Regulatory Perspective on Remaining Challenges for Utilization of Pharmacogenomics-Guided Drug Developments

Abstract

Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

KEYWORDS::

• biomarker
• drug development
• international harmonization
• personalized medicine
• pharmacogenomics
• regulatory science

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the official views of Pharmaceuticals and Medical Devices Agency.

Financial & competing interests disclosure

This work was supported by Health and Labour Sciences Research Grant from Ministry of Health, Labour and Welfare of Japan. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. The authors used NAI, Inc. to check use of English language. This writing assistance was funded by the Health and Labour Sciences Research Grant from Ministry of Health, Labour and Welfare of Japan.

Additional information

Funding

This work was supported by Health and Labour Sciences Research Grant from Ministry of Health, Labour and Welfare of Japan. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.Writing assistance was utilized in the production of this manuscript.The authors used NAI, Inc. to check use of English language. This writing assistance was funded by the Health and Labour Sciences Research Grant from Ministry of Health, Labour and Welfare of Japan