Kevin Warner Email & Phone Number

Salt Lake City, UT

Orange County, California Area

• Led three cross-functional CMC teams covering all aspects related to formulation and manufacturing process development to support commercial development of topical products.
• Managed a dermal formulation development group
• Developed topical dermatology formulations including: suspension gel, fixed-dose combination formulations, creams, foam and solid lipid suspensions.
• Developed manufacturing processes for dermal formulations and conducted technology transfer to manufacturing sites (clinical manufacturing and commercial manufacturing sites).
• Identified creative strategies and conducted studies to address technical issues during product development (e.g., formulation issues encompassing chemical and/or physical stability, and process development challenges)
• Manage third part CROs and CMOs (from formulation development to commercial manufacturing process) to deliver on project objectives on time and on budget.

• Provide scientific leadership to R&D department responsible for developing novel dermal and transdermal formulations intended for clinical trials.
• Led cross functional CMC teams responsible for all aspects of dosage form development up to pilot scale GMP production.
• Worked collaboratively with business development, and KOLs to identify and drive product development opportunities that align with Company’s strategic interests.
• Conducted due diligence for potential in license opportunities.
• Authored CMC section for INDs.

• Developed 2 novel topical formulations utilizing DuraPeel technology and manufacturing process to support phase 1/2 clinical studies.
• Developed transdermal matrix patch to support phase 2 clinical study.
• Co-inventor of DuraPeel, a novel dermal drug delivery platform.
• Helped build and grow new R&D organization with respect to talent and processes.
• Managed CRO activities related to formulation and packaging development.
• Presented company technology in support of potential out-license opportunities.

• Led cross functional CMC team in activities related to formulation, method development, and process development of a transdermal product.
• Led group of scientists responsible for product formulation development of topical and transdermal dosage forms.
• Designed and conducted research to develop formulations utilizing DuraPeel technology (a novel topical drug delivery platform).
• Authored CMC section for INDs.

• Designed and established R&D laboratory space for analytical method and formulation development activities.
• Developed transdermal matrix patch formulations for evaluation in phase 1 studies. Enabled systemic delivery of drugs with poor solubility and permeability.
• Developed HPLC assay and related substance analytical method to evaluate stability of lead formulations.
• Conducted in vitro skin permeability experiments and utilized results to optimize drug delivery profile of topical and transdermal formulations.
• Applied in depth knowledge of basic science principles (emulsion properties, solubility and distribution phenomena, rheology, etc) to design experiments and contribute to development of DuraPeel a novel topical drug.

Ph.D., Pharmaceutics And Pharmaceutical Chemistry

Bs, Chemistry