Requesting Your Feedback on the First KidneyX Prize Competition
This Request for Information closed on September 14, 2018.
This is one of two Requests for Information (RFIs) that the U.S. Department of Health and Human Services (HHS) is publishing related to the Kidney Innovation Accelerator (KidneyX). KidneyX, established in April, 2018, is a new public-private partnership between 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. KidneyX’s goal is to improve quality of life for people living with kidney diseases.
This RFI solicits feedback on plans for an upcoming KidneyX prize competition with an expected launch on or about October 25, 2018 (subject to final agency approval and decision). This proposed prize competition is planned to challenge participants to develop alternative therapies for kidney failure. HHS will take comments on this RFI into consideration as it continues to develop the proposed prize competition.
The period for comments begins with the publication of this document. Submissions must be received on or before September 14, 2018, to be considered.
You may submit comments, identified by the title, “KidneyX Prize Comment” by:
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 methods.
For Further Information
Contact Ross Bowling, Ph.D.; email@example.com; 202-260-7158.
Section I. Supplementary Information
To spur innovation in the prevention, diagnosis, and treatments of kidney diseases, HHS and ASN have entered into a public-private partnership, KidneyX. HHS and ASN plan to run a series of KidneyX prize competitions that will support early stage companies, teams, or innovators that have promising solutions or technologies that can prevent, diagnose, and/or treat kidney diseases. KidneyX also aims 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.
For more than half a century, people with kidney failure have had only one treatment option other than a transplant: dialysis. Dialysis clears excess fluid and filters out some of the toxins that the kidney normally excretes, but dialysis replicates only the kidney’s filtration function, and only while the patient is on dialysis. Dialysis is a life-saving technology, but it still leaves patients with substantial morbidity, mortality, and a limited quality of life. Most dialysis in the United States is performed in hemodialysis units, where patients with kidney failure are connected to hemodialysis machines for three to five hours, three times a week. Some advances on in-clinic dialysis have occurred, including home treatment and peritoneal dialysis, but key limitations of in-center dialytic therapy as currently practiced include its intermittent nature, the need for patients to travel to receive treatment, and the failure to restore other kidney functions besides simple filtration clearance. Although kidney transplantation can extend lifespan and improve patient quality of life, at present the number of kidney donations does not come remotely close to meeting the current need.
Overview of the Proposed First KidneyX Prize Competition
HHS and ASN plan to launch a KidneyX prize competition on or around October 25, 2018, to generate solutions that offer people living with kidney diseases significant alternatives to dialysis as it is generally practiced today. This proposed prize competition, subject to final agency approval and decision, is planned to attract ideas and participants from outside the traditional kidney space as well as from within it. The competition is intended to catalyze development of new classes of kidney replacement therapeutic options for patients, options intended to improve and extend patient quality of life. The goal is not necessarily to build a better dialysis machine or to provide iterative improvements to dialysis: other possibilities may include constructs that do not resemble dialysis as it is currently practiced, but rather shift the paradigm for how kidney failure is managed. Of particular interest is applying advanced technologies from other scientific and medical fields to innovative renal replacement therapy technologies.
HHS and ASN recognize that many potential competition participants may have applicable technologies, concepts, or expertise from domains that have not previously been considered in improving renal replacement therapy. Similarly, there may be innovators working on component technologies or discrete concepts that may have utility as one part of a novel renal replacement therapy device. As such, HHS and ASN plans to encourage solvers with concepts for specific kidney replacement therapeutic options as well as solvers who believe their concept might be a component in developing a successful kidney replacement therapeutic option. For a discussion of current scientific and technological development needs in renal replacement therapy, please consult the Kidney Health Initiative’s “Technology Roadmap for Innovative Approaches to Renal Replacement Therapy.”
