, PhD, is Director of Enterprise Architecture in the Pharma R&D IM organization at Johnson & Johnson Pharmaceutical Research and Development. In this role, he leads a group responsible for developing Architecture for strategic IM investments across Pharma R&D. 

Prior to joining Information Management, Somesh was responsible for rolling out EDC (electronic data capture) processes globally as head of the eTrials group within Clinical Operations.  

Over the past few years, Somesh has played a leadership role in the strategic development of innovative clinical processes and platforms aimed at improving R&D productivity and efficiency. These include the implementation of a global clinical trials management system (CTMS), a clinical data warehousing/data mining initiative to support proactive safety surveillance, a global clinical trials registry designed for public disclosure of trials, and a new platform for managing health care compliance (HCC).  

Recently, he has been active in exploring ways to leverage emerging health care IT platforms including electronic medical records (EMRs) to drive evidence-based Medicine (EMB), personalized medicine, and new knowledge discovery (KD) for the improvement of clinical trials, drug safety, and outcomes research. 

 Somesh holds a Masters and PhD in Biochemical Engineering from the University of Michigan and an undergraduate degree in Engineering from Indian Institute of Technology. His early career involved the development of large-scale cGMP processes for manufacturing genetically engineered drugs and biologics, including a number of growth factors, monoclonal antibodies, and vaccines. His interests gradually shifted toward clinical operations and informatics as he recognized that inefficiencies inherent in traditional clinical trial processes were playing a key role in declining pharmaceutical R&D productivity. The "engineer" in him was convinced that an informatics-enabled integrative approach utilizing data emerging from preclinical, clinical, and postmarketing realms in concert with advanced analytics, modeling, and simulation techniques was the key to turning around this situation.  

Somesh is a frequent speaker at forums sponsored by organizations such as DIA, CDISC, PhRMA, and Clinical Trials Congress. He serves on the Advisory Board for the Department of Chemical Engineering at the University of Michigan and lectures on eClinical technologies in a graduate-level course conducted by the University's Pharmaceutical Engineering Department.  

He lives with his wife Shefalika and two children, Vishan and Ruhani, in Princeton, New Jersey.  

 PhD, Johnson & Johnson Pharmaceutical Research and Development

News

Applied Clinical Trials-11-01-2006

ACT would like to welcome Somesh Nigam to our Editorial Advisory Board and introduce him to our readers.