Founded in 2018, HD-RSC leads collaborations that accelerate advancement of Huntington’s disease (HD) therapies to improve the lives of all affected. The Problem Huntington’s disease (HD) is an autosomal-dominant neurodegenerative disorder caused by expansion of a CAG trinucleotide repeat in the huntingtin gene that encodes a mutant ...

2021年9月11日 · To generate a new evidenced-based HD Integrated Staging System (HD-ISS) using a formal consensus methodology, the RSF considered prognostic biomarkers, signs, and symptoms of HD, and performed empirical data analysis.

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The HD Regulatory Science Consortium (HD-RSC), a precompetitive C-PATH initiative, created the Regulatory Science Forum working group (RSF), which includes industry and academic representatives (Long being among them). The RSF was tasked with generating the new evidenced-based HD-ISS.

2021年9月11日 · The Huntington’s Disease Regulatory Science Consortium (HD-RSC. 23) is dedicated to building regulatory science strategies and creating new tools and methods to accelerate and de-risk the development and approval of HD therapeutics (see supplementary material). The HD-RSC

Here, the Biomarker Working Group of the HD-RSC summarizes the cross-sectional evidence indicating that regional brain volumes, as measured by volumetric magnetic resonance imaging, are reduced in HD and are correlated with disease characteristics.

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2019年9月23日 · Objective: To align with regulators on the utility and development strategy of novel clinical outcome assessments for use in Huntington’s disease (HD) clinical trials. Background: The HD-RSC is a joint activity of the Critical Path Institute and CHDI Foundation and is creating and pursuing a regulatory science strategy for HD. Emerging ...