Abreos Biosciences, a San Diego-based biotech company and leader in the precision dosing of biological therapeutics, just announced a research collaboration with the FDA’s Center for Drug Evaluation and Research (CDER) to develop several therapeutic drug monitoring assays based on the Veritope™ platform. With this platform, Abreos rapidly produces sensitive and specific custom reagents that are easily adapted to different assay platforms, including point of care.
"This research collaboration with the team at the FDA is very important because it shows that the agency is focused on precision medicine as a means to improve outcomes and lower costs. We are very excited that they chose to work with us and recognize the benefits of our unique dose monitoring platform. In our minds, this is another indication that the simple idea of getting the right dose for the right patient can align all the key stakeholders in the healthcare ecosystem," said Bradley Messmer, Ph.D., CEO and founder of Abreos.
The overarching goal of this collaborative research by FDA-CDER and Abreos Biosciences is to study and evaluate novel methodologies for bioanalytical measurements of biologics & biosimilars. The FDA requires the use of methods that can be developed and validated rapidly to respond to urgent regulatory needs. Additionally, the methodology developed from this research will be applied to FDA-sponsored studies to characterize pharmacokinetic-pharmacodynamic effects of drugs.
Both sides hope that the use of novel technology for determining concentration of biological drugs can result in more efficient pathways for ensuring the safety and efficacy of human drugs.