Biomarkers and Drug Development: Regulatory Perspective | Christopher Leptak

Foresight Biotech & Health Extension Group sponsored by 100 Plus Capital

Christopher Leptak | CDER Biomarker Qualification Program, FDA : Biomarkers and Drug Development: Regulatory Perspective

Christopher Leptak, Director of the CDER Biomarker Qualification Program at the FDA, will join us for a discussion on how to develop biomarkers for FDA-recognized diseases. While aging is not an FDA-recognized disease, and thus falls outside of the scope of this discussion, Christopher may help us shed light on the development of biomarkers for those diseases which are FDA-recognized. Introductory remarks by Christopher will be followed by a group discussion. For context and background reading, Christopher co-authored the article: “What evidence do we need for biomarker qualification?” Abstract:“Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.”

Zoom Transcription:

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[sueroy]

WOW, someone once told me about the academ mind, so crowded with egotistical, over exaggeration. Which leaves no room for any other experiences.