Critical Path Institute (C-Path) and CHDI Foundation have joined forces to create a consortium geared toward clearly defining regulatory pathways for faster approval of new Huntington’s disease (HD) treatments.
The new HD Regulatory Science Consortium (HD-RSC) will gather participants from the Huntington’s disease community to expedite regulatory endorsement and to facilitate clinical data standardization and collaboration.
Drug development tools, such as biomarkers and clinical outcome assessments, will be made public to help diminish risks associated with drug development, to speed time to drug approval, and to inspire drug developers into the Huntington’s realm.
The HD-RSC was created in response to the US Food and Drug Administration’s (FDA) Guidance for Industry and FDA Staff – Qualification Process for Drug Development Tools.
Among other projects, the HD-RSC will focus on the regulatory qualification of biomarkers and outcome measures, and the development of a clinical trial simulator. The consortium will also collaborate with the Clinical Data Interchange Standards Consortium (CDISC) to develop therapeutic data standards and then store and share the data to be used as a foundation for projects across the board.
C-Path, a non-profit organization dedicated to accelerating new approaches that advance medical innovation and regulatory science, will be in charge of managing the consortium’s daily activities. The group will meet for the first time in the second quarter of 2017.
CHDI, a non-profit biomedical research organization focused only on Huntington’s, will be in charge of planning and start-up funds.
Because of the HD-RSC’s pre-competitive approach, CHDI, C-Path and others will share data and other knowledge to avoid duplicating efforts. The consortium aims to boost collaboration in innovative ways so that scientific advances can be translated quicker into new therapies.
“One of the fundamental challenges to drug development for a genetically predetermined disease such as [Huntington’s disease] is shifting the paradigm for drug approval, so that we can intervene as early as possible; ideally, this would eventually be before any overt symptom onset,” Martha Brumfield, PhD, president and CEO of C-Path, said in a press release.
Brumfield stressed that quantitative analytical approaches to address the problem, data sharing, standardization, and aggregation through a defined procedure are most important to the process.
“In this regard, C-Path’s core competencies in clinical data standards development, as well as secure data management, standardization, and curation, will be tapped. These skills, combined with C-Path’s track record of success in consortium building and regulatory science, and CHDI’s extensive data resources and research network, provide a solid foundation for the HD-RSC’s success,” Brumfield said.