Prit Lakhani

Principal Scientist @Bristol Myers Squibb

Work with internal and external partners in a highly collaborative environment to successfully advance drug product development programs from early candidate nomination to commercial technology transfer. Accountable for designing, developing, and scale-up oral dosage forms to support preclinical toxicology studies and clinical studies (Phase Assess physicochemical, biopharmaceutical, formulation, and process risks of new drug candidates that are critical for design & selection of API & oral dosage forms. Design and execute risk mitigation strategies using formulation and process technologies that would enable robust and efficient drug product development. Experience with Mini-piloting tools for formulation scale-up. Author technical reports and documentation to support regulatory filings. Biopharmaceutics lead on project matrix to identify various biopharmaceutics related risk for the drug product, such as food effect, pH effect and employ mitigation strategies with drug product development team- Perform, develop, and validate in vitro characterizations— such as pH effect and food effect— using various novel strategies and technologies to assess Bio-pharmaceutics Risks for immediate release as well as controlled release oral formulations- Develop PBPK gastroplus models for biopharmaceutics risk assessments for robust drug product development. Strategic Innovation Lead on project matrix teams: Gain deep understanding of our customers to develop value-based customer centric products through strategic innovation.