Transforming Health: Innovation in FDA Science

September 11, 2019 - September 12, 2019

The 2019 U.S. Food and Drug Administration (FDA) Science Forum offers an exciting opportunity to see first hand how FDA's researchers are using novel science and technologies to inform FDA’s regulatory decision-making—and drive innovation. FDA’s Science Forum welcomes the public, industry, academia, patient advocates, sister agencies, and current and potential collaborators, to learn about the Agency’s regulatory science—the type of science that is rarely undertaken by industry or academia, but that makes critical contributions to product quality and safety. National Institutes of Health Director Dr. Francis Collins will give the keynote address.

Forum topic areas include: 

  1. Precision Health: Research exploring topics that may enable precision health for individuals and special populations such as sex differences, the microbiome, personalized modeling, genetics, computational modeling, and in vitro/in vivo assessment of an individual’s susceptibility to toxicity or efficacy.

  2. Advanced Technology: Advanced technologies like 3D printing and nanomaterials; the methods, tools, materials, and products used either to make or evaluate products FDA regulates.   
  3. Product Accessibility, Integrity, and Security: Theory, modeling, methodology, product development, availability, usefulness, cybersecurity, product shortages, and terrorism.
  4. Predictive Tools: In vitro/in vivo assays and computational modeling that can offer links between such assays and human responses, tools that predict population-level responses from smaller datasets, and identifying biomarkers and tools that predict toxicity and efficacy of FDA-regulated products in humans and animals.
  5. Advancing Digital Health and Artificial Intelligence: Using computers for modeling and simulation of phenomena relevant to FDA’s mission, e.g. analyzing large data sets; collecting and assessing real-world evidence, including understanding and harnessing artificial intelligence and evaluating digital health devices.
  6. Outbreak! FDA’s approach to prevention and response, including prevention through cybersecurity and promoting medical product and food security, and rapid response to infectious disease and foodborne pathogen outbreaks, e.g. the use of the animal rule, emergency communication devices, rapid diagnostic tests, anti-microbial resistance.
  7. Addiction: Neurobiology, treatment using opioids, cannabinoids, nicotine, and other addictive compounds; including chemistry, biology, user behavior and exposure, social science and marketing, modeling, and prescribing behavior.
  8. Empowering Consumers, Patients, and Other Stakeholders: Studies of stakeholder understanding of and interaction with labels, advertising, products, education, and campaigns. Includes campaign development and effectiveness, outreach, and other activities and the science of patient input.
Dr. Francis Collins

Dr. Francis S. Collins, is the 16th Director of the National Institutes of Health (NIH). Dr. Collins is a physician-geneticist noted for his landmark discoveries of disease genes and his leadership of the international Human Genome Project, which culminated in April 2003 with the completion of a finished sequence of the human DNA instruction book. He served as director of the National Human Genome Research Institute at NIH from 1993-2008. Before coming to NIH, Dr. Collins was a Howard Hughes Medical Institute investigator at the University of Michigan. He is an elected member of the National Academy of Medicine and the National Academy of Sciences, was awarded the Presidential Medal of Freedom in November 2007, and received the National Medal of Science in 2009.

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