This August 2011, the FDA released its guidance on “Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification”. This document was developed under the auspices of the International Conference on Harmonization (ICH) and therefore is intended to apply across all ICH regulatory regions (US, Europe, & Japan). Although this guidance primarily focused on the qualification of genomic biomarkers associated with drug or biotechnology product development, the principles articulated in this document are applicable the qualification of a broader spectrum of biomarkers (e.g. imaging, proteomics).
The main purpose of this document is to establish consistent technical standards for the submission of nonclinical and clinical biomarker qualification information. In keeping with the structure of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD), the guidance proposes a submission format consisting of 5 parts (or modules):
· Section 1 (Regional Administrative Information) è CTD Module 1
· Section 2 (Summaries) è CTD Module 2
o Biomarker qualification overview
o Analytical Assay Data Summary
o Nonclinical Biomarker Data Summary
o Clinical Biomarker Data Summary
· Section 3 (Quality Reports) è CTD Module 3
· Section 4 (Nonclinical Study Reports) è Module 4
o Analytical assay development reports
o Analytical assay validation reports
o Nonclinical study reports (in vitro)
o Nonclinical study reports (in vivo, specify species)
· Section 5 (Clinical Study Reports) è Module 5
o Analytical assay development reports
o Analytical assay validation reports
o Clinical pharmacology study reports
o Clinical efficacy and/or safety study reports
Since biomarker qualification can occur at anytime during the drug development process and may involve several qualification stages (e.g. nonclinical, clinical), the structure of the submission is intended to be flexible enough to accommodate different context but also to be consistent regardless of the specific context proposed.
With the release in July 2011 of the draft guidance on “In Vitro Companion Diagnostic Devices” (see my earlier post Companion In Vitro Diagnostics (IVD) Development: some clarity at last), and the release in October 2010 of the draft guidance “Qualification Process for Drug Development Tools”, the release of this latest guidance demonstrate that the FDA has fully embraced the active use of biomarkers in support of drug development and personalized medicine
Thierry
Sornasse for Integrated Biomarker Strategy
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