Standard one-size-fits-all dosing paradigms are clearly not optimal, and we hope that our drug monitoring tests can be used in clinical trials and enable precision dosing. We are excited to work with FDA CDER on testing this novel technology.
SAN DIEGO (PRWEB) March 26, 2019
Abreos Biosciences, a San Diego-based biotech company and leader in precision dosing of biological therapeutics, is pleased to announce a research collaboration with the FDA’s Center for Drug Evaluation and Research (CDER) to develop several methods to measure the drug concentration of biologic drugs 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 in clinical trials.
“Biologics are among the most powerful therapeutics available for many serious diseases, but there is enormous inter-patient variability in their pharmacokinetics. Standard one-size-fits-all dosing paradigms are clearly not optimal, and we hope that our simple and deployable drug monitoring tests can be used in clinical trials and enable personalized, precision dosing. We are excited to work with CDER on testing this novel technology.” said Bradley Messmer, Ph.D., CEO and founder of Abreos.
The overarching goal of this collaborative research between 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.
It is hoped by both sides that the use of the novel technology for determining concentration of biological drugs can result in more efficient pathways for ensuring the safety and efficacy of human drugs.
For additional information please go to http://www.abreos.com or contact info(at)abreosbio(dot)com.