C-Path Global Impact Conference 2025: Connecting the Dots Between Reasonably Likely Surrogate to..

Описание: This session from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) provides an expert panel discussion focused on the development, qualification, and application of biomarkers in progressive diseases, specifically autosomal dominant polycystic kidney disease (ADPKD) and Alzheimer’s disease (AD). The conversation is led by C-Path CEO Klaus Romero, Executive Director of its Polycystic Kidney Disease Outcome Consortium (PKDOC) Sorin Fedeles, Eisai Senior Vice President of Clinical Research Michael Irizarry, Mayo Clinic Rochester Professor of Medicine and Senior Associate Neera Dahl, and Hyman, Phelps & McNamara Director James Valentine.

The conversation begins with a detailed overview of the journey to qualify total kidney volume (TKV) as a prognostic biomarker for ADPKD, highlighting its significance in clinical practice and drug development. The panel then draws parallels between the TKV biomarker story in kidney disease and the evolving role of imaging biomarkers, particularly tau PET imaging and amyloid PET, in Alzheimer’s disease.

Key Topics of Discussion included:

FDA and EMA Qualification of TKV

Disease Progression Modeling and Simulation

Transition from Observational to Clinical Trial Data

Alzheimer’s Disease Biomarkers

Importance of Patient Perspectives

Incorporation of Patient Voice in Biomarker Meaningfulness

Ongoing Needs for Biomarkers in PKD

Biomarker Harmonization and Future Directions in Alzheimer’s

Balancing Uncertainty and Patient Access

Importance of Saving Biospecimens for Future Biomarker Development.


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About Critical Path Institute C-Path is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org. #CPath #drugdiscovery #researchgrants #globalhealth #drugdevelopment #datasharing #researchfunding #raredisease #academicresearch #regulatoryscience #globalhealth #consortia #collaboration #FDA #EMA #T1D #Parkinsons #Alzheimers #PKD #Duchenne #ALS #biomarkers