Xceleron, a provider of bioanalytical accelerator mass spectrometry (AMS) services for accelerated early drug development, has entered into a partnership with JCL Bioassay, a Japanese CRO and provider of bioassay services for preclinical and clinical developments. The partnership seeks to offer drug developers access to a range of sensitive and robust analytical platforms for early clinical development across Asia, Europe, and North America.
"This partnership emphasizes the crucial role of contemporary analytical platforms in driving down the cost of drug development. Whether in Phase 0 or enriched Phase I, we can confidently provide critical pharmacokinetic and pharmacodynamic information before Phase II," said Dr Michael Butler, CEO of Xceleron, in a press statement.
Over the years, Phase 0 and enriched Phase 1 studies have been used successfully in to investigate a range of developmental endpoints such as the presence of drug at tissues or cells of interest, absolute bioavailability, and human metabolism. These studies when conducted early in drug development allow confident decision-making that offers a cost-effective alternative when compared to later stages of clinical development.
More than 100 analytical methods for Phase 0 and enriched Phase I investigations have been developed between Xceleron and JCL Bioassay. Both companies recently built laboratories that are equipped and staffed specifically for the purpose of conducting ultra-low level analyses under good laboratory practice (GLP) and good clinical practice (GCP) conditions. This partnership will provide access to clinical design expertise as well as appropriate analytical platforms for the purpose of early clinical investigation.