Is Real World Data Really Representative of the Real World? Addressing Biases in RWD

Is Real World Data Really Representative of the Real World? Addressing Biases in RWD MarchMar 07 2023 02:00pm - 03:15pm

March 7th, 2023 2-3:15 PM PT/ 5-6:15pm ET

In the cardiovascular disease state there are several digital health technologies and wearables to support patients. However, in cardiovascular clinical trials there are a disproportionate number of men who participate versus women, and when looking further into diversity into these trials, an even greater disparity among underrepresented populations.

The Evidence Development Subcommittee will  provide a panel to discuss the solutions addressing the challenges of RWD, how to navigate those challenges, and provide resources for the adequate use of RWD for cardiovascular disease.

  • Proliferation of RWD for medical technology on the market
  • How to objectively validate RWD and assess limitations from a lens of diversity and inclusivity
  • Address those challenges/limitations and how to mitigate them
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Jaime Wheeler, MBA, CPhT

Jaime Wheeler, MBA, CPhT is the Senior Vice President of Clinical Affairs for Transcatheter Heart Valves at Edwards Lifesciences. She has worked in both medical device and pharmaceutical research for over 25 years focusing on the strategy, design, and conduct of clinical research across various therapeutic areas including: Cardiology, Rheumatology, Pain Management, Peripheral Vascular/Embolic Protection and Structural Heart. She has managed multiple divisions and regions including an expatriate assignment in Tokyo, Japan. She was the Clinical lead on three successful Merger and Acquisition deals, the largest worth $1.5B. Ms. Wheeler holds two Bachelor of Science degrees, a Master of Business Administration degree, she was a prior Virginia State Emergency Medical Technician (EMT-B) and is a Certified Pharmacy Technician (CPhT). She currently sits on the AdvaMed Working Group for Women in Cardiovascular Device Trials, is a founding member of the MedTech Color Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research, and is an alumnae Board Member for OneOC in Santa Ana, California.

Jon C. George, MD, MBA

Dr. Jon C. George, MD completed his medical training at University of Cincinnati College of Medicine in Cincinnati, Ohio; Internal Medicine residency and Cardiovascular Disease fellowship training at University Hospitals Case Medical Center in Cleveland, Ohio; and Interventional Cardiology and Endovascular Medicine subspecialty fellowship training at Temple University Hospital in Philadelphia, Pennsylvania. He additionally procured his Masters in Business Administration at Temple University Fox School of Business in Philadelphia. He is presently an Interventional Cardiologist and Endovascular Medicine Specialist at Pennsylvania Hospital, University of Pennsylvania Health System in Philadelphia and the President and Chief Executive Officer of ReVascMedProfessionals, a comprehensive cardiovascular center in Philadelphia. He previously served as Director of the Cardiac Catheterization Laboratory and Director of Interventional Research at Einstein Medical Center in Philadelphia, Pennsylvania, and Clinical Professor of Medicine at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, Pennsylvania. He has published more than 100 papers in reputed journals, book chapters, and textbooks, and serves as a reviewer and editorial board member for multiple journals. He is also Editor of the top-selling Evidence-Based Guide to Interventional Cardiology and Endovascular Medicine. In addition, he has received numerous honors and awards for his contributions to research and clinical cardiology including Top Doc recognition in Philadelphia in several consecutive years.

Misti Malone, PHD

Misti Malone, PhD is the Assistant Director of the Peripheral Interventional Devices Team in the Office of Cardiovascular Devices in the Center for Devices and Radiological Health at FDA. Following completion of her doctorate in Biomedical Engineering, she joined FDA in 2012 as a lead reviewer for vascular surgery and peripheral interventional devices. As the Assistant Director, her primary responsibilities involve regulatory oversight of peripheral vascular devices across the total product life cycle, including submission review and supporting internal and external partnerships to bolster efficient device evaluation. She is actively involved in collaborations related to collection of global clinical evidence and real-world evidence to support clinical and regulatory decision-making as part of RAPID (a multi-stakeholder registry collaborative), the US-Japan Harmonization By Doing group promoting global regulatory solutions, and various other groups to support strategic priorities and FDA’s mission. She has authored several publications in various journals to share her group’s review perspectives.

Paul Coplan, ScD, MBA, MPH

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.

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