Experience:

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Wetzel Chemistry Consulting, LLC
Albany, OH,
2005-present, Principal

How Clients Benefited in Drug Development:

  • Novel active pharmaceutical ingredient (API) manufacturing processes were developed
  • API and impurity structures were elucidated and impurities qualified
  • API polymorphs were characterized
  • Analytical and bioanalytical methods were developed and validated
  • Novel oral, dermal and parenteral formulations were developed
  • APIs and drug products were manufactured under cGMP, enabling clinical trials
  • Chemistry, 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
  • New chemical entity, solid form, process and formulation patent applications were filed

How Clients Benefited in Drug Discovery:

  • Several chemical series were prioritized according to their potential to yield drug-like leads for an anti-cancer target
  • The binding mode, structure-activity relationships and likely sites of off-target binding were elucidated for two leading chemical series
  • Predicted off-target binding was experimentally verified for several key cross-reactivity sites
  • Testing strategies were designed and implemented for efficient prioritization of new compounds and minimization of off-target interactions
  • New analogs with improved selectivity for the desired target were identified
  • Patent applications were carefully written, Examiner concerns were addressed and patents were issued

How Clients Benefited in 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

BioMimetix JV, LLC, Greenwood Village, CO
2013 – present:
Director, Chemistry, Manufacturing & Controls

South Rampart Pharma, Inc., New Orleans, LA
2019 – present:
Director, Chemistry, Manufacturing & Controls

Ohio University, Athens, OH
2007 – 2009:
Visiting Assistant Professor, Department of Chemistry and Biochemistry

Lundbeck Research USA
Paramus, NJ.
2003-2005, Director, Chemistry Support Services

  • 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.

Synaptic Pharmaceutical Corporation
Paramus, NJ.
1990-2003, positions of increasing responsibility, culminating in Director, Department of Chemistry

  • 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.

Suntory Institute for Bioorganic Research
Osaka, Japan
1988-1990, Postdoctoral Fellow

  • Explored the chemical relationship between the brown planthopper (Nilaparvata lugens) and its intracellular yeast-like symbiote through deuterium labeling and GCMS techniques.