What is NEI’s challenge?
NEI’s 3D Retina Organoid Challenge (3D ROC) aims to generate a 3-D human retina culture system that recapitulates the complexity, organization, and function of the human retina. Technological breakthroughs could allow researchers and physicians to better understand, diagnose, and treat retinal diseases. 3DROC is asking for publication quality data showing development of prototypes.
Mandatory Registration Deadline: October 1, 2021
Final Submission Deadline: June 1, 2022
What is a prize competition?
A prize competition, or challenge, is a competition in which a prize is offered to a winning participant(s) whose solution meets the award criteria. Success depends on meeting the challenge’s defined scientific goals. The America COMPETES Act is the original prize authority. The American Innovation and Competitiveness Act updated this federal prize competition authority in December of 2016 under the Science Prize Competition Act. In addition to stimulating innovation that has the potential to advance the agency’s mission, these pieces of legislation encourage public-private partnerships and commercialization of final products.
How rigid is NEI’s definition of “organoid”? Can complex multi-layered, multicellular systems be considered organoids?
Our definition of organoid can be flexible, as long as the final tissue is human, 3D, properly oriented, and meets the other morphological and physiological evaluation criteria requirements outlined in the challenge announcement. Ultimately, the organoid systems that most closely meet these criteria will win the challenge. Creativity, for instance using perfusion and other engineering techniques, is encouraged to enhance organoid systems, but “tissue on chip” approaches that do not reflect the complexity and fully represent the physiology, structure, and function are outside the scope of this challenge. Explants are also outside the scope of the challenge.
I am not a US citizen or permanent resident. Can I still participate in the challenge?
Non-U.S. citizens and non-permanent U.S. residents are not eligible to win a prize (in whole or in part) under the America COMPETES Act. NIH generally permits non-U.S. citizens and non-permanent U.S. residents to register for and participate in NIH Challenges. Such individuals may, for example, participate as part of a team that satisfies the applicable eligibility criteria and may be recognized when the results are announced, but they are not permitted to receive any monetary prizes.
Official language regarding eligibility: Each team must designate a captain who must be a U.S. citizen or permanent resident who is responsible for all correspondence regarding this Challenge.
To be eligible to win a prize under this challenge, an individual or entity—
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. However, non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced.
May federal employees participate in the challenge?
Innovators may NOT be federal entities or federal employees acting within the scope of their employment. Innovators may NOT be employees of HHS acting in a personal capacity. If employed by a federal agency other than HHS, innovators should consult with an ethics official at their respective agencies to determine if participation violates federal ethics rules.
Can federal funds be utilized to form submissions?
Yes. Federal grantees or recipients of cooperative agreements may use Federal funds from a grant award or cooperative agreement to develop their challenge submissions or to fund efforts in support of their challenge submissions as long as the use of such funds is consistent with the purpose, terms, and conditions of the grant award or cooperative agreement.
What do I need to do if I plan to use federal funds?
Grantees or recipients of cooperative agreements intending to use Federal funds must register for and participate in the challenge on behalf of the awardee institution, organization, or entity. Before registering, applicants should confer with their Program Officers (PO's) so they can determine if the use of such funds is consistent with the purpose, terms, and conditions of the grant award or cooperative agreement.
If a grantee or recipient of a cooperative agreement uses Federal funds and wins the challenge, the prize must be treated as program income for purposes of the original grant in accordance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR § 200).
How are the submission review and winner selection processes structured?
All submissions will be reviewed by both a technical advisory panel and group of federal judges. The technical panel will evaluate prize competition entries and, via summary statements and suggested rankings, will provide technical advice to the federal judges.
The federal judges will also evaluate the submissions and will consider the technical advice provided by the technical reviewers. The 3-D ROC coordinators will brief the NEI Director, Dr. Michael Chiang. Ultimately, the winner(s) will be selected by Dr. Chiang and the NIH Director, Dr. Francis Collins.
Who are the technical advisory panelists and federal judges?
The technical advisory panel is made up of individuals with cross-disciplinary expertise that will be necessary to best evaluate the submissions. Several advisory panel members have direct experience in the fields of ophthalmology, retinal biology, drug screening, and toxicology. Others have expertise related to technical aspects of the challenge requirements, such as functional validation. The names of the technical advisory panel members will be posted upon confirmation of their participation.
The federal judges have a range of expertise related to the challenge topic, in areas such as organoid and multi-organ systems development, stem cell biology, retina organoid biology, bioengineering, and nervous system development.
NEI reserves the right to add members to the technical and judging panels upon receipt of proposals, if additional expertise is needed.
A list of the technical and federal reviewers for Phase II of 3-D ROC can be viewed here.
Can I be part of multiple teams?
NEI will allow each solver to be a team lead on one proposal and a team member on one other proposal. Therefore, each solver may be involved in 2 proposals total.
What if my team changes?
Teams should be formed and considered finalized as of the mandatory registration in October 2021.
Unique or unusual circumstances that involve change of institutions or personnel should be immediately disclosed to the NEI Office of Regenerative Medicine.
After I register my intent to participate, can I switch categories later - Meaning for example that we register as a Team, but if during the next year we end up needing to use federal funds, would we be allowed to switch to Entity?
Unfortunately, no. Once you register on behalf of a TEAM or ENTITY, that is how you must submit for the final deadline.
I have many members on my team; can my biographical sketch exceed 2 pages? What should be included in my biographical sketch?
No; the bio sketch for all team members is limited to two pages, regardless of team size. The bio sketch can be used in combination with the feasibility section to show that your team has the expertise to carry out the proposed protocol. For each team member, we suggest including only highly relevant publication(s) (e.g., the most recent or the one that specifically defines a particular method), a very brief summary of expertise, any accomplishments that are directly relevant to the team members’ abilities to carry out their proposed roles, and any other directly relevant information.
Can I submit for Phase III if I haven’t previously participated in this challenge?
Yes. Participation in Phase I and Phase II is not required for you to submit for Phase III.
What does the mandatory registration in October 2021 entail?
Teams will be required to register their intent to participate in this challenge. They will be expected to provide an abstract that clearly states the advantages and novelties of the retina organoid (300 word and/or 2- page max), indicate what category they plan to submit for (disease modeling or drug screening), the names of all team members, and submit the 3DROC Registration Form.
A meeting consultation with the NEI Office of Regenerative Medicine will also be strongly encouraged. Teams have the option of submitting preliminary data along with their abstract . In return, teams will be provided with feedback on their abstract & preliminary data to help aid in the progression of their project, if requested.
Will the abstracts submitted for the mandatory registration be made public?
These abstracts will not be made public – these will only be viewed by the 3DROC coordinators. NEI leadership (Director & Deputy Director) will receive a brief summary of what was submitted.
What is the difference between collaborator and team member - how do I determine how to categorize people?
The team members are the folks that you want to receive recognition and are eligible to receive prize money and collaborators are those that you just want to receive recognition, if your team wins.
We view team members as those that are actually doing work on the submission and collaborators as folks that you may consult with. Team members have to sign the registration form and collaborators do not, since they are not technically participating in the challenge.
May innovators ask additional questions?
Questions can be emailed to the NEI Office of Regenerative Medicine.