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Media Advisory: GW and FDA to Hold Workshop on Computational Standards for High-Throughput Sequencing for Regulatory Sciences

This workshop will discuss ways to facilitate HTS (NGS) computational analysis information communication with FDA; Critical for anyone interested in high-throughput sequencing or big data research in the U.S.

WASHINGTON (Feb. 23, 2017) — The George Washington University (GW) and the U.S. Food and Drug Administration (FDA) will hold a workshop, “High-Throughput Sequencing Computational Standards for Regulatory Sciences,” March 16-17, 2017 in Bethesda, Maryland.

Raja Mazumder, Ph.D., associate professor of biochemistry and molecular medicine at the GW School of Medicine and Health Sciences, is leading a project in collaboration with several FDA scientists to develop a framework for community-based development of standards for harmonization of High-throughput Sequencing (HTS) computations and data formats to promote interoperability and bioinformatics verification protocols. This will validate data and computations while encouraging interoperability. Their goal is to leverage existing HTS analysis and reporting standards to produce a powerful, standardized and community-centric infrastructure for reporting computations related to regulatory analysis of HTS data to FDA. This can be achieved by the use of biocompute objects.

Next steps will be discussed at this workshop with key stakeholders – medical researchers, FDA regulatory scientists, HTS or next-generation sequencing data platform developers, pharmaceutical scientists and bioinformaticians, big data experts, and more – as the way computational analysis are submitted to the FDA changes. The conversation will also take place at #biocompute2017.

WHO: GW and the FDA. The workshop chairs are Raja Mazumder, Ph.D., associate professor of biochemistry and molecular medicine at the GW School of Medicine and Health Sciences, and Vahan Simonyan, Ph.D., lead scientist at the FDA.

Speakers include technologists and scientists from the FDA, National Institutes for Health, Centers for Disease Control and Prevention, Merck, Seven Bridges Genomics, DNAnexus, GenomeNext, Attain, Common Workflow Language project, FHIR Genomics, GA4GH and many others. For a detailed agenda and information on the organizing committee, please visit https://hive.biochemistry.gwu.edu/htscsrs/workshop_2017_agenda.     

WHERE: Porter Neuroscience Research Center, 35A Convent Drive (Room GE 620), Bethesda, MD 20892; Can also attend remotely via live webcast and follow along at #biocompute2017.   

WHAT: Developing a framework for community-based development of standards for harmonization of HTS computations and data formats to promote interoperability and bioinformatics verification protocols. This is critical for anyone that communicates computational analysis with the FDA.

WHEN: Thursday, March 16, from 8:30 a.m. - 5 p.m. ET; Friday, March 17, from 8:30 a.m. - 5 p.m. ET

REGISTER: Visit https://hive.biochemistry.gwu.edu/htscsrs/workshop_2017 to register now, in person or via live webcast.

*MEDIA*: If you are interested in attending the workshop or speaking to Dr. Mazumder, please contact Lisa Anderson at lisama2@gwu.edu or 202-994-3121.