Effective drug development programs ideally begin exploring biomarker candidates at the preclinical phase.
Pre-Clinical Validation Testing
Drugs that modify blood function (red blood cell health, thrombosis, WBC activation, etc.) often have corresponding clinical endpoints that are subjective and not easily evaluated in a clinical trial.
Even the best compounds evaluated in the most well-designed clinical trials can be derailed in the absence of biomarkers that can stratify the target population, monitor the effect of the drug, or serve as a surrogate endpoint.
At Functional Fluidics, we understand that effective drug development programs must begin exploring biomarker candidates at the preclinical phase.
Animal or Observational Pre-Clinical study
Whether it is an animal study or an observational study on a target patient population, Functional Fluidics can:
- Assess the efficacy of a drug based on functional markers of blood cell performance
- Refine the mechanism of action of a drug based on in vitro blood function properties
- Measure the pharmacodynamic response to red blood cell-modifying drugs as well as other blood function modifying drugs
- Refine the dose and timing for optimal drug administration and maximum efficacy with minimal detrimental effects on blood cell function
- Guide transition of a drug from in vitro, to animal, to human studies / clinical trials
- Analyze the data from our extensive clinical data database to plan future studies for maximum impact
- Stratify patient sample population and enrich your recruitment through functional biomarker-defined selection criteria
Proprietary Lab Developed Tests
Whether your drug is in preclinical development or it already been approved by the FDA, healthcare providers will need well-validated biomarkers to objectively assess the impact on red blood cell health, and ultimately patient health. Our suite of proprietary cell function assays can help validate assumptions or support clinical claims.
- Flow Adhesion:
Our Flow Adhesion Assays capture the adhesive properties of an individual’s blood cells during conditions that simulate physiologic blood flow.
- Mechanical Fragility (MF):
Our Membrane Fragility assay determines the stability of the intact RBC membrane, which indicates the health of the RBC and may predict RBC survival.
Functional Fluidics Assays
Our suite of proprietary cell function assays can help validate assumptions or support clinical claims.
Publications & Abstracts
Longitudinal Evaluation of a Standardized P-Selectin Flow Adhesion Bioassay: Potential Role for the Assessment and Prediction of Vaso-Occlusive Episodes in Sickle Cell Disease
Sevuparin blocks sickle blood cell adhesion and sickle-leucocyte rolling on immobilized L-selectin in a dosedependent manner
Impact of environment on Red Blood Cell ability to withstand mechanical stress
An approach to measuring RBC haemolysis and profiling RBC mechanical fragility
Low molecular weight heparin inhibits sickle erythrocyte adhesion to VCAM-1 through VLA-4 blockade in a standardized microfluidic flow adhesion assay
A Longitudinal Study to Identify and Assess Adhesion Indices during Vaso-Occlusive Crises in Adults and Adolescents with Sickle Cell Disease