Artificial Kidney Prize, Phase 2: FAQ
Q: Do I have to submit a Phase 1 application in order to participate in Phase 2?
No, you can submit a Phase 2 solution even if you did not participate in Phase 1.
Q: When are submissions due?
The submissions period for Track One ends on October 28, 2022, at 4:59pm EDT. The submissions period for Track Two ends on January 28, 2023, at 4:59pm EST.
Q: Where should I submit my solution?
All submissions will be completed and submitted through the competition submission site. You may access this site through the following link: https://www.kidneyx.org/compete.
Q: KidneyX encourages collaboration, but I am concerned about my Intellectual Property (IP) rights; how does KidneyX deal with IP?
Entrants retain ownership of their concepts, including any software, designs, research, or other intellectual property (IP) that they develop in connection therewith. To find out more information, please refer to the official Announcement of Requirements and Registration.
Q: Who owns the intellectual property in KidneyX submissions?
Each participant will retain ownership of all intellectual property rights in their submissions and solutions.
Q: Does the U.S. Department of Health and Human Services (HHS) require participants to grant use licenses?
Yes. Each participant (whether participating singly or in a group) and each entity grants to HHS an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly (e.g., on websites) the abstracts on the web or elsewhere. Additionally, winners will retain ownership of their intellectual property rights in the solution, but must grant to the federal government the nonexclusive, nontransferable, irrevocable, paid-up license to practice, or have practiced for or on its behalf, the solution throughout the world for federal purposes. A nonexclusive license means that the grantors of the licenses are free to grant licenses in their submissions and solutions to other parties as they see fit.
Q: How much funding is available in the Artificial Kidney Prize?
For Phase 2, $10.5 million in funding is available, with prizes divided across both tracks. At the discretion of HHS and ASN, it is anticipated that up to three (3) Track One winners will divide $4.5 million in funding, while up to six (6) Phase Two winners will divide $6 million in funding.
Q: Who can participate in the KidneyX Artificial Kidney Prize Phase 2? Can non-US citizens participate?
The Artificial Kidney Prize Phase Two is open to both U.S. and international participants. To be eligible to receive any monetary prizes, participants, whether participating singly or as a team, must register for the Competition and designate an individual or entity as the official entrant. Entrants must be a citizen or permanent residents of the United States, or a legal entity with its primary place of business in the United States. An entrant that is a non-U.S. citizen, nonpermanent resident, or non-U.S.-based legal entity may be eligible to win a monetary prize awarded by ASN, at the discretion of ASN and provided the entrant meets all other eligibility requirements as stated in the additional Competition rules, terms, and conditions. While it is the desire of ASN and HHS that entrants from all over the world be able to participate in the Competition, ASN and HHS reserve the right to exclude from participating or from winning, citizens of any nation that prohibits or restricts the Competition from proceeding as set forth herein, or that imposes requirements, including, without limitation, registration or bonding of the Competition, or translation of the Official Rules, Terms, and Conditions.
Requests for Assistance
Q: How can I connect with others interested in this topic to possibly form a team?
The Artificial Kidney Prize is built on the foundational belief that innovators from a range of backgrounds must leverage multidisciplinary expertise and collaborations to develop solutions to improve the lives of people with kidney diseases, their families, and care partners. Participants are encouraged to consider expanding their teams or working collaboratively with others. KidneyX supports these efforts with its Solver Community, which will connect you with other community members who have also opted in. By entering the Solver Community, you are agreeing to have your information shared with other community members.
Q: Can people with kidney diseases who aren’t submitting solutions help KidneyX?
HHS and ASN have designed KidneyX to be patient-centered. People with kidney diseases have representation throughout the KidneyX governance structure, judging processes, and Summit discussions. People with kidney diseases or their care partners that are interested in volunteering to serve as an expert resource to KidneyX are asked to contact KidneyX by emailing KidneyX@asn-online.org.
Q: Where can I learn more about current technical or scientific needs in renal replacement therapy or how the kidney functions?
The Kidney Health Initiative’s (KHI) Technology Roadmap for Innovative Approaches to Renal Replacement Therapy provides the scientific and technological foundation for the Redesign Dialysis prize and is an excellent first resource. HHS and ASN are also currently working to develop scientific overview sheets for the Redesign Dialysis prize, and those documents will be added to KidneyX.org when they are complete. In the meantime, if you have scientific questions, please reach out to KidneyX@asn-online.org.
Q: How do I register to participate in this competition?
Once you apply through the competition submission site, your entry will automatically register you as a participant.
Q: Who should apply for Track One of the Artificial Kidney Prize Phase 2?
For Track One, the competition focuses on advancing the development of a bioartificial kidney prototype along a pathway and timeline toward first-in-human studies. See the objectives described on the submission site. Track One offers a space for scientists, professionals in the medical field, people with kidney diseases, companies, and innovators to expand from their institutional knowledge and collaborate toward innovative changes.
