MAY 11, 2016 12:00 PM PDT

The FDA's experience with emerging genomics technologies - past, present and future

  • Director, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research (NCTR), FDA
      Dr. Tong is Director of Division of Bioinformatics and Biostatistics at FDA's National Center for Toxicological Research (NCTR/FDA). He has served a science advisory board member for several large projects involving multiple institutes in Europe and USA. He also holds several adjunct positions at universities in US and China. His division at FDA is to develop bioinformatic methodologies and standards to support FDA research and regulation and to advance regulatory science and personalized medicine. The most visible projects from his group are (1) leading the Microarray Quality Control (MAQC) consortium to develop standard analysis protocols and quality control metrics for emerging technologies to support regulatory science and precision medicine; (2) development of liver toxicity knowledge base (LTKB) for drug safety; (4) in silico drug repositioning for the enhanced treatment of rare diseases; and (4) development of the FDA bioinformatics system, ArrayTrackTM suite, to support FDA review and research on pharmacogenomics. In addition, his group also specializes in molecular modeling and QSARs with specific interest in estrogen, androgen, and endocrine disruptor. Dr. Tong has published more than 200 papers and book chapters.


    Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation sequencing (NGS) represents an advanced genomic approach with a far-reaching impact in drug development, personalized medicine, food safety and beyond. Rapid progress in NGS over the last few years has demonstrated its translation from an exploratory to an applied stage. As a result, the FDA has received an increasing amount of NGS data supporting the evidence for the safety and efficacy of new medical products and the agency is now facing challenges with respect to developing standards for receiving data and ensuring reproducible results. This presentation will discuss the FDA-led community wide consortium project, known as the SEquencing Quality Control (SEQC) project, which developed a comprehensive plan to assess the power and limitations of RNA-seq. The project involved >180 participants from ~80 organizations and generated large RNA-seq data sets covering a broad range of biological samples (human, rat, and reference samples) with which many critical issues of applying RNA-Seq in clinical application and safety assessment were evaluated and discussed. The presentation will provide an overview and main conclusions of the SEQC project. In addition, the new SEQC project (SEQC2) which is in the planning stage will be also explained. SEQC2 is focused on whole-genome sequencing and target gene sequencing.

    Learner objectives:

    • Learn about the FDA’s Voluntary eXploratory Data Submission (VXDS) program and its impact to the FDA guidance to industry for genomic data submission
    • Learn about the FDA led community wide MicroArray Quality Control (MAQC) consortium to develop standards and bioinformatics solutions for microarrays and next-generation sequencing 

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