title: 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.
authors: Office of New Drug II, Pharmaceuticals & Medical Devices Agency (PMDA), Tokyo 100-0013, Japan.
authors: Yasuto
authors: Y
authors: Otsubo
authors: Akihiro
authors: A
authors: Ishiguro
authors: Yoshiaki
authors: Y
authors: Uyama
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods; D004348:Drug Labeling; D033161:Government Regulation; D017408:Guidelines as Topic; D007391:International Cooperation; D007564:Japan; D010597:Pharmacogenetics
chemical_list: D015415:Biomarkers