NCATS ASPIRE Design Challenges Questions and Answers

What is the NIH HEAL (Helping to End Addiction Long-termSM) Initiative?

The NIH HEAL (Helping to End Addiction Long-term SM) Initiative is a trans-agency effort to address the national opioid epidemic. The initiative will bolster research to improve treatments for opioid misuse and addiction and enhance pain management. More information can be found here: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

What are the NCATS ASPIRE Design Challenges for Translational Innovation in Pain, Opioid Use Disorder and Overdose?

Through the NCATS ASPIRE Design Challenges, NCATS aims to develop innovative and catalytic approaches to help solve the opioid crisis through development of next generation non-addictive analgesics with new chemistries, data-mining and analysis tools and technologies, as well as biological assays that will revolutionize discovery, development and pre-clinical testing of new and safer treatments of pain, opioid use disorder and overdose.

For Stage 1, NCATS is asking for innovative ideas to be submitted as concept proposals. For envisioned Stage 2, NCATS plans to ask for data showing development of prototypes.

Stage 1: Design Challenges; December 31, 2018 to May 31, 2019

  • Concrete, tangible concept proposals
  • $500,000 total prize per challenge; may be split among multiple winners
  • After the winners are announced, they will be invited to travel to NIH to present their ideas. The goal at this meeting would be to identify collaboration opportunities with other winners for the envisioned Stage 2.

Stage 2: Reduction-to-practice (envisioned follow-on challenge); Expected kick-off Fall 2019

  • Open to all eligible innovators. Stage one winners are encouraged to continue to the reduction-to-practice stage.
  • New teams with innovative ideas will be allowed to enter the challenge at this stage.

What is a prize competition?

For a prize competition, or “challenge,” a monetary award is offered to a winning participant(s) whose solution meets the judging criteria. Success depends on meeting the challenge’s defined scientific goals. The America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act (America COMPETES Act) is the original prize authority. The American Innovation and Competitiveness Act (AICA) (PDF - 362KB) updated this federal prize competition authority in December 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.

What are some advantages to using the prize competition mechanism?

A prize competition provides the best means of achieving the objectives of the NCATS ASPIRE Program because it addresses the intractable problem of transforming synthetic chemistry from an empirical endeavor to a predictive undertaking. While certain capabilities exist under other funding instruments available to NCATS, the constellation of capabilities required to reward and spur the degree of innovation, collaboration and transparency requisite to advance the NCATS ASPIRE Program, at a pace appropriate to address a public health emergency, is available only under prize authority. Critical to the success of the program are several capabilities: engage diverse and non-traditional stakeholders, including individuals unaffiliated with an organization, who may not otherwise take advantage of NIH opportunities (e.g., NSF, DARPA and NIST grantees), as well as citizen scientists; ensure high visibility to ignite and sustain interest and momentum through broad advertisement using the federal challenge.gov platform to augment traditional means (e.g., the NIH Guide to Grants and Contracts); jumpstart the effort by rapidly identifying successful designs to move toward the immediate scientific objective in the context of the opioid crisis and simultaneously obtain generalizable information to disseminate due to NCATS’ ability to immediately share winning designs with the public; and mitigate risks by awarding cash prizes for completed designs instead of providing funding for yet-to-be-developed designs.

May non-U.S. citizens and/or non-permanent residents participate in the challenge?

Yes. While 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.

Each team must designate a captain who must be a U.S. citizen or permanent resident and who is responsible for all correspondence regarding this challenge.

The official language regarding eligibility can be found on NCATS’ Challenge Details page.

May federal employees participate in the challenge?

Participants may NOT be a federal entities or federal employees acting within the scope of their employment. Participants may NOT be employees of HHS acting in a personal capacity. If employed by a federal agency other than HHS, participants should consult with an ethics official at their respective agencies to determine if participation violates federal ethics rules.

Is an account with challenge.gov required to compete, and how do prospective participants set up such an account?

