.jpg "Paul M. Coplan, ScD, MBA, FISPE photo")
VP, MedTech Epidemiology and Real-World Data Sciences
Office of the Chief Medical Officer, Johnson & Johnson
Paul Coplan, ScD, MBA, is vice president and head of MedTech Epidemiology and Real-World Data Sciences at Johnson and Johnson. Paul is involved in predictive analytics, finding solutions to lack of unique device identifier information in electronic health records, benefit-risk assessment, label extensions using real-world evidence, linking digital and wearable data with electronic medical record data, and building international database applications for medical devices. Paul has played a key role in the Phase 3 trials and postmarketing plan negotiations leading to successful FDA and EMA approval of 8 vaccines, 9 pharmaceutical products and 3 medical device products over the past 25 years in pharmaceutical and biologic drugs, vaccines and medical device research. He has authored or coauthored over 120 peer-reviewed journal articles and over 450 international conference abstracts/posters. He has conducted studies in 15 countries and established clinical trial centers in Africa and Southeast Asia for HIV vaccine and microbicide research. Paul is also an adjunct assistant professor in Epidemiology at the University of Pennsylvania Perelman School of Medicine. He has a Doctor of Science degree in Epidemiology and Biostatistics from Harvard University, an MBA from Wharton Business School at the University of Pennsylvania, a Master of Science in Public Health and Nutrition from the University of Massachusetts, a BS Honors in Biochemistry and Physiology and a Bachelors in Medical Sciences from the University of Witwatersrand.
Paul is a member of the National Evaluation System for Health Technology's Active Surveillance Workgroup and the Medical Device Innovation Consortium Science of Patient Input Steering Committee. Paul has led pre-competitive initiatives for collaboration between companies, regulators and academics in creating benefit-risk frameworks for medical product evaluations, assessing the safety of HIV medications, vaccines, opioid analgesics, and REMS.
