Real-World Data (RWD) and Evidence Generation in Medical Product Development: Past, Present, and Future

View the full presentation here

Seminar on Real-World Data (RWD) and Evidence Generation in Medical Product Development: Past, Present, and Future

On December 2, 2024, we had the honor of co-hosting a landmark seminar focused on the evolving role of real-world data (RWD) and real-world evidence (RWE) in medical product development. This event was initiated by the Israel Ministry of Health and organized in collaboration with the Therapeutics Development and Regulatory Science program at Tel Aviv University’s Faculty of Health and Medical Sciences and the Ministry of Health's Medical Technology, Health Information, Innovation and Research Directorate.

As medicine and regulatory science advance, RWD—sourced from electronic health records, insurance claims, and patient registries—has become a transformative force in clinical trials, drug development, and patient care. This seminar provided a critical platform for regulators, academics, and industry experts to discuss the past, present, and future of evidence generation in drug development.

Key Speakers and Participants:
We were privileged to host leading experts, including:
Dr. John Concato, Dr. Marie Bradley, Dr. Leonard Sacks, and Mr. Phil Budashewitz from the U.S. FDA’s Office of Medical Policy (OMP) at CDER.
Prof. Shlomo Berliner, Prof. Ronen Loebstein, Prof. Amos Catz, and Prof. Ran Balicer—renowned Israeli clinicians and regulatory science experts.
Roy Cohen, Hadas Eshel-Geva, and Liat Nadai-Arad—data experts from Israeli hospitals and the Ministry of Health, alongside Dr. Osnat Luxenburg, Director, and Dr. Catherine Ela and Dr. Anat Boehm-Cagan of the Israeli Medical Technology Directorate.

Discussions highlighted:
The global challenges and opportunities in integrating RWD into clinical trials and regulatory frameworks.
The critical role of international collaboration in ensuring the successful implementation of RWD in future research.
The balance between scientific innovation and regulatory oversight to enhance clinical study quality while safeguarding patient safety.

This seminar underscored the potential of RWD and RWE to shape the future of medical product development, improve patient outcomes, and drive healthcare innovation.

As the journey continues, we look forward to further collaborations and knowledge-sharing to advance regulatory science and evidence generation.

—
Dr. Michal Roll & Prof. Noam Shomron
Co-Chairs, Regulatory Science MSc Program
Faculty of Health and Medical Sciences, Tel Aviv University