NIH / NIMH Funding Opportunities for NeuroAIDS Treatment
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NIH / NIMH Funding Opportunities for NeuroAIDS Treatment
NIH / NIMH Funding Opportunities for NeuroAIDS Treatment
Jing Bao, M.D., Ph.D.
Program Officer - Preclinical Therapeutics Development Program
HIV Pathogenesis, Neuropsychiatry, and Treatment Branch
Center for Mental Health Research on AIDS
National Institute of Mental Health / NIH
Jing Bao, M.D., Ph.D.
Program Officer - Preclinical Therapeutics Development Program
HIV Pathogenesis, Neuropsychiatry, and Treatment Branch
Center for Mental Health Research on AIDS
National Institute of Mental Health / NIH
20th International Conference
on Antiviral ResearchApril 29 - May 3, 2007
Westin Mission Hills Resort Palm Springs, California
20th International Conference
on Antiviral ResearchApril 29 - May 3, 2007
Westin Mission Hills Resort Palm Springs, California
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National Institutes of Health (NIH)
• Nation's medical research agency – making important medical discoveries that improve health and save lives
• A part of the U.S. Department of Health and Human Services, the primary Federal agency for conducting and supporting medical research
• Composed of 27 Institutes and Centers • Provides leadership and financial support
to researchers in every state and throughout the world
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NIMH Mission: To reduce the burden of mental illness and behavioral
disorders through research on mind, brain, and behavior
• Division of Adult Translational Research
• Division of AIDS and Health & Behavior Research
– Center for Mental Health Research on AIDS
– Director: Ellen Stover, Ph.D.
• Division of Services and Interventions Research
• Division of Pediatric Translational Research
• Division of Neuroscience and Basic Behavioral Science
• Division of Extramural Activities
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Center for Mental Health Researchon AIDS (CMHRA)
Supports domestic and international studies to:
• develop behavioral change and prevention strategies to reduce the transmission of HIV and other sexually transmitted diseases (STDs)
• develop and test interventions to reduce the neuropsychiatric
morbidity associated with HIV infection; clarify the impact of using new biomedical technologies on HIV risk behaviors
• clarify the pathophysiology of HIV CNS infection and associated motor/cognitive disturbances; identify the role of couples, families, and communities in preventing and adapting to HIV/STDs
• develop therapeutic agents to prevent or reverse the effects of HIV on the CNS; and improve the effectiveness and efficiency of mental health services relevant to HIV infection and people living with HIV and co-occurring mental illness
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CMHRAHIV Pathogenesis, Neuropsychiatry, and Treatment Branch:
Contact: Dianne M. Rausch, Ph.D. (Deputy Director CMHRA)
– Mechanisms of Neuropathogenesis Program (9A-ASNP)Contact: Jeymohan Joseph, Ph.D.
– Viral/Host Genetics Program (9A-ASNG)Contact: Jeymohan Joseph, Ph.D.
– Neuropsychology/Neuropsychiatry of HIV Infection Program (9A-ASNM)Contact: David M. Stoff, Ph.D.
– HIV-Therapeutics/Clinical Trials & Psychiatric Pathogenesis Program (9A-ASNK)Contact: Kathy Kopnisky, Ph.D.
– Pre Clinical Therapeutics Development Program (9A-ASNK1)Contact: Jing Bao, M.D., Ph.D.
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HIV Infection
Neurological Complications Psychiatric Complications
HIV dementiaCognitive disordersCNS infectionsPolyneuropathies
Mood disordersDepressionManiaPsychosis
Raines, Radeliffe, and Treisman, 2005
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Antiretroviral Agents
Neurological Complications
Psychiatric Complications
Raines, Radeliffe, and Treisman, 2005
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Raison et al., 2005
Bi-Directional Bi-Directional CommunicationCommunication
Immune system “talks” to the brain –
releases cytokines, releases cytokines, causes behavioral causes behavioral changeschanges
the brain “talks” to the immune system -
releases hormones, etc. releases hormones, etc. that regulate immune that regulate immune responsesresponses
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Currently there is no single best approach to the CNS-related consequences of HIV
• NNRTIs (e.g., efavirenz): can penetrate CNS but cause significant side effects
• NNTIs (e.g., zidovudine): effective in suppressing CNS viral load and symptoms but can cause neuropsychiatric side effects
• PIs less likely to produce depression but have lower CNS penetration and more interactions with psychotropics
Need: Novel agents that are effective and tolerable for HIV CNS disease
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Preclinical Therapeutics Development for NeuroAIDS
• R21 (PA- 07- 528)
http://grants1.nih.gov/grants/guide/pa-files/PA-07-528.html
• R03 (PA- 07- 529)
http://grants1.nih.gov/grants/guide/pa-files/PA-07-529.html
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• Novel assays, in vitro/vivo models (rodent or SIV in particular) useful for drug screening.
