Ravisekhar Kasibhatta, Vice President, Clinical Research of Lupin Pharmaceuticals, India. A Professional in Clinical Research having in-depth knowledge of Clinical, bioanalytical, Pharmacokinetic & pharmacodynamics of pharmaceutical domain. Good understanding skills to do In-vitro BE studies, IVIVC & Biopharmaceutics and have analytical and problem-solving skills, focussed approach, adaptive to the changing environment and progressive attitude with strong result orientation & timely deliverable.Active team player of senior management in strategizing the business of outsourcing Clinical Trial / medical research business for Generic product program in various therapeutic areas. A fair working knowledge on Generic Clinical trial for Derma, Ophthalmic, Respiratory products for conducting clinical endpoint studies. A good understanding & skills to conduct PK / PD studies for Biosimilarprogram.Expertise in setting up CROs, Bioanalytical & Clinical laboratories meeting the ISO standards, GCP/GLP compliance & other applicable international quality / regulatory standards. Well versed with latest analytical instruments like LC-MS/MS systems employed in analysis of BA/BE study samples using SPE, LLE, Derivatization techniques & ELISA Techniques etc.
Baxter Healthcare APAC Region
Vice President, Medical Regulatory & Clinical