Research Programs

Biomarkers Consortium

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

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

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

The Biomarkers Consortium’s Kidney Safety Project aims to qualify novel biomarkers of drug-induced acute kidney injury.

Biomarkers Consortium

The Biomarkers Consortium’s PET Radioligand Project, completed in December 2012, developed improved, more sensitive PET radioligands with higher binding to the peripheral benzodiazepine receptor. Findings from this study suggest that the [11C]PBR38 ligand, in particular, may be useful in detecting progression from mild cognitive impairment or treatment response in Alzheimer’s Disease.

Biomarkers Consortium

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

The Sarcopenia 1 project launched in 2010 and aimed to establish the first evidence-based definition of sarcopenia (muscle weakness), which is still not recognized as a medical condition.

Biomarkers Consortium

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.

Biomarkers Consortium

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

Biomarkers Consortium

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.