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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 transformation of emerging point-of-care (POC) technologies into viable, clinically-focused solutions that facilitate diagnosis of conditions on NASA’s Medical Conditions List during long-duration space flights as well as in terrestrial clinical settings. The solicitation seeks technologies that have a commercial potential that would benefit from investments that make them suitable for long-duration spaceflights. For example, miniaturizing a table-top device into a hand-held device, reducing the need for and extending the shelf-life of consumables, and improving ease-of-use, are all important developments.

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 “Deep Artificial Intelligence Medical Support”.

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). 

The key variables for medical technologies developed for use in deep space are related to performance/accuracy, mass, volume, power, speed, ease of use, reliability/durability, shelf life, and mass/volume of consumables; each of these should be optimized when designing devices for clinical monitoring. Additionally, fluids behave very non-intuitively in microgravity and hence considerable caution and pre-flight testing is required approaches involving fluids. Microfluidics, which depend on capillary action rather than bulk fluid flow, are highly preferred as they significantly reduce these concerns. Other examples of limitations imposed by long-duration space flight and related desirable attributes/specifications for use during long-duration space flights are shown in the following table (adapted from Strangman, 2018):

Spaceflight Limitation

Device Design Attributes/Specifications

 

Low-resource environment

 

Multiuse devices

Reusable device components

Low maintenance components, minimize moving parts

Components robust to failure in space environment

 

Long distances and high cost to orbit

Minimize mass

Minimize volume

Minimize consumables

 

Communication delays

Easy-to-use devices

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

Automated data management

 

Fluids in microgravity

Noninvasive devices

Minimize fluid samples

Reduce or eliminate fluids required

Analog testing (e.g., parabolic flight)

Sealed environment

Use nontoxic materials and fluids

Off-gas testing

Limited power generation capabilities

Minimize power demands

Busy astronaut schedules

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

The specific focus of this call for proposals is on the development of noninvasive or minimally-invasive (e.g., finger stick) devices to conduct standard medical assessments of multiple blood components (complete blood count, basic metabolic panel, and liver function tests) for onboard clinical diagnosis in long-duration space flights, with all aspects of the device’s form factor and operation appropriate for use in outer space given the constraints shown in the above table as well as others that may apply. Preference may be given to multi-function or flexible/modular systems that enable examination of additional analytes.

Proposed technologies must be in the Proof of Value stage or later at the time of the application (TRL 5). Ideally, solutions would cover all of the desired blood components with a single platform, but a platform that can be demonstrated for a subset of these components and that has the potential to expand to other components is allowable.

To accelerate clinical adoption of these technologies for use in space as well as terrestrial clinical settings, the following performance criteria apply for this solicitation:

  1. Result Availability: Results must be available within 10 to 20 minutes or sooner so that decisions can be made in a timely fashion based on the test results.
  2. Ease of Use: The user interface with the device should be designed to ensure regulatory compliance under the clinical laboratory improvement amendment (CLIA-88) with minimal requirements for intervention by the operator. Results readout must not be subjective but easy to read using color change readout, digital or graphic formats.
  3. Reducing Operator Errors: The device should have built in software safeguards to ensure proper operation and reduce common errors such as lock-out for failed quality control (or failure to perform quality control), lock-out of expired consumables, etc.
  4. Sample Types: Samples that do not require a trained phlebotomist such as capillary finger-stick whole blood or saliva is significantly preferred to venous blood samples.
  5. Storage of Consumables: All consumables including reagents, calibrators and quality control materials should be able to be stored at room temperature. The minimum shelf life is 2 years, although 5 years is preferred.
  6. Device Footprint: Devices should be designed to have as small a footprint as possible. Small handheld devices, or devices that are easily integrated into a spaceflight vehicle, are optimal.
  7. Information Connectivity: All devices should be capable of being interfaced to an electronic medical record system.
  8. Analytic Performance: As a general rule, the device should be equivalent to central laboratory instruments with regard to analytical accuracy, reportable range, and precision.

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 match TRISH funding at one-to-one level (a 100% cost-share) 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 tests as well as potential for additional tests in the future in a configuration 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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