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
Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins
Thursday, October 13, 2022
12:00 p.m. - 1:00 p.m. EST
Webcast
About the Speakers
Sarah Rogstad, Ph.D.
Senior Scientific Advisor
Office of Testing and Research (OTR)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
Dr. Sarah Rogstad is the Senior Scientific Advisor in the Office of Testing and Research (OTR) in the Office of Pharmaceutical Quality (OPQ). She received her Ph.D. in Pharmacology from the University of Colorado and her B.S. in Biology-Chemistry from Harvey Mudd College. She joined FDA in 2014. Her expertise is in mass spectrometry of protein, peptides, and complex products, and she is the lead for FDA’s multi-attribute method (MAM) research.
Frances Namuswe, Ph.D.
Lead Chemist
Division of Biotechnology Review and Research III (DBRRIII)
Office of Biotechnology Products (OBP)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
Frances Namuswe is a Lead Chemist in the Office of Biotechnology Products (OBP), which conducts review, regulation, and research of biological products and biosimilar products. She received a B.A. in Chemistry from Grinnell College and a Ph.D. in Chemistry from the Johns Hopkins University, where she used small molecules and synthetic peptide models to understand the active sites and reaction mechanisms of different metalloenzymes. Prior to joining FDA, she conducted postdoctoral research at the National Institutes of Health studying protein-protein and protein-DNA interactions involving zinc finger proteins. She has 10 years of experience assessing product quality of biological products including biosimilars and combination products characterized by various analytical methods including mass spectrometry. She also currently serves as one of the FDA representatives on the CASSS mass spectrometry committee.
Past Grand Rounds
2022
- Polio Vaccines: Past, Present, and the Future
- One Health at FDA: From Concept to Application
- Some Perspecitves 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]
-
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]