FDA intends for many individual components of Critical Path to be carried out by consortia. One early model is the Predictive Safety Testing Consortium, established by the non-profit Critical Path Institute (C-Path) and eight pharma companies. The participants have agreed to cross-test each other's pre-clinical laboratory methods to determine which are most effective in detecting kidney, muscle, and liver toxicity.
C-Path will submit the resulting data to FDA, which will weigh whether the information supports new guidance on detecting kidney or liver safety problems during development. The goal is to identify the most informative tests—animal, in vitro, or clinical—for predicting toxicity, explains C-Path president Ray Woosley.
With early insight into which compounds have unacceptable side effects, companies can avoid spending on unpromising drug candidates and spur efforts to find safer compounds. Consortium members will have access to data on test methods—and opportunities to license resulting patentable technologies.
Another consortium, the Oncology Biomarker Qualification Initiative, was formed by FDA, the National Cancer Institute (NCI), and the Centers for Medicare and Medicaid Services (CMS). The group's first project is to evaluate whether PET scans can provide a marker for early drug response in non-Hodgkin's lymphoma. The project could create a new tool for assessing how well molecular imaging technology reveals drug interaction with a target. The results may be useful, moreover, for tumor staging and helping providers, payers, and patients make treatment and coverage decisions.
Woodcock regards the opportunities list as an evolving document and expects to issue an update of activities underway this summer. One project on the table is an FDA–industry effort to identify biomarkers that already exist, to demonstrate the practical value of such measures.
FDA participated in an Institute of Medicine workshop on cancer biomarker development in March and plans to hold a workshop on what type of evidence is needed to qualify biomarkers for different purposes. This should lead to a general biomarker qualification guidance describing ways to link biomarker validation to intended uses. Additional guidances on specific qualified markers will follow, possibly starting with documents on testing for liver and kidney toxicity. Also on the agenda is draft guidance on drug–diagnostic co-development.