Technology in Pharmacogenetic Decision Making: FDA lead consortium efforts

When:  Feb 15, 2018 from 12:30 PM to 2:00 PM (ET)
Where pharmacogenetics branch studies the variation of the different metabolic pathways leads to the individual difference in the drug responses. It is important to understand the associated technologies that can help tremendously in PGx related decision making. In order to make PGX related decision making, it’s important to have the understanding of technologies that offer PGX related understanding. PGx studies the genetic variability correlation with the drug response. However, it is important to reliable and reproducible method for measuring the genetic variability. To add to the confusion, the publication of studies with dissimilar or altogether contradictory results, obtained using different microarray and sequencing platforms to analyze the identical genetic, has raised concerns about the reliability of this technology. To achieve this goal, FDA lead consortium bough together various platforms of technology and develop the gold standard for operating procedures for using genomic technology to get reliable, reproducible results. Efforts of the consortium was to communicate, promote, and advance reproducible science principles and quality control for analysis of the massive data generated from the existing genomics technologies to aid in the PGX related decision making. 

This webinar will provide the examples for the best practices for performing Pharmacogenomics related experiments and it will also explain the data analysis highlights to get reliable reproducible results using microarrays as well as sequencing. This webinar will also discuss the challenges and future goal for genomics technologies and its reliability in PGx related decision making.

Learning Objectives:
  • Review and introduce pharmacogenetics related technologies.
  • Explain correlating genetic polymorphism and genetic constituent of patients assessments.
  • Discuss the gold standard genomics data submission.
Contributors: Dr. Tong is Director of Division of Bioinformatics and Biostatistics 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. In addition, 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 ArrayTrackTMsuite 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.


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