We have previously reported on the European Medicine Agency’s (EMA) increased focus on the area of personalised medicines. The original blog post can be found here.
The EMA and the Committee for Medicinal Products for Human Use (CHMP) has now released for consultation a concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle. The use of predictive biomarkers is an aspect of personalised medicine used to decide treatment or dose selection.
The concept paper highlights that under the new in vitro diagnostic medical devices Regulation (Regulation (EU) 2017/746), the assay used to measure a biomarker will be considered a companion diagnostic for the first time. The concept paper proposes the development of guidance relating to the interface between medicinal products and predictive biomarker assays, including companion diagnostics. That guideline would aim to establish close-knit development programmes between developers of medicinal products and of IVDs, and use of clinical trials to generate evidence required to support validation of the diagnostic, so that gaps in evidence and validations may be avoided. In the post-approval stage the guideline will consider the role of a predictive biomarker assay in the risk management plan for medicinal products if there could be important risks associated with incorrect patient selection.
The deadline for comments is 15 November 2017, and the EMA anticipates that a draft guideline will be available nine to 12 months after the end of the public consultation on the concept paper. This draft will then be released for a six-month public consultation.