1 Catalyst Award for Early-Stage Investigators Pursuing Research on HIV Comorbidities, - PowerPoint Presentation

1. 1Catalyst Award for Early-Stage Investigators Pursuing Research on HIV Comorbidities, Coinfections, and Complications (CCCs)(DP1- Clinical Trial Optional)PAR-23-024

2. PanelistsPeter Perrin NIDDK peter.perrin@nih.govEmmanuel Mongodin NHLBI emmanuel.mongodin@nih.govGeraldina Dominguez NCI domingug@mail.nih.govDenise Russo NICHD denise.russo@nih.govRoss Shonat CSRKhoa Nguyen NIDDK2

3. NIH Director's Pioneer Award (NDPA)What: NIH Director's Pioneer Awards seek to identify and support scientists with outstanding records of creativity pursuing new research directions to develop pioneering approaches to major challenges in biomedical, social science, and behavioral research. Such research requires that unusual flexibility and resources be given to the investigator.How: Program was designed and implemented to be very distinct from R01 applications and their review. Emphasis on Investigator qualities, significance, and innovation Applications are shorter, narrative essay rather than specific research proposal 3

4. Research Strategy EssayNo specific aims or detailed research strategyProject descriptionEvidence of PD/PI innovativenessHow the planned research differs from the PD/PI's past or current workSuitability for the Catalyst Award programStatement of research effort commitmentMinimum of 4 person-months of research effort each year to the project supported by the Catalyst Award4

5. Research Strategy EssayRefer to RFA for all “Additional Instructions” Excerpt: Research Strategy: Upload the Essay here (Six pages total)Describe your innovative vision for addressing a major problem related to HIV comorbidities, coinfections, and complications within the mission of one or more of the participating components. Explain the importance of this problem or challenge, and your qualifications to lead this project. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. 5

6. Scientific FocusFocus on CCC Priority AreasAreas of interest include:novel mechanistic research into pathogenic processesidentification of novel preventive or therapeutic targets, interventions, or therapiesnovel approaches to delineate unique biological pathways for HIV-associated CCCs in PWH as compared to those CCCs in people without HIVpathogenesis of multimorbid HIV-associated CCCs; and/or identification of unique drug targets for CCCs in the context of HIVAdditional mission-specific interests of participating Institutes/CentersEnable new research directionsFundamental new insights into potential solutions to problemsMay derive from development of innovative approachesMay derive from unconventional hypotheses6

7. Institute/Center Specific InterestsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Projects aimed at elucidating the unique biological mechanisms leading to HIV-associated CCCs within its missionIntegrate HIV basic science and pathobiology, pathophysiology, and/or metabolism. These include:Gastrointestinal immune and microbial homeostasis, enteropathy, noncommunicable liver and biliary diseases, viral hepatitis, and obesityMetabolic/endocrine dysfunction and perturbationsKidney disease, benign genitourinary diseases and disorders, and hematologic sequelae.Contribution of NIDDK-relevant pathogenic processes to HIV pathogenesis in other tissues and organ systems (ex: gut-liver axis, gut-adipocyte axis)Projects are expected to undertake a "wet bench" approach.Not supported: projects with primarily epidemiological focus.Basic experimental studies involving humans (BESH) allowed, but other Clinical Trials (safety & efficacy trials of interventions) not allowed7

8. Institute/Center Specific InterestsNational Heart, Lung, and Blood Institute (NHLBI)Multi-disciplinary and mechanistic research aimed at deciphering the complexity of HIV-associated CCCs related to heart, lung, blood, and sleep (HLBS) disorder priorities, including interactions between HIV infection, aging, the effect of existing risk factors and the impact of multiple medication use.High-priority topics will include (but are not limited to):Immune activation and chronic inflammationEffects of the microbiome and virome on HIV-associated CCCsAging and immune-senescenceNHLBI expects projects to undertake a "wet bench" approach Not supported: projects with a primarily epidemiological focus. NHLBI will not support clinical trials with this initiative.8

9. Institute/Center Specific InterestsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Biomedical research to understand the effects of infection with HIV among populations central to the NICHD mission, including:Pregnant, postpartum, and lactating womenInfants, children, adolescents and young adultsPeople with intellectual and developmental disabilities Individuals with physical disabilities or mobility impairmentsStudies are expected to align with the HIV/AIDS research priorities outlined by the NIH Office of AIDS Research (OAR) in NOT-OD-20-018 UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding.9

10. Institute/Center Specific InterestsNational Cancer Institute (NCI)Projects advancing our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying HIV infection. Specific areas of interest include etiologic factors, coinfections, cofactors, immunopathogenesis, diagnosis, and consequences of both non-AIDS defining and AIDS-defining malignancies in populations with an underlying HIV infection. Proposed clinical trials must be mechanistic clinical studies that meet NIH's definition of a clinical trial.Examples of mechanistic clinical trials can be found in NOT-OD-18-010Not supported: Clinical trials seeking to establish safety, assess clinical efficacy or effectiveness, and/or study/manage/implement, preventive, therapeutic, or services interventions.10

11. 11Timetable for Review and Award2023Letter of Intent DueReceipt DateReview DateAdvisory CouncilEarliest AwardsApril 01, 2023May 01, 2023July/August 2023October 2023December 2023

12. 12Application ComponentsEssay – up to 6 pages:Project Description, including elements such as scientific problem/challenge, importance, premise, and pioneering approachEvidence for PD/PI innovationHow is research direction different from past or ongoing research?Why the Catalyst Award mechanism?Statement of research effort commitmentBiographical Sketch – NIH Biosketch including statement of most significant research accomplishmentsList of current and pending research supportIdentification of how they will accommodate 33% (4 person months) of their research effortHuman and/or animal subjects plans (as appropriate)No Letters of Reference required

13. 13Frequently Asked QuestionsAre multiple PI grants allowed?No, applications are single PI only.Is a Letter of Intent mandatory?Not mandatory, though it would be appreciated.What is the budget limit?$350,000 per year in Direct Costs.Human and/or animal subjects plans (as appropriate)