Indiana CTSI Center for AIDS Research Pursuing an NIH Developmental CFAR Grant

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Indiana CTSI Center for AIDS Research Pursuing an NIH Developmental CFAR Grant Indiana CTSI – Purdue Retreat April 21, 2014

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Indiana CTSI Center for AIDS Research Pursuing an NIH Developmental CFAR Grant. Indiana CTSI – Purdue Retreat April 21, 2014. What is a Center for AIDS Research (CFAR)? Mission Objectives per NIH. Providing scientific leadership and institutional infrastructure dedicated to HIV/AIDS research - PowerPoint PPT Presentation

Transcript of Indiana CTSI Center for AIDS Research Pursuing an NIH Developmental CFAR Grant

Page 1: Indiana CTSI Center for AIDS Research Pursuing an NIH Developmental CFAR Grant

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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Indiana CTSI Center for AIDS ResearchPursuing an NIH Developmental CFAR Grant

Indiana CTSI – Purdue Retreat

April 21, 2014

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What is a Center for AIDS Research (CFAR)?Mission Objectives per NIH

• Providing scientific leadership and institutional infrastructure dedicated to HIV/AIDS research

• Stimulating scientific collaboration in interdisciplinary and translational research

• Strengthening capacity for HIV/AIDS research in resource-limited settings

• Fostering scientific communication

• Sponsoring training and education

• Promoting knowledge of CFAR research findings and the importance of HIV/AIDS research through community outreach

• Promoting and supporting innovative NIH HIV/AIDS research initiatives

• Establishing collaborative research between and among CFARs, and supporting HIV/AIDS research networks

• Facilitating technology transfer and development through promotion of scientific interactions between CFARs and industry

• Supporting research on prevention and treatment of HIV infection in hard-to-reach populations, especially inner city, rural poor, and disadvantaged minorities

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What is a Developmental CFAR (D-CFAR)?

• D-CFARs specifically are to assist in the development of a competitive standard CFAR and TO CORRECT ANY DEFICIENCIES THAT WOULD ADVERSELY AFFECT A FULL CFAR APPLICATION

• The D-CFAR application is to identify gaps and how the grant would fill those gaps. Examples include:– New cores to provide services across disciplines/institutions– Initiate HIV/AIDS studies with investigators in resource-limited settings or

other unique clinical sites– Expand collaborations between behavioral science and basic science

investigators – Expansion of communications technology among investigators who have

begun or are planning collaborative studies– Use the Developmental Core to fund a study that encompasses two

scientific disciplines (especially two that may not have previously collaborated)

– Develop an outreach program that could not be initiated with institutional or research grant funding

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CFAR (D-CFAR) Funding

• These are P30 Center Core grants• D-CFAR grants provide up to $750,000 in total costs

(roughly $480K direct costs) per annum for up to 5 years• Not renewable – goal is to then apply for full CFAR status

that provides higher amounts each year (~1-3M) based on the institution’s base NIH AIDS funding; duration is 5 years and is renewable

• Awarded and administered by NIAID but funds come from multiple institutes

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Why do we need a D-CFAR?

In terms of HIV/AIDS research, the state of Indiana has a critical mass of productive investigators and institutional resources. However, there are potential opportunities for additional, novel, collaborative research not currently being pursued.

What are the ‘holes’ in developing a larger HIV/AIDS research portfolio?

1.We currently have limited (if any) scientific communication across CTSI campuses

2.Investigators do not know what is available in terms of resources/expertise at other CSTI campuses

3.We have little interdisciplinary/multidisciplinary scientific collaborations and do not tend to involve other groups not traditionally involved in HIV/AIDS research

4.Many NIH PAs and RFAs never get pursued by Indiana investigators, possibly because of the lack of understanding of how to find interested collaborators and experts with the needed knowledge to build a team in a timely manner

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We have the CTSI, so what would a D-CFAR do for us?

• Infrastructure grant that provides support for administrative and shared research support to focus specifically on HIV/AIDS research

• Provides core facilities, expertise, resources, and services not otherwise readily obtained through traditional funding mechanisms

• Emphasis on interdisciplinary collaboration, esp. between basic and clinical investigators, translation from lab to the clinic, and inclusion of investigators from diverse backgrounds (including prevention and behavioral change research)

• PAR-14-041 (http://grants.nih.gov/grants/guide/pa-files/PAR-14-041.html)

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Current CFAR (Red) and D-CFAR (Green) Sites

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CFAR Added Value (Must demonstrate this in an eventual application)

• Examples of measurable added value:

– Developmental Core awards resulting in collaborations, publications, or successful major research grants

– Interdisciplinary publications

– Evidence of CFAR enhancement and support of existing programs at the institution

– Research activities initiated to address prevention and treatment questions in hard-to-reach populations (inner city, rural poor, and disadvantaged minorities)

– Development and utilization of a program income mechanism for Cores

– The initiation of institutional support for activities previously supported by the CFAR

