Letter of Intent: Clinical Accelerator Initiative (CAI)

Letter of Intent (LOI) submissions are due December 6, 2024
Submissions must be through ProposalCentral

• LOI Submission Deadline: December 6, 2024
• Invitations Extended for Presentations: by January 2025
• Invitations Extended for Grant Applications: by March 2025
• Award Notifications: by July 2025

I. Program Description

The purpose of the Dr. Robert F. Vizza Clinical Accelerator Initiative (CAI) is to advance the mission of the Lustgarten Foundation by accelerating the translation of research discoveries into clinical trials. Through the CAI, the Lustgarten Foundation will provide academic, clinical researchers the opportunity to propose science-driven concepts seeking to advance the development of new therapies for pancreatic cancer patients while furthering our understanding of disease biology.

The CAI is meant to support trials concepts that are:

• Innovative and highly collaborative
• Based on strong pre-clinical and/or clinical scientific rationale
• Utilizing deep, translational analyses to demonstrate on-target drug mechanism(s) of action and hypotheses around disease biology
• Advancing the development of novel therapies for pancreatic cancer patients with plans for continuation, if successful

The CAI is not meant to support trials concepts that are:

• Incremental, first-in-human safety or dose-finding studies
• Irrelevant to the mission of the Lustgarten Foundation and without the goal of advancing the development of novel therapeutic approaches for pancreatic cancer patients

II. Qualifications and Requirements of Research Investigator(s)

Applicants must hold an M.D., D.M.D., D.V.M., Ph.D., or equivalent degree and have a faculty position or equivalent at a college, university, medical institution, or other research facility. Proposals may be submitted by domestic and foreign non-profit or public organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. There are no citizenship requirements for this program.

Research Investigator(s) funded through the CAI typically:

• Are leading significant pancreatic cancer and/or relevant focus area research
• Have a demonstrated track record of significant contributions to the field as evidenced by publications, peer-reviewed funding and an ability to advance projects to clinical impact
• Are willing to interact and/or collaborate with researchers at outside institutions including the Lustgarten Translational Advisory Group and other Lustgarten Foundation-Funded Investigators

III. Funding and Governance

While the budget and duration of funding will be dependent on the needs of each trial, CAI trials are typically funded up to a total budget of $1.5M – $2M over a period of up to 3 years, inclusive of deep translational analyses and indirect costs.

Additional expectations:

• Indirect costs may not exceed a maximum of 10% of direct costs
• Funded investigators will be expected to interact routinely with the Lustgarten Foundation and associated Translational Advisory Group.
• Continued funding throughout the project will be dependent on timely receipt of bi-annual progress reports and annual financial reports.
• Clinical and and translational data generated from CAI trials will be ingested into the Lustgarten Foundation Clinical Information Database (LUCID)

IV. Review Process

The CAI uses a multi-step application process beginning with submission of an LOI through ProposalCentral. Successful LOI submissions will be invited to present their trial concept, rationale, and design to the Lustgarten Foundation Translational Advisory Group (TAG). Successful presenters will then be invited to submit a full CAI grant application which will be reviewed competitively by a panel of expert peer reviewers.

V. Questions regarding this Request for Proposals should be directed to:

Jaclyn Lyman, MSc
Head of Clinical R&D
[email protected]