Kevin Ruff

Sr. Director of Research & Development

Kevin’s career spans much of the pharmaceutical development cycle - from mechanism of action studies through clinical trials. Kevin has worked in R&D researching small to medium scale processes for manufacturing early phase clinical active ingredients. He has also worked in process development for large-scale manufacturing of later phase clinical active ingredients. Kevin has been involved in the commercialization (pre-validation, validation, etc.) of a number of API manufacturing processes. He has designed numerous in-vitro and in-vivo studies to investigate the mechanism of action of substances. Kevin has designed toxicological/safety studies and bioavailability studies in preparation for registrations. He has been involved in the design and conduct of numerous clinical trials, primarily dealing with rheumatologic conditions. Kevin spent some time early in his career at the FDA reviewing the analytical portion of New Drug Applications. He has also successfully obtained international approvals for the import and registration of both ingredients and finished dosage forms throughout a wide variety of geographies (Europe, Asia, South America, etc.).