Leveraging Global Healthcare Data for Real-World Insights and Evidence Generation

Xinxin (Katie) Zhu is Global Director of Real-World Evidence (RWE) at Boston Scientific and Adjunct Faculty in Cardiovascular Medicine at Yale University. She leads RWE initiatives to inform regulatory strategy, evidence generation, and healthcare value demonstration across diverse therapeutic areas. She serves on the Governance Committee of the National Evaluation System for health Technology (NEST). Her previous contributions include leadership and advisory roles with the NIH Bridge2AI Consortium, the Federal eHealth Exchange, the Agency for Healthcare Research and Quality, Yale University, Columbia University, and SUNY Downstate Health Sciences University. She previously served as Chief Medical Information Officer at Kforce Government Solutions and Macannie, Physician Scientist Lead at the IBM T.J. Watson Research Center, Associate Medical Director at Pfizer, and Clinical Manager at Philips. She is a co-inventor of 13 granted patents and co-editor of the Springer book Personal Health Informatics and the Elsevier book Digital Health. Dr. Zhu is a Fellow of the American College of Medical Informatics, the American Medical Informatics Association, and the International Academy of Health Sciences Informatics. She trained in anesthesiology before earning an M.S. in Computer Science from Rensselaer Polytechnic Institute and a Ph.D. in Biomedical Informatics from Columbia University through the NLM Informatics Fellowship.

Sean Lilienfeld, a board-certified neurologist, is Vice President of Corporate Global Clinical & Medical Affairs and Pre-Clinical Research. He also leads the corporate safety and clinical strategy teams. In these roles, he is responsible for driving efficiency and best practices in clinical and pre-clinical science, and medical affairs strategy across Boston Scientific and providing global leadership for the company’s evidence generation strategy. Sean has published extensively in the medical literature and has presented papers and abstracts at many US and international meetings. He is an inventor holding 10 patents. In his 30 year industry career, following 7 years as a practicing neurologist, he has been involved in successful NDAs, PMAs and IDEs in the fields of neurology, orthopedics, cardiology, endoscopy, urology and oncology and has always seen his role as that of the patient advocate inside industry.

Paul Coplan is the Vice President of Epidemiology and Real-World Data Sciences for Medical Devices at Johnson & Johnson. He leads a team of epidemiologists, data programmers, and biostatisticians, focusing on real-world evidence, postmarket surveillance, market access and medical device innovation. He also is the chair of the Governing Committee for the National Evaluation System for health technology (NEST). Dr. Coplan holds a Doctor of Science in Epidemiology and Biostatistics from Harvard School of Public Health, a Master’s in Public Health from the University of Massachusetts, Amherst, and an MBA from Wharton Business School at the University of Pennsylvania. He has played a pioneering role in using epidemiology and real-world data to develop new vaccines, medicines, and medical technologies, contributing to the development of 9 vaccines, including for cervical cancer, Covid-19, bacterial pneumonia, meningitis, shingles, and hepatitis, medications for HIV, cancer, and severe pain, and medical devices to treat atrial fibrillation, sutures, laproscopic surgery, hip and knee replacement, and trauma orthopedic devices. Additionally, he is a Fellow of the International Society for Pharmacoepidemiology and has served as an adjunct professor of Epidemiology at the University of Pennsylvania Perelman School of Medicine for over 22 years.

Steven E. Labkoff is a physician executive and clinical informatician with more than 30 years of experience using data, technology, and analytics to advance healthcare and life-sciences research. As Principal and Co-Founder of Luminant Consulting, he advises healthcare organizations, research institutions, and life-sciences companies on AI strategy, data architecture, real-world evidence, registry science, and clinical development innovation.

He is also a Collaborating Scientist in the Department of Biomedical Informatics at Beth Israel Deaconess Medical Center and Harvard Medical School. Previously, he served as Vice President of Development and Medical Affairs Analytics at Bristol Myers Squibb and held senior leadership roles at Pfizer, AstraZeneca, and other healthcare and life-sciences organizations. As Chief Data Officer of the Multiple Myeloma Research Foundation, he led development of CureCloud, a direct-to-patient platform integrating patient-generated, clinical, and genomic data.

Dr. Labkoff has taught at Harvard Business School and Yale School of Management and is a frequent speaker. He is a Fellow of the American College of Physicians, the American College of Medical Informatics, and the American Medical Informatics Association, and serves as an advisor and venture partner to Boston Millennia Partners. He also founded and co-hosts the podcast Practical AI in Healthcare.