Wetzel Chemistry Consulting, LLC

Chemistry Leadership for Drug Discovery and Development

 

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Recent client comments

 

"At Neovia Oncology we have relied on Wetzel Chemistry Consulting for several years. Neovia uses a hub-based business model, which requires all of our functions to be managed by consultant experts without oversight. This means they must be both diligent and insightful. We have retained Wetzel Chemistry Consulting every year because they show in their performance that they care as much for our success as we do. In fact, this year we faced a potentially serious drug stability issue that Wetzel Chemistry Consulting investigated and resolved without cost or delays to us. Since 2013 Wetzel Chemistry Consulting has provided the following services:

  • Managed CMC activities for clinical candidate

  • Confirmed the chemical structure of clinical candidate by 2D NMR

  • Wrote CMC sections for IND and addressed all CMC-related agency concerns, resulting in Study May Proceed letter from FDA in Jan 2016

  • Managed manufacturing campaign for 3 new lots of drug product

I am happy to provide references for Wetzel Chemistry Consulting."

 

Trevor Blake, Founder & CEO, Neovia Oncology

email: tblake[at]neoviaoncology[dot]com

 


 

"BioMimetix JV, LLC, is a biotech firm that was formed in 2013 to move a new class of compounds out of academic discovery to pharmaceutical development and ultimately to commercialization. In the past four years, we have taken two lead compounds through scale-up chemistry to cGMP products and have launched four clinical trials (both topical for dermatology and injectable for cancer therapy). Two of those trials are now in Phase 2.

 

Dr. John Wetzel has managed all CMC activity for this program, which includes:

  • Process optimization for scale-up chemistry,

  • Manufacture of >1 kg of API under cGMP for both lead compounds,

  • Development of analytic methods,

  • Development and manufacture of a single dose injectable drug product and 2 different topical drug products,

  • Detailed characterization of API solid forms to overcome hygroscopicity-related analytical challenges,

  • Identification and qualification of API impurities,

  • API and drug product stability analysis.

Dr. Wetzel also wrote the CMC sections for our four INDs and satisfactorily addressed all agency CMC concerns.

 

Dr. Wetzel’s management of our CMC program has been outstanding and is a major reason why BioMimetix has moved so quickly through to multiple clinical trials. He has been prompt, thorough and accurate in defining, implementing and monitoring all of our CMC processes.  This included implementing and monitoring contracts with multiple vendors to conduct chemistry, manufacture of both API and drug products, and carry out stability testing.

 

Dr. Wetzel has my highest recommendation. He is extremely knowledgeable in all aspects of CMC, easy to work with and extremely effective in meeting all project goals and timelines."

 

James D. Crapo, MD, Manager, BioMimetix JV, LLC

 


"I have known and worked with Dr. Wetzel for more than 15 years, as a consultant for his previous employer when we were working on teams to develop drugs, and for more than a decade, with John serving as a consultant to a number of Gad Consulting Services' clients and directly to Gad on a number of projects for our clients.

John is a highly talented and hardworking pharmaceutical chemist, with both broad knowledge and skills and the ability to learn and master new skills when necessary for solving problems and completing projects brought to him by employers and clients. His projects successfully supported during this time were in both the drug discovery and drug development areas.

In Drug Development:

  • Chemistry, Manufacturing and Controls (CMC) documents were provided in support of >10 Investigational New Drug Application (IND), New Drug Application (NDA) and postapproval filings
  • Chemistry concerns raised by regulatory agencies were successfully addressed
  • Two drugs received U.S. marketing approval
  • Active pharmaceutical ingredients (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 druglike 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 addition, John has repeatedly solved minor issues that could prevent or delay the progress of a project. His help in such matters has been invaluable.

I and Gad Consulting Services and a number of our clients depend on Dr. Wetzel as our go-to for small molecule CMC issues of all flavors, and in more than a decade he has not let us down. I recommend him without reservation."

Shayne C. Gad, Ph.D., DABT - Principal, Gad Consulting Services

contact:  www.gadconsulting.com

 


 

For additional client comments, please see https://www.linkedin.com/in/johnwetzel/

 


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