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Can your research help avoid the call "Houston, we have a problem"?!? 

A year and a half ago, the Translational Research Institute for Space Health (TRISH) was stood up with the imperative purpose of funding radical, disruptive science and technologies that could be translated to protect and optimize human health and performance during long-duration, deep space exploration missions.

Different from most grant organizations, TRISH is focused on very early stage (needs proof of concept, for example) and very late stage (ready to go to market, for example) research; we do not fund incremental scientific research.

Working closely with NASA’s Human Research Program, the Baylor College of Medicine led institute, a consortium that includes Caltech and MIT, TRISH has already funded ground-breaking technologies designed to keep astronauts safe. Find out more about TRISH.

About the Initiative and this Call for Proposals

TRISH is soliciting proposals for the rapid development of commercially available or viable computer-based algorithms that facilitate diagnosis of medical conditions on NASA’s Medical Conditions List in addition to other medical conditions that may occur and require treatment during long-duration space flights as well as for terrestrial applications.

Note that this solicitation is being administered by CIMIT in support of TRISH. Also note that TRISH is running another solicitation in parallel, also administered by CIMIT, called “Point-of-care Diagnostics for Long-duration Space Flight”.

While astronauts are generally healthy, medical issues can occur during long-duration space flights as on Earth, and space flight increases the risks for certain medical complications, including muscle atrophy, bone demineralization, cardiovascular deconditioning, motion sickness, visual problems (perhaps related to elevated intracranial pressure), kidney stones (resulting in part from bone demineralization), back pain, urinary retention, toxic exposure, decompression, ear infection, and corneal abrasions (due to an excess of floating objects in-flight) (Strangman, 2018).

Definitive medical care is not feasible on spaceflight missions. In-flight medical expertise and supplies will be limited during long-duration space flights, and therefore definitive care may be weeks to months away. Additionally, long-duration missions will be limited in telemedicine support. Therefore, on-board medical diagnostic systems need to either provide user-guidance capabilities or minimize training time by being exceptionally intuitive and easy to use.

Limitations and related desirable attributes/specifications for use during long-duration space flights for an algorithmic tool for generating a differential diagnosis are shown in the following table (adapted from Strangman, 2018):

Spaceflight Limitation

Device Design Attributes/Specifications

 
Low-resource environment

Multiuse devices, or devices integrated into the vehicle

Components robust to failure in space environment

 

Communication delays

Easy-to-use devices

Built-in self-guidance or just-in-time training systems

Automated data management

Limited power generation capabilities

Minimize power demands

 Busy astronaut schedules

Minimize time required for training, setup, use, and data management

The specific focus of this call for proposals is on the development of a computational diagnostic clinical decision support system that can autonomously evaluate medical data from crew and consult medical guidelines to provide medical decision support without a connection to NASA. Coverage of the diagnoses outlined in the Medical Conditions list is required, as is other common medical conditions that may occur and require treatment during long-duration space flights.

It can be assumed that the astronaut’s complete medical history will be available, as will vital signs, EKG, output from regular medical exams, possibly ultrasound imaging, and other physical signs as obtained onboard by a physician-astronaut or other crewmembers with less medical expertise and experience. In addition, the computational system should be able to refine the differential diagnosis based on the results of a CBC with differential, basic metabolic panel, and liver function tests. No other medical diagnostic modality (such as X-rays) will be assumed to be available.

Proposed technologies must be in the Proof of Value stage or later at the time of the application (TRL 5).

To accelerate clinical adoption of these technologies for use during long-duration space flights as well as terrestrial clinical settings, the system must be comprehensive, accurate, easy to use with minimal potential for operator error, and should facilitate therapeutic decisions, store results for later downloading and analysis, and connect and integrate with electronic medical record systems.

Award Requirements

  1. Applicants: Eligible applicants must qualify as small business under the definitions of the SBIR program: small companies (defined as less than 500 employees) based on operating in the U.S. They may have sub-awards to universities, but the primary recipient will be the company.

  2. Matching: Recipients are required to cost share/match 100% of the award from a non-federal source. Private sector money is preferred.

