EuropaBio Submission of Comments on Biomarkers Qualification: Guidance to Applicants

23.06.2008

EuropaBio Submission of Comments on Biomarkers Qualification: Guidance to Applicants

EuropaBio welcomes the introduction of a qualification process for biomarkers that will allow industry the opportunity to seek guidance from, and reach agreement with, the CHMP and other agencies on the development programme needed for qualification of biomarkers. In this new approach to biomarker qualification, a pilot approach is also highly supported. As learnings are gained from the pilot, these should form part of a shared and interactive exchange among key stakeholders as indicated by the suggestions of workshops and public fora.
 
Overall, from a scientific point of view, we find the draft guideline to be well prepared, although the guidance document is somewhat confusing with respect to the Scientific Advice procedure described. It is not clear if mention of Scientific Advice refers to the existing CHMP procedure with all its processes and timings or to a specific Scientific Advice procedure for biomarkers involving the same composition of advice team as the full qualification process, i.e. the Qualification Team.
 
We presume that the latter is the case but would like clarification on this. Furthermore, from the document, it is not clear why companies should request this Qualification Advice or Scientific Advice – i.e. what are the incentives towards the applicants.
A related question is with respect to the voluntary submission. What is the nature of the voluntary submission? Will the process remain as a voluntary system and are there options to withdraw in the middle of the process and what impact does this have on future submissions?
 
The major hurdle for the implementation of a qualification procedure that will be used voluntarily by industry is the issue of confidentiality. Although the procedure allows for the removal of commercially confidential information from the data released for public consultation, in many cases the qualification data will have been generated through studies performed as part of the clinical development programme for a NCE. As such, the applicant may need to remove a significant amount of commercially confidential information such that insufficient information remains for a meaningful public consultation. A key learning arising from the proactive industry-regulatory exchanges on genomic biomarkers (pharmacogenetics and pharmacogenomics) is that emerging biomarkers are integrated as part of the drug development datasets and typically are not standalone.

 

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