Yes. Every entrant must register for the challenge, even if participating as a member of a team. Innovators can access the registration and submission platform by searching for “NCATS ASPIRE Design Challenges for Translational Innovation in Pain, Opioid Use Disorder and Overdose.” When you’re ready to submit, create your account as in indicated at https://challenge.gov/a/buzz/pages/about-us:

  1. Click “login” and select “register.”
  2. Create a challenge.gov username and password of your choice.
  3. Provide an email address to help us verify your account.
  4. Check your email for an alert from challenge.gov to verify your account and complete the process.
  5. Now, you’re ready to submit!

How do prospective participants with existing challenge.gov accounts register for this challenge?

To register for a NCATS ASPIRE Design Challenge, simply click the orange “Follow this Challenge” button in the upper right corner of the NCATS ASPIRE page on challenge.gov.

What will be the method of payment?

Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.

How will prizes be awarded?

Prizes will be awarded directly to the team lead of the winning team, so award apportionment within a team is not applicable. All members of winning team(s) will be announced and recognized by NCATS. Winning team members will be listed on the NCATS website and promoted through various other NCATS communications.

May participants fund development of submissions with federal funds?

No. Participants may not fund the work to participate in this challenge using federal grants. As required by the America COMPETES Act, the challenge announcement states that “federal grantees may not use federal funds to develop their challenge submissions…” Therefore, alternative funding must be used to do the work.

What are the options for participating in this challenge without using federal grants?

Some ideas for alternate funding sources include using development money from the participant’s institution, starting a crowdfunding campaign, and applying for grants from non-federal organizations with similar goals and missions.

May a participant’s company (a for-profit private entity) participate?

Yes, provided that the private entity matches funds or provides documented in-kind contributions at a rate of not less than 50 percent of the total federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018. Winner(s) will be required to demonstrate that matching funds and/or in-kind contributions were committed to achieve the winning solution.

How are entries evaluated and winners selected?

All entries will be evaluated using a two-step process. First, technical consultants will independently evaluate prize competition entries and suggest rankings, which will be provided to the judges. The judges then will evaluate the submissions and consider the input from the technical consultants. Winners will be selected by the federal judges.

Who are the technical advisory panelists or subject matter experts (SMEs)?

The technical advisory panelists often are referred to as subject matter experts (SMEs) with cross-disciplinary expertise that will be necessary to best evaluate the submissions. Technical consultants will have direct experience in the fields of synthetic chemistry, drug discovery and development, database and/or algorithm development, and development of novel physiologically relevant biological assays. Pain, addiction and overdose experts will be included as well. The names of the technical consultants will be posted on the NCATS ASPIRE webpage upon confirmation of their participation. NCATS reserves the right to add technical consultants upon receipt of entries, if additional expertise is needed.

Who are the judges?

The judges will be federal employees who have extensive expertise related to the topics of the challenges, including, but not limited to, a wide spectrum of expertise along the drug discovery and development continuum, 2-D and 3-D biological assay development, stem cell biology, pain biology, bioengineering, and development of tools and technologies for data analysis.

The names of the federal judges will be posted on the NCATS ASPIRE webpage upon confirmation of their participation. NCATS reserves the right to add members to the judging panels upon receipt of entries, if additional expertise is needed.

May entrants participate on multiple teams?

Yes. An individual may be a team lead on multiple and clearly distinct entries and/or a team member on multiple entries.

May a participant submit more than one solution per challenge? If so, how distinct do the solutions need to be?

Yes. NCATS will allow submission of more than one solution per challenge; however, each solution proposed must be clearly distinct and utilize innovative approaches to the challenge. Different approaches would likely require different expertise that would need to be represented on the team.

May entrants respond to multiple challenge areas? Or is it best to consolidate and respond to the challenge for the overall solution that comprises two or more challenge areas (Challenge 5)?

Yes. Entrants may respond to multiple (two or more) challenge areas. If an entrant’s solution integrates two or more areas in a single solution from the very beginning, Challenge 5 is a better option. Fewer teams are anticipated to compete at this level. If a participant chooses to enter a solution for Challenge 5, he/she still may compete for individual challenges. If selected, the winners should be willing to team up with other innovators to work towards an integrated solution in the follow-up Reduction-to-Practice phase.

What information should be included in an entry?

