2021 “$100,000 for Start a SUD Startup” Challenge

Challenge Summary:

The National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), announces the annual “$100,000 for Start a SUD Startup” Challenge. The Challenge goal is to support research ideas in the area of Substance Use Disorders (SUDs) that are intended to be the foundation for the development of successful new startups. NIDA expects that the Challenge will enable the winners to test the premise that their research idea can be fostered into a biotech startup, and that eventually the newly created startups will contribute to the pool of innovative small business companies that can successfully compete for NIDA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding.

The Challenge will offer up to ten awards of $10,000 each and technical expertise and mentoring from NIDA biomedical entrepreneurship experts. The Challenge total purse is up to $100,000.

Subject of the Challenge:

NIDA is reissuing this Challenge after confirming its success and popularity within the community. The Challenge is a competition for participants with research ideas in the Substance Use Disorder (SUD) research area that are purposefully intended to be the foundation for the development of new successful biomedical startups. NIDA offers $100,000 conjointly with technical mentoring from NIDA biomedical entrepreneurship experts. NIDA expects that the prize competition will inspire and enable the winners to test the premise that their SUD research idea can be fostered into a biotech startup. This Challenge is unique because NIDA intends to provide prize money and dedicated biomedical entrepreneurial assistance to the “would be” startup founders much earlier than most investors, incubators, or traditional models of research funding (e.g., small business grants). However, NIDA anticipates that the newly created startups will eventually contribute to the pool of innovative small business companies that can successfully compete for NIDA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding.

What does it take to participate in the Challenge? The participants must have a research idea directly related to SUD or that could be extended or adopted to be useful for SUD. For a platform technology, the research idea must be broad enough to address multiple conditions, diseases, or indications, including SUD. For example, if the idea would only work for cancer or diabetes, entering this Challenge is not appropriate. However, if the plan is to test an idea for a research tool that would further an understanding of neurobiology or epigenetics relevant to SUD to advance the field faster and with greater fidelity, entering this Challenge is appropriate. The participants must also be interested in creating a startup around their research idea with the goal of creating the startup product for the target customers. Here, the term “product” is used in its broadest definition. Product is any source of value for the people who become customers. Services, subscriptions, software as a service (SaaS), physical/tangible products (biomedical devices, drugs, etc.), aggregations, etc. could all provide value and thus be considered startup products. The startup product could be the result of novel scientific discoveries, repurposing an existing technology for a new use, extending a research observation or discovery made in a different scientific field into the SUD area, devising a new business model or distribution/delivery channel that unlocks new value, or simply bringing a product or service to a previously underserved customer.

The potential startup founder must also have the passion, drive, discipline, ability to work collaboratively, and willingness to be coached to push forward under conditions of business uncertainty.

The winners of this Challenge are encouraged and offered training to use the prize money to develop a minimum viable product (MVP), to obtain customer feedback to discover if the MVP meets the customer needs, and to assess the feasibility of science-based small business creation within 6 months post-award. Post Challenge, as with all other NIH grant applicants, NIDA staff will provide technical assistance and guidance about the grant submission process, including how to submit an SBIR/STTR application to NIDA’s small business programs.

Dates:

• Challenge Launch: August 19, 2021
• Submission Start: August 30, 2021 9:00 AM ET
• Submission End: November 16, 2021 11:59 PM ET
• Judging Period: November 29, 2021 to December 10, 2021
• UPDATE: Winners Announced: January 10, 2022

Statutory Authority to Conduct the Challenge

NIDA is conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719]. The general purpose of NIDA is to conduct and support biomedical and behavioral research, health-services research, research training, and health information dissemination with respect to the prevention of drug abuse and the treatment of drug abusers. This Challenge is consistent with and advances the mission of NIDA as described in 42 U.S.C. 285o in that it supports biotech startups in the development of research ideas that would further an understanding and management of SUD. As this Challenge is consistent with and advances the mission of NIDA in that it seeks to identify novel strategies to combat drug addiction, any submissions pursuing ideas in the areas of alcohol use disorder and pain will not be accepted.

Prizes

Amount of the Prize:

The total prize purse is $100,000. NIDA will award up to ten awards of $10,000 each along with mentoring from NIDA biomedical entrepreneurship experts. The names of the winners and the titles of their submissions will be posted on the NIDA website.

Award Approving Official:

The Award Approving Official for this Challenge will be the Director of NIDA.

Payment of the Prize:

Prizes awarded under this Challenge will be paid by electronic funds transfer and may be subject to Federal income taxes. NIH/NIDA will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. For team submissions, the prize will be paid to the designated team leader.

