Biomarkers play a vital role in drug discovery and development. The evaluation of biomarkers is integral to the development of new drugs. Biomarker analysis has catalyzed precision medicine research by providing new targets for therapy.
Biomarker analysis and validation help in the classification of patient populations according to the severity of a particular disease.
Biomarker-analysis design is a randomized trial. Its analysis encompasses the evaluation of treatment benefit within the sample groups defined with respect to biomarker concentration.
The Uses Of Biomarkers In Drug Development Processes
For Target Discovery and Validation
At this initial level, biomarker analysis is used to identify targets and justify them for being the best receptors pertaining to a particular therapy. For example, HER2 proto-oncogene was identified as a poor prognosis factor.
Use In Lead Discovery
Target associated biomarker assays are used at this stage to identify leads. Upon clear identification, the leads are then further optimized with the use of models developed with biomarker endpoints.
Use In Preclinical Studies
At this stage, specific animal models are selected that have the previously selected biomarker features. This stage also has another crucial role for biomarker assays in validating new models for diseases. This is also when biomarker testing services conduct toxicity and safety tests for the chosen drug.
Use In Clinical Trials
This stage gives a clear reflection of whether the drug component has been a success or a failure and reaching target cells. Biomarker validation is also used at this stage to define the rational selection of a possible combination of drugs. The selected biomarker at this stage can be used to predict the outcomes of the clinical trials.
There is quite a difference between biomarker validation and the techniques used for routine lab validation besides pharmacokinetics. There are existing guidelines from the FDA on biomarker validation used for PK studies only about small molecules but not directly relating to valid biomarker assays. On the other hand, routine lab validation is where specific tests are performed on humans for treatment or diagnosis of diseases.
Assay Method Category
The biomarker assays quasi-quantitative, whereas bioanalytical ones are generally definite quantitative.
No specific lab practices are allocated in this parameter for biomarker validation, but for bioanalytical ones, GLP is standard.
Nature Of Analyte
This is endogenous in the case of assays and exogenous in the case of bioanalytical practices.
Storage stability for biomarker validation is conducted through study samples, whereas the biological matrix is spiked through drugs in bioanalytical procedures for stability testing.
For controlling quality, biomarker assays use a substitute or a surrogate matrix, whereas authentic samples are used in bioanalytical procedures.
These are made in study matrices in case of bioanalytical assays, whereas biomarker ones use matrices other than study samples.
The key parameters that set apart biomarker validation are the nature of the procedure, study samples used, and the quantitative factor, which is relative in this case.
This has offered multiple opportunities to test out new drugs flawlessly in the past decade. Choosing the right provider for biomarker testing services is crucial as the same GLP doesn’t apply in this case, so standards must be maintained through reputed services only.