Drug Development in Kidney Disease: Proceedings From a Multistakeholder Conference.

Area of Science:

• Nephrology
• Pharmacology
• Clinical Research

Background:

• Drug development in nephrology has seen limited innovation over recent decades.
• Emerging therapies, such as sodium/glucose cotransporter 2 inhibitors, show promise for kidney disease.
• There is a critical need to stimulate research and development for novel kidney disease treatments.

Purpose of the Study:

• To identify and address existing barriers in nephrology drug development.
• To explore opportunities for improving all phases of kidney disease drug development.
• To foster collaboration among stakeholders to advance therapeutic innovation.

Main Methods:

• Convened a multi-stakeholder conference (Duke Clinical Research Institute, April 2019) including academia, industry, government, and patient advocacy groups.
• Discussed key challenges and opportunities across the drug development pipeline.
• Reviewed strategies for enhancing research networks, trial design, and data utilization.

Main Results:

• Identified several opportunities to optimize kidney disease drug development from discovery to clinical practice.
• Highlighted the importance of interconnected data and research networks.
• Emphasized the potential of surrogate endpoints, adaptive trial designs, and real-world data.

Conclusions:

• Progress in nephrology, exemplified by SGLT2 inhibitors, indicates a potential renaissance in kidney disease drug development.
• Strategic improvements in research infrastructure, trial methodologies, and data integration are essential.
• Enhanced collaboration and focus on generalizability and uptake are vital for translating discoveries into improved patient care.