  3. Use of Funds: All funds are intended to be used to move the product along the commercialization path in parallel with spaceflight applications and to be spent on technical work, clinical proof of concept, etc., but not for “business activities” (e.g., a “market study”, patent prosecution, FDA documentation, etc.)

  4. Intellectual Property (IP): The company retains IP ownership rights, with “walk-in” and “use” terms consistent with the SBIR program.

  5. Invoicing: Awardees must invoice on a reimbursement basis.

  6. All grant awards are subject to the provisions detailed in 2 CFR Parts 200 and 1800 (i.e., for higher education, hospital, and non-profit entities) and 14 CFR 1274 (i.e., for commercial firms).

  7. The PI shall provide a final written report to TRISH.

  8. Institutions awarded TRISH funding must report each invention disclosure or patent application resulting from their TRISH research grant to both TRISH and NASA within 60 days of investigator disclosure to the home institution. 
     
    For NASA:
    Submit either a hard copy of Form 1679 to NASA Innovative Partnerships Office, Mail Code AF2, 2101 NASA Parkway, Houston, TX 77058 OR submit online. In the field designating contract number, please cite NNX16AO69A. 
     
    For TRISH:
    In addition to reporting on intellectual property on the annual project report, please also send copies of the institutional invention disclosure AND NASA Form 1679 or the summary from the online disclosure via email to cmmoreno@bcm.edu.      
     
  9. Publications: For TRISH-funded research, please clearly identify support received from TRISH in all publications, invention disclosures, copyrights and patents, using the following phrase: “This work is supported by the Translational Research Institute through NASA Cooperative Agreement NNX16AO69A.”

    Please note that prior to submission for publication, any research publications or presentations utilizing research data from Life Sciences Data Archive (LSDA) or crew medical data from Lifetime Surveillance of Astronaut Health must be submitted to the organization that supplied the data for review to ensure that no personally identifiable information data is included. In addition, recognition of either or both of these data sources must be included in the publication’s or presentation’s acknowledgments section if not otherwise included in the document.

    TRISH-funded authors and co-authors will be required to deposit copies of their peer-reviewed scientific publications and associated data into NASA’s publication repository called NASA PubSpace, managed by the NIH’s PubMed Central. This excludes patents, publications that contain material governed by personal privacy, export control, proprietary restrictions, or national security law or regulations.

Submitting an Expression of Interest (Pre-proposal)

The awards process under this solicitation begins with submission of an Expression of Interest form, which must be submitted through the TRISH web-based submission system and can be accessed here.

The submission site will be open to submit Expression of Interest forms on March 8 and will close at 11:59PM EST on Thursday, April 12, 2018.

To submit an Expression of Interest, enter the fields requested on the 3-page form within the word-limits noted. You can invite others into the private site to help you complete the form. You can save the form, exit and return later to compete the form before the deadline. Once satisfied, you can submit the completed form for consideration. Once submitted, you will get a confirmation and can no longer edit the form.

The first page requests a brief description of your project idea and the subsequent sections address each of the review criteria. You may provide references, but these must be included in the word limit per section.

Please check the FAQ's: if you have any questions or email CIMITGrants@partners.org.

Submitted Expressions of Interest will be reviewed based on the applicant’s descriptions of the following:

  1. Solution: Likelihood of being able to perform all the required diagnoses with the available data as well as a robust, expandable platform suitable for long-duration space flight.
  2. Scope of Work: The proposed work is aligned with making the solution compatible with long-duration space flight and consistent with the funding level being sought.
  3. Readiness: The prior work is of high quality and demonstrates that the proposed solution has reached the desired maturity level (at or beyond “Proof of Value” stage).
  4. Commercial Potential: Has a demonstrated high potential for commercial introduction in under 5 years (e.g. team, regulatory pathway, customer feedback, value proposition, etc.)
  5. Resources: The team, coupled with the proposed resources (from TRISH, CIMIT, any other sources) is sufficient for the project stage and proposed work.

A subset of applicants who submit Expressions of Interest will be invited to submit full proposals on April 26, 2018, with further details provided in the acceptance letter. Full proposals will be due June 5, 2018.

