Infectious diseases physician with extensive track record of successfully developing biopharmaceutical products across multiple modalities in privately and publicly funded small biotech and large global pharmaceutical companies. Built and led multi-functional and multi-national R&D teams to create and implement development and registration strategies leading to approval and commercialization of numerous products in US, Europe, Japan and other countries worldwide including Maviret, Viekirax, Technivie, Sovraid and Doribax. Proficient in all aspects of drug development from investigational new drug (IND) through new drug application (NDA/MAA) submissions and approvals, including project team leadership, strategic global development planning and implementation, regulatory interactions, FDA advisory committee presentation, and hands-on Phase 1-4 clinical protocol development and execution. Extensive experience developing intravenous, oral and inhaled antibiotics, antivirals, monoclonal antibodies and vaccines.
Specialty : Pediatric infectious diseases
FPIDS Member