Back in September the US Food and Drug Administration announced that it was going to delay its publication of draft guidance on the qualification of drug development tools, originally promised for the summer.  However, this draft guidance was finally published at the end of October.  While still in draft form, the Guidance substantially expands on the outline of the pilot qualification process given in an article written by two members of the Center for Drug Evaluation and Research published in 2007.

The new guidance principally provides information on the proposed administrative process that will be followed by the FDA in order to qualify new drug development tools (DDTs).  Qualification is defined as “a conclusion that within the stated context of use, the results of assessment with a DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review.”  The document discusses two forms of DDT – biomarkers and patient-reported outcome scales.  There are couple of points that bear discussion in relation to biomarkers.

Firstly, the new qualification procedure is aimed at enhancing the utility of a qualified biomarker across the industry.  Hence, while previously use of a biomarker may have been part of an NDA, IND or BLA, this new programme is designed to make public those biomarkers that satisfy the qualification process, so that future drug development programmes can take advantage of already knowing that the biomarker has been qualified for a particular purpose.  Of course, wherever a new biomarker is proprietary, it can be retained as such by not using the new qualification process, but by remaining part of the NDA, IND or BLA.  This new programme, it seems therefore, is not particularly aimed at individual companies, but more towards collaborative groups that together can share the burden of the development of the drug development tools and submission to the FDA.  Indeed, less than a month after the draft guidance was published, several major pharmaceutical companies and leading academic institutions announced such a collaborative biomarker consortium for COPD.

Secondly, while there is detailed information as to the administrative process, there is no information on the level of evidence required by the FDA to take a biomarker through from submission to qualification.  There are a number of discreet stages that have to be undertaken, but nowhere are the criteria on which a new biomarker will be assessed described.  The means by which such an assessment may be made are described:  In the first stage they include a consultation process between the submitter and the FDA, and formal …

The Cambridge Partnership is the only professional services company in the UK exclusively dedicated to supporting companies in the biotechnology industry. We specialize in providing a “one-stop shop” for accountancy, company secretarial, IP management and admin services. The Cambridge Partnership was founded in 2012 to fill a gap. Running a biotechnology company has little …