ACT would like to welcome Somesh Nigam to our Editorial Advisory Board and introduce him to our readers.
Somesh Nigam, 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.
Somesh Nigam, PhD
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.
Somesh Nigam, PhD, Johnson & Johnson Pharmaceutical Research and Development
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
November 20th 2024Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.