The rapid development of new technologies that interrogate variability in human DNA and RNA, combined with powerful computing hardware and software, has made it practical to investigate genetic and genomic determinants for risk of human disease or predictors of human response to drugs.
Our company conducts genetic and genomic research within our own clinical trials and in collaboration with external organizations that have collected human genetic and genomic samples and health data.
Collecting genetic and genomic samples is a critical foundation for human genetic research strategies. We collect genetic and genomic samples in our clinical trials, primarily to understand how genetic and genomic variation impacts patient response to medicines. 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 contribute to the underlying disease, which has the potential to identify new drug targets for that disease.
We also collect genetic and genomic 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 underway globally.
During clinical trials, we obtain appropriate subject consent for use of the genetic and genomic samples in accordance with the ethical principles of human-subjects research, which have their origins 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. We apply the ethical principles for research involving human subjects to the collection and use of genetic and genomic samples. This includes respect for persons/autonomy, beneficence and justice.
When collaborating with external organizations, we ensure that consent has been obtained by individuals who have contributed DNA or RNA and/or health-related data to the organization via these same standards.