Career Highlight
- Has overseen multi-kilogram API manufacturing campaigns with as many as 18 steps, as well as the development and manufacturing of parenteral, dermal, and oral clinical trial materials
- Author of CMC documents in support of >10 investigational new drug applications (INDs), new drug applications (NDAs), and post-approval filings, resulting in 2 FDA approvals and multiple phase 1 and phase 2 trials
- Co-inventor of 21 issued US patents related to drug discovery, and co-author of 26 peer-reviewed publications
- B.S., Chemistry (Ohio University), Ph.D., Chemistry (The Johns Hopkins University), Post-doc Training (Suntory Institute for Bioorganic Research in Osaka, Japan)
Background Experience
John Wetzel, Ph.D., is the Director of Chemistry, Manufacturing & Controls (CMC) at South Rampart Pharma,Inc.. Dr. Wetzel brings extensive industry experience in CMC of new chemical entities. He has overseen multi-kilogram API manufacturing campaigns having as many as 18 steps, and the development and manufacturing of parenteral, dermal, and oral clinical trial materials. To date, he has authored the CMC documents in support of more than ten Investigational New Drug Application (IND), New Drug Application (NDA), and post-approval filings. These filings resulted in two drugs receiving U.S. marketing approval and several more entering Phase 1 and Phase 2 clinical trials.
Dr. Wetzel’s extensive expertise in CMC activities has positioned SRP-3D (DA) for the upcoming Phase 1 clinical trial. Dr. Wetzel’s work on drug development includes managing synthetic route scouting, process optimization, analytical method development/qualification, structure elucidation, impurity qualification, polymorph characterization, API manufacturing, drug product formulation and manufacturing, and stability studies. He has provided chemistry input to small molecule development programs targeting immunomodulation, cancer, pain, headache and CNS disorders. He is a co-inventor of 21 issued US patents related to drug discovery, and co-author of 26 peer-reviewed publications. Dr. Wetzel earned a B.S. in Chemistry (Ohio University) and Ph.D. in Chemistry (The Johns Hopkins University), followed by post-doctoral training at the Suntory Institute for Bioorganic Research in Osaka, Japan.
