Dr. Mukesh Kumar

Ex- SVP, Global Clinical R&D, – (Dr Reddys Lab, CIPLA)
Clinical Research Director, Global R&D, (Sanofi, Daiichi Sankyo)
Physician and clinical pharmacologist (MD) with ~ 25 years of experience in global clinical development
Experience- high quality ~200 clinical trials & 1000 BE studies, track record of NO 483 in ~ 80 inspections (FDA, EMA)
Solid track record of cost-effective global quality clinical development execution for generic & 505(b)(2) opportunities
Contributed in ~ 50 innovative and ~ 150 complex generic products: led clinical, pharmacology (PK-PD) and biopharmaceutic aspects including negotiations for generic and 505 (b)(2) clinical path
Successful design of clinical strategy and execution of multiple injectable, oral and respiratory complex generic and 505(b)(2)