Faster, more efficient ways to develop diabetes biomarker assays

May 20, 2014 8:55:00 PM

In the race against diabetes

With the incidence of obesity and associated type II diabetes soaring, the race is on for the pharmaceutical industry to generate even better treatment for diabetes. GLP-1 (glucagon-like peptide 1) is an important biomarker for obesity and diabetes, and indeed a number of type II diabetes drugs are targeted at the GLP-1 receptor.

 

Diabetes-US

For example, in February Eli Lilly announced positive results from the sixth Award trial for their once-weekly experimental drug dulaglutide, a GLP-1 receptor agonist. The trial indicated that the drug was as effective at lowering blood sugar levels as other market-leading drugs.

 

Dulaglutide has been submitted to the FDA and the EMA for approval, with a decision expected by September. In this crowded field of GLP-1-related drugs, Eli Lilly are chasing others including GlaxoSmithKline with their once-weekly drug albiglutide, which has recently received approval for marketing in Europe but still awaits FDA approval.

Faster development means greater profits

Every day that a drug is not on the market means significant lost revenue for a pharma company. The race to market drives the need for faster development, enabled by more efficient methods for quantitating diabetes biomarkers. Pressure is on pre-clinical labs to quickly develop and validate assays that are sensitive, use small amounts of sample for pre-clinical screening, and deliver results rapidly for data-driven decision making.

A real-world example

This is exemplified by the experiences of Mark Dysinger, Senior Scientist at Pfizer. His group’s need for speed led them to use Gyrolab xP workstation for diabetes biomarker assay development, targeting GLP-1 in particular. Gyrolab xP workstation enabled them to turn data around faster, make critical decisions more quickly and give them the potential to get drugs onto the market sooner.

 

As Mark says, “Gyrolab xP workstation is an enabler”. You can find out more about his experiences by watching a video recording of his presentation.

Mark’s group also compared Gyrolab xP workstation with other Ligand Binding Assay platforms in the measurement of GLP-1*. The authors concluded that their study ”underscores the importance of due diligence when selecting an assay platform; there are no silver bullets, and one must take into account what is necessary for project needs and the intended use of the data”.

Gyrolab advantages reported

They did, however, find that the Gyrolab assay offered several advantages, including broad dynamic range, sensitivity, reproducibility and low sample volume. The throughput of Gyrolab xP workstation was also a clear advantage over the other platforms assessed. This is the kind of performance that pharma companies need in order to get new therapeutics onto the market ahead of the competition. Faster assay development, with reliable results, leads to faster drug development. 

 

Gyrolab assay development offered several advantages, including broad dynamic range, sensitivity, reproducibility and low sample volume.

 

Download the GLP-1 Gyrolab Assay Protocol

 

 


 

Reference:

*Fraser, S, Dysinger, M, Soderstrom, C, Kuhn, M, and Durham, R. Active Glucagon-Like Peptide 1 Quantitation in Human Plasma: A Comparison of Multiple Ligand Binding Assay Platforms, Journal of Immunological Methods (2014), doi: 10.1016/j.jim.2014.03.025

 

Topics: Assay Development, Diabetes biomarkers