Paul Coplan, ScD, MBA, is vice president and head of Medical Device 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 successful FDA approval of 8 pediatric and 1 adult vaccine and 9 drugs over the past 24 years in pharmaceutical and biologic drugs, vaccines and medical device research. He has published over 70 peer-reviewed journal articles and over 400 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 has led or participated in pre-competitive initiatives for collaboration between companies, regulators and academics in creating benefit-risk frameworks for medical product evaluations, assessing the safety of antiretroviral cocktail therapies for HIV, establishing methods for safety surveillance of vaccines using real-world evidence, establishing clinical trial infrastructure in Africa and Southeast Asia for HIV vaccine and microbicide trials, establishing regulatory pathways for approval of treatments of infectious diseases in developing countries, building and evaluating Risk Evaluation and Mitigation Strategies (REMS) to train healthcare providers on safer opioid prescribing, and establishing methods for evaluating postmarket effectiveness of opioids intended to reduce opioid overdose and abuse.