EMA, the European Drug Regulator Published Draft Reflection Paper on the Co-development of Pharmacogenomic Biomarkers and Assays in the Context of Drug Development.
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The increasing knowledge of variation within the human genome is being used for the development of34 personalised and stratified medicine, with the aims of decreasing the number of adverse drug reactions and increasing the efficacy of drug therapy. Significant pharmacogenomic research has focused on understanding the molecular mechanisms underlying certain adverse drug reactions and on recognising biomarkers (BMs) that identify individuals at risk. A genomic biomarker (in this document referred to as PGBM) is a measurable DNA and/or RNA characteristic that is an indicator of normal biologic processes, pathogenic processes, and/or response to therapeutic or other interventions. The co-development of drugs and PGBMs may open new and often contentious issues: they need to be addressed in the different contexts of PGBM use, moving progressively from PGBM discovery to PGBM use in non-clinical phases and finally to clinical phases of drug development. An individual assay implies a specific test method, reagents and platform which are developed and validated together for the detection, choice and measurement of specific PGBMs. The assay may be subject to performance evaluation during a qualification process independently of a specific drug under development consideration. The level of scientific stringency applied to the assay will depend on the knowledge accumulated about the PGBM and the drug(s) under consideration, as well as the implication of its use. It is recognised that for well established PGBMs relevant to drug developments such as the CYP 450 polymorphic enzymes, there are commercially available in vitro diagnostic medical devices (IVDs). However, for discovery PGBMs, when initially used specifically in non-clinical toxicity or pharmacology studies, and planned to be used afterwards in the clinical drug development context, either customization of existing assays or new development of specific tests may be needed (e.g. assays to identify PGBMs based on new splicing iso-forms or new mRNA profiles.
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