The Critical Path Institute (C-Path), together with CHDI Foundation, Inc. (CHDI), today announced the official launch of C-Path’s Huntington’s Disease Regulatory Science Consortium (HD-RSC). In addition to these cofounders, the consortium also includes more than 20 different member organizations, including industry partners, academic institutions, and nonprofit societies. HD-RSC members will work to advance innovation in regulatory science methods, supporting clearer development and regulatory pathways that lead to the approval of Huntington’s disease (HD) therapeutics.
“C-Path has an established record of success in leading precompetitive consortia whose members collaborate to advance innovation in the regulatory science of drug development. We value this new partnership with CHDI, an organization that also embraces collaboration as a mechanism to more quickly and efficiently reach a common goal,” said Martha Brumfield, PhD, President and CEO of C-Path. “We look forward to combining our strengths in this new consortium: C-Path’s successful track record in overseeing global consortia and CHDI’s HD therapeutic domain knowledge.”
HD-RSC will provide the platform for the collaboration needed to facilitate clinical data sharing and standardization, to support the development of modeling tools, and to bring forward these tools as well as biomarkers and clinical outcome assessments for regulatory endorsement. These drug development tools will be made publicly available to help accelerate the time to drug approval and de-risk the drug-development pathway, thereby further incentivizing drug developers to enter the HD sphere. HD-RSC will work collaboratively with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) staff to align on areas of high unmet need in developing therapies for this devastating disease.
“With this dedicated regulatory science consortium, stakeholders can share data and knowledge while avoiding duplication of efforts,” said Robi Blumenstein, President of CHDI. “It provides a forum for everyone interested in HD therapeutics, including regulators, to participate in the development of an appropriate regulatory pathway that will deliver therapeutics to patients and families as soon as possible. This aligns perfectly with CHDI’s mission to rapidly and collaboratively develop therapeutics that substantially improve the lives of individuals affected by Huntington’s disease.”
Charles Sabine, an HD patient-advocate, emphasizes the need to move forward with purpose in HD drug development: “We have hope,” he said, and “hope can only be built on the trust that everyone is working as fast as they can in the same direction.”