The Kidney Health Initiative (KHI) was created in September 2012 through the signing of a memorandum of understanding between the American Society of Nephrology and the U.S. Food and Drug Administration. It is important to give recognition here to Dr. Ronald J. Falk, who in his role as ASN President at the time, was the true visionary and champion behind the formation of KHI (together with strong support from FDA leadership).
The rationale behind the formation of KHI was simple. Despite the very significant morbidity, mortality, and economic cost associated with diseases of the kidney, there were almost no new therapies entering the kidney space. The mission for KHI, therefore, was well defined: to create an innovation substrate that would facilitate the passage of drugs, devices, and biologics into the kidney space, and to do so in a multi-disciplinary fashion that would include all the diverse stakeholders in the field.
Starting from a small group of interested stakeholders, KHI today comprises over 90 member organizations that include all the different stakeholder groups in the kidney disease area: patients and patient organizations; industry partners including large pharma, small biotech, and dialysis organizations; health professional organizations; and federal agencies (which, in addition to the FDA, include the Centers for Medicare & Medicaid Services [CMS], National Institutes of Health [NIH], and Centers for Disease Control and Prevention [CDC]).
KHI creates an innovation substrate for the passage of safe and effective therapies into the kidney disease area through the coordination of member-driven projects in five priority areas, such that the output of these projects, which can include white papers, data standards, workshops, or roadmaps, will facilitate the passage of drugs, devices, and biologics into the kidney disease area for the benefit of our patients. The five priority areas are 1) Patient Partnerships, 2) Biomarkers and Pathogenesis, 3) Regulatory Interactions, 4) Clinical Trial Design, and 5) Clinical Trial Infrastructure.
A number of our projects, for example, have focused on the development of clinical trial end points (in vascular access, IgA nephropathy, FSGS, lupus nephritis, and primary hyperoxaluria). We hope that the published multi-stakeholder white papers in these areas (with FDA participation) will result in a better defined product development pathway, making it more attractive and less risky for both industry and academia to enter into these areas. Similarly, we hope that an ongoing project that focuses on the development of a patient-centered roadmap for innovative renal replacement therapy—with strong regulatory and reimbursement domains—will serve as a catalyst for interest, investment, and disruptive innovation in the dialysis area.
A key distinguishing feature of KHI has been the placement of the patient perspective front and center in all of our activities. This has happened in large part owing to a strong and empowered Patient and Family Partnership Council (championed by the late long-time dialysis patient and advocate Celeste Castillo Lee; a Kidney Week Memorial Lectureship in her name is scheduled for Friday, October 26). The Patient and Family Partnership Council is closely involved in all KHI projects (from initial selection to implementation to dissemination of the output), and has been critical to the success and impact of KHI.
So what are the things that KHI has changed over the past 5 years?
At a tangible level I do believe KHI has shown the kidney community that diverse stakeholder groups can in fact work together toward a common achievable goal. In addition, the output from KHI projects is beginning to serve as a catalyst for therapeutic product development in the kidney disease area.
At a more intangible level, I strongly believe that the presence of an organization like KHI has given hope to our patients, created interest and excitement among healthcare professionals caring for kidney patients, and most important, has instilled enthusiasm and confidence in our industry partners. And, not surprisingly, I believe that these intangible benefits are likely to be far more important than the tangible benefits that have accrued as a result of the Kidney Health Initiative.
But what about the future?
My personal view is that the real impact of KHI is yet to come. We have been extremely successful over the past 5 years in bringing the renal community together and in doing projects that we hope will serve as a catalyst to steer interest, innovation, and investment (i3) into the kidney disease area. Having established ourselves as a respected and recognized entity, however, we now need to leverage our infrastructure and our members to do much more. Now is the time for us to be bold, to tackle head on some of the “grand challenges” that we face in kidney disease, such as clinical trial infrastructure, the need to create both a clinical urgency and a business imperative for the development of new therapies for kidney disease, and the targeted use of a combination of information technology and artificial intelligence, within every aspect of kidney disease, in order to develop an individualized precision medicine approach with better screening and stratification pathways. Now is the time for KHI to be the facilitator and convener, the large tent, if you will, for innovation in its broadest sense within the kidney disease area.
On a more personal level, it has been both an incredible honor and a humbling experience to have led the Kidney Health Initiative for the past five years. I owe KHI far more than I could ever have contributed to it. This is because KHI has allowed me to interact with an amazingly diverse and talented group of people, spurring my mind to grow and mature in ways I had never thought possible. I am a far more complete and holistic person today than before I joined KHI, and for that I will always remain grateful to KHI and to all the people who make KHI what it is (the KHI staff [with special mention of Melissa West, the KHI project director], the KHI Board of Directors, our member organizations, and our many friends and champions within FDA, NIH, and CMS who have worked so hard for KHI’s success).
Finally, the most important message that I have learned personally from my association with KHI is this: KHI is basically a platform or meeting place for diverse stakeholders in the kidney disease space; the creation of such a meeting place, however, can result in wonderful and impactful progress in the field, in addition to long-lasting friendships.