Programs

To tackle the human health challenges that face the world today, the FNIH develops collaborations with top experts from government, industry, academia and the not-for-profit sector and provides a neutral environment where we can work productively toward a common goal.

Biomarkers Consortium - I-SPY TRIAL-2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and MoLecular Analysis): An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

Phase II trial of novel investigative breast cancer agents in the neoadjuvant setting that uses biomarkers and adaptive design to accelerate the clinical trial process.

Biomarkers Consortium - High Definition Single Cell Analysis of Blood and Tissue Biopsies in Patients with Colorectal Cancer Undergoing Hepatic Metastasectomy

The project seeks to show that a liquid biopsy can serve as a source of rare circulating cells (CTCs) to comprehensively represent the traditional solid biopsy. The project is designed in two stages to demonstrate the correlation between liquid and solid biopsies in an observational clinical study with metastatic colorectal cancer (mCRC) patients undergoing resection of liver metastases.

Biomarkers Consortium - Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Clinical Endpoint Development (HABP/VABP)

The Biomarkers Consortium’s Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) Project aims to develop clinically relevant endpoints in clinical trials to improve antibacterial trial feasibility.

Biomarkers Consortium - Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) Lung and Lymphoma

Build the case for FDA incorporation of FDG-PET into outcome measures for lung cancer and lymphoma.

Biomarkers Consortium - Carotid MRI Development and Validation via an AIMHIGH Sub-Study

The goal of this project was to conduct a 75-patient study at a total of 15 centers to determine the reproducibility of the non-invasive technique of carotid magnetic resonance imaging (CMRI). Results established a standardized carotid MRI protocol and determined, for the first time, that kinetic parameters of carotid atherosclerotic plaque are reproducible and can be used for multi-center studies.

Biomarkers Consortium - Developing Endpoints for Clinical Trials in Community Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Infections (ABSSSI)

The Biomarkers Consortium’s Developing Endpoints for Clinical Trials in CABP and Skin Infections aims to develop approaches that will help the U.S. Food and Drug Administration develop efficacy outcome measures (endpoints) for modern-day clinical trials of investigational agents for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Biomarkers Consortium - Bone Quality Project

The Biomarkers Consortium’s Bone Quality Project aims to evaluate and to identify biomarkers of bone strength and quality changes by analyzing pooled imaging and biochemical data from multiple clinical studies to allow definition of better clinical endpoints.

Biomarkers Consortium - Diabetes Drug Development: Identification and Validation of Markers That Predict Long-Term Beta Cell Function and Mass

This is the first project in a two-stage strategy that seeks to characterize beta cell function for predicting long-term beta cell response to an intervention based on short-term measures. The first stage’s goal is to characterize key methodological issues in the assessment of beta cell function by evaluating Mixed Meal Tolerance (MTT) and Arginine Stimulation Tests against the standard Frequently Sampled Intravenous Glucose Tolerance (FSIGT) Test in a series of clinical studies.

Biomarkers Consortium - In Silico Modeling of Biomarkers of Atherosclerosis: Estimating Risk Reduction and Residual Risk from Statin Therapy

The Biomarkers Consortium’s In Silico Modeling of Biomarkers of Atherosclerosis: Estimating Risk Reduction and Residual Risk From Statin Therapy’s goal was to identify a time-dependent, dynamically-responsive panel of extant markers that change in response to Phase II intervention and predict Phase III clinical cardiovascular outcomes to build the model. This model would support cardiovascular drug development decision-making and assessment of atherosclerotic risk in the development of drugs for other indications.

Biomarkers Consortium - Evaluation of the Utility of Adiponectin as a Biomarker for Predicting Glycemic Efficacy

The primary objective of this project was to determine whether a 30kDa adipocyte-secreted protein, adiponectin, has utility as predictive serum biomarker of glycemic control in normal non-diabetic subjects and patients with type 2 diabetes, following treatment with a novel and promising new class of compounds, PPARγ agonists. Results confirmed previous relationships between adiponectin levels and metabolic parameters, and support the robust and predictive utility of adiponectin across the spectrum of glucose tolerance.