• Studies that ameliorate HIV or HAART-related neurotoxicity
• Basic and pilot clinical therapeutics research to understand the biological consequences of taking anti-retroviral medications in the presence of other medications (particularly psychiatric medications) used to treat comorbid conditions
Preclinical Therapeutics Development for NeuroAIDS
R21 (PA- 07- 528) and R03 (PA- 07- 529)
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“Therapeutics Development for HIV/AIDS-Associated
Neuropsychological Disorders”
• SBIR: PA-06-432 http://grants1.nih.gov/grants/guide/pa-files/PA-06-432.html
• STTR: PA-06-433 http://grants1.nih.gov/grants/guide/pa-files/PA-06-433.html
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• Small Business Innovation Research (SBIR) Set-aside program for small businessconcerns to engage in federal R&D --
with potential for commercialization
• Small Business Technology Transfer Research (STTR)
Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization
Program Descriptions
2.5%
0.3%
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SBIR/STTR: 3-Phase ProgramSBIR/STTR: 3-Phase Program
PHASE I Feasibility Study
PHASE II Full Research/R&D
PHASE III Commercialization Stage Use of non-SBIR/STTR Funds CAP (Commercialization Assistant program)
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“Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders”
SBIR (R43/44) and STTR (R41/42)
1. Novel agents, methods, biomarkers, and drug delivery technologies that can directly or indirectly eliminate/eradicate HIV reservoirs in the brain
2. Novel assays/models of neurotoxicity and treatment efficacy measures are invited as are novel in vitro/vivo models that can be used for screening potential therapeutic agents
3. Studies that examine agents or therapeutic strategies that protect/ameliorate/treat the long-term side effects of antiretroviral agents in the presence or absence of psychotropic medications
4. Development of adjunctive therapies against the consequences of HIV in the CNS and/or mental illness comorbidity
5. Phase I & II clinical trial studies
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“Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders”
(SBIR/STTR)
• Phase I: $250,000/year for 2 years
• Phase II:$450,000/year for 3 years
• Receipt dates: May 7, Sep 7, January 7
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National Institutes of Health/ NIMH
Funding Opportunities For Pre-clinical and Clinical Therapeutics Development for NeuroAIDS
http://grants1.nih.gov/grants/guide/pa-files/PA-06-528.html (R21) http://grants1.nih.gov/grants/guide/pa-files/PA-06-529.html (R03)
http://grants1.nih.gov/grants/guide/pa-files/PA-06-432.html (SBIR) http://grants1.nih.gov/grants/guide/pa-files/PA-06-433.html (STTR)
• Novel agents, methods, biomarkers, nanoparticles, and drug delivery technologies to eradicate HIV reservoirs in the brain
• Novel in vitro/vivo models of neurotoxicity and treatment efficacy measures• Novel therapeutics and adjunctive agents that attenuate the long-term side effe
cts of antiretroviral agents • Drug-drug interactions between ARVs and psychotropics• Development of IND applications• Phase I and II clinical studies
$275K for the two-year period (R21) $50K per year for two years (R03) $250K for phase I for up to two years and $450K for phase II for up to three year
s may be requested (SBIR/STTR)
NIMH supports the development of innovative technologies /approaches for the treatment of HIV/AIDS-associated mental and neurological disorders, including but not limited to:
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Contacts
• Kathy L. Kopnisky, Ph.D. 301.443.7726 [email protected]
• Jeymohan Joseph, Ph.D. 301.443. 6100
• David M. Stoff, Ph.D.301.443.4625 [email protected]
• Jing Bao, MD, Ph.D.301.443.8542
• Kathy L. Kopnisky, Ph.D. 301.443.7726 [email protected]
• Jeymohan Joseph, Ph.D. 301.443. 6100
• David M. Stoff, Ph.D.301.443.4625 [email protected]
• Jing Bao, MD, Ph.D.301.443.8542