FDA Grand Rounds
The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.
Thursday, April 11, 2019
12:00 p.m. - 1:00 p.m. EST
Presented by
Richard A. Forshee, PhD
Associate Director for Research
Office of Biostatistics and Epidemiology
FDA's Center for Biologics Evaluation and Research
Webcast Lecture
Uncertainty is the only certainty there is: Potential approaches for making public health decisions
About the Presentation
In 2012, FDA's Center for Biologics Evaluation and Research (CBER) was reviewing a submission for the first home-use HIV test kit. Among the many important questions discussed were:
1. What is the sensitivity and specificity of the test?
2. Who was likely to use it?
3. Would people switch from professional testing to home-use testing?
4. Would early detection with test reduce HIV transmission?
Formal benefit-risk assessment was used to address these questions and the results of the analysis were presented to the Blood Products Advisory Committee.
Many significant public health decisions face such uncertainty and yet the decisions still must be made. We must frequently consider data and analyses from disparate sources, including randomized clinical trials, large observational studies, reported international experience, passive surveillance, case studies, and animal studies when deciding on product approval or regulatory policy. Formal benefit-risk assessment approaches can help decision-makers understand how the key sources of uncertainty affect their decisions and help to integrate different types of data and analyses in their deliberations.
A benefit-risk assessment framework can serve as the foundation for communication strategies both among the decision-makers and with the broader community of stakeholders. This presentation will introduce key benefit-risk assessment concepts and tools and show examples where formal benefit-risk assessment has supported difficult public health decisions.
About the Presenter
Dr. Richard Forshee leads the Analytics and Benefit-Risk Assessment Team for CBER's Office of Biostatistics and Epidemiology at FDA. He works on a wide range of issues related to the risks and benefits of blood and blood products and vaccines as well as human cell and tissue products. Dr. Forshee has won numerous awards, including the FDA Service Award and the CBER Hope Hopps Memorial Award. He has published more than 60 scientific articles. Before joining FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.
Past Grand Rounds
2019
2018
- Jerky Pet Treats and illness in dogs: a collaborative approach to investigating a mysterious outbreak
- Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling
- The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes
- Bisphenol A: Toxicology and Pharmacokenetic Data to Inform Ongoing Safety Assessments
- How Simulation Can Transform Regulatory Pathways
- FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders
- Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine
- Ethnicity- and Gender-Related Differences in Alzheimer's Disease
2017
- Assessing the Safety and Effectiveness of New and Emerging Therapeutic Ultrasound Technologies
- Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs
- Genome Trakr: How a Large Network of Sequencing Laboratories is Transforming Food Safety and Public Health
- Serious and Actionable Risks, Plus Disclosure: investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads
- Vaccine adjuvants: New ways to evaluate their safety and effectiveness
- Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products
2016
- The Host Response to Whooping Cough Infection and Vaccination
- Antibiotic resistance surveillance in the age of genomics: New answers to old questions
- FDA Research into 3D Printing of its Regulated Products
- Rapid Screening of Dietary Supplements for Undeclared Ingredients
- Metabolomics and Proteomics Biomarkers: Discovery and Validation in Toxicity Studies