Commercialization-Innovation Pilot Awards

Introduction/Overview

The Clinical and Translational Science Institute (CTSI) at the University of Pittsburgh in partnership with the office of the Chief Scientific Officer (CSO) of UPMC seek applications for the Commercialization-Innovations Pilot Awards. These awards are part of a series of funding opportunities to stimulate research for which implementation may involve inventions or commercialization. This specific opportunity will support early stages of work and projects originating from the University

Many basic discoveries are more likely to benefit individuals and populations if they are embodied into sustainable products or practices. Multiple funding strategies can support translation or implementation of innovations including support from large companies, start-up company funding from venture capital, and SBIR / STTR grants from NIH or other federal agencies.

This Pilot will support teams in the earliest stage of their path towards competitive proposals for these extramural sources of funding. For example, a team that is almost ready to make an invention disclosure might use this Pilot to collect key experimental data to support their claims. A team that is developing a device might use this Pilot to create the initial prototype. A team that already has an invention might use this Pilot to refine the invention for a market or de-risk the invention in order to attract extramural funding.

This funding opportunity is not intended for projects that have already secured external investment or other grant funding. If the investigators or members of the team have had prior commercialization experience or SBIR/STTR funding, the application must make clear that this is a new project or invention.

This funding opportunity intends to support work leading to new drugs, new therapeutics, or new technology. Applications must focus on a clearly identified invention or product that has a potential for commercialization. While we will not exclude applications addressing other areas, there are other programs on campus planned or designed to support digital health, develop new medical devices, and to attract commercial partners.

Parts of projects that are not typically covered by other awards but that would be responsive to this Pilot might include the following:

• Completing a market analysis for an invention
• Initial prototyping or design of a product that embodies the IP
• Stakeholder evaluation of usability of a proposed new product
• Comparing different design options for a product as part of down selection
• Completing key experiments to support claims about IP or to de-risk IP
• Completing a related project with a commercial entity to show partnership

Eligibility: This funding opportunity is intended to support early innovation from within the University similar to the STTR awards (https://www.sbir.gov/tutorials/preparing-proposal/). The Pilot does not exclude projects that involve partnerships with commercial entities, but the majority of work must be conducted on campus, and the majority of funds must be expended within the University of Pittsburgh. We expect and encourage partnerships with external businesses that can accelerate translation of research. University investigators also may be on a path to start their own business as part of the translation. While we value efforts that may help investigators set up companies or partner with external companies, funding of those external entities will not be the focus of this opportunity. Nevertheless, some teams may find that efforts within this Pilot program facilitate those partnerships. Other funding mechanisms on campus are planned and designed for projects in which commercial partners assume a larger role (https://www.oiep.pitt.edu/faculty).

Tiered (Phase 1 / Phase 2) Funding: Like SBIR/STTR grants, this Pilot will be part of a two-phase funding opportunity. Initial Phase 1 awards will be $25,000 over 12 months, during which projects are expected to define and reach concrete milestones.

At 6-9 months after project start, teams will be eligible to compete for follow-on Phase 2 awards of up to $75,000 over 12 months to begin at the end of Phase 1. Phase 2 awards will be competitive, will consider progress in Phase 1, and are not guaranteed. Fewer Phase 2 awards will be available for funding. Depending on response and applications, both Phases of these awards may be offered again in the future.

Intellectual Property: University faculty should follow the procedures for protecting IP as outlined by OIE (https://www.oiep.pitt.edu/faculty/commercializing-your-idea). While this Pilot is jointly supported by CTSI and the UPMC CSO Office, participation will not imply any changes in usual policies and procedures related to inventions nor will it require intention to partner with UPMC for subsequent funding. However, CTSI and the CSO will provide the option and opportunity for interested investigators to present projects to UPMC Enterprise or other potential partners who might provide follow-on funding.

CTSI Assistance (Optional)

The Innovation Core of CTSI provides consultation and resources for investigators working on projects with potential for implementation in the marketplace.

Research facilitators at CTSI are available to assist investigators at any stage of a project. Facilitators can advise on finding collaborators, regulatory issues, human research protection, other required approvals, and research design or conduct.

Limited statistical consulting on projects is available from CTSI's Biostatistics, Epidemiology, and Research Design (BERD) Core.

Funding Information

Applicants for Phase 1 can request up to $25,000 in direct costs, with a maximum funding period of one year.

The funding cycle will be for 12 months after the start date; no extensions of this award period will be made. Funding cannot start until any necessary regulatory approvals have been received (IRB, hSCRO, IBC, CORID, IACUC). Projects must start within 3 months of Notification of Award. Projects that do not start within 3 months will be forfeited.

CTSI pilots do not have any mechanism for no-cost extensions; any funds that are not used during the award period will be forfeited.

This award is eligible for CTSI Bonus Awards as described on the separate Bonus Award page. For bonuses requested in this award, “community partners” should be representative groups and does not include corporate partners.

