Biomarker-IVD Validation

Advanced clinical research consulting for efficient product development, from dose-finding to confirmatory trials

Almustat has advanced knowledge and extensive real-world experience delivering innovative analytical strategies to pharmaceutical and biotech companies.

ANALYTICAL VALIDATION

Different aspects of assay performance:

Precision, limit of detection and linearity
Sensitivity, specificity, and predictive values
According to ISO standards and CLSI guidelines
For different assay platforms: single/multiplex, microarrays, mass-spectrometry, ELISA, RT-PCR, etc.

CLINICAL VALIDATION AND UTILITY

Efficiency and reliability for clinical use

Validation of biomarkers coupled with the therapeutic development.
Validation of biomarkers in the absence of a gold standard
Increased efficiency and reduced costs by using a unique Bayesian methodology that takes development data into account.

The development and qualification of biomarkers are keys to the future of drug development and personalized medicine.

Precision medicine relies on validated biomarkers that allow classification of patients by their probable disease risk, prognosis, or response to treatment.

Our statisticians have developed methods and published extensively on surrogate endpoints and biomarker-based endpoints to expedite drug development in precision medicine, notably in cancer research.

BIOMARKER APPLICATIONS

DIAGNOSTIC BIOMARKERS
Including in-vitro diagnostic devices (IVDs) and imaging tools as companion diagnostics for precision medicine
PROGNOSTIC BIOMARKERS
For patient enrichment and selection of treatment strategies
PREDICTIVE BIOMARKERS
For treatment choices and effective implementation of precision medicine
RESPONSE, SAFETY and MONITORING BIOMARKERS
For drug development and clinical use
SURROGATE BIOMARKERS
That can replace clinical endpoints in clinical trials

COMPANION DIAGNOSTICS AND CLINICAL DEVELOPMENT IN ONCOLOGY/ A STATISTICAL PERSPECTIVE

This webinar provided a discussion around the need for integration of biomarker and IVD validation in clinical development, with a focus in oncology and companion diagnostics.
It highlighted how flawed analytical and/or clinical validation can jeopardize a biomarker’s and drug’s clinical utility and showcase why biomarkers deserved statistical rigor throughout the development and validation process.