Biomarker development has become an indispensable tool in personalized medicine drug development. Health care costs expenditures for biologics therapeutics paired with individualized, personalized medicine is driving the need for biomarker development, which is the companion diagnostic medical device (CDx), that allows treating the right patient at the right time with the right drug or drug combination at the right dose. Early biomarker development may be facilitated by leveraging biorepositories or biobanks from human-derived specimen, representing the target disease. Legally authorized biorepositories or biobanks thus may provide a versatile “tool” to determine performance characteristics and/or analytical/ clinical validity of the in vitro diagnostic medical device, in the specific context of drug use prior to moving into clinical phase. Authorization of biobanks for research and commercial use originates from compliance to Declaration of Helsinki and in principle is based on national and international legislation, statutory requirements and informed consent provided by donors, while informed consent may be waived in some circumstances. Europe is currently facing a 5 year “grace period” with respect to transition of regulations for CDx biomarker development, even though the new Regulation on In vitro Diagnostic Medical Devices (IVDR) has already come into effect May 26, 2017. The changing regulatory conditions and the availability of various biorepositories paired with new European unequivocal provisions for CDx biomarker development and conformity assessment procedures for approval (CE-marking) may allow to develop biomarker performance characteristics and/ or analytical/clinical validity even in the absence of contemporaneously sourced clinical trials specimen. This article sheds some light on regulatory challenges with respect to upcoming changes with the IVDR and illustrates the pitfalls associated with the CDx biomarker in the use of biorepositories.
Hess RD and Laaff H
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