Dr. Sharma is Chief Scientific Officer and a passionate researcher with over 20 years of extensive experience in Clinical Research, Medical Imaging, and Data Science. As an MD, Dr. Sharma possesses extensive expertise in implementing clinical trials criteria including collaborating with regulatory agencies and sponsors customizing new clinical trial designs and criteria. He has made pioneering contributions in imaging data analytics, metrics, and the utilization of big data for reader performance and predictive risk-based models.
Dr. Sharma has been instrumental in designing medical and regulatory strategies for IND, NDA, ANDA, 505(b)(2) submissions to various regulatory agencies across the globe including USFDA, EMA, MHRA, NMPA and DCGI. He had successfully implemented Biosimilar development and registration pathway, encompassing study design, regulatory advice, endpoint selection, and protocol development resulting in some of the earliest biosimilar approvals globally. Dr. Sharma’s expertise and leadership have been invaluable in shaping medical and regulatory strategies to meet the highest standards and gain regulatory (incl accelerated) approval for breakthrough therapies.
Dr. Sharma had been instrumental in successfully launching new services, expanding into new geographies, and introducing innovative products that have had an immediate positive impact on patient health and company growth. Moreover, he played a crucial role in the development and rapid deployment of a PACS-based Central Review System, significantly impacting the company’s strategy leading to successful NDA submission. Dr. Sharma has also utilized AI/ML techniques, including deep learning, in radiology and imaging applications such as COVID (and other lesion) detection models, multi-variate confusion matrix for reader performance, and predictive models using industry-first use cases.
