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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:
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Managed CMC activities for clinical candidate
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Confirmed the chemical structure of clinical
candidate by 2D NMR
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Wrote CMC sections for IND and addressed all
CMC-related agency concerns, resulting in Study May
Proceed letter from FDA in Jan 2016
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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:
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Process optimization for scale-up chemistry,
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Manufacture of >1 kg of API under cGMP for both
lead compounds,
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Development of analytic methods,
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Development and manufacture of a single dose
injectable drug product and 2 different topical
drug products,
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Detailed characterization of API solid forms to
overcome hygroscopicity-related analytical
challenges,
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Identification and qualification of API
impurities,
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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:
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Chemistry, Manufacturing and Controls (CMC)
documents were provided in support of >10
Investigational New Drug Application (IND), New
Drug Application (NDA) and postapproval filings
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Chemistry concerns raised by regulatory agencies
were successfully addressed
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Two drugs received U.S. marketing approval
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Active pharmaceutical ingredients (APIs) and
drug products were manufactured under cGMP,
enabling clinical trials
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Technical challenges were solved in API
synthesis
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API manufacturing costs were reduced
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Toxic and environmentally hazardous chemistry
was eliminated from an API synthetic process
In Drug Discovery:
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Several chemical series were prioritized
according to their potential to yield druglike
leads for an anti-cancer target
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The binding mode, structure-activity
relationships and likely sites of off-target
binding were elucidated for two leading chemical
series
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Predicted off-target binding was experimentally
verified for several key cross-reactivity sites
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Testing strategies were designed and implemented
for efficient prioritization of new compounds
and minimization of off-target interactions
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New analogs with improved selectivity for the
desired target were identified
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Patent applications were carefully written
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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/
To learn about our other service offerings, click
here.
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