Our partners Amplion recently published an interesting blog post on the benefits of biomarkers in informing earlier decisions in the drug development process – “fail early, fail fast” to save time and money, and increase approval success. An interesting read, check it out!
There is a well-established high rate of late-phase failure of clinical drug development programmes. Biomarkers can help us to understand a compound’s potential efficacy or safety risk at a much earlier stage and greatly improve the efficiency, and reduce the costs, of drug development. However, this requires thorough validation of a biomarker’s correlation with clinical outcomes, which, though improving, is still in many ways a dark art.
Ongoing work is being done to clarify and standardize the level of evidence required for biomarker qualification for different Contexts of Use. Industry collaboration is also increasing around the process of biomarker qualification, particularly the validation of high-need safety biomarkers. Collaborations such as the Critical Path Institute’s (C-PATH) – Predictive Safety Testing Consortium (PSTC) and the Innovative Medicines Initiative’s (IMI) – Safer and Evidence-based Translation (SAFE-T) Consortium are leading the way in the development of such key biomarkers to submit for formal qualification for subsequent widespread use. Hopefully, these initiatives will soon begin to translate into real improvements in the efficiency and success of global drug development efforts.
Image credit: Stefan Schurr, Fotolia