All research results are made available publicly within 12 months of the completion of the study group’s genotyping. The SAEC has developed a data portal to provide the research community with free and unencumbered access to study data. Results obtained in initial studies can thus be reevaluated by researchers who can determine their validity as predictive markers.
The Serious Adverse Event Consortium (SAEC) is a nonprofit organization comprised of leading pharmaceutical companies, and academic institutions with scientific and strategic input from the U.S. Food and Drug Administration (FDA). The mission of the SAEC is to help identify and validate DNA-variants useful in predicting the risk of drug-related serious adverse events (SAEs).
Patients respond differently to medicines and all medicines can have side effects in some people. The SAEC’s work is based on the hypothesis that these differences have a genetic basis, and its research studies will examine the impact genes can have on how individuals respond to medicines. The SAEC’s initial studies are focused on identifying the genetic markers associated with drug-related liver toxicity (the leading cause of acute liver failure) and Steven Johnsons Syndrome (SJS, a severe form of skin necrosis).
In addition to supporting original research of drug-related SAEs, the SAEC will:
- Establish open-use research practices and standards
- Encourage greater efficiency by pooling talent and resources under a common leadership with public safety-driven goals
- Enhance the public’s understanding of how the industry, academia and government are partnering to address drug-related adverse events
The SAEC collects already available SAE data from the participating pharmaceutical companies and academic institutions in streamlined databases. These well-characterized databases of DNA from individuals who have experienced drug-related liver toxicity and SJS are then be compared with control cases to identify genetic variants that may be associated with these SAEs. To support their investigation into the genetic determinants of SAEs, researchers use data from The SNP Consortium and Hap Map Project, which mapped genetic variants (single nucleotide polymorphisms, or SNPs) in conjunction with the Human Genome Project. The identification of these genetic variations is believed to be essential to develop safer drugs while also identifying patient populations for whom a medicine will have the greatest likelihood of providing medical benefits with the fewest risks.
The SAEC is also exploring partnerships with other private and government institutions to continue their research. If their initial studies are successful, the SAEC hopes to examine other major drug-related adverse events to determine their underlying genetic causes.