Progress Reports

Unique to this Pilot Award, CTSI requests milestone-driven progress reports for funded projects. Specifically, teams are encouraged to work towards a 6-month report of progress that will help in selection of teams to compete for Phase 2 funding within CTSI. We request a final progress report after 12-months.

Given the focus of this Pilot Award, progress reports may have novel formats and should include a presentation or pitch for any invention. CTSI will offer assistance developing progress reports and presentations that may help teams to compete for other follow-on funding.

Eligibility

The Principal Investigator (PI) must be a faculty member in the University of Pittsburgh Schools of Health Sciences. Postdoctoral trainees and trainees in clinical training programs are not eligible to serve as PI. Faculty member on early-career training awards or clinical research scholars (i.e. recipients of K-series or similar career development grants) are eligible. New PIs are strongly encouraged, but submissions from established investigators will be accepted if they meet other eligibility criteria.

This funding opportunity is intended to support early innovation from within the University similar to the STTR awards (https://www.sbir.gov/tutorials/preparing-proposal/). The Pilot does not exclude projects that involve partnerships with commercial entities, but the majority of work must be conducted and the majority of funds must be expended within the University of Pittsburgh. If the PI already has developed a commercial venture (e.g. a licensed start-up company), that venture cannot be the recipient of the Pilot award. The PI must receive and administer this award in their role as a member of the University faculty, following established policies and procedures for Conflict of Interest, disclosure and licensing (https://www.coi.pitt.edu/outside-activities/licensed-start-companies).

Study teams that involve cross-disciplinary collaborations are strongly encouraged. Co-investigators may be from other universities. However, CTSI’s primary mission is to promote research at the University of Pittsburgh, and applicants should justify any extensive off-campus collaboration. Partnerships with non-academic community partners are also acceptable.

Questions? Contact the CTSI Pilot Core at ctsipilots@pitt.edu.

Submission and Review Information

Round 1: Letter of Intent (LOI)

Applications will be evaluated in two rounds: (1) a brief letter of intent, and (2) a full application.

Round 1: Letter of Intent (LOI)

Submit a letter of intent that summarizes the proposed research. Each submission must include the following sections:

1. Study Title: Include the title of the proposal at the top of the page, with the PI name and contact email.
2. Abstract/Scope of Work (500 word limit): Provide a high-level overview of the project and the proposed work. Clearly identify the IP, product or topic of commercial interest. Clearly identify plans for follow-on funding (SBIR/STTR, startup funding, internal Pitt awards, etc.)
3. Study Team: Provide the names and affiliations of all members of the study team and a brief description of their roles (25-50 words per person)
4. Suggested Reviewers: To facilitate the second round of review, please suggest two or more Pitt/UPMC faculty members to potentially serve as non-conflicted scientific reviewers. For each suggested reviewer, list their name, title, department, and contact email.

Letters of Intent should be in the form of a single PDF document. The font should not be smaller than Arial 11; margins must be no smaller than 0.5 inches. All materials must be uploaded to the Powered by PInCh® web site by 11:59:59 PM on August 8, 2022. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

SUBMISSION PORTAL

 

Round 1: Review Criteria

The review of letters of intent will be conducted by the faculty and staff of CTSI and the office of the CSO of UPMC. Proposals will primarily be evaluated based on responsiveness to the funding opportunity announcement, as well as potential impact of the proposed work. The results of this evaluation will determine which investigators will be invited to submit a full proposal for the second round.

Applications for this funding opportunity must clearly identify the intellectual property (IP) that the team is advancing or developing.

Round 2: Full Application

Applications should be in the form of a single PDF document; please use Arial size 11 font, with margins of 0.5 inches. All materials must be submitted before 11:59 p.m. on September 5, 2022. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

Applications must include the following sections. Please start each new section on a new page.

• Cover Sheet (one page): Include the following details:
  • Project Title
  • Names, titles, affiliations and preferred contact email for the Co-Principal Investigators (faculty members)
  • Scientific Abstract (maximum 250 words): Summarize your proposal
• Research Plan (maximum five pages including tables/figures): Please address the components in typical NIH proposals including the following:
  • Specific Aims: What will this project accomplish?
  • Significance: What need or problem will this project solve?
  • Innovation: What is the new IP or approach?
  • Approach: How will the team achieve the Specific Aims? What milestones can objectively define when the Aims have been achieved?
  • Commercialization plan: Clearly identify the IP, product or topic of commercial interest. Describe a well-defined path from the pilot to future funding, licensing, or efforts that will lead to widespread availability and implementation. Clearly identify plans for follow-on funding (SBIR/STTR, startup funding, internal Pitt awards, etc.)

Applications for this Pilot should address the unique requirements identified in the review criteria SBIR/STTR grants. Specifically, teams must demonstrate Innovation, Potential for Commercialization, and Capabilities of the Team (https://www.sbir.gov/tutorials/preparing-proposal/).

