Washington, DC - The U.S. Food and Drug Administration is holding the 2019 FDA Science Forum, ”Transforming Health: Innovation in FDA Science,” on the agency’s White Oak campus on Sept. 11, 2019, from 8:30 a.m. - 4:45 p.m. and September 12, 2019, from 9 a.m. - 4 p.m. The two-day event will showcase the collaborative efforts of FDA’s scientists as well as nationally renowned scientists from outside the agency.

“Sound science, innovative research, and careful evaluation of data are at the heart of the FDA’s public health mission. The FDA is home to world-class scientists whose groundbreaking research provides new insights to inform our regulatory approach on topics ranging from digital health to pathogen outbreaks to addiction. Our agency is recognized as a public health authority around the world, thanks to the robust scientific expertise of our staff,” said FDA Acting Commissioner Ned Sharpless, M.D. “The FDA’s Science Forum is a unique opportunity for the public to engage with and learn directly from experts that are pioneering research in public health science and technology outside of the more formal regulatory process. There is a substantive exchange of knowledge and viewpoints among colleagues here at the FDA, and we are excited to have an opportunity to share that experience with our stakeholders. I’m particularly honored that Dr. Francis Collins, director of the National Institutes of Health, has agreed to join me as this year’s keynote speaker, highlighting again the importance of collaboration and partnership across public health agencies and the medical profession in advancing scientific innovation.”

Highlights from key topic areas include:

• Precision Health: Presenting a novel proposed regulatory framework for digital health, the potential for genomic biomarker use in cardiovascular disease trials, and research on sex differences during drug development.
• Advanced Technologies: The latest on methods, tools, materials, and products used either to make or evaluate products FDA regulates, such as genome editing or sequencing (in food safety), predictive tools for toxicity and efficacy, and modeling and simulation for medical devices.
• Product Accessibility, Integrity, and Security: Strategies for protecting the U.S. food system against attack; an advanced, risk-based method for screening imported food shipments for security and safety; strategies for preventing and mitigating biological product shortages.
• Advancing Digital Health and Artificial Intelligence: The potential impact of artificial intelligence in medical devices; using computers for modeling and simulation of phenomena relevant to the FDA’s mission, e.g. analyzing large data sets; collecting and assessing real-world evidence, such as understanding and harnessing artificial intelligence and evaluating digital health devices; using large datasets for predictive modeling of polypharmacy issues.
• Novel approaches to emerging disease threats or foodborne outbreaks:The FDA’s approach to preventing and responding to infectious disease and foodborne pathogen outbreaks, including the use of the animal rule, emergency communication devices, rapid diagnostic tests, anti-microbial resistance, and protecting people from emerging infectious disease threats.
• Addiction: Overview of drug abuse and addiction in the U.S.; chemical and in vivo strategies for determining potency and efficacy of novel synthetic opioids in the rat model; FDA assessment of the abuse potential of central nervous system-acting drugs; chemistry, biology, user behavior and exposure, social science and marketing, modeling, and prescribing behavior.

The FDA’s Office of the Chief Scientist provides strategic leadership and support for the agency’s regulatory science and innovation initiatives through cross-agency coordination and collaboration. As the host of the Science Forum, the office has drawn from agency-wide expertise to develop sessions that integrate knowledge and skills across FDA product centers, reflecting the collaborative nature of the agency’s mission and the unique role that regulatory science plays in transforming public health.