Breakfast Workshop E: An Update from the FNIH Consortium: Progress and Guidance on the Use of the Data

Date/Time: Sunday, April 10, 2022 - 7:30 AM to 8:30 AM
Room: Bellevue
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Description:

An Update from the FNIH Consortium: Progress and Guidance on the
Use of the Data

The overarching goal of this project is to verify the novel radiographic measures, MRI measures and biochemical markers discovered in Phase I of the FNIH Biomarkers Consortium OA Project that can be used as

  • Clinical endpoints
  • Prognostic markers of disease progression
  • Predictive markers of treatment response (efficacy of intervention)

The data generated will be submitted to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) to qualify the imaging and biochemical biomarkers pertinent to knee OA for use in OA drug development.

This session will include a presentation of the design/ overview of the project; the results of MRI, biochemical and radiographic markers of disease progression prognosis; next steps in pursuit of qualification an overview of where to find the study phase I data and how to merge it with the larger OAI datasets.

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