FDA In Brief: Science Forum Highlights Regulatory Science Advancements in Protecting and Promoting Public Health

FDA in Brief

• For Immediate Release: May 18, 2021

The following quote is attributed to FDA Chief Scientist Rear Adm. Denise Hinton

“I am extremely proud of the hard work and dedication of our scientists, whose expertise and creativity enable us to develop the tools and resources to support the scientific developments that are shaping our world and making a profound impact on the lives of Americans.

Although the COVID-19 pandemic has underscored the significance of the FDA’s scientific activities and our collaborative efforts with our domestic and international stakeholders, this event is a reminder that the work of protecting and promoting public health goes on every day, in every area we regulate.

As part of this work, we conduct regulatory science research, which is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of certain FDA-regulated products. Our research enables the agency to understand and assess risk, prepare for and respond to public health emergencies, and help ensure the safety of products used by patients.”

Additional Information

• The 2021 FDA Science Forum, Science as the Foundation for Protecting and Promoting Public Health, is a unique opportunity for stakeholders to engage with and learn directly from FDA experts about a variety of cutting-edge research topics that are at the forefront of public health. The event will take place virtually on May 26 from 9 a.m. – 3:30 p.m. and May 27 from 9 a.m. – 2 p.m.
• The event is hosted biannually by the FDA’s Office of the Chief Scientist, which provides strategic leadership and support for the FDA’s regulatory science and innovation initiatives through cross-agency coordination and collaboration. It will showcase the collaborative efforts of the more than 11,000 scientists at the FDA as well as invited nationally renowned scientists, including Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases.
• Key topic areas that FDA scientists and external presenters will discuss include:
  • Improving Clinical and Postmarket Evaluation: Use of real-world evidence, complex innovative trial design, modeling-informed product development, product safety surveillance and digital health.
  • Tools to Effectively Use Big Data: Use of artificial intelligence and big data.
  • Empowering Patients and Consumers: Studies of stakeholder understanding of and interaction with labels, advertising, products, education and campaigns.
  • Product Development and Manufacturing: Examining biomarkers, novel technologies (e.g., alternative methods for toxicity assessment), and advanced manufacturing (a collective term for medical product development and manufacturing that incorporates technology or established techniques using innovative methods with the potential to improve medical product quality, address product shortages and speed time-to-market).
  • Advancing Products Based on Novel Technologies: Regenerative medicine, individualized and precision medicine and examination of the microbiome/microbiota. There is extensive data-based evidence that human, animal and environmental microbiota play significant and varied roles in states of health and disease.
  • Medical Countermeasures, Infectious Disease, and Pathogen Reduction Technologies: Research on medical countermeasures and technologies to support pathogen reduction of FDA-regulated medical products. This topic also includes the use of innovative technologies to reduce pathogen contamination and reduce or eliminate pathogens from FDA-regulated medical products to prevent transmission of infectious disease through their use.
  • Food and Cosmetic Safety: Continuous surveillance of the human and animal food supply for ongoing and emerging threats, development of methods for threat detection and quantitation, deployment of those methods to domestic and global partners, predictive toxicology and risk assessment, and strategic analysis of large amounts of data from numerous sources. Communication of these results and activities is vital to informing the public of the safety of the human and animal food supply.
  • Substance Use, Misuse, and Addiction: This topic will explore substance use and use disorders due to controlled substances, including prescription opioids, benzodiazepines and stimulants. Some common measures important in determining the abuse liability of a product can include pharmacokinetics, patterns of use and the subjective effects of that product.