SEATTLE—Mass spectrometry specialist Accium BioSciences and clinical research company Radiant Research recently announced the signing of a co-marketing agreement that will see the two companies combine their expertise in microdosing or Phase 0 analysis to provide more extensive clinical services worldwide. The partnership will effectively see the two companies become a one-stop shop in the growing area of pre-clinical and early clinical pharmacokinetics (PK) testing.
"Accium has identified and established a network of highly qualified and experienced companies that provide services critical to our analytical offering (i.e., 14C synthesis providers, animal testing facilities, clinical services providers)," says Mr. Michael Chansler, Accium's VP Business Development. "Radiant Research is a recognized and experienced clinical pharmacology provider known for its excellence in radiolabeled studies. By combining our respective service offerings, we can provide a 'Bundled Services' approach for our clients making it easier for contracting and insuring seamless quality processes."
Accium specializes in accelerator mass spectrometry (AMS) analytical services. AMS is a highly sensitive method used to identify very small amounts of tracer compounds as they pass through test subjects. Dr. Ali Arjomand, Accium president and COO, says this sensitivity is key for PK profiling.
"Since only 20 uL of blood or plasma is required for AMS measurement at each time point, a full PK profile can be determined from a single mouse or rat," he explains. This reduces the total number of animals required in a study and introduces less variability since all the time points are collected from a single animal. It also means that very little labeled drug is needed for human studies, reducing the risk to human volunteers.
Washington-based Radiant offers a suite of clinical trials services through more than 50 clinical research sites across the U.S.
According to Mr. Mike Lester, Radiant president and CEO, the relationship between the two companies will allow them to combine all aspects of microdosing studies.
"Microdosing technology is a new research tool that will significantly reduce clinical trial failures due to poor pharmacokinetic profiles," he explains. "While the applications of microdosing can be broad, Phase 0 testing allows for human pharmacokinetic data with reduced toxicology, CMC, and regulatory investment. The result is that researchers will know earlier if a drug development candidate has an adequate pharmacokinetic profile and help drug development companies move the right compounds into development."
