Abstract
Pharmaceutical companies have increasingly utilized genomic data for the selection of drug targets and the development of precision medicine approaches. Most major pharmaceutical companies routinely collect DNA from clinical trial participants and conduct pharmacogenomic (PGx) studies. However, the implementation of PGx studies during clinical development presents a number of challenges. These challenges include adapting to a constantly changing global regulatory environment, challenges in study design and clinical implementation, and the increasing concerns over patient privacy. Advances in the field of genomics are also providing new opportunities for pharmaceutical companies, including the availability of large genomic databases linked to patient health information, the growing use of polygenic risk scores, and the direct sequencing of clinical trial participants. The Industry Pharmacogenomics Working Group (I-PWG) is an association of pharmaceutical companies actively working in the field of pharmacogenomics. This I-PWG perspective will provide an overview of the steps pharmaceutical companies are taking to address each of these challenges, and the approaches being taken to capitalize on emerging scientific opportunities.Supplementary InformationThe online version contains supplementary material available at 10.1007/s00439-021-02282-3.
Highlights
The collection of DNA samples from clinical trial participants, especially in early phase clinical trials, has become standard practice for most pharmaceutical companies
Genomics has become an integral part of drug development, from early target discovery through the late stages of clinical development
The challenges outlined in this perspective, while significant, will continue to be addressed going forward as pharmaceutical companies pursue precision medicine strategies broadly across drug development
Summary
The collection of DNA samples from clinical trial participants, especially in early phase clinical trials, has become standard practice for most pharmaceutical companies. Rapid scientific advances in the field of genetics have provided new and emerging
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