The 3rd Forum on Regulatory Science and Biomedical Innovations

The 3rd Forum on Regulatory Science and Biomedical Innovations was successfully held on June 7-8th, 2019, at the Stanford Center at Peking University.

Initiated and organized by the Stanford Center for Innovative Study Design. The focus of this year’s forum is on the Real-World Evidence in Biomedical Product Development and Regulatory Science. About 150 international and Chinese scholars and researchers, US and Chinese regulators, and pharma/biotech leaders attended the event.

Over the last decade, significant strides have been made in medical research, which leads to great improvement in human health. With increasing availability of real-world data (RWD), such as electronic health and medical records and mobile health data, and rapidly evolving analytic techniques to generate real-world evidence (RWE) from the RWD, there are vast research interests in academia, industry, and regulatory agencies on how to use the RWE to inform regulatory decision and to assess the potential benefits and/or risks of medical products. On May 8, 2019, the US FDA published the draft guidance for industry on “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.” On May 29, 2019, the Chinese National Medical Product Administration (NMPA) published their call for comments on the draft guidance on “Basic Considerations for Using Real-World Evidence to Support Drug Development.” Our forum was timely organized to discuss the challenges and research opportunities on the topic.

Three keynote speakers were invited, representing academia, government, and industry. Our first keynote speaker was Professor Ping-yan Chen, Chair of the Department of Biostatistics, Southern Medical University, Guangzhou, China. Professor Chen chaired development committee of tri-parties (Chinese academia, industry, and NMPA) for the Chinese draft of the guidance on RWE published on May 29, 2019. Professor Chen provided unique perspectives of their committee work and explained the considerations recommended in the guidance document. The second keynote speaker, Dr. Jing Chen, was from the Chinese NMPA on the evaluation of generic medications in China. The 3rd keynote speaker was Dr. Donald Yin, Vice President and Head of Economic and Data Science at Merck. He shared with us the examples and insights on the use of real-world data and evidence in the pharmaceutical industry.

Two invited panel discussions on “The Challenges and Opportunities for Using RWE in Medical Produce Development and Regulatory Oversights” and “Statistical Evidence on Regulatory Decisions” were also well received.

In addition, there were six invited scientific sessions on topics from the use of historical control data in confirmative trials, challenges in regulatory evaluation of generic drugs, diagnosis test and prediction models, Use of RWE for regulatory decisions, big data and artificial intelligence in precision health, and from the real work data to real world evidence.

Several feedbacks commented that this was the highest quality academic event in recent years.

The event was co-sponsored by the Stanford Center at Peking University and Peking University Health Science Center. The event was funded in part by mProbe and Merck.