NIDA reserves the right, at its sole discretion, to (a) cancel, suspend, or modify the Challenge, and/or (b) not award any prizes if no entries are deemed worthy.

Rules

Eligibility Rules for Participating in the Challenge:

The Challenge is open to teams of participants 18 years of age or older. No prior startup experience is necessary. Participants must be a group of individuals (i.e., a team assembled with the purpose of participating in this Challenge). Teams may be a newly formed group of founders, may represent an entity (e.g. academic institution, non-profit organization), or may have applied to past “Start a SUD Startup” Challenge competitions. If the team applied to a past Challenge and was not selected for a prize, they may apply again with the same or a new idea, and if the team applied to a past Challenge and was selected for a prize, they may apply again with a new idea for a new startup. 

(1) To be eligible to win a prize under this Challenge, Participants —

• Shall have registered to participate in the Challenge under the rules promulgated by the National Institutes of Health (NIH) as published in this announcement;
• Shall have complied with all the requirements set forth in this announcement;
• In the case of an individual participating 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.
• Shall not be a federal entity or federal employee acting within the scope of their employment;
• Shall not be an employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity;
• Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency ethics official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this Challenge;
• Shall not be a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).
• Must have an intention to form a United States-based startup or be a United States-based new startup (i.e. in the early stage of formation and growth).
• Shall be 18 years of age or older at the time of submission.

(2)  Federal grantees may not use federal funds from a grant award to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.

(3)  Federal contractors may not use federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.

(4)  By participating in this Challenge, Participants agree to assume any and all risks and waive claims against the federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.

(5)  Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no Participant participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.

(6)  By participating in this Challenge, each Participant agrees to indemnify the federal government against third party claims for damages arising from or related to Challenge activities.

(7)  A Participant shall not be deemed ineligible because the Participant used federal facilities or consulted with federal employees during the Challenge if the facilities and employees are made available to all Participants participating in the Challenge on an equitable basis.

(8)  By participating in this Challenge, each Participant warrants that they are sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the Participant (or is an improved version of an existing work that the Participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which the Participant is aware.

(9)  By participating in this Challenge, each Participant grants to the NIH permission to display publicly their names and title of their submission on the NIDA website. Each Participant will retain all other intellectual property rights (e.g., copyright) in their submissions, as applicable. To receive an award, Participants will not be required to transfer their intellectual property rights to NIH, but Participants must grant to the federal government the permissions recited herein.

(10)  Each Participant agrees to follow all applicable federal, state, and local laws, regulations, and policies.

(11)  Each Participant participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such Participant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.

Disqualification:

Submissions may be disqualified for plagiarism, falsification of any information submitted, use of copyrighted material without permission, and use of profanity, violent images, or nudity. NIDA is not responsible for lost, late, incomplete, invalid, unintelligible, or misdirected entries, which will be disqualified. As this Challenge is consistent with and advances the mission of NIDA, in that it seeks to identify novel strategies to combat drug addiction, any submissions pursuing ideas in the areas of alcohol use disorder and pain will not be accepted.

Judging Criteria

Basis Upon Which a Winner Will be Selected. The judging panel, comprised of federal employee scientists, will consider the following 5 criteria and make recommendations to the award approving official based upon their assessments of the criteria. Each criterion will be scored with a maximum of 10 points.

1. Team/Founders Aptitudes (0-10 points). Does the team demonstrate a high level of ability and dedication? Is the passion, drive, discipline, ability to work collaboratively, and willingness to push forward under conditions of extreme business uncertainty successfully demonstrated?
2. Validation of Unmet Needs (0-10 points). Are there significant needs for the proposed product or service? How do you know? Does the project address an important problem or a critical barrier to progress in the field of SUD/drug abuse research? If the aims of the project are achieved, how will scientific knowledge, technical capability, service, or clinical practice be improved? How will those improvements be measured or established? Is there evidence of market research?
3. Idea Novelty (0-10 points). Does the proposed idea utilize novel theoretical concepts, approaches, methodologies, instrumentation, service, or interventions for SUD/drug addiction research? Is the proposed product novel in a broad sense? Are refinements, improvements, or new applications of theoretical concepts, approaches, methodologies, instrumentation, or interventions proposed?
4. Approach (0-10 points). Are the overall research strategy, methodology, and analyses well-reasoned and appropriate to test the proposed idea? Does the approach take the feedback from the end-users or end-user need assessment into account?
5. Commercialization (0-10 points). Is there a clear path for the product/service to reach the market? Are the product users and purchasers clearly identified? Is there evidence of market research or analysis of competitors?

