NIH / NIMH Funding Opportunities for NeuroAIDS Treatment Jing Bao ,  M.D., Ph.D. Program Officer - Preclinical Therapeutic...
National Institutes of Health (NIH) <ul><li>Nation's medical research agