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Requesting Your Feedback on KidneyX

This Request for Information closed on September 14, 2018.

Summary

This is one of two Requests for Information (RFIs) that HHS is publishing related to the Kidney Innovation Accelerator (KidneyX). KidneyX, established in April 2018, is a new public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN). HHS and ASN plan to hold a series of KidneyX prize competitions to develop innovative solutions that can prevent, diagnose, and/or treat kidney diseases.

This RFI solicits feedback on how the KidneyX project can be most effective, while the second RFI seeks your input on plans for an upcoming KidneyX prize competition focused on developing alternative therapies for kidney failure.

Dates

The period for comments begins with the publication of this document. Submissions must be received on or before September 14, 2018, to be considered.

Submissions

You may submit comments, identified by the title, “KidneyX Project Comment” via the following methods:

E-Mail: please send responses to KidneyX@hhs.gov.
Mail: please send mail to
KidneyX c/o Ross Bowling
200 Independence Avenue SW, Room 624D
Washington, D.C., 20201

Please submit comments by one of these two methods.

For Further Information

Contact Ross Bowling, Ph.D.; ross.bowling@hhs.gov; 202-260-7158.

Section I. Supplementary Information

Background

Approximately 17 percent of adults in the U.S. have chronic kidney disease (CKD).[1] Approximately 700,000 of these cases have progressed to end stage renal disease (ESRD), with over 500,000 people requiring chronic dialysis to survive and 200,000 people having received kidney transplants.[2] CKD and especially ESRD are debilitating, often drastically reducing the quality of life of people living with kidney diseases. Despite the high cost of dialysis treatment, these patients’ 5-year life expectancy is worse than that of most cancer patients.[3] Kidney transplantation can extend lifespan and improve quality of life, but the number of kidney donations does not come remotely close to meeting the current demand. Treatment of chronic kidney disease and end stage renal disease is extremely expensive for the Federal government: Medicare alone spends more than $64 billion each year to care for people with CKD and an additional $34 billion to care for people with ESRD. [4]

For the past 50 years, advances in treatments for kidney diseases and kidney failure have been modest, with few major innovations reaching people who live with kidney diseases. Several barriers may be limiting kidney health innovation, including: 1) lack of capital, 2) risks associated with early-stage research and development, and 3) low levels of meaningful input from other medical, scientific, or technological fields.

KidneyX

In view of the historical barriers to kidney health innovation, HHS and ASN have entered into a public-private partnership to help spur innovation in the prevention, diagnosis, and treatment of kidney diseases. This partnership, called the Kidney Innovation Accelerator (KidneyX), is planned to entail a series of prize competitions to address the needs of people living with kidney diseases. These prize competitions are intended to support companies, teams, or innovators that have promising solutions or technologies. One of KidneyX’s goals is to encourage experts and entrepreneurs from other fields to become involved in this important work, leading to a more dynamic, diverse, and collaborative environment in kidney health. Through KidneyX, HHS and ASN intend to drive additional private investments to these projects.

In KidneyX prize competitions, HHS and ASN will identify and describe a problem or unmet need related to kidney diseases for participants to address (for example, finding a new class of kidney replacement therapeutic options for patients, or designing better diagnostic methods). Each prize competition announcement will outline that prize competition’s scope, prize amounts, eligibility rules, submission process, and criteria for selecting winners. After the submission period ends, a panel of judges will review the submissions and an authorized official will select the winners from the submissions received. Some prize competitions may include multiple phases.

Because new innovators often lack experience in product commercialization, KidneyX prize competitions are planned to help prize winners receive input and feedback from patients, investors, business and manufacturing experts, scientists, engineers, and others as needed. By bringing innovators together with government representatives from the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the National Institutes for Health (NIH), KidneyX will help participants receive useful feedback, to the extent appropriate for each agency, early in the product development process via existing regulatory pathways. Please note that the participation of government entities is not a guarantee of any particular result (e.g., premarketing authorization approval or clearance by FDA, coverage or payment at a particular rate by CMS, or the award of an NIH grant).

KidneyX’s goal is to improve quality of life for people living with kidney diseases. This means not only developing new technologies but also supporting patient access to these technologies. KidneyX prize competitions will require participants to demonstrate how patient feedback has informed their research/product development goals. KidneyX is also intended to ensure that participants receive feedback on their projects from people living with kidney diseases.

Future KidneyX prize competitions may cover a range of topics dealing with prevention, treatment, and diagnosis of kidney diseases. Future topics might include:

  • Medications– a variety of treatments for kidney diseases, including drugs and biologics
  • Diagnostics – point-of-care or at-home testing kits, better methods to measure kidney function
  • Patient-centered Tools – electronic health record tools designed to identify and track diseases, applications to empower patients to manage kidney diseases, methods to improve communication within the patient community
  • Next Generation Dialysis – wearable or implantable dialyzers, tissue engineering
  • Prevention –– methods to identify people at risk of kidney diseases and to slow the progression of those with early stage or chronic kidney disease

Section II. Request For Information

We seek your feedback on how the KidneyX project can best spur innovation in preventing, diagnosing, and/or treating kidney diseases. While we encourage all relevant comments, we are interested particularly in responses to the following questions. You may respond to some or all of the questions:

  1. What unmet needs – including those related to product development—should KidneyX prize competitions focus on? If you have ideas for more than one topic area/issue, how would you rank them in order of importance? If you are a person living with a kidney disease, what makes these topic areas for product development important?
  2. What assistance or services might HHS and ASN offer to KidneyX prize winners that would encourage the greatest participation from a broad range of innovators?
  3. In what ways might HHS and ASN, through KidneyX, effectively encourage collaboration or cooperation between participants/prize winners while respecting their intellectual property rights?
  4. Particularly for those interested in participating in a KidneyX prize competition but unfamiliar with kidney functions and diseases, what information would you find it most useful for HHS and ASN to share publicly?


[1] Report to Congressional Requesters: National Institutes of Health – Kidney Disease Research Funding and Priority Setting; United States Government Accountability Office; December 2016.

[2] United States Renal Data System, 2017 USRDS Annual Data Report, https://www.usrds.org/2017/
download/2017_Volume_1_CKD_in_the_US.pdf
, 6.

[3] Kirsten L. Johansen. “Life Expectancy Gains for Patients with ESRD,Clin. J. Am. Soc. Nephrol. 2018 13: 11-12; United States Renal Data System: Epidemiology of kidney disease in the United States, 2017; Centers for Disease Control and Prevention: Cancer Survival Data: 5-Year Relative Survival by Selected Primary Site, Race, Sex, and Age Group, 2017

[4] United States Renal Data System, 2017 USRDS Annual Data Report, https://www.usrds.org/2017/
download/2017_Volume_1_CKD_in_the_US.pdf
, 6.

 

Content created by Office of the Chief Technology Officer (CTO)
Content last reviewed on September 26, 2018