Funding Announcement: the Precision Medicine Implementation Program (PreMIP)

Key dates:

• Pre-application deadline: April 30^th 2022
• Invitations for full application: May 31^st 2022
• Full application deadline: July 15^th 2022
• Anticipated date of funding decision: August 31^st 2022
• Start of funding: October 1^st 2022
• End of funding period: September 30^th 2025

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The Precision Medicine Implementation Program (PreMIP), from the Institute for Precision Medicine, offers funds to accelerate Precision Medicine approaches leading to improved patient care through implementation and commercialization. The goal of PreMIP is to generate data with a high level of causal evidence that may result in a change of clinical care.

The scope of projects funded by PreMIP should support integrating Precision Medicine tools and approaches with UPMC’s clinical knowledge and volume, patient data and expertise to uncover and apply new ways to predict, diagnose, and treat disease. Projects may generate data via a randomized controlled trial or real-world evidence. Proposals are invited from programs with immediate to near-term clinical impact, and/or long-term potential for commercialization and should focus on one or more of the following three themes:

1. Development and integration of omics to advance patient care. Discovery, development or application of diagnostic tools and treatments informed by the integration of ‘-omic’ information beyond what is described in the human genome for a defined disease or specific patient subgroup. This multi-omic deep-phenotyping approach encompasses using multiple “omes” to better understand mechanisms of disease, expand and improve upon the current diagnosis and taxonomy of disease, explore potential avenues of disease prevention, or evaluate focused omics driven interventions in specific populations. Discovery phase proposals without near-term clinical impact must articulate long-term clinical or translation potential.
2. Advancing care through implementation science. Employ the scale of UPMC to better understand the etiology, progression and/or treatment of diseases which have an outsized burden on the healthcare system. New concepts of treatment may be explored, particularly those involving pragmatic clinical trials or which incorporate implementation frameworks, comparative effectiveness, and/or cluster randomization of UPMC hospitals or practice sites. Proposals will apply to large patient populations and should include feasible, generalizable, rapidly scalable clinical implementation solutions within the UPMC system.
3. Development of novel approaches to tailoring therapy: Use of therapies based upon, and informed by, the molecular basis of disease (for example, genomics, proteomics, epigenomics, etc.) and integration of approach into UPMC clinical workflows. These new paradigms or treatment applications should be selective and/or designed based on the unique biological characteristics of a patient’s disease or condition and include for example identifying somatic mutations in cancers to direct targeted therapy.

Applications must be collaborative in nature and should include multisource data such as clinical (e.g., UPMC clinical analytics, electronic health records, devices, insurance claims); molecular (e.g., genomics, metabolomics, proteomics); imaging (e.g., MRI, pathology slides); and patient-generated (e.g., mobile health devices, apps) data. Early engagement of the UPMC Health Plan is encouraged, and any diagnostic testing should utilize UPMC clinical laboratories as much as possible. Partnerships with industry are encouraged and potential for commercialization of results, such as development of a diagnostic test or clinical tools, is also encouraged.

Key priorities for the IPM include supporting Precision Medicine programs building durable, reusable resources, policies, and infrastructure within the UPMC system, implementing new clinical practices with clear demonstration of patient and health system value, and enabling commercialization and partnership opportunities.

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Funding

Awarded projects will receive $1,000,000 in total over a 3-year period contingent on annual assessment of adequate progress. Only projects feasible with short term return of value with this level of support should be submitted for consideration. Funds will be released using a staged approach based on milestones and deliverables outlined in the application (see application instructions for more details) with a pilot phase (year 1) providing proof of principle and building of necessary infrastructure, and then if appropriate 2 more years of funding.

• Phase 1: $250,000 for initial project milestones (year 1)
• Phase 2: Additional $750,000 for years 2 and 3 combined, conditional on sufficient and timely progress during initial milestones
• Only direct cost funding will be provided (no indirect costs) and can be used for:
  • Salary support
  • Programming time, statistical support, and data collection activities
  • Support for study implementation in practice and/or hospital settings including purchasing of supplies and diagnostic testing
  • Applicants must include a written cost estimate for all requested services (such as core facilities, data requests, clinical tests) when applicable, in their proposals.
  • Travel support will only be funded to the extent that it is integral to the completion of the project. Attendance at professional meetings is not eligible.

• Funds can only be used for activities detailed in the application.
• Funds are non-transferrable.
• Funds must be used within the project period
• Funds not used during the program period will be returned to the IPM at the end of the project.
• Continued funding during the award period is contingent on compliance with awardee requirements and sufficient progress towards pre-stated milestones which will be assessed annually before release of funding.

