报告题目⛹️‍♂️👩🏿‍🎓：The FDA experience with emerging genomics technologies and biomarker development

报告人：Weida Tong，Director of Division of Bioinformatics and Biostatistics and Senior Biomedical Research Service at FDA’s National Center for Toxicological Research

主持人：石铁流 教授

报告时间🖱：2018年9月20日 下午14:00—15:00

报告地点🤙🏿：天美娱乐534小会议室

 

报告人简介：Dr. Tong is Director of Division of Bioinformatics and Biostatistics and Senior Biomedical Research Service (SBRS) at FDA’s National Center for Toxicological Research (NCTR/FDA). He has served science advisory board for several multi-institutional projects in Europe and USA. He also holds adjunct appointment at several universities. He is the founder and board chairperson of newly established international MAQC Society. 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) conducting the Microarray and Sequencing Quality Control (MAQC/SEQC) 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 various tools such as 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 250 papers and book chapters.

 

报告内容🙇‍♂️🏇🏽：Emerging genomics methodologies contribute to our understanding of disease and health. However, its value in clinical and regulatory applications requires rigorous assessment and consensus between various stakeholders. The presentation overviews the FDA efforts in this field with a specific discussion of the FDA led community wide Microarray/Sequencing Quality Control (MAQC/SEQC) consortium. The consortium promotes standardization and quality control to address alarming concerns on the lack of reproducibility in the generation, analysis, and interpretation of genomics data. Specifically, the presentation will discuss some of advancements in this area based on the data generated from MAQC/SEQC and beyond. In addition, the fourth MAQC project, known as SEQC2, will be introduced which is focused on assessing the power and limitations of whole genome sequencing and target gene sequencing in clinical application and precision medicine. In the end, a set of lessons-learned and general guideline will be provided to explicitly consider reproducibility, a fundamental hallmark of good science, in analysis of transcriptomics data.