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John M. Wetzel, Ph.D.

Wetzel Chemistry Consulting, LLC

 

Member profile details

Photo
First name
John M.
Last name
Wetzel, Ph.D.
Organization
Wetzel Chemistry Consulting, LLC
 

Contact information

City
Albany
State or Province
Ohio
Zip Code
45710
Country
United States
Phone
(740) 698-0420
Phone (Alternate)
(201) 693-0031
 

Specialties and Services

Fields of Expertise
  • Analytical
  • Expert Witness
  • High Performance Liquid Chromatography
  • Literature and Patent Searches
  • Manufacturing
  • Medicinal Chemistry
  • Organic Chemistry
  • Patents
  • Pharmaceutical
  • Process Troubleshooting
  • Regulatory Affairs
  • Research and Development
  • Separations and Purification
  • Spectroscopy
  • Synthesis
Other Fields of Expertise
Chemistry, Manufacturing and Controls (CMC)
Services
Management of active pharmaceutical ingredient (API) and drug product manufacturing
Authoring of CMC regulatory documents
Chemistry support of patent prosecution
Litigation consulting
Due diligence
Compound design, synthesis and evaluation
Laboratory infrastructure design and implementation
 

Additional Information

Additional Info
How clients have benefited:

In Drug Development:

- CMC documents were provided in support of >10 Investigational New Drug Application (IND), New Drug Application (NDA), and postapproval change filings
- Chemistry concerns raised by regulatory agencies were successfully addressed
- Two drugs received U.S. marketing approval
- APIs and drug products were manufactured under cGMP, enabling clinical trials
- Technical challenges were solved in API synthesis
- API manufacturing costs were reduced
- Toxic and environmentally hazardous chemistry was eliminated from an API synthetic process

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

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

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.
Education
Ph.D., Chemistry, The Johns Hopkins University, Baltimore, MD, 1988.
B.S., Chemistry, Ohio University, Athens, OH, 1982.
Patents
Co-inventor on 21 U.S. Patents
Publications
Co-author of 25 peer-reviewed publications
Miscellaneous
Grants:

Principal Investigator for Phase I and Phase II SBIR Grants

Reviewerships:

Journal of Medicinal Chemistry
Journal of Combinatorial Chemistry

Technical Societies:

American Association of Pharmaceutical Scientists
American Chemical Society
Association of Consulting Chemists and Chemical Engineers
Regulatory Affairs Professionals Society


For detailed qualifications, please see: www.wetzelconsulting.com
The ideas, advice and positions expressed by individual members of the Chemical Consultants Network are the member's own and not the responsibility of CCN or its sponsors, the American Chemical Society and the American Institute of Chemical Engineers.

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