• References (no page limit): Literature cited does not count toward the five-page limit for the Research Plan.
• Budget with Justification (no page limit): Use PHS 398 Forms Pages 4 and 5. The budget justification should include sufficient detail for reviewers to assess whether appropriate resources have been requested.
• An additional page should be included for the budget justification. All pieces of equipment, including any type of computer or related device, must be explicitly justified as critical to the performance of the proposed research. Any salary requested should include non-federal fringe benefit rates.

 Pilot Award funds may not be budgeted for:

•  Salary support for the PI or faculty collaborators*
•  Routine office supplies or communication costs, including printing
•  Meals or travel, including to conferences, except as required to collect data
•  Professional education or training
•  Computers or audiovisual equipment (exceptions require clear justification)
•  Manuscript preparation and submission
•  Indirect costs

*Effort is required of the Principal Investigators and must be reflected on the budget page, cost-shared by the respective departments. Reviewers understand that this may be a very small proportion of effort given the size of this award but will be cautious if investigators do not appear to have sufficient time to complete a project. Please note, an applicant who is currently the recipient of a mentored career development award (e.g., K12, K23, etc.) or a foundation-supported career development award may subsume the effort devoted to the project under the career development award if the project proposed is consistent with the career development award.

Any salary support requested in a submitted budget should reflect University of Pittsburgh’s fringe benefit rates for non-federally-funded projects https://www.osp.pitt.edu/about/data-proposal-preparation-general. If an award is made, a budget meeting will be held between principal investigators, their respective research administrators, and financial administrators from the CTSI. If necessary, minor adjustments to the requested budget will be made at that meeting.

Proposal Timeline (one page): Describe milestones and timeline for completion of the project. These milestones are critical for the pilot program because all awards must be expended during the one-year award. The CTSI Pilot program does not have mechanisms to allow no-cost extensions. In the event an award is made, investigators should immediately confer with CTSI staff if any delay in initiation or completion of the project is anticipated.

Human and/or Animal Subjects (no page limit): pilot awards must address Protection of Human Subjects, Adequacy of Protection Against Risks, Data and Safety Monitoring Plans, Inclusion of Women and Minorities, and Inclusion of Children.

Human Research Protection Office (HRPO) approval is not required prior to submission. However, HRPO approval is required for all projects involving human subjects before project funding may begin. Although animal research is expected to be rare in this program, the Institutional Animal Care and Use Committee (IACUC) must approve any projects involving animal subjects prior to final funding approval.

In this section, applicants must describe any human and/or animal subject issues, as well as the sources of materials that will be obtained from human subjects. If human subjects are involved, provide a description of their involvement and characteristics, specific risks to subjects who participate, and protection against those risks. Reviewers may consider whether significant delays in approval are an anticipated barrier for project completion when selecting projects. Evidence of prior or ongoing HRPO / IACUC review is encouraged. Similarly, this section should discuss if other special regulatory approval is required prior to funding: Human Stem Cell Research Oversight (hSCRO), Institutional Biosafety Committee (IBC), Committee for Oversight of Research Involving the Dead (CORID), Radiation Safety Office (RSO), etc.

NIH Biosketches (no page limit): Include biosketches of no more than 5 pages each for the Principal Investigators and for any other investigator whose expertise will be critical for successful completion of the project. The personal statement in any biographical sketch should be appropriate for the project proposed in the application.

Round 2: Review Criteria

Review of the pilot proposals will use the NIH review criteria and Program-specific criteria to evaluate the scientific merit and transdisciplinary nature of the project. Reviewers will score final applications on an NIH scale (1-9) in the domains of Significance, Investigators, Innovation, Approach, and Environment. Special emphasis will be given to a rating of the overall impact of the proposed project. Note that the review (based on the criteria below) will be adjusted to the pilot nature of the award.

NIH Review Criteria: Scientific Merit

1. Overall Impact: The likelihood for the project to exert a sustained, powerful influence on the research field
2. Significance: Does the project address an important problem or a critical barrier to progress in the field?
3. Investigators: Are the PD/PIs, collaborators, and other researchers well suited, sufficient, and able to conduct the project? Is the Team appropriate for developing the product or invention?
4. Innovation: Does the project use novel theoretical concepts, approaches, methodologies, instrumentation, or interventions? Is there a clearly new invention at the center of this project?
5. Approach: Are the strategies, methods, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
6. Environment: Are the personnel, equipment, and other physical resources available to the investigators to perform the proposed research within the time frame allotted?

Program-Specific Criteria:

7. Commercialization Potential: Does this project lead to or have potential for a product that will be sustainable and marketable?
8. Intellectual Property (IP): Does the project have defined IP? Has the team considered and appropriately address the protection of IP?
9. Commercialization Plan: Does the team have a defined plan for follow-on funding or for licensing that will move the product towards implementation?