Author: [AUTHOR] Published on 3/11/2019 3:15:00 PM

First Qualified Biomarker for Parkinson's Disease by Regulatory Agency

The Critical Path for Parkinson's (CPP) Consortium has received positive qualification opinion by EMA for the use of dopamine transporter (DAT) neuroimaging as an enrichment biomarker to identify patients more likely to progress in Parkinson disease (PD) clinical trials.  The basis of this qualification was a quantitative  PD progression model, which demonstrated the enrichment utility of DAT neuroimaging via clinical trial simulations.

CPP, a Critical Path Institute (C-Path) consortium, aims to accelerate drug development for Parkinson's by advancing quantitative solutions that can optimize the evaluation of drug efficacy and safety. Do you want to help lead CPP's digital drug development tools initiative in Parkinson disease?  Apply here.

This communication was prepared by the Critical Path for Parkinson's (CPP) Consortium.

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