Joseph V. Bonventre, MD, PhD, who leads the multidisciplinary team who developed the roadmap, spoke at the annual ASN Kidney Week press conference Thursday morning. The roadmap is available to the public on the KHI website and will be featured in an upcoming publication of the Journal of the American Society of Nephrology.
The stimulus for KHI’s signature initiative was a commitment statement given at the 2016 White House Summit on Organ Donation, committing KHI to “identify the scientiﬁc, technical, and regulatory milestones needed to achieve the goal of creating a bioengineered alternative to dialysis as renal replacement therapy”. KHI formed a multidisciplinary team including representatives from government agencies, device manufacturers, researchers, clinicians, dialysis providers, and most importantly patients to consider the steps needed to provide RRT innovations to patients with kidney diseases. This diverse group’s goal was to provide innovators and entrepreneurs clear pathways and expectations for bringing new RRT technologies to market to improve the quality of life of patients.
“While we should not underestimate the complexities of both the technological challenges and regulatory requirements involved in bringing innovative ESRD products to market, a roadmap will help to bring innovators from various fields into the “kidney space” with new ideas, “out of the box” approaches, and substantive financial resources from corporate, philanthropic and venture capital communities. Our current and future patients rely on our drive and persistence to provide solutions which improve their quality of life.” Joseph V. Bonventre, MD, PhD
The roadmap is distinguished by four key elements:
A patient-centered focus, with a clearly delineated, patient-developed vision of improved patient quality of life
Increased opportunities for multidisciplinary collaboration,
Multiple solution pathways with various time horizons,
Common design requirements to ensure that all solutions meet the same minimum technical expectations.
This approach allows the roadmap to foster multidisciplinary innovation, help funding and regulatory agencies evaluate RRT project proposals, encourage new interest in the field, and offer increased treatment options to people with end stage kidney disease.
Innovations catalyzed by the roadmap are urgently needed for kidney disease patients in the United States and around the world. Kidney disease is a serious and under-recognized world epidemic. More than 40 million people in the United States are living with kidney diseases, and nearly 700,000 have ESRD, for which there is no cure. Despite the significant burden of kidney diseases, there has been a dearth of innovation in RRT compared to other areas of medicine.
The roadmap provides guidance to innovators, researchers, and entrepreneurs who can change the status quo and bring innovation to the kidney community. The roadmap has many practical applications in the hands of innovators. First, the roadmap will foster the creativity and multidisciplinary innovation needed to spur advances in RRT. Second, it will help funding agencies and proposal reviewers evaluate the relevance and potential impacts of RRT project proposals. Third, the roadmap will encourage new interest and investment in the RRT field. Lastly, for patients the roadmap offers increased treatment options and an improved quality of life to patients living with kidney disease.