Q: Who should apply for Track One of the Artificial Kidney Prize Phase 2?
For Track Two, the competition focuses on describing how their tool adapts innovations from fields such as regenerative medicine, cellular engineering, systems biology, and/or synthetic biology to solve a specific challenge for developing artificial kidneys. We particularly welcome submissions from scientists, companies, and innovators who work outside the kidney space and/or are still laying the foundational framework for their projects.
Q: How do I know if my research is ready for submission to Phase 2 Track Two?
Track Two of this Competition incentivizes the development of enabling tools for the artificial kidney community. For this competition, an enabling tool could optimize the application, efficiency, and/or scalability of regenerative medicine, cellular and tissue engineering, systems biology, synthetic biology, and/or similar cell-based methods to advance the development of an artificial kidney platform, broadly defined as bioengineered, biomechanical, xenotransplant, chimera, or another non-human organ platform. Applicants must concisely describe the challenge that an artificial kidney developer faces and how their solution could address that specific issue with details for development and proof-of-concept evaluation. Recognizing that many of these innovations might have been designed for non-kidney applications, specific kidney expertise or data supporting proof-of-concept towards an artificial kidney could benefit a submission but are not required for submission.
Q: How will my research be evaluated?
Judging Criteria for Track One
- Functionality Replication: The degree to which patient input has framed the targeted functions and design of the prototype. The degree of confidence that the plans for bioartificial kidney prototype will achieve critical kidney functions safely and continuously. See the Technology Roadmap for Innovative Approaches to Renal Replacement Therapy for examples of kidney functionality.
- Development Progress and Plan: The degree to which the submission demonstrates a novel adaptation of regenerative medicine, cellular engineering, systems biology, and/or synthetic biology in the development of a prototype bioartificial kidney.
- Preliminary proof of concept: The likelihood that future objectives are achievable in advancing a prototype of a bioartificial kidney towards animal studies, first-in-human studies, and/or clinical trials.
- Development progress and plan: The amount of progress completed relative to funding received, the rigor of plans, and the confidence in the team to execute. The degree of patient engagement in the design and/or evaluation of a prototype. Plans that describe the work needed beyond the submission should include future critical milestones, timelines, and collaborations to achieve animal studies, first-in-human studies, and clinical trials.
Judging Criteria for Track Two
- Functionality Replication: The degree of justification and confidence that the enabling tool or component(s) address a critical challenge in the development of an artificial kidney platform. See the Technology Roadmap for Innovative Approaches to Renal Replacement Therapy for examples of kidney functionality.
- Level of Innovation: The degree to which the submission identifies a barrier in the development of an artificial kidney platform and describes how an enabling tool can be created through an adaptation of regenerative medicine, cellular engineering, systems biology, and/or synthetic biology, beyond established scientific methods and technology.
- Preliminary Proof of Concept: The likelihood of success that the application of regenerative medicine, cellular engineering, systems biology, and/or synthetic biology concepts towards the development of an enabling tool or component can be created to address a challenge in developing an artificial kidney platform.
- Development Progress and Plan: The amount of progress completed relative to funding received, the rigor of plans, and the confidence in the team to execute. Plans that describe the work needed beyond the submission include future critical milestones and collaborations.
Q: Who are the judges for Artificial Kidney Prize Phase 2?
HHS and ASN are currently identifying a group of experts with diverse scientific, medical, investment, and technical expertise, including patient representation. The Competition judges will be identified on KidneyX.org at the conclusion of the competition.
Q: How will checks be distributed to prize competition recipients?
Monetary prizes awarded will be paid by electronic funds transfer and may be subject to local, state, and/or Federal income taxes.
Q: Can prize awards be paid to an organization?
The intent of the prize competition is to award individuals or teams who produce the best solution to a problem presented in the challenge. However, we recognize that submissions may be made on behalf of an existing institution/organization. Therefore, payments may be made to that entity at the request of the individual or team.
Q: Will these products take decades to develop?
The Artificial Kidney Prize Phase Two judging criteria consider projects’ development progress and plans. We will be prioritizing solutions that have a greater likelihood of becoming a product (or a component of a product) as described in the submission and future plans. More broadly, KidneyX is designed to build a thriving ecosystem of innovation in kidney health, which requires supporting products in all phases of development. This spectrum of development is best exemplified by the Kidney Health Initiative’s Technology Roadmap for Innovative Approaches to Renal Replacement Therapy.
Q: How can my organization support KidneyX?
KidneyX is seeking additional partners. Organizations interested in supporting KidneyX (whether by providing financial resources, scientific expertise or other means) are encouraged to contact KidneyX staff at KidneyX@asn-online.org.
Q: How can I stay informed about KidneyX?
To receive updates on KidneyX, you can follow KidneyX on Twitter (@Kidney_X) or subscribe to our newsletter by emailing KidneyX@asn-online.org.
Q: How can I contact KidneyX?
You can contact KidneyX via e-mail at KidneyX@asn-online.org or through our contact form.