Drugs

3 Biomarker Information Sources Affecting Drug Development

CDER Office of New Drugs Biomarker Qualification Program co-director Chris Leptak says there are three sources of biomarker information that can affect drug development and potentially facilitate a drug approval. Appearing in an agency video, Leptak says that the three primary sources for biomarker evidence that can be considered by FDA to inform regulatory decisions are:

Scientific Community Consensus that comes primarily from published scientific studies that can lead to improved scientific understanding of a disease or a biologic process. The challenge, he says, is that the information accrues over time, is many times not gathered with a common intent, and is shared in such a way that comparing information across publications is difficult.
Specific Drug Approval Process involving biomarker use as part of the development of a specific investigational new drug or biologic. Leptak says the information for a given drug program can be used by other drug companies if the biomarker ultimately proves to have more generalized applicability.
CDER Biomarker Qualification Program can establish a biomarker’s value for a particular context of use in drug development and for regulatory review.

“Each pathway has strengths and limitations,” Leptak says, “that sponsors should take into account given the particular reasons and circumstances for using a biomarker in drug development, including what resources are available, the type of biomarker, and opportunities for collaboration with others. Emerging regulatory experience with these various pathways and data sources suggests that some types of biomarkers may be more appropriate for one pathway over another. However, this choice is not always clear, particularly in early development stages. More clarity is needed as to when regulatory acceptance of biomarkers would follow one path or another. Ultimately, since biomarker development is a voluntary activity, the developer retains the choice of which pathway to pursue. Whether the drug developer is a company or a consortium, and regardless of which pathway is selected for applying biomarkers in a drug development program, consulting FDA is a critical step to achieve success.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome