A new concept paper published by the European Medicines Agency will pave the way for the development of guidance on good genomics biomarker practices. In it the EMA proposes a framework for the generation and assessment of robust genomic datasets throughout a medicine’s life cycle, with the aim of enhancing transparency, consistency, reproducibility and cross-validation between genomic-driven studies.
The agency expects its future guidance to promote and facilitate the use of genomic data for the development of personalised medicines, the safety monitoring of medicines and the early diagnosis of disease.
Problem: translation into clinical tools lagging
The EMA says new knowledge about biomarkers is being generated faster than it can be translated into clinically usable tools. In particular, it notes that the following aspects often lead to non-reproducible and clinically non-validated biomarker data:
- lack of transparent rationale for the choice of genomic techniques
- difficulties in obtaining sufficient samples to address clinical correlations
- poorly designed clinical trials (from the genomics perspective)
Thus, guidance is needed to promote the choice of appropriate genomic methodologies during a product’s development and life cycle so that the data accrued can be integrated to generate useful pharmacogenomics testing modalities. The guideline would also highlight key scientific aspects for the translation of the available genomic biomarker data into clinical practice.
The agency notes that good genomic practices may also be a useful reference at the time when the new legislation governing companion diagnostics, in-house testing and medical devices come into force in Europe.
A three-month consultation on the concept paper runs until 4 November 2014. The EMA expects a draft guideline to be available nine to 12 months after that; it will be released for six months of external consultation before finalisation.