March 8, 2023 | Office of Sponsored Programs
Limited Submission Funding Opportunity: Dr. Ralph and Marian Falk Medical Research Trust Catalyst Award Program
Deadline for internal proposals is March 20
The Dr. Ralph and Marian Falk Medical Research Trust supports investigators by funding “medical research to improve treatments of the past and eventually find cures for diseases for which no definite cure is known.”
The Falk Medical Research Trust program provides support for breakthrough research designed to overcome roadblocks in scientific progress through two separate linked awards:

  • The Catalyst Research Award provides seed funding over one to two years to help investigators lay the foundation for the Transformational Award. 

The Catalyst Research Award Program provides an opportunity to conduct preliminary work on high-risk, high-reward research addressing a wide variety of clinical disease areas. The target of the Falk Catalyst’s funding are projects at the intersection of technology and clinical science, intended to move from basic science insights toward solutions, techniques, and tools that can be transferred to clinical practice in the near term. Catalyst research projects must describe specific milestones and benchmarks that, if successfully met, would enable recipients to apply for additional funding through the two-year Transformational Award Program.

The reviewers include professionals with translational expertise such as academic researchers, venture capital investors, and biotech executives. Translational research, as described by NIH, covers a lot of ground from basic science to health services research. For investigators who have previous experience with NIH awards, this is most similar to the small business innovation research award program, rather than an R01 mechanism.

Research Focus
This program is designed to support projects that address critical scientific and therapeutic roadblocks. If successful, these projects will open new avenues for treating and curing disease. The program has three principal areas of focus:

  • Identification of biological markers of disease activity and progression
  • Identification of targets for therapeutic interventions
  • Development of therapeutic agents that will disrupt, arrest, or prevent the disease process

New for 2023
In addition to pre-clinical research studies as described above, proposals for investigator-initiated trials (human clinical studies that are initiated, managed, and sponsored by the investigator or investigator’s institution) may be considered if the following criteria are met:

  • The proposed Catalyst project is feasible to complete during the Catalyst grant period (12–24 months) and within the award budget. The work, if successful, will lay the foundation for a Transformational Award involving 24–36 months of additional funding.
  • The study is original, hypothesis-driven, sufficiently powered to produce a result that could change clinical practice or support the implementation of a larger confirmatory trial, rigorously conducted, and supported by strong preliminary data.
  • Investigators and institutions have the appropriate skills, expertise, facilities, equipment, and staff in place to conduct the proposed research.
  • Investigators have evidence of a credible plan in place to acquire the necessary regulatory and safety approvals and to recruit subjects so that the work will be feasibly completed within the study period. For reasons of feasibility, studies without IND approval (if needed) and studies without evidence of a robust participant recruitment pipeline or an existing cohort in place before application submission are discouraged. If the timing of regulatory approvals or recruitment is in doubt the project will not be approved for funding.
  • The investigator and institution assume all legal liability and regulatory responsibilities as sponsor-investigator. All trials must be registered at ClinicalTrials.gov. 

Examples of acceptable research areas include the human clinical testing of:

  • An already licensed drug, nutraceutical, physical or psychologic therapy, or medical device for a different or new therapeutic indication (repurposing)
  • A currently approved therapy in a new patient population (e.g., pediatric use of an adult therapy)
  • A combination of individual therapies to improve clinical outcomes
  • A small open label trial likely to show a human signal that could lead to a funded randomized placebo-controlled trial
  • Methods of improving diagnostic success
  • A comparison of two different treatment options for a disease to improve physician-patient decision-making
  • The tracking or testing new biomarkers or endpoints
  • Therapeutic impact over time to improve clinical decision-making and/or outcomes
  • New imaging modalities/agents 

Collaborations
The Falk Medical Research Trust encourages investigative teams that involve synergistic collaborations between industry, government, academic, and disease-advocacy organizations. Collaborations are encouraged to integrate teams horizontally across different disciplines, to involve both PhD and MD researchers, and to integrate teams vertically in terms of investigator seniority.

Collaborations should combine complementary expertise capable of addressing roadblocks and accelerating achievement of critical research objectives. Proposals may extend or apply such ongoing collaborations or establish new ones.
LIMIT ON NUMBER OF PROPOSALS PER ORGANIZATION
Ann & Robert H. Lurie Children’s Hospital of Chicago is invited to submit up to two applications.

KEY DATES
  • Internal Proposal Due: March 20 (by 5:00 p.m. CT)
  • Sponsor Proposal Due: June 15 (by 2:00 p.m. ET)

INTERNAL PROPOSAL GUIDELINES
The Internal Research Proposal should be prepared with 1/2-inch margins, all around, and 11-point font size and type. Internal proposals have a 2-page limit including figures (references may be placed on a third page), and describe succinctly how the proposed research project addresses critical scientific and therapeutic roadblocks that may open new avenues for treating and curing disease. Proposals should include the following components:
  • Background and significance: Provide a rationale for the entire Transformational Research Program, while providing a context for the proposed Catalyst Research Award. 
  • Specific aims: These should be specific, measurable, and necessary preliminary steps for the overall research effort. These aims will form the basis of the Catalyst Award milestones.
  • Preliminary studies/preliminary data (if available)
  • Research design, experimental methods, and analytical plan: Include a brief description of the role of each key investigator.
  • Research limitations and contingencies
  • Catalyst Project milestones and research plan table: Create a summary table that shows each milestone, the associated benchmark measure(s) of success, and estimated timeline; it may also include other explanatory material (including key personnel or collaborators). The successful completion of these activities will form the basis of subsequent Transformational Award applications. Please include specific data, methods, and benchmarks that will demonstrate achievement of each milestone.

The Limited Submission Advisory Committee panel will be asked to use the Catalyst review criteria in evaluating the proposals:
  • Translational potential: Project moves a basic science insight toward a solution, technique, or tool that can be transferred to clinical practice in the near term. Catalyst Award projects must be poised to successfully transition into a Transformational Award. High translational potential is an essential prerequisite for a favorable score.
  • Impact: The proposed research project addresses a critical scientific or therapeutic roadblock, will open a new avenue for treating or curing a disease, and will have high impact on improving the lives of patients, if successful. May be high risk.
  • Investigative team: The investigative team has the right combination of expertise and high potential to successfully carry out the project, and access to necessary infrastructure. Collaboration with synergistic industry, government, academic, or disease-advocacy organizations that integrate complementary expertise is an additional, but not required, positive factor.
  • Project: The proposed work is based on sound precedents and a clear rationale. Objectives are technically feasible. Research methodology is realistic and sufficiently powered. Catalyst Award milestones and benchmarks should have potential to demonstrate that the innovation warrants further investment through a subsequent Transformational Award. Requested budget and duration are appropriate and realistic for the research proposed.

SUBMISSION OF THE INTERNAL PROPOSAL
Prepare your proposal as a single PDF file named “LastName-FirstInitial-Falk-2023,” replacing “LastName” with your last name and “FirstInitial” with your first initial. Submit your internal proposal file to [email protected].

CONTACT FOR ADDITIONAL INFORMATION
Robin S. Lewis, Director of Office of Sponsored Programs, 312-503-7063 or [email protected].

Robin S. Lewis, MPA, CRA, CPRA
Director, Office of Sponsored Programs 
Stanley Manne Children’s Research Institute
Ann & Robert H. Lurie Children’s Hospital of Chicago
C 901.569.4556 | T 312.503.7063 | F 312.503.7059
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