KHI Pilot Projects 2013
Promoting Kidney Health and Innovative Treatments for Kidney Disease: Barriers and Potential Solutions
Patient Care Issue:
More than 20 million Americans have CKD and more than 600,000 Americans have kidney failure or ESRD. Too few new products treating or preventing kidney disease have appeared on the market as companies and researchers face a variety of barriers to the innovation of new therapies in the kidney community.
Barriers exist in the discovery phase of development, in developing new therapeutics, and in establishing the evidence base for clinical practice. These obstacles include a lack of infrastructure, uncertain regulatory landscape, lack of universally accepted clinical trial endpoints, and payer and reimbursement challenges.
A workgroup comprised of KHI members from patient groups, health professional organizations, industry, and representatives from FDA examined, defined, and explained the major barriers to innovation in kidney health. The white paper also identified potential solutions to those barriers. This project framed the strategic priorities that will stimulate innovation in kidney disease.
The workgroup's manuscript was published in the Journal of the American Society of Nephrology (JASN) in July 2016.
Timeframe for completion:
- Peter Linde, MD, FASN, AbbVie Inc. (KHI Board of Directors)
- Patrick Archdeacon, MD, Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA (KHI Co-Chair)
- Matthew D. Breyer, MD, FASN, Eli Lilly and Company (KHI Board of Directors)
- Ronald J. Falk, MD, FASN, University of North Carolina Chapel Hill (KHI Board of Directors)
- Jula Inrig, MD, FASN, Quintiles Global Clinical Research Organization (KHI Board of Directors)
- Reshma Kewalramani, MD, FASN, Amgen Inc. (KHI Board of Directors)
- Celeste Castillo Lee, Raleigh, NC (Liaison for the Vasculitis Foundation) (KHI Board of Directors)
- Carolyn Y. Neuland, PhD, Center for Devices and Radiological Health (CDRH), FDA (KHI Board of Directors)
- Prabir Roy-Chaudhury, MD, PhD, FASN, University of Arizona (KHI Co-Chair)
- James A. Sloand, MD, FASN, Baxter International Inc. (KHI Board of Directors)
- Kimberly Smith, MD, MS, Center for Drug Evaluation and Research (CDER), FDA and formerly Center for Medicare and Medicaid Services
- Jennifer Snook, PharmD, Chicago, IL