Predictive biomarker shows information about our body. It helps to evaluate
how well a treatment is likely to work in a particular patient.
To develop predictive biomarker, various technologies such as genomics,
proteomics, transcriptomics, and genomics based on blood/tissue samples
and clinical information from patients are required.
New Predictive Biomarker
The above graph shows that cancer lives rates are affected by predictive biomarkers, and estimates that approximately 800,000 cancer patients are affected by predictive biomarkers and the number is expected to increase due to the discovery and development of new predictive biomarkers.
Predictive Biomarker Can be
Risk assessment, diagnosis, prognosis prediction,
predict treatment responses and monitor disease progress
in cancer research.
Playing an important role in determining guidance at all stages of
drug development, evaluation at clinical trial stage and
Minimizing the risk and high costs of development failures due to
absence of treatment effect and the occurrence of drug toxicitiy
during clinical trials.
Overall cost reduction in drug development to the full-time and
clinical phases of drug development.
Medical Needs of
Predict the extent to which a drug is effective or toxic
by differentiating a patient group into a drug efficacy response
and a non-response group
Reduce unnecessary treatment and side effects
May introduce personalized medical treatment
Use of Predictive Biomarker in New Drug Development
Drug Development Process Based on Predictive Biomarker
Patient’s clinical resource
MOA & POC
Study design (patient cohort)
Safety, Clinical POC, Efficacy
Post market surveillance
Clinical benefit reports
Predictive Biomarker Discovery Platforms
ROLE OF PREDICTIVE BIOMARKER IN DEVELOPING DRUGS
When developing new drugs, predictive biomarker plays an important role.
The stages of developing predictive biomarkers are as follows: Discovery → Validation → POC → Clincial Validation → Clinical Approval
Below is a more detailed development process of both Target drug & Biomarker.
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