Who, in FDA, evaluates biomarker data and recommends for or against qualification?
The initial data evaluation and qualification recommendation is made by the Biomarker Qualification Review Team (BQRT). This team is comprised of reviewers drawn from offices within CDER (and others in FDA as appropriate). The team will have representation from each of the disciplines necessary (as appropriate) to ensure adequate breadth of expertise.
What if CDER declines the LOI request?
If CDER declines the request to initiate the biomarker project described in the LOI, a communication to the submitter will include the reasons for the decision, and any advice on alternative paths for biomarker development and consideration.
Can an imaging biomarker be qualified if the imaging agent used in biomarker development is unapproved?
In some cases, measurement of an imaging biomarker will require administration of a specialized imaging agent (drug). Qualification of the biomarker is distinct from marketing approval of the imaging agent. When the imaging agent is already approved and the biomarker context of use relies on imaging agent use that is consistent with the imaging agent’s approved labeling, biomarker development can proceed without need of an IND. When feasible, imaging biomarker contexts of use should be carefully planned and described so that, if qualified, no unapproved indication for use of the imaging agent is implied or can be inferred. When the imaging agent is not already approved, the clinical studies supporting biomarker development will need to be performed under an IND.
Can different assays or methods be used by drug sponsors when using a qualified biomarker in an IND/NDA/BLA?
Drug Sponsors may choose to use, within their IND/NDA/BLA the same assays or methods that were used by the submitter to arrive at qualification, or may choose to use an alternate assay. When planning to use a qualified biomarker, drug Sponsors should identify within their IND/NDA/BLA which methodology or assay is proposed for use. If the methodology or assay is the same as was used to generate the data to support the Qualification, no further information on the method or assay is needed to support the context of use. When Sponsors choose an alternate assay or method they should provide the Review Division, via submission to the particular IND/NDA/BLA, information to support the conclusion that the alternate method or assay is similar to those that are known to support the qualified context of use. This will most easily be accomplished when a comparison of performance on appropriate test samples can be performed with the new assay and the assay used in qualifying the biomarker. When that comparison can be adequately evaluated, the drug Sponsor will not need to obtain additional evidence to support the use of the biomarker measurements for the qualified context of use.
Who do I contact for more information?
CDER-Biomarker Qualification Program