Dr. Manish Sharma

Passionate & highly motivated researcher with more than 20 years of rich experience in the field of Clinical Research, Medical Imaging and Data Science, and proven track record for innovation, transformation, and intrapreneurship. Instrumental in launching new services, geographies, or products across each role utilizing diverse experience and expertise for an immediate positive impact on patient health and company growth.

MD with extensive expertise in implementation of existing trial methodologies and adept at collaboration with regulatory agencies discussing implementation of ‘new’ clinical trial designs. Pioneering work in imaging data analytics, metrics, and utilization of big data for reader performance and data driven expansion. Use of AI/ML techniques including deep learning in radiology and imaging through COVID (and other lesion) detection models, multi-variate confusion matrix for reader performance and predictive models using industry first uses cases. Development and deployment of PACS based Central Review System in record time more than a decade back for an immediate impact on company strategy leading to successful NDA submission.

Responsible for designing medical and regulatory strategy including IND, NDA, ANDA, 505(b)(2) submissions to various regulatory agencies including USFDA, EMA, MHRA, DCGI etc. Implemented global Biosimilar development & registration pathway including study design, regulatory advice, endpoint selection & protocol development resulting in some of the earliest biosimilar approvals.