February 3, 2017
February 3, 2017
Speaker: Dr. David Litwack
Food and Drug Administration
Title: FDA and the Precision Medicine Initiative: Working with the Research Community to Develop New Regulatory Approaches for Genomic Tests
Location: Biomedical Engineering Building Auditorium
Time: 1:30 p.m. to 2:30 p.m.
Dr. Litwack received a B.S. in Chemistry from the University of Chicago, and a PhD. in Biology from MIT. After postdoctural studies at the Salk Institute for Biological Studies, he joined the faculty of the University of Maryland School of Medicine as an Assistant Professor in the Department of Anatomy and Neurobiology. In 2010, Dr. Litwack was awarded an AAAS Science and Technology Policy Fellowship in NCI's Office of Biorepositories and Biospecimen Research. In 2012, Dr. Litwack joined the Personalized Medicine Staff of the Office of In Vitro Diagnostics and Radiological Health at the FDA, where he develops policies to guide the review of investigational biomarker tests, companion diagnostics, and next generation technologies.
The use of accurate and reliable next generation sequencing (NGS)-based laboratory test for clinical genomics is critical for advancing precision medicine. As part of President Obama's Precision Medicine Initiative (PMI), the US Food and Drug Administration (FDA) proposed a regulatory framework for regulating NGS tests that is designed to promote innovation in this field. To develop and implement this framework, the FDA is working with the scientific community to leverage the latest research findings and clinical evidence, and to accelerate research on the development and performance of NGS technology. This seminar will discuss those efforts, with a special focus on precision FDA, a free cloud-based platform designed to advance a better understanding of NGS test performance.
Prior to the seminar, a networking lunch will be held with Dr. Litwack at the Busch Dining Commons at noon. If interested, please RSVP by Feburary 1st to Joseph Sherba, firstname.lastname@example.org.
For more information, please contact Corina White at email@example.com.