Submissions that are responsive and comply with the entry requirements will be reviewed by a panel of judges consisting of federal employees. The responsive and compliant submission entries will be scored in accordance with the judging criteria outlined above. Scores from each criterion will be weighted equally, but failure to meet a minimum standard for any one criterion might disqualify a submission. The score for each submission will be the sum of the scores from each of the voting judges. The scores will be listed in order, from highest to lowest. Challenge contenders with sufficiently high scores will then be contacted via tele- or videoconference. Those meetings will be used to gather more details about the information provided in the Submission Package and to determine the up-to-date level of participants’ availability, interest, and commitment. Final prize recommendations will be determined based on the judges’ scoring and tele- or videoconference meetings.

How to Enter

Registration Process:

Participants must be a group of individuals (i.e., a team assembled with the purpose of participating in this Challenge). Each team is required to identify a team leader who registers and submits a required Submission Package on behalf of the team. The team leader must send the completed registration form and all submission materials to NIDAChallenge@nih.gov with the subject line “Start a SUD Startup Submission Package” by the specified submission deadline date and time. You can download the registration form here.

Submission Requirements:

Each submission for this Challenge requires a complete Submission Package. The Submission Package includes the registration form, a 4-page written proposal describing the idea, and a 5-minute video introducing the team (see requirements below for the proposal and video). Both the idea and the 5-minute video will be evaluated. Submissions that do not follow the format described below will be disqualified and removed from the prize considerations.

1. Proposal. The proposal must consist of a PDF file with at least 1-inch margins and be no more than four (4) pages long. Font size must be no smaller than 11-point Arial. All submissions must be in English. The participants must not use the HHS logo or official seal or the logo of NIH or NIDA in the submissions and must not claim federal government endorsement.
   
   In the proposal:
   • Idea Description. Describe how your research idea would further an understanding of SUD and be the foundation for a successful startup. The research idea must be defensible and evidence based. (1 page)
   • Team Technical Competence and Research Experience. Convince the Challenge judges of your technical competence. Be brief, persuasive, and only present the relevant information. Do not use the NIH Bibliographic Sketch format. (0.5 page)
   • Prototype Description and Step-by-Step Use of Final Product, as Envisioned. Describe, in as many details as possible, what the prototype of your envisioned product would look like. Then, walk the Challenge judges through the typical use of the product, using simple terms and instructions. (1.5 pages)
   • Need Validation. Explain the methods you will use (how, when, where, whom) to determine whether the product is needed by the target customer and whether that end user/customer would be willing to pay for the product. (1 page)
2. Video. A brief 5-minute video must be posted to YouTube and the link to the video provided. In contrast to the proposal, the video is intended to introduce the team, not the research idea. The team and its people are the most important evaluation criteria for entrepreneurial success.
   
   In the YouTube video:
   • In one minute or less, tell NIDA who on your team is the lead “hacker,” also known as technical lead, with the skills to develop your product and to focus on the available technology options and requirements.
   • In one minute or less, tell NIDA who on your team is the lead “hipster,” also known as the end user/customer need lead, the person concerned with the customer experience and design. This team member understands the end-user of your product and focuses on the medical and healthcare delivery issues (most often, a practicing SUD physician, clinical department manager, etc.).
   • In one minute or less, tell NIDA who on your team is the lead “hustler,” also known as the business or entrepreneurial lead, with the skills or aspirations to focus on the overall business objectives, customer definition, business plan, etc.
   • Tell NIDA how long you have known each other and relay something that can illustrate the drive or the desire of each team member to become a startup founder.
   • What unique skill set, background, or experience does this team have that has led them to pursue this idea?
   • Tell NIDA something about each team member that demonstrates a high level of perseverance and grit.
   • Tell NIDA about a time when your great idea was rejected. What was your response?

Additional Information

For Further Information Contact:

Challenge email: NIDAChallenge@nih.gov

Sara Lioi, Ph.D.
NIDA Challenge Administrator
Office of Translational Initiatives and Program Innovations (OTIPI)
National Institute on Drug Abuse (NIDA)
Building 31 Room 1B59
Bethesda, MD 20814
Phone: (301) 827-5829
Email: sara.lioi@nih.gov

Elena Koustova, Ph.D., MBA
NIDA Challenge Manager
Director, Office of Translational Initiatives and Program Innovations (OTIPI)
National Institute on Drug Abuse (NIDA)
Building 31 Room 1B47B
Bethesda, MD 20814
Phone: (301) 496-8768
Email: elena.koustova@nih.gov