS-guided HPLC purification strategy for library purification.Conducted numerous HPLC separations, including enantioselective separations and high-throughput library purifications, on milligram and gram scales.Procured and maintained NMR, LCMS, HPLC and other instruments.

Explored the chemical relationship between the brown planthopper (Nilaparvata lugens) and its intracellular yeast-like symbiote through deuterium labeling and GCMS techniques.Advisors: Prof. Koji Nakanishi and Dr. Yoko Naya.

Phd, Chemistry

Bs, Chemistry