In some ways, biomarkers represent a new drug development paradigm. The pharmaceutical industry is increasing its focus on ‘patient-centered medicine’ or ‘personalized medicine’. Biomarkers form an integral part of this approach, as well as towards drug development in general.
Biomarkers can play a role in determining the safety and efficacy of a drug. Additionally, they can find use in predicting a drug candidate to which a specific patient may respond more positively. This purpose requires the use of a qualified biomarker that has undergone clinical validation. The use of biomarker assays ensures that the choice is fit-for-purpose.
Additionally, biomarker validation and testing are employed at various stages of the drug development process. This is done to reduce costs and accelerate drug development.
Use of Biomarker Assays in Drug Discovery
Biomarker validation is necessary to identify robust biomarkers that can assist in diagnosis, monitoring of drug activity, and therapeutic response. Biomarker testing services rely on choosing the right assay for validation. This can significantly improve decision-making throughout the drug development process.
Discovering a new biomarker can indeed revolutionize the development and use of a therapeutic. However, this requires the establishment of a concrete validation process. This process should be able to handle technological as well as regulatory challenges. The larger focus, therefore, is on biomarker assay validation as a way to improve the prospects of a new drug.
The Test of Preclinical Study
As the development moves to the preclinical phase, the biomarker will go through more stringent validation. Assay validation can be useful in new disease models, though the challenge is using appropriate animal models. To move forward, in vivo testing should ideally show biomarker properties comparable with patient populations.
Assay validation with pharmacokinetic and pharmacodynamic models forms an important part of the drug development process. Additionally, biomarker validation during preclinical studies also helps identify the safe dosage of a drug. Assessing the toxicity and safety of a drug along with its therapeutic use allows development to move to the clinical phase.
Biomarkers and Clinical Study
In most cases, it is generally accepted that a biomarker may not be fully validated even well into clinical trials. For example, Phase 0, I, and even early Phase II development may not provide enough information for biomarker use within a trial. A carefully planned approach is recommended for incorporating biomarker testing in the early phases of a trial.
While academic clinical researchers lead the trials, the experts for test development and implementation are biomarker testing services. It is one of the reasons why Contract Research Organizations and labs are so widely relied upon during drug development.
During the clinical trial, biomarkers can be used as a criterion in the selection of human volunteers. Additionally, close monitoring paired with assay validation can provide early information on the success or failure of the study. Considering pharmacological effects on biomarker-based endpoints can help decide drug dosage, scheduling, and efficacy.
The use of mechanism-based biomarkers and biomarker validation can help study disease activity. It can also present information on the process and interactions between disease targets and targeted therapy.