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Eligibility

• The project PI must be a full-time faculty member at the University of Pittsburgh.
• Faculty can only submit one application for which they are the Principal Investigator, but individual faculty members can be listed as co-investigators on more than one proposal.
• Project teams must include co-investigators from at least two University of Pittsburgh departments.

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Application Process and Timeline

Pre-applications are required and are due on April 30^th, 2022. Selected proposals will be invited to submit a full application with notifications sent by May 31^st, 2022.

Invited full applications are due July 15^th, 2022 with anticipated funding decisions by August 31st, 2022 and an October 1^st, 2022 start date.

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Letter of Intent / Pre-application Guidelines

LOI / Pre-application deadline: April 30^th 2022

A 2-page pre-application is required by April 30^th, 2022. Pre-proposals will be programmatically reviewed, and limited invitations will be made for full applications based on the pre-application material submitted.

The pre-application should consist of:

• Cover page detailing the Principal Investigator and anticipated Co-Investigators (names, contact information, departments)
• 2-page summary of proposal including how the proposal will lead to improved patient care, health system value, and/or commercialization opportunities. Pre-application should detail key milestones over the 3-year funding period.

Pre application materials should be in Arial 11-point font or larger, left justified, with at least one-half inch margins.

Pre-applications should be submitted by email (xavierjm@upmc.edu) to Jennifer Xavier, PhD, Associate Director for Research, Institute for Precision Medicine by 5pm on April 30^th, 2022. Dr Xavier may also be contacted for program enquiries and clarifications.

Invitations to submit full applications will be made by May 31^st, 2022. We anticipate inviting 6-8 full applications. On invitation to prepare a full application, investigative teams will meet with IPM leadership to provide feedback and guidance with leveraging existing Pitt/UPMC and IPM infrastructure towards reusable and cohesive implementation strategies.

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Full Application Guidelines

Full application deadline for invited proposals: July 15^th, 2022

Proposals should consist of the following sections and be presented in this order:

• Completed cover page (template to be provided)
• Abstract (1 page or less)
• Brief description of how the proposal will lead to improved patient care and/or commercialization opportunities (20 lines)
• Project proposal/research plan, including a project timeline and project-specific milestones (6 pages)
• References
• NIH biosketches for key personnel
• Budgets (starting October 1^st, 2022) for years 1, 2 and 3.

Please use the NIH’s standard “Detailed Budget for Initial Budget Period” form for each annual budget. The NIH “Detailed Budget for Initial Budget Period” form PHS 398 (Rev. 03/2020 Approved Through 02/28/2023) can be downloaded at https://grants.nih.gov/grants/funding/phs398/phs398.html.

• Budget justification
• Letter from PI’s Department Chair approving direct-only costs (no indirect costs)
• Letters of support (if applicable)

Application materials should be in Arial 11-point font or larger, left justified, with at least one-half inch marginsand should be submitted as a single combined PDF file of requested components.

Proposals that are incomplete or otherwise do not follow instructions will be returned to the investigator without review. Keep in mind that proposals will be read by individuals from a range of disciplines. Proposals should minimize the use of discipline-specific terminology and provide clear, non-technical explanations.

Applications should be submitted by email (xavierjm@upmc.edu) to Jennifer Xavier, PhD, Associate Director for Research, Institute for Precision Medicine by 5pm on July 15^th, 2022. Dr Xavier may also be contacted for program enquiries and clarifications.

Funding decisions are expected by September 30^th, 2022. If your project is selected for funding, please be prepared to obtain IRB approval immediately after receiving the funding decision.

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Review Process and Criteria

Applications will be evaluated for completeness, feasibility, likelihood of completing the project in three years, and responsiveness to the RFA. Applications that are accepted will proceed to scientific review.

The goal of this funding is to enhance personalized patient care and value within the UPMC system while reinforcing Pitt and UPMC as leaders on the national stage through high impact publications of practice changing precision medicine and commercialization opportunities.

Scientific reviews: Reviewers will use NIH review criteria to score submissions based on scientific merit, innovation, the use of unique UPMC resources, and potential impact.

Funding decisions: In addition to scientific review scores, the following criteria will be used in making funding decisions:

• Is the project likely to demonstrate a meaningful impact on patient care and result in high impact publications of practice changing precision medicine?
• Is the project likely to generate novel insights leading to commercialization and/or partnership opportunities?
• Will the project build on existing UPMC precision medicine strategy, resources, or policies in a way that it will also enable future projects? Are the solutions scalable?
• Does the project make valuable use of existing UPMC infrastructure? Is the project feasible within the UPMC health system within the project period?
• Is the scientific team multidisciplinary? Are key stakeholders meaningfully engaged including community partners?
• Will the proposed project provide insights that could be generalizable to other projects, or could it lead to the adoption of best practices in precision health?