Transcript HIV/AIDS research

Indiana CTSI Center for AIDS Research
Pursuing an NIH Developmental CFAR Grant
Indiana CTSI – Purdue Retreat
April 21, 2014
ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
www.indianactsi.org
What is a Center for AIDS Research (CFAR)?
Mission Objectives per NIH
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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?
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We currently have limited (if any) scientific communication across CTSI campuses
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Investigators do not know what is available in terms of resources/expertise at other
CSTI campuses
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We have little interdisciplinary/multidisciplinary scientific collaborations and do not
tend to involve other groups not traditionally involved in HIV/AIDS research
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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-14041.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)
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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
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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
Advisory/Overnight
Committee
(Internal)
ADMINISTRATIVE CORE
DEVELOPMENTAL
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
BASIC SCIENCE
CORE
• HIV virology
• HIV Immunology
• Omics
• Cellular physiology
• Genetics discovery
(related to HIV disease
progression, therapeutic
response, comorbidities)
• Gut translocation assays
Scientific Advisory
Committee
(External)
CLINICAL SCIENCE
CORE
• Human subjects research
(phase 1-4, observational
cohorts)
• Pediatrics
• Maternal health
• Clincal pharmacogenomics
• Pharmacology
• Biobanks (Indiana and Int’l)*
COMMUNITY
ADVISORY BOARDS
(Domestic 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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Proposed Goals of an Indiana CTSI D-CFAR Application
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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 resourcelimited 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/collab
orations.aspx)
Development of public-private partnerships (Biocrossroads, Discovery Park) with
technology transfer mechanisms
Dedicated recruitment of investigators from under-represented/minority populations
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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
www.indianactsi.org
ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
www.indianactsi.org
ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
www.indianactsi.org
ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
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ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
www.indianactsi.org
ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
www.indianactsi.org
ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
www.indianactsi.org
ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
www.indianactsi.org
ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH
www.indianactsi.org
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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