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R&D

Innovative Science Affordable Medicine

PREDICTIVE BIOMARKER

What is predictive biomarker?

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
post-marketing stage.

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
Predictive Biomarker

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

Assay development
Analytical validation

Biomarker evaluation
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.