FY18.1 Funding Opportunity Overview: Individual Investigator - - PowerPoint PPT Presentation

FY18.1 Funding Opportunity Overview: Individual Investigator Research Awards for Clinical Translation

February 16, 2017

Presented By: James Willson, MD Patty Moore, PhD

Individual Investigator Research Awards (IIRA) for Clinical Translation

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AGENDA 2:00 – 3:00 p.m. High-Level Overview + Q&A James Willson, M.D.,

CPRIT Chief Scientific Officer

Patty Moore, PhD.,

Manager for Academic Research

Goal

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Promote clinical research leading to a better understanding of the clinical efficacy of a cancer therapy

• r diagnostic device.

Rationale

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Supports conduct of hypothesis-based studies on novel cancer therapies or devices in early-phase clinical trials

• r completed trials where the outcome is known.

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Individual Investigator Research Awards for Clinical Translation

Research Objectives

• Innovative hypothesis driven clinical studies.
• Involve patients enrolled prospectively in clinical trial or
• Involve analysis of biospecimens (completed trial) in

which outcomes are known.

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RFA Responsive Elements

• Clinical studies of new or repurposed drugs, hormonal therapies,

immune therapies, surgery, radiation therapy, stem cell transplantation, combinations of interventions, or therapeutic devices

• Applications proposing development and validation of a biomarker or an

imaging biomarker may be submitted provided the research plan includes validation steps that involve patients treated on a clinical trial.

• Early-phase clinical trials of agents or combination of agents for which

there are robust nonclinical data, even if there is no biomarker, as long as the early-phase clinical trial will lead to determining if activity

• bserved in the laboratory can be replicated in patients.

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If Clinical Trial Proposed

• Budget justification must include timeline for trial initiation

and accrual targets

• Provide documentation the proposed trial is feasible within

project timeline

• Investigational new drug application (IND) or equivalent;

investigational device exemption(IDE) from FDA should be cited

• If IND not yet available then include summary letter from pre-

IND meeting

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Funding Information

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Maximum of $400,000 per year for a period of up to 3 years.

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Applicants conducting a clinical trial may request up to $600,000 in total costs per year for up to 4 years.

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Key Dates - Cycles 18.1

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Process Timeline

RFA Posted January 5, 2017 CPRIT Application Receipt System (CARS) Opens March 15, 2017 CPRIT Application Receipt System (CARS) Closes June 8, 2017 Peer Review October 18-25, 2017 Oversight Committee February 14, 2018

Applying for an IIRACT Award

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Go to https://cpritgrants.org/ to view current RFAs

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Go to https://cpritgrants.org/ to submit an application

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Application deadline: June 8, 2017

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Contact Information

Phone: 866-941-7146 Email: Help@CPRITGrants.org Monday through Friday, 7 a.m. to 4 p.m. CT

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Scientific and Programmatic Questions

Phone: 512-305-8491 Email: pmoore@cprit.texas.gov Web: www.cprit.state.tx.us

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Questions?

• Submit your questions using “Questions” on the GoTo

Webinar control panel.

• You do this by typing your question into the question box

and clicking SEND.

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