– Mentoring and training of young investigators

– Promoting and supporting new collaboration and moving the HIV/AIDS field forward through CFAR-sponsored meetings and activities

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Application Requirements

• Four required Cores– Administrative, Developmental, Clinical science, Basic science– More Cores can be proposed

• Up to three Scientific Working Groups (optional, but highly recommended)– Subgroups of investigators organized around central themes that are not

currently addressed – Collaborative efforts across diverse disciplines– Not the same as a Core, which is used by all investigators– Named Director required to identify new high impact studies and to lead

development of new proposals for external funding submission– Must consist of a minimum of three independent investigators who are

conducting separate peer-reviewed and funded research projects– Can be transient (e.g. if a SWG achieves its goals of new publications and/or

funding, then the CFAR may dissolve the SWG and focus on new SWGs)• Demonstration of institutional commitment

– Level of institutional funding, space allocation, co-funding, endowments, and designation of center program status in the institutional bylaws

– Letter from Dean or similar official

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Noted Strengths at the Indiana CTSI Campuses

• CTSI (newly refunded, provides infrastructure across campuses) • Multiple funded HIV researchers across a variety of specialties

– Virology, Co-infections, STIs, therapeutic trials, cardiovascular, renal, pulmonary, behavioral research, implementation/operational science, sexual health, pharmacology, drug development (and on and on….)

• AMPATH-Kenya-Eck-Global Health Initiatives• Other prominent centers of excellence (IUSOM and IUPUI Signature

Centers, Center of Immunobiology, CTSI Cores) that could easily be bridged to include HIV research (Aging, Alcohol, HPV, Women’s Health, Pain, PREGMED, Tobacco Cessation)

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Noted Strengths at the Indiana CTSI Campuses

• CTSI Phase I unit with Covance• T32 fellowship training grants in Microbiology (includes

HIV/AIDS)• CITE Program (K30) training in clinical research• CTSI training grants• Drug Discovery Center, Agriculture/Nutrition expertise,

Engineering/Nanotech at Purdue• Center for Sexual Health Promotion, Kinsey Institute,

Rural Health for HIV/STD Prevention at IU Bloomington

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What has been done so far?

• Initial commitments of support from Dean’s Office at IU and with CTSI leadership in October 2013

• Outreach to all CTSI member institutions to gain support and identify interested parties

• Lots of phone calls and emails• Overall verbal commitments to move forward• Here we are today

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Potential D-CFAR Organizational Structure

ADMINISTRATIVE CORE

COMMUNITY ADVISORY BOARDS

(Domestic and Int’l)

Scientific Advisory Committee (External)

Advisory/OvernightCommittee(Internal)

DEVELOPMENTAL CORE

BASIC SCIENCE CORE

CLINICAL SCIENCE CORE

• Pilot development grants• Junior investigator career development awards (both domestic and int’l)• Investigators new to HIV research (both domestic and int’l) as bridge funding mechanism• Recruitment of new faculty

• HIV virology• HIV Immunology• Omics• Cellular physiology• Genetics discovery (related to HIV disease progression, therapeutic response, comorbidities)• Gut translocation assays

• Human subjects research (phase 1-4, observational cohorts)• Pediatrics• Maternal health • Clincal pharmacogenomics• Pharmacology• Biobanks (Indiana and Int’l)*

OTHER POSSIBLE CORES, SUBCORES, OR SWGs• Global Health (not just Kenya)*• Biostatistics/data management/bioinformatics*• Drug/vaccine development*• Behavioral sciences*• Community outreach/retention into care*• Alcohol/tobacco/drug addictions*• Co-infections• Quality of life/comorbid conditions• Aging• Malignancies• Curative strategies• Prevention (pharmacologic/behavioral/vaccine)

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• Establish an Indiana CTSI-wide organizational structure– Involvement by all institutions at every level– Administrative governance specific to HIV/AIDS

• Develop core services, new research collaborations, developmental/educational participation across the CSTI (domestic and international)

– High priority: Bring together disciplines not currently involved in HIV/AIDS– International biobank (including DNA)– International electronic medical record system (linking to biobank samples)– KL2-type awards for new/junior investigators; bridge grants to transition

investigators to HIV/AIDS; international training programs for those in resource-limited settings

– New OMICS laboratory-based core services; drug development core services• Integrate into existing inter-CFAR programs such as CNICS, Behavioral

SciencesBiostatistics, Sub-Saharan Working Group (http://www.niaid.nih.gov/LABSANDRESOURCES/RESOURCES/CFAR/Pages/collaborations.aspx)

• Development of public-private partnerships (Biocrossroads, Discovery Park) with technology transfer mechanisms

• Dedicated recruitment of investigators from under-represented/minority populations

Proposed Goals of an Indiana CTSI D-CFAR Application

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Examples of currently open PA/RFA related to HIV/AIDS

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

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