European Medicines Agency looks to stimulate better use of genomic data and biomarkers in medicines development and safety monitoring

The European Medicines Agency (EMA) has released a draft concept paper today for public consultation outlining the key elements that will be developed in a guideline on good genomics biomarker practices.

Recognising the importance of genomics in the development of innovative, targeted treatments and to inform the best use of medicines, the concept paper proposes a framework for the generation and assessment of robust genomic data. Comments on the paper are invited until 31 October 2014 and should be sent to [email protected]. 

The outcome of the consultation will inform the future guideline, which will aim to set out the key principles underpinning the generation of robust clinical genomic datasets throughout a medicine’s lifecycle, including the rationale for using genetic investigation, the choice of genomic techniques and biomarkers, the impact on the relevant study design, and the appropriate level of analysis and reporting of genomic data. The guidance would also highlight key scientific aspects of the translation of the available genomic data into clinical practice.

With this guidance the EMA aims to enhance transparency, consistency, reproducibility and cross-validation between genomic-driven studies. This is expected to promote and facilitate the use of genomic data for the development of so-called personalised medicines (a medical approach which is tailored to a patient or group of patients), the safety monitoring of medicines and the early diagnosis of disease.

Due to genetic variability, not all people respond in the same way to the same medicines. The development of new technologies allows new knowledge to be generated on how a person’s genetic makeup influences his or her response to certain medicines, both in terms of efficacy and safety. Genomic data have become increasingly important during the evaluation of a medicine’s benefits and risks as well as in post-authorisation safety monitoring to inform the best use of medicines.