The FDA Grand Rounds is webcast every other month 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 presentation is followed by questions from the audience.
Register here for remote access to webcast and CE credit
FDA Attendees: To access the webcast remotely and earn CE credit, register through the Scientific Professional Development Calendar or FDA Notices.
Thursday, November 10, 2016
12:00 to 1:00 p.m., Eastern Standard Time (EST)
Metabolomics and Proteomics Biomarkers Discovery and Validation in Toxicity Studies
Richard Beger, MS, PhD
FDA’s National Center for Toxicological Research
About the Presentation
Metabolomics and proteomics technologies are being used in nonclinical and clinical studies to discover translational biomarkers in biofluids that would enable us to diagnose and predict toxicity before it occurs. Dr. Beger will discuss the discovery of metabolomics and proteomics biomarkers following administration of acetaminophen in mice, rats, and children. He will also discuss another study exploring biomarkers of doxorubicin cardiotoxicity.
The metabolomics and proteomics biomarkers that have been identified to date have the potential to protect public health by enabling safer drug development and clinical management. These biomarkers would provide us with earlier indications of toxicity and disease-induced damage in clinical and nonclinical studies.
About the Presenter
Dr. Beger is an 18-year veteran of FDA’s National Center for Toxicological Research and an internationally recognized leader in toxicology. He uses computational modeling, metabolomics, and proteomics to develop translational approaches to improve drug safety as well as disease detection and management. Dr. Beger has made numerous groundbreaking advances in the area of metabolomic biomarker discovery.
At the Arkansas Children’s Hospital in Little Rock, Arkansas, Dr. Beger has collaborated on metabolomics studies on biofluids of children without exposure to acetaminophen, upon therapeutic treatment, and in acetaminophen overdose situations. These studies found metabolic changes that translated between the preclinical and clinical studies. Dr. Beger is the 2016 winner of the prestigious Society of Toxicology Translational Impact Award.
- The Host Response to Pertussis 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
Sign up for latest news on leading-edge scientific research, initiatives, and events at FDA