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.
Upcoming Event
Applied Regulatory Research to Address the Ongoing Opioid Crisis
Thursday, October 12, 2023
12:00 p.m. - 1:00 p.m. ET
Webcast
About the Speaker
Lidiya Stavitskaya, Ph.D.
Pharmacokineticist
Division of Applied Regulatory Science
Office of Clinical Pharmacology, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)
Dr. Stavitskaya received her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore in 2011. She joined Division of Applied Regulatory Sciences (DARS) in Center for Drug Evaluation and Research (CDER), as a Computational Toxicologist in 2014. Dr. Stavitskaya has extensive research experience in the areas of medicinal chemistry and regulatory computational pharmacology and toxicology. Dr. Stavitskaya’s current focus is to improve FDA’s ability to predict drug safety issues and to expand the use of chemical informatics and predictive modeling in safety assessment.
Zhihua Li, Ph.D.
Pharmacokineticist
Division of Applied Regulatory Science
Office of Clinical Pharmacology, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)
Dr. Zhihua Li is the Principal Investigator of several computational biology and quantitative systems pharmacology projects at Division of Applied Regulatory Sciences (DARS). He has been leading the in silico workstream under a global effort to develop a new regulatory paradigm for cardiac safety. He also led the development of translational models to evaluate the effects of opioids and opioid antagonists that informed the development and regulatory decision making for some recent opioid antagonists products.
Past Grand Rounds
2023
- Acquisition of Host Iron by Corynebacterium diphtheriae: Iron-Regulated Surface Factors as Possible Vaccine Candidates
- The Plasmid Puzzle: Finding Solutions in Salmonella
- FDA’s Global Substance Registration System (GSRS) Unique Ingredient Identifiers (UNIIs) uniquely define substances in FDA-regulated products
- Electron Microscopy, Still a Powerful Research Tool
- Identification of Persistent Organic Pollutants in Foods: Method Development and Automation
- Microphysiological Systems as Novel Disease Models and Drug Development Tools
- A Modular Approach for Enhanced Plasmid Subtyping and AMR Gene Profiling of Plasmids
- The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars
2022
- Wastewater Surveillance for SARS-CoV-2 Variants: a pandemic response project leveraging FDA’s GenomeTrakr network
- Medical Extended Reality: Applications and Challenges
- Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins
- Polio Vaccines: Past, Present, and the Future
- One Health at FDA: From Concept to Application
- Some Perspectives on Data Science and Coronaviruses
- The Saga of Phosphatidylinositol 3-Kinase (PI3K) Inhibitors
- MinION Sequencing of Foodborne Pathogens
- An Overview of Tattoo Ink Research at the National Center for Toxicological Research
- Challenges in Predicting the Environmental Exposure Concentration of Terrestrial Animal Drugs
- Development and Testing of Warnings for Tobacco Products: Scientific and Regulatory Considerations
2021
- Closer to Zero
- The Development of Cellular-Level Structural and Functional Biomarkers of Eye Disease Enabled by Adaptive Optics
- Laboratory and Clinical Studies to Investigate Whether Ranitidine Converts to a Probable Carcinogen in Humans
- Immune System Responses to Therapeutic Proteins: Getting up close and personal
- SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern
- FDA's work with African Swine Fever from a policy and regulatory perspective
- Project Orbis: Global Collaborative Oncology Review Program
- Electrical Safety in CTP Regulated Products
- Studies of SARS-CoV-2 NSP1 and Envelope Protein
- Research and Development of Radioanalytical Capabilities for Detection of Radionuclides in Food
- FDA Grand Rounds: The CORE Network (or How I Learned to Love Lettuce…)
2020
- Assessment of Safety and Efficacy of Fecal Microbiota for Transplantation Products
- Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve?
- Bioequivalence of Complex Topical Generics: In Vitro and In Vivo
- Advancing the Science of Real-World Data to Address the COVID-19 Pandemic
- Nanotechnology: Over a Decade of Progress and Innovation at FDA
- A Pandemic and a Call to Action for One Health: The FDA One Health Initiative
- Artificial Intelligence for Regulatory Science Research
- Analysis of Per and Polyfluoroalkyl Substances (PFAS) in foods- Analytical method development, challenges and successes
- Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology
- Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays
- Quality Control: Stopping infections before they happen through safer endoscope reprocessing
2019
- Vet-LIRN – How FDA’s Network of Veterinary Diagnostic Laboratories advance animal food safety and public health by conducting outbreak investigations and monitoring resistance in animal pathogens [Archived]
- Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices [Archived]
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Cyclospora Cayetanensis: The Crossroads Between Scientific Advances and Knowledge Gaps [Archived]
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Uncertainty is the only certainty there is: Potential approaches for making public health decisions [Archived]
2018
- Jerky Pet Treats and illness in dogs: a collaborative approach to investigating a mysterious outbreak [Archived]
- Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling [Archived]
- The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes [Archived]
- Bisphenol A: Toxicology and Pharmacokenetic Data to Inform Ongoing Safety Assessments [Archived]
- How Simulation Can Transform Regulatory Pathways [Archived]
- FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders [Archived]
- Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine [Archived]
- Ethnicity- and Gender-Related Differences in Alzheimer's Disease [Archived]
2017
- Assessing the Safety and Effectiveness of New and Emerging Therapeutic Ultrasound Technologies [Archived]
- Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs [Archived]
- Genome Trakr: How a Large Network of Sequencing Laboratories is Transforming Food Safety and Public Health [Archived]
- Serious and Actionable Risks, Plus Disclosure: investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads [Archived]
- Vaccine adjuvants: New ways to evaluate their safety and effectiveness [Archived]
- Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products [Archived]
2016
- The Host Response to Whooping Cough Infection and Vaccination [Archived]
- Antibiotic resistance surveillance in the age of genomics: New answers to old questions [Archived]
- FDA Research into 3D Printing of its Regulated Products [Archived]
- Rapid Screening of Dietary Supplements for Undeclared Ingredients [Archived]
- Metabolomics and Proteomics Biomarkers: Discovery and Validation in Toxicity Studies [Archived]