Opportunities to Engage With the FDA About Qualification During Biomarker Development

Hello. I’m Dr. Kylie Haskins with the FDA’s Center
for Drug Evaluation and Research, also known as CDER. In this module, I will highlight some of the
many opportunities that biomarker developers interested in qualifying a biomarker have
for interacting with CDER’s staff. These interactions can help guide biomarker
development from the early phase of development through qualification of the biomarker. Biomarker development can be a long and resource-intensive
process. CDER offers multiple opportunities for biomarker
developers to engage with FDA staff, which can help to clarify the path and ensure that
activities stay on track. FDA offers biomarker developers interested
in seeking qualification three primary opportunities for engagement: the Critical Path Innovation
Meeting, the Letter of Support Program, and the Biomarker Qualification Program. An initial opportunity for biomarker developers,
in the early stage of development, to engage FDA is the Critical Path Innovation Meeting. These meetings cover innovative strategies
that aim to address a broad range of challenges in drug development. Among these innovations are biomarkers in
the early phase of development that are not yet ready for CDER’s Biomarker Qualification
Program. A Critical Path Innovation Meeting offers
an opportunity for CDER and the biomarker developer to explore the potential of a proposed
biomarker. The meeting is not a forum for obtaining regulatory
decisions and it is not a formal part of the biomarker qualification process. Instead, the intent of the meeting is to help
developers understand some of the important regulatory questions FDA may have about the
proposed biomarker and obtain general advice early in the development process. Topics for meetings held to date are publicly
available on the program’s website. The second opportunity is for biomarker developers
with preliminary data to engage with CDER staff through the Letter of Support Program. Biomarker developers can request a Letter
of Support from CDER for promising biomarkers that have a potential application in drug
development. CDER will evaluate the acceptability of the
request and determine whether to issue a letter. A Letter of Support is meant to enhance the
visibility of a biomarker, demonstrate the FDA’s support for the development of the
biomarker, encourage collaborative efforts, and stimulate additional studies. The letter briefly describes CDER’s thoughts
on the potential value of a promising biomarker across multiple drug development programs
and encourages further evaluation. The letter does not connote qualification
of a biomarker and does not endorse a specific biomarker test or device. CDER has issued 14 Letters of Support for
promising biomarkers and these letters are publicly posted on the program’s website. A third opportunity for biomarker developers
to engage with FDA is the Biomarker Qualification Program, which requires a greater level of
data than the Letter of Support Program. The qualification process includes three submission
milestones that have increasing levels of evidence required: the Letter of Intent, the
Qualification Plan, and the Full Qualification Package. Specifically, at each submission milestone,
the qualification requester will receive a formal written determination letter from the
FDA accepting or declining the submission. This letter will also include the rationale
for the decision, advice, and requests for additional information, as appropriate. Formal written determinations will be publicly
available on the FDA website and will be updated on at least a biannual basis. Throughout the biomarker qualification process
requesters can engage the program to seek clarification regarding the content of a determination
letter or to obtain additional information about the qualification process, as needed. After qualification, if additional data is
generated for the biomarker that supports an expanded context of use in drug development,
the biomarker developer can seek qualification of the biomarker for the expanded COU and
may engage with the FDA throughout the new qualification process. Throughout biomarker development there are
opportunities to interact with FDA to enhance the prospects for successful development and
qualification of a biomarker for a specified context of use. This module served as a brief introduction
to opportunities for engaging with FDA about qualification during biomarker development
through the Critical Path Innovation Meeting, the Letter of Support Program, and the Biomarker
Qualification Program.

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