Available Award Levels

For those teams invited to submit full applications for funding, there will be three levels of awards available depending on the maturity of solutions and scope of proposed work described in the applications: CRAASH Awards, Validation Awards, and Accelerator Awards:

CRAASH Awards

CRAASH Awards are for teams that have advanced the technology to the Proof-of-Value stage but have not demonstrated that they have advanced the other domains critical to commercial success in healthcare (clinical, market/business, and regulatory) to the same stage. CRAASH is a 10-session program that starts and ends with in-person meetings, with two-hour web-based meetings in between each week. CRAASH was developed to help early stage teams/businesses launch successful HealthTech solutions, such as devices, diagnostics and e-/digital health innovations, etc. Teams work with seasoned executives from CIMIT. It requires teams to interview stakeholders to define and validate who its customers are, and what they want, need, and value (users, economic buyers, etc.). It also helps them explore if and how a sustainable business can be built as well as why your next funder will make an investment, concluding with a “pitch” to investors – including TRISH. CRAASH recipients can subsequently apply for Validation or Accelerator Awards. Teams are provided a travel allowance for the in-person meetings and approved travel to conduct stakeholder interviews. The time of team members is covered by the applicant and becomes a cost-share that can be applied if successful in winning a Validation or Accelerator Award.

Validation Awards

The goal of the Validation Award is to do enough work to demonstrate that key issues that are seen as reasons the solution will fail to become a commercial success can be overcome so that a viable path forward to patient care exists. It is not hypothesis-driven research, but most often includes technical experiments. “Business Activity” research is also included, but will only be funded through the industry-match. The results are intended to demonstrate the commercialization potential of an innovation sufficiently to give enough confidence to subsequent funders, be they TRISH or other government, philanthropic, or commercial, that the potential for clinical impact is significant enough to invest. Activities included in a Validation Award may support the team members and/or external resources, such as consultants, and include such things as rapid prototyping for use in customer validations, manufacturability and reliability assessments, supply-chain projections, IP Freedom-to-Operate and patentability assessments, validating regulatory and reimbursement pathways, etc. While the plans may include some of the Business Activities, the budgets will make it clear that the associated costs will be borne by the cost-share and not from TRISH funds.

Funding will be up to $50K per Validation Award, with a 100% cost-sharing match in addition, and duration is expected to be between three to six months. The award amounts are total costs. Budgets should include direct and indirect costs.  If you are using an indirect cost rate, it must be a federally negotiated rate. 

Accelerator Awards

Accelerator Awards are meant to move an innovation through the milestones in the Translation Phase, with success being sufficient commercial funding to launch sales and/or a NASA specific deliverable. Such projects are expected to be sustained post-award through commercial funding with a focus on product introduction and creating revenues. These projects are largely scientifically and technically de-risked, but require further development and investment of money and/or business development expertise to attract interest from an entrepreneur or commercial entity for licensing and commercialization. Accelerator Award projects get support in terms of money, but more importantly, for those that need it, they get the support of experienced HealthTech entrepreneurs with the skills required, such as members of the CIMIT Accelerator Team. The team consists of successful serial entrepreneurs – see brief bios here. One is assigned to provide active hands-on leadership for the team to fill a gap. This can range from acting as an interim CEO or taking leadership on issues such as marketing, supply chain, operations, partnering, fund raising, etc. The team as a whole acts as a quasi-board, providing balanced perspectives on issues from technology to marketing, manufacturing, and distribution, etc.

Funding will be up to $250K per Accelerator Award, with a 100% cost-sharing match in addition, and duration is up to one year. The award amounts are total costs. Budgets should include direct and indirect costs.  If you are using an indirect cost rate, it must be a federally negotiated rate. 

Timelines

March 8, 2018: Expression of Interest site open

April 12, 2018: Deadline for Expression of Interest submissions

April 26, 2018: Full proposals invited

June 5, 2018: Deadline for full proposals

July 6, 2018: Award recipients notified

Reference

Strangman G. Space biomedical instrumentation. In: Young LR, Young JP, eds. Encyclopedia of bioastronautics. Springer 2017.

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