Gaining FDA Support for a Prognostic Biomarker, Giving Patients Hope

Samer Mouksassi

As a clinician scientist, I get really excited about helping sponsors develop new treatments for patients. For some diseases, the lack of a validated prognostic biomarker is an impediment to developing effective treatments. In this blog post, I’ll discuss how we worked with the Critical Path Institute (C-Path) Polycystic Kidney Disease Outcomes Consortium to gain FDA support for a prognostic biomarker for a rare disease, autosomal dominant polycystic kidney disease (ADPKD). Having a validated biomarker will help spur new research and clinical trials to find a treatment for ADPKD.

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