Accium and Quintiles utilise AMS to provide unique services
agreement, which intends to offer turnkey Exploratory-IND,
Microdosing and Information-Rich Phase I clinical trials services
to biopharmaceutical researchers.
The partnership aims to make full use of the first fully commercial Accelerator Mass Spectrometry (AMS) analytical facility in the US.
The new services are in keeping with the FDA plans that has seen the issuance of an Exploratory IND guidance that gives the pharmaceutical industry new tools to conduct pharmacokinetics (PK) and ADME (absorption, distribution, metabolism and excretion) trials earlier in the clinical development process.
Using these trial designs and tools, pharmaceutical companies have the ability to select the best compound for further development earlier in the process.
"This allows an efficient use of their R&D budgets and a more rapid advancement of their new therapies," said Joseph Lacz, vice president, Clinical Technology Services, Quintiles.
Human microdosing is a concept, which relies on the ultrasensitivity of accelerator mass spectrometry (AMS). It is now possible to conduct a full human metabolism study after administration of as little as 0.5 microgram of drug substance.
In microdosing one or more drug candidates are taken into humans at trace doses. This information is then used as part of the decision tree to select which of the microdosed drugs has the appropriate PK parameters to take further.
The aim of these low dose screening ADME studies is to ensure that drugs do not have to be dropped later down the development pathway because of inappropriate metabolism eg first pass, too short a half-life, poor bioavailability etc.
Seattle-based >Accium BioSciences is the first company to fully commercialise Accelerator Mass Spectrometry (AMS) services in the US with a focus on early drug development.
Drug developers use bioanalytical platforms to evaluate pharmacokinetic (PK), biodistribution and metabolism of new drugs candidates, which include isotope-tagged liquid scintillation counting (LSC) methods, HPLC, and LC/MS/MS.
Accelerator Mass Spectrometry (AMS) is a highly-sensitive instrument designed to quantify the amount of isotope present in a sample. It is used in drug development to detect trace amounts of 14C-labeled compounds in biological samples.
AMS is so sensitive that it is only used for isotopes having concentrations of parts per billion to parts per quintillion in the isolated elemental sample. Recently, AMS instruments have been developed to quantify long-lived radioisotopes that are particularly suitable for pharmaceutical research,