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 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 2
Individual Investigator Research Awards for Clinical Translation Goal Promote clinical research leading to a better § understanding of the clinical efficacy of a cancer therapy or diagnostic device. Rationale Supports conduct of hypothesis-based studies on novel § cancer therapies or devices in early-phase clinical trials or completed trials where the outcome is known. 3
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. 4
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 observed in the laboratory can be replicated in patients. 5
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 6
Funding Information Maximum of $400,000 per year for a period of up to 3 § years. Applicants conducting a clinical trial may request up to § $600,000 in total costs per year for up to 4 years. 7
Key Dates - Cycles 18.1 Process Timeline RFA Posted January 5, 2017 CPRIT Application Receipt March 15, 2017 System (CARS) Opens CPRIT Application Receipt June 8, 2017 System (CARS) Closes Peer Review October 18-25, 2017 Oversight Committee February 14, 2018 8
Applying for an IIRACT Award Go to https://cpritgrants.org/ to view current RFAs § Go to https://cpritgrants.org/ to submit an § application Application deadline: June 8, 2017 § 9
Contact Information Phone: 866-941-7146 Email: Help@CPRITGrants.org Monday through Friday, 7 a.m. to 4 p.m. CT 10
Scientific and Programmatic Questions Phone: 512-305-8491 Email: pmoore@cprit.texas.gov Web: www.cprit.state.tx.us 11
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. 12
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