A newly formed nonprofit corporation unites industry, academia and government in first large-scale study of genetics and drug safety. The Serious Adverse Event Consortium (SAEC) will work to identify genetic markers that may help predict which individuals are at risk for serious drug-related adverse events (SAEs).
Pharmacogenetics and pharmacogenomics deal with the genetic basis underlying variable drug response in individual patients. The traditional pharmacogenetic approach relies on studying sequence variations in candidate genes suspected of affecting drug response. On the other hand, pharmacogenomic studies encompass the sum of all genes, i.e., the genome. Numerous genes may play a role in drug response and toxicity, introducing a daunting level of complexity into the search for candidate genes. Pharmacogenomic analysis can identify disease susceptibility genes representing potential new drug targets.
Current concepts in drug therapy often attempt treatment of large patient populations as groups, irrespective of the potential for individual, genetically-based differences in drug response. In contrast, pharmacogenomics may help focus effective therapy on smaller patient subpopulations which although demonstrating the same disease phenotype are characterized by distinct genetic profiles. Whether and to what extent this individual, genetics-based approach to medicine results in improved, economically feasible therapy remain to be seen.
The SAEC’s research studies will examine the impact genes can have on how individuals respond to medicines. 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 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.