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.
The Saga of Phosphatidylinositol 3-Kinase (PI3K) Inhibitors
Thursday, May 12, 2022
12:00 p.m. - 1:00 p.m. EST
Webcast
About the Speakers
Nicholas Richardson, DO, MPH and Yvette Kasamon, MD
Clinical Team Leader
Division of Hematologic Malignancies II (DHM II)
Office of Oncologic Diseases (OOD)
Food & Drug Administration (FDA)
Nicholas C. Richardson DO, MPH, is a Clinical Team Leader in the Division of Hematologic Malignancies II within the Office of Oncologic Diseases, at the Food and Drug Administration (FDA). Prior to joining the FDA, he completed his pediatric residency and chief residency at A.I. duPont Hospital for Children/Thomas Jefferson University and fellowship in pediatric hematology and oncology at Vanderbilt University Medical Center. Dr. Richardson’s clinical and regulatory interest include Hodgkin and non-Hodgkin lymphoma, clinical utilization of minimal residual disease, pediatric drug development in oncology, innovative clinical trial designs including master protocols, and patient advocate engagement.
Yvette Kasamon, MD, is a clinical team leader in the Division of Hematologic Malignancies II within the Office of Oncologic Diseases at the FDA. Before joining the FDA in 2015, she completed an internal medicine residency at the Brigham and Women’s Hospital and a hematology-oncology fellowship at Johns Hopkins University, then joining its faculty as a clinical investigator with a focus on lymphoma. Dr. Kasamon’s clinical and regulatory interests include Hodgkin lymphoma, non-Hodgkin lymphoma, and CLL. She remains an Adjunct Associate Professor of Oncology at Johns Hopkins.
About the Presentation
Several drugs called phosphatidylinositol 3-kinase or PI3K inhibitors have been FDA approved for patients with chronic lymphocytic leukemia (CLL), a cancer of the blood, and certain types of lymphoma, a cancer of the immune system, such as follicular lymphoma (FL) and marginal zone lymphoma (MZL). The PI3K inhibitor drug class is associated with notable side effects that can be serious or fatal, including infection, diarrhea, liver problems, rash, and inflammation of the lungs. There are clinical trials showing concerns with survival in patients with CLL or lymphoma because of the serious side effects of the PI3K inhibitor drug class. Information on the PI3K inhibitor drug class will be discussed and how it impacts future PI3K inhibitors developed for patients with cancer. Broader considerations in clinical trial design and endpoints for cancer drugs will be discussed, using this drug class as an example.
For technical assistance please contact: Madison.Hanson@fda.hhs.gov
Past Grand Rounds
2022
- 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]
-
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]