Mission & Objectives

The SAEC will identify and validate DNA-variants useful in predicting the risk of drug induced serious adverse events.  Techniques drawn from the fields of pharmacogenetics and pharmacogenomics (PGx) will be used.

  • Coordinate network[s] for obtaining well phenotyped cases and controls for SAE PGx research [discovery and validation]
  • Define the required content for an optimal SAE genotyping panel[s]
  • Evaluate computational methods to effectively apply whole-genome SNP mapping technology to SAE marker development
  • Create a publicly available “knowledge base” to identify PGx markers for predicting key SAEs
  • Manage IP relating to PGx markers useful in predicting SAEs to ensure broad and open access
  • Develop a cross-disciplinary forum to address clinical and scientific issues related to PGx of SAEs
  • Enhance the public’s understand of how the industry and FDA are partnering to address the drug-induced SAE issue