Please provide the team lead’s name and affiliation, names and affiliation of other team members, and indicate the name of the challenge in which you are competing. Please refer to the application template for further information.

May an entrant’s biographical sketch exceed five pages? What should be included in the biographical sketch?

No. The biosketch is limited to five (5) pages. The biosketch may be used in combination with the feasibility section to demonstrate that the entrant’s team has the expertise to carry out the proposed protocol. For each team member, NCATS suggests including a brief summary of expertise, any accomplishments that were directly relevant to the team members’ abilities to carry out their roles, and any other information directly relevant to a challenge the participant is entering.

When should teams form, and what is NCATS’ level of involvement with the teams?

NCATS expects the team formation aspect for challenges to be flexible and of maximum benefit towards addressing the challenge area (i.e., assemble your teams as needed to push the science forward). If you are proposing to incorporate ideas/technology outside your area of expertise, you and the team members with the expertise should agree to work together in advance of submitting the proposal, so that the team members and their expertise can be presented in the “feasibility” section (see the application template). Each team member must register on challenge.gov, but no announcement of the team is required prior to the submission deadline. Teams may also form, add members, divide, or merge at any point during the competition.

Any agreements among participants who decide to collaborate are at the discretion of those involved. NCATS is not overseeing collaborations, and each team is responsible for its own assembly and disassembly. NCATS simply wants to maximize the flexibility for all participants, in order to have the best chance of achieving the solution. For example, if a non-winning team finds that it is not feasible to move forward without winning some seed money from the proposal, and the team disassembles, we encourage those with expertise and interest to pursue membership with other teams.

Are preliminary data required for the design solutions?

Preliminary data are NOT required but are allowed.

Are participants required to use a particular data set?

No. Data may be aggregated from available public and/or private sources, provided that participants certify that they have the proper freedom to operate, utilize and present the data in an open source format. Please provide the license and terms under which they are provided for all included datasets.

May participants ask additional questions? Are program staff available to discuss scientific or technical questions by phone?

Questions can be emailed to NCATSASPIREChallenge@mail.nih.gov. NCATS staff members are not available for discussions by phone or through direct emails.

What are included in matching funds or in-kind contributions?

Matching funds may include cash expenditures by the entrant and the value of allowable third-party in-kind contributions. Allowable in-kind contributions may include volunteer services, loaned/donated equipment, space, staff salaries, supplies, etc. In all cases, costs and contributions are subject to verification before a prize can be awarded. The source of these matching funds excludes federal grants and contracts, including SBIR/STTR grants. State or local funds, private or corporate donations can be used to meet the matching requirement. No federal funds will be considered, even if for activities related to submitting the entry, but not developing the design, to determine the amount of matching funds. Funds from other nonfederal entities or nongovernmental entities may be used.

Is there a minimum amount of matching funds required to enter the competition?

No. There is no minimum amount of matching funds required to enter the competition. However, the amount of the prize will be adjusted so that the prize amount reflects the amount of the matching funds documented with the submission. The amount of matching funds will not be considered in the assessment of the quality of the design.

How should a prospective participating company (for-profit private entity) document the matching funds?

For-profit entities should include specific information that identifies the source and amount of all funds to be considered when determining the amount of matching funds that supported development of the submitted design. In addition, submissions should also include a statement of assurance that federal funds were not used to develop the design that is being submitted for the challenge. Costs and contributions will be subject to verification before a prize can be awarded.

When is documentation of matching funds required?

The documentation of the contribution of matching funds is due at the time the design is submitted, not upon receipt of the prize award.

Will applications to advance in vivo biological assays be considered?

No. Only in vitro biological assays that are physiologically relevant and use renewable sources of human cells (such as iPSCs) will be considered. The assay must be amenable to high-throughput screening in the future.

For the envisioned reduction to practice stage, will winners of the Design Challenges be required to work with each other?

No. While all winners of the design challenges will be invited to participate in this stage, no teaming will be forced. As with these Design Challenges, collaboration will be highly encouraged. New teams with innovative approaches also are invited to apply.

Does NCATS have a video where applicants can learn more?

Yes. Applicants are encouraged to learn more from this informational applicant video.