Empirical data analysis was used to calculate healthy-control-based landmark variable cut-offs for stage classification and to internally validate the framework. The group used a formal consensus methodology to consider which prognostic biomarkers, signs, and symptoms of HD would be best for defining stages. The RSF was tasked with generating the new evidenced-based HD-ISS. 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).

Long is one of the academic members of a larger working group formed under the auspices of the Critical Path Institute (C-PATH), a non-profit that advances regulatory science opportunities. In a recent symposium at Vanderbilt University Medical Center (Nashville, TN), Jeff Long, Ph.D, Professor of Psychiatry and Professor of Biostatistics at the University of Iowa, presented an overview of a newly proposed staging system for HD: the HD Integrated Staging System (HD-ISS). The HD-ISS is based on a biological definition of HD that considers the full course of HD starting at birth, and provides an evidence-based staging system that fills a gap in HD clinical research The Huntington’s Disease Integrated Staging System (HD-ISS): A New Staging System for More Targeted Research

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