This prize competition is planned to run in two phases. In Phase 1, it is expected that solvers will be asked to submit their ideas and solutions related to renal replacement therapy. Judges will review submissions and an authorized official will select up to 10 Phase 1 winners from the submissions received (see Section D, below, for anticipated submission rules and judging criteria). Phase 1 winners are expected to receive cash prizes and may be invited to present their ideas to an audience of stakeholders from across government, investor, patient, industry, academia, and non-profit sectors. Phase 2 of the prize competition, also open to the general public, is anticipated to ask participants to build or further develop a proposed solution to improve or transform renal replacement therapy. At the end of Phase 2, judges will review submissions and an authorized official will select winners (based on criteria established in the prize competition announcement) for a cash prize. Funding for this proposed prize competition is anticipated to come from ASN.
Because new innovators often lack experience in product commercialization, KidneyX plans 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 & Medicaid Services (CMS), and the National Institutes for Health (NIH), HHS plans to help participants receive useful feedback, to the extent appropriate for each agency, early in the product development process. 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 under Medicare, or the award of an NIH grant). Additionally, any such input provided by government entities would be made available to all solvers on an equal basis, as well as to members of the public, consistent with applicable law and policy.
HHS and ASN are committed to supporting patient access to new technologies, and will therefore facilitate opportunities for prize competition participants to obtain feedback from kidney patients and their families and care partners, including their preferences for benefit/risk tradeoffs for innovative alternatives.
Scope of the Prize Competition
This proposed KidneyX prize competition intends to seek solutions in the following areas:
Replicating Kidney Functions:
- Blood Filtration (filtering blood to remove waste and excess fluid)
- Electrolyte Homeostasis (maintaining appropriate levels of key minerals in the blood)
- Fluid Regulation (regulating the amount of and/or removing excess fluid)
- Toxin Removal and Secretion (limiting or preventing toxins in the bloodstream)
- Filtrate Drainage and Connectivity (removing excess filtrate after processing; connectivity issues for filtration, processing, and exterior drainage)
Improving Patient Quality of Life:
- Minimizing impact/intrusion of therapy on family/care partner(s) and social life
- Improving ability to work, travel, and engage in recreational activities
- Minimizing burden on the family and care partner(s) and improving quality of life
- Increasing mobility and physical activity
- Reducing disease and treatment complications
- Providing more choices for treatment
- Liberalizing diet and fluid regulation
- Reducing medication burden
Improved renal replacement therapy access (vascular or peritoneal access needed for treatment)
Addressing engineering challenges (e.g., preventing clotting, bleeding, and infection in vascular circuit and associated devices)
Safety monitoring functions
The prize competition announcement will include additional details about current scientific and technological needs in renal replacement therapy. It will draw this information from the Kidney Health Initiative’s “Technology Roadmap for Innovative Approaches to Renal Replacement Therapy,” which is currently accepting public comments.
Anticipated Rules for the Prize Competition
Cash prizes for this prize competition are anticipated to be provided by ASN.
Anticipated Submission Requirements:
A solver’s Phase 1 submission, which will be used to determine Phase 1 winners, is anticipated to require the following information:
- A comprehensive description of the proposed solution or component technology in 10 pages or less, 8.5 x 11 inch page, 10-point font or greater and one inch margins including:
- A one-paragraph executive summary that clearly describes the proposed solution (or component technology), how it applies to opportunities in kidney replacement therapy, and estimated patient impact
- A summary of evidence supporting the proposed approach. Appendices describing existing, unpublished experimental data that support your proposed solution may be included and will not count towards the page limit. Please be concise in your presentation and include only relevant data in support of your solution.
- Vision for commercialization and (if relevant) medical product development
- Descriptions of methods and technologies key to implementation
- Challenges or potential pitfalls that need to be considered or addressed
- Discussion of the potential for collaboration (e.g. what gaps in your proposed solution exist, how might your component technology fit with other components to create a solution, where do you need additional input?).
- Team composition, including each team member’s experience and relevant expertise
- A feasibility assessment and description of your ability to execute the proposed solution or component technology in Phase 2, including supporting precedents and any essential resource(s) you may have or will need.
