AvivoClin, which was set up last year, is part of Azopharma’s efforts to capture a share of the potentially lucrative contract microdosing market and expands on the units existing Phase I to III trial offering.
The 25,000 sq ft Dayton Beach facility can accommodate 100 trial participants. In addition, the expanded unit has a dedicated intensive care facility and staff that the firm believes will help it win contracts for Phase 0 studies where close monitoring is required.
Azopharma did not respond to in-PharmaTechnologist’s request for additional information. In a statement issued by company, CEO Phil Meeks is quoted as saying “The increased space and capabilities allow us to better serve the needs of our clients.”
Meeks added that the central laboratory services, also recently added at the Daytona site, will help the firm provide a higher level of clinical service.
Microdosing a potentially big market
Phase 0, or microdosing, trials use accelerator mass spectroscopy (AMS) analysis to predict the absorption, metabolism, distribution and elimination (ADME) and pharmacokinetics (PK) of sub-therapeutic amounts of candidate compounds in volunteer subjects.
In general it is thought that such trials are safer than therapeutic dose studies due to the low concentrations involved and, as a result, are subject to less stringent regulations and can be completed more quickly and at a lower cost than Phase I studies.
However, the US Food and Drug Administration (FDA) is yet to be completely convinced. A spokesperson from the agency's Centre for drug Evaluation and Research (CDER) told Outsourcing-pharma that: "there is still uncertainty as to how well microdoses predict pharmacokinetics of pharmacologically active doses."
"Since the issuance of the "Exploratory IND" guidance by CDER 3 years ago, where micro dosing was recognized as one of the new ways of learning quickly about a drug in humans at early stage, we in CDER have seen only a limited number of applications utilizing this tool."
Despite this, the general consensus among pharmaceutical firms is that microdosing trials are likely to increase in popularity as drugmakers try to minimise candidate failure risk in the increasingly competitive global market.
Much of the work carried out in this area is being spearheaded by contract research organisations (CRO). Xeleron, one of the markets leaders, published research indicating that Phase 0 PK data for 15 of 18 drugs it tested in a recent trial closely matched the PK observed at Phase I.
In addition, reports suggest Xeleron’s collaboration with the European Microdosing AMS Partnership Programme (EUMAPP), details of which are due to be published this year, will produce similar positive results and will further validate the technique’s utility.
The main hurdle preventing the more widespread acceptance and use of microdosing is that drugmakers are often reticent to release details of Phase 0 studies for reasons of commercial sensitivity.
For example, some companies are unwilling to share data from candidates that are perceived as failing in order to avoid potential damage to their R&D reputations and provide hints to rivals as to the markets they are targeting.