Precision New Drug R&D: How to Intervene Early with Accompanying Diagnostics and Biomarker Strategies

Biomarker-driven new drug development model

Traditional new drug research and development often use disease type and stage as the main basis for inclusion, while the precision research and development model emphasizes stratification of the population through biomarkers.Biomarkers can be genetic mutations, expression levels, protein modifications, metabolites, or imaging indicators, and their central role is to help determine whether a patient is more likely to benefit from a particular type of treatment or to suggest potential safety risks.

In early preclinical studies, using detection methods such as transcriptome, proteome, or circulating tumor DNA, researchers can observe changes in signaling pathways after drug treatment to provide reference for enrollment criteria and efficacy evaluation in subsequent clinical trials.This pattern does not guarantee the success of a candidate molecule, but it often helps to improve the homogeneity of the study population and reduce ineffective exposures.

General pathway for concomitant diagnostic development to synchronize with drug clinical studies

Concomitant diagnostics are tests used to identify patient populations suitable for the use of a particular drug, and their development often needs to be advanced in tandem with drug clinical trials.General pathways include: identifying candidate biomarkers before the drug enters key clinical studies, establishing assays and completing analytical performance validation; utilizing the method for patient screening or stratification in clinical trials; and subsequently determining the intended use and interpretation criteria for concomitant diagnoses based on clinical data.

Marker Screening: Select measurable biomarkers in combination with available literature, omics data, and early clinical signals.

Detection platform selection: common parties