- A list of anticipated development milestones over one and two year time frames
- Identification of area(s) in which to seek and consider patient input
- Publicly shareable abstract of proposed solution or component technology—all Phase 1 winners will agree to allow this to be published on the KidneyX.org site.
Phase 2, like Phase 1, is anticipated to be open to the public (i.e., it is anticipated that you will not need to be a Phase 1 winner to participate in Phase 2). A solver’s Phase 2 submission, which will be used to determine Phase 2 winners, is anticipated to require the following information:
- Description of area of innovation and how the advancements they have made through the course of this prize competition could be applied to opportunities in renal replacement therapy;
- Overview of proposed solution (or component technology) and estimated patient impact;
- Summary of evidence supporting approach;
- Evidence of consideration of patient input provided and used with regard to need for and suitability of technology;
- Documented collaborations with industry or other entity to show movement toward commercialization;
- Overview of progress to date, including evidence of collaboration with others to advance prototype development if applicable;
- Long-term vision for medical product development and its commercialization;
- Next steps envisioned/proposed for product development, including gaps in existing technologies that need to be addressed and may be outside the scope of this specific product/component technology; and
- Publicly shareable abstract summary of work and/or peer-reviewed publication.
Anticipated basis upon which winners will be selected:
A multi-disciplinary judging panel will review Phase 1 and Phase 2 submissions, and an authorized official will select the winners from the submissions received. If submissions require specific subject matter expertise not represented by the judging panel, then the panel will invite additional experts to provide input as necessary.
Evaluation criteria for Phase 1 participants:
- Nature and extent of anticipated benefit(s) to patients (patient centered impact),
- Feasibility of producing a functional prototype (including scientific and technological rigor), and
- Potential to significantly improve or add synergistically to the landscape of technologies to manage kidney failure.
Additional criteria for Phase 2 participants:
- Demonstration of significant advancement towards the development of prototypes or component technologies,
- Demonstration that future integration of technologies (if applicable) can ultimately address patient needs, and
- Demonstration for prototype to significantly advance towards readiness of human or animal studies (if applicable).
Anticipated Eligibility Rules:
To be eligible to win a prize under this prize competition, an individual or entity—
(1) Shall have registered to participate in the prize competition;
(2) Shall have complied with all the requirements set forth on the KidneyX website for participation in this prize competition;
(3) For prize money from HHS and/or ASN, who are jointly sponsoring this prize competition – In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States;
(4) May not be a Federal entity or Federal employee acting within the scope of their employment (all non-HHS federal employees must consult with their agency Ethics Official to determine whether the federal ethics rules will limit or prohibit the acceptance of a KidneyX prize);
(5) Shall not be an HHS employee;
(6) Federal grantees may not use Federal funds to develop submissions unless consistent with the purpose of their grant award; and
(7) Federal contractors may not use Federal funds from a contract to develop KidneyX prize competition applications or to fund efforts in support of a KidneyX prize competition submission.
SECTION II. REQUEST FOR INFORMATION
HHS seeks your feedback on this proposed prize competition. 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:
- Do you think that the scope described in part C, above, is appropriate for this proposed prize competition? Are there additional areas for consideration in improving renal replacement therapy?
- Particularly for individuals who have experience receiving or providing dialysis, what issues or shortcomings have you observed regarding dialysis treatment? Are there particular elements of the treatment process that might be improved?
- Particularly for individuals and entities that might participate in this prize competition but are unfamiliar with kidney issues, what additional information or types of interactions regarding kidney diseases or kidney functions would you find most useful for HHS and ASN to share publicly?
- HHS is interested in gauging the current level of public interest in participating in the proposed prize competition discussed in this RFI. If you are considering participating in this KidneyX competition or have an idea that you believe would have impact, we ask that you submit a short letter describing your interest, including a primary point of contact. This letter does not require you to submit a proposal to the prize competition itself, and a letter is not required in order to be eligible to participate in the proposed prize competition.