The rapid development of new technologies that interrogate variability in human DNA, combined with powerful computing hardware and software, has made it practical to investigate genetic determinants for risk of human disease or predictors of human response to drugs.
Our company conducts genetic research within our own clinical trials and in collaboration with external organizations that have collected human genetic samples and health data.
Collecting genetic samples is a critical foundation for human genetic research strategies. We collect genetic samples in our clinical trials primarily to understand how variable genetics impact patient response to the drugs. This enables us to communicate information to regulatory authorities and prescribers that will improve the use of our medicines. It also enables us to understand how genetics contributes to the underlying disease, which has potential to identify new drug targets for that disease. We also collect genetic samples outside of our clinical trials, often in collaboration with academic institutions or pre-competitive consortia. This is an important way of leveraging many of the large-scale biobanking efforts that are ongoing globally.
During clinical trials, we obtain appropriate subject consent for use of the genetic samples in accordance with the ethical principles that have their origin in the Declaration of Helsinki, U.S. FDA requirements (21 CFR 50.20, 50.25 and 50.27), the International Conference on Harmonisation (ICH) E6 Good Clinical Practices guidelines, and the 1997 UNESCO Declaration on the Human Genome and Human Rights.
When collaborating with external organizations, we ensure that consent has been obtained by individuals who have contributed DNA and/or health-related data to the organization via these same standards.