The Epidemiology of Medical Devices and Surgical Procedures: Innovations and Opportunities
Paul Coplan, ScD, MBA, FISPE
VP, Head of Medical Device Epidemiology and Real World Data Sciences, Office of Chief Medical Officer and Medical Devices Companies, Adjunct Assistant Professor, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman, School of Medicine, Philadelphia, PA 19104
Paul is the Vice President of Epidemiology and Real-World Data Sciences for Medical Devices at Johnson and Johnson, leading a team of 30 epidemiologists, data programmers and health service researchers. Paul completed a Master’s in Public Health at the University of Massachusetts, Amherst, a Doctor of Science in Epidemiology and Biostatistics at Harvard School of Public Health, and an MBA at Wharton Business School at University of Pennsylvania.
Paul has been a pioneer in using epidemiology and real-world evidence to develop new vaccines, medicines and medical technology, to assess their safety and effectiveness after marketing, and in using real world evidence for market access and label expansion purposes. He has helped develop 9 widely used vaccines, 9 medicines and several medical devices. In addition, Paul has taught Epidemiology at University of Pennsylvania Perelman School of Medicine as an adjunct professor for the past 22 years. He has authored over 100 peer-reviewed scientific articles and 500 international medical conference presentations, conducted studies in 15 countries and has worked with the FDA, EMA, Chinese, Canadian and other national regulatory authorities.
Paul is a member of the National Evaluation System for Health Technology’s Data Quality Workgroup and the Medical Device Innovation Consortium Science of Patient Input Steering Committee. He 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, and opioid analgesics; establishing clinical trial infrastructure in Africa and Southeast Asia for HIV vaccine and microbicide trials; building and evaluating Risk Evaluation and Mitigation Strategies (REMS); and epidemiologic evaluation of cobalt-containing orthopedic implants.
Mary Beth Ritchey, PhD, MSPH, FISPE
Associate Research Professor, Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, Rutgers University
Associate Professor, Rutgers School of Public Health, Rutgers University