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Technology in Pharmacogenetic Decision Making: FDA lead consortium efforts

The Personalized Medicine Webinar Series

Moderated by: Shraddha Thakkar (U.S. FDA)

About the Webinar: 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.

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