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NCATS ASPIRE Design Challenge 4
Biological Assays for Translational Innovation in Pain, Opioid Use Disorder and Overdose
Department of Health and Human Services - National Institutes of Health
Submission Start: 12/31/2018 12:00 PM ET
Submission End: 05/31/2019 12:00 PM ET
SUMMARY OF NCATS ASPIRE DESIGN CHALLENGE 4
Biological Assays for Translational Innovation in Pain, Opioid Use Disorder and Overdose
Challenge 4 aims to address the need for novel, physiologically relevant biological assays that can accurately replicate the safety profile and effectiveness of existing drugs to treat addiction and/or overdose, and that can be reliably used in predictive assessments of new analgesics or drugs to treat addiction and/or overdose; and/or be able to anticipate the degree of addictiveness of an analgesic prior to clinical testing. This challenge requires submission of only a detailed description of the design of the assay(s), not the final working assay(s).
Evaluation criteria that reviewers will be asked to address are specified under the "Judging Criteria" tab.
For complete details on the challenge, visit the NCATS ASPIRE Design Challenge 4 details page.
About NCATS ASPIRE Design Challenges
The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH) is inviting novel design solutions for A Specialized Platform for Innovative Research Exploration (NCATS ASPIRE) Challenges as part of the NCATS ASPIRE Program. The goal of the NCATS ASPIRE Design Challenges is to reward and spur innovative and catalytic approaches towards solving the opioid crisis through development of: (1) novel chemistries; (2) data-mining and analysis tools and technologies; and (3) biological assays that will revolutionize discovery, development and pre-clinical testing of next generation, safer and non-addictive analgesics to treat pain, as well as new treatments for opioid use disorder (OUD) and overdose. The first phase of these prize competitions is implemented through a suite of concurrent companion design challenges that comprises a separate challenge for each of four areas: chemistry database, electronic laboratory knowledge portal for synthetic chemistry, algorithms, and biological assays; and an additional challenge for a combined solution to at least two Challenge areas. At this stage, innovators are expected to submit designs, not final products or prototypes. NCATS envisions following these design challenges with a follow-on, but distinct, final reduction-to-practice challenge, which will aim to invoke further scientific and technological development of the model system. Winners of the design challenges will be invited to present their designs so that, in the envisioned follow-up Reduction-to-Practice Challenge, an open competition, teams will be able to form multi-disciplinary collaborations to advance and integrate the most feasible and promising approaches to the multiple challenges into a single integrative platform. Innovators will be invited to demonstrate final solutions.
The NCATS ASPIRE Design Challenges are part of the of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.
NCATS refers to participants in the NCATS ASPIRE Design Challenges as “innovators” because all solutions will require highly innovative approaches to achieve success. Innovators should clearly state how and why the proposed solution would provide significant advances over currently available tools. Innovators may choose to compete in one or more individual challenges to address a single area (Challenges 1-4) or propose a combined solution for at least two Challenge areas (Challenge 5).
For further information send an email to NCATSASPIREChallenge@mail.nih.gov.
Cash Prize Amount: $500000
The total prize purse is $500,000. Up to five (5) winners will be selected.
For details on payment of the prize and for-profit entity matching requirement, visit the NCATS challenge details page.
Innovators must be 18 years of age or older and may participate singly or as part of one or more teams. Teams are not limited in the number of members. 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. Teams may also merge, collaborate, subdivide or otherwise organize themselves and their members as needed to prepare a solution for this Challenge.
- To be eligible to win a prize under this Challenge, an individual or entity:
- Shall have registered to participate in the Challenge under the rules promulgated by NIH as published in this notice;
- Shall have complied with all the requirements set forth in this notice;
- 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 not be a federal entity or federal employee acting within the scope of their employment;
- May not be an employee of HHS (or any component of HHS) acting in their personal capacity;
- 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;
- May 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, stepparent, child, or stepchild).
- Federal grantees may not use federal funds to develop their Challenge submissions unless use of such funds is consistent with the purpose of their grant award and specifically requested to do so due to the Challenge design and as announced on Challenge.gov.
- Federal contractors may not use federal funds from a contract to develop their submissions or to fund efforts in support of their submissions.
- Submissions must not infringe upon any copyright or any other rights of any third party.
- By participating in this Challenge, each individual (whether competing singly or in a group) and entity agrees to assume any and all risks and waive claims against the federal government and its related entities (as defined in the COMPETES Act), 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.
- Based on the subject matter of the Challenge, the type of work that it will possibly require and an analysis of the likelihood of any claims for death, bodily injury, property damage or loss potentially resulting from Challenge participation, no individual (whether competing singly or in a group) or entity participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.
- By participating in this Challenge, each individual (whether competing singly or in a group) and entity agrees to indemnify the federal government against third-party claims for damages arising from or related to Challenge activities.
- An individual or entity shall not be deemed ineligible because the individual or entity used federal facilities or consulted with federal employees during the Challenge if the facilities and employees are made available to all individuals and entities participating in the Challenge on an equitable basis.
- By participating in this Challenge, each individual (whether participating singly or in a group) and each entity grants to NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share and display publicly the submission on the web or elsewhere. Each innovator will retain all other intellectual property rights in their submissions, as applicable.
- NIH reserves the right, in its sole discretion, to (a) cancel, suspend or modify the Challenge and/or (b) not award any prizes if no entries are deemed worthy.
- Each individual (whether participating singly or in a group) or entity agrees to follow all applicable federal, state and local laws, regulations and policies.
- By participating in this Challenge, each individual (whether participating singly or in a group) warrants that he or she is the 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 innovator (or is an improved version of an existing work that the innovator 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 innovator is aware. To receive an award, innovators will not be required to transfer their intellectual property rights to NIH, but innovators must grant to the federal government a nonexclusive license to practice their solutions and use the materials that describe them. This license must grant to the United States government a nonexclusive, nontransferable, irrevocable, paid-up, royalty-free license to practice or have practiced for or on behalf of the United States throughout the world any invention made by the innovators that covers the submission. In addition, the license must grant to the federal government and others acting on its behalf a fully paid, nonexclusive, irrevocable, worldwide license in any copyrightable works that the submission comprises, including the right to reproduce, prepare derivative works, distribute copies to the public and perform publicly and display publicly said copyrightable works. To participate in the Challenge, each innovator must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the innovator’s rights to the federal government.
- Each individual (whether participating singly or in a group) and entity participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such innovator’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.
- By participating in this Challenge, each individual (whether participating singly or in a group) agrees to allow NCATS to publicly display (e.g., on websites) solution abstracts, as submitted by innovators in the submission package.
- By participating in this Challenge, each individual (whether participating singly or in a group) assures NCATS that any data used for the purpose of submitting an entry for this Challenge competition, were obtained legally through authorized access to such data.
Basis upon Which Submissions Will Be Evaluated
A panel of federal and non-federal reviewers, with expertise directly relevant to the Challenge, will evaluate the solutions based on feasibility and ability to achieve the criteria listed below. The solutions and evaluation statements from the technical panel will then be reviewed by federal employees serving as judges, who will select the Challenge winners, subject to the final decision by the Award Approving Official. The NCATS will provide feedback from the technical experts and judges to the winners and non-winners on their respective submissions.
The points assigned to each set of evaluation criteria are guidelines from NCATS to suggest which scientific milestones are of emphasis and interest to the Center. All winners are highly encouraged to participate in future NCATS ASPIRE Reduction-to-Practice Challenges that NCATS is planning.
Only complete submissions will be reviewed.
Challenge 4. Biological Assays for Translational Innovation in Pain, Opioid Use Disorder and Overdose. This Challenge aims to address the need for novel, physiologically relevant biological assays that accurately replicate the safety profile and effectiveness of existing drugs and that can be reliably used in predictive risk assessments of new analgesics or drugs to treat addiction and/or overdose to molecular signature(s) and/or be able to anticipate the degree of addictiveness of an analgesic prior to clinical testing. This Challenge requires submission of only a detailed description of the design of the assay(s), not the final working assay(s).
The goal of this Challenge is to reward and spur innovative solutions to the development of a novel physiologically relevant biological assay to advance pre-clinical discovery and development of non-addictive treatments for pain, drug addiction or overdoses. Current in vitro assays and in vivo models to study pain and addiction and test potential treatments are very limited. Pharmacological probe, lead and drug development have traditionally utilized canonical cell lines (such as CHO or HEK293) that heterologously express the molecular target of interest, and studies that are performed in animal models often do not fully recapitulate human physiology and may identify candidate compounds without effects in more human physiology-relevant systems. Therefore, NCATS is inviting innovators to propose and develop novel “disease-in-a-dish” assays of pain perception, addiction or overdose that advance the understanding of different types of pain, identify differences in inter- and intra-individual pain and the associated risk of developing chronic pain and/or addiction and make possible the development of improved, non-addictive drugs to treat these conditions. 2D and 3D human disease-relevant screening platforms may include but are not limited to normal and diseased human iPSC-derived sensory/pain neurons (such as peripheral, dorsal root ganglia [DRG], spinal cord, thalamus); neurons relevant to reward pathways; and other tissues important for pain, addiction and overdose, including blood-brain barrier (BBB). The assays will be adjudicated on their physiological relevance, robustness and reproducibility, and their future potential to be amended to automation and scalability for medium to high-throughput screening assays.
Initially, the assay can be designed for low-throughput screening; it is expected that even at low throughput, multiple technical replicates will be compared in the same experiment. Eventually, the assay should be amenable to automation and scalable to medium- (96-well plate) to high-throughput screening (using, for example, high-content imaging, drug validation/toxicity, functional genomic screening).
The innovators are encouraged to consult NCATS’ Assay Guidance Manual (link is external) to learn more about appropriate designing of a drug screening assay.
For the envisioned Reduction-to-Practice phase, the innovators will be expected to demonstrate the viability rate of cells in 2D or 3D models, at a particular throughput (90% viable), and provide data indicating how the functional morphological features are maintained in the system over time.
Evaluation Criterion 1: Impact and Innovation (20 points)
- To what degree is the proposed assay creative, original and biologically relevant?
- To what extent is the assay design feasible? Does it have a high likelihood of success?
- To what extent is the proposed solution innovative, and how high is its potential to significantly improve the state of science?
- To what extent will the proposed assay accelerate discovery, development and pre-clinical testing of new and safer treatments of pain and/or opioid use disorder (OUD) and overdose?
- To what extent are novel concepts, approaches, methodologies and technologies proposed or existing approaches applied to the design in a novel way?
- To what extent does the proposed assay incorporate cross-disciplinary techniques (e.g., cell biology, imaging, electronics, engineering, etc.)?
- Is the proof-of-concept data using currently available pain drugs, drugs of addiction and/or addiction/overdose treatments proposed?
- How well will the assay(s) demonstrate biological and physiological relevance to a specific application (pain, addiction or OUD)?
- Is a relevant proof-of-concept study of the innovators’ choice proposed for the subsequent Reduction-to-Practice stage?
Evaluation Criterion 2: Model System and Assay Design (20 points)
- How physiologically relevant is the proposed model system that is being assayed?
- To what extent is the assay designed and amenable for validation taking into consideration the target being studied using appropriate drugs/compounds and controls?
- Are the appropriate cell types co-cultured in the model system at physiological ratios? What is the origin of the cells, and how relevant are the cell types to the model system?
- What is the assay’s readout (e.g., biochemical, fluorometric, phenotypic), and is this sufficient to maximize the value of the assay?
- How long will it take to perform the assay in full? Is the timing of the assay appropriate? (What is an assay’s development cycle time?)
- How many technical replicates will the assay support?
- Can the assay be multiplexed?
- Are secondary/specificity/selectivity assays proposed to confirm the initial data?
- What are instrumental, computational and data storage requirements?
Evaluation Criterion 3: Assay Robustness, Reproducibility and Scalability (10 points)
- How well does the proposal describe plans to assess inter- and intra-laboratory utility, transferability and reproducibility?
- How well are the protocols described? Are the protocols sufficiently clear and detailed to facilitate inter- and intra-laboratory utility and reproducibility?
- For the Reduction-to-Practice phase, how would an assay’s robustness and reproducibility be demonstrated?
- Is the assay designed to minimize bias — for example, are the cells seeded, differentiated, cultured manually?
- Are appropriate experiments proposed that will address the stability of the assay components and reagents?
- To what extent is the data collection and analysis automated?
- To what degree could the assay be integrated with other Challenge(s) in a subsequent Reduction-to-Practice phase?
How To Enter
- View the "Solution Submission Instructions and Template" section of the NCATS ASPIRE Design Challenges details page.
- Create an account on Challenge.gov, or use an existing account, to submit your solution, including all information required in the application template.
- Use the Submission Template to format your submission.
- Submit your proposal by NOON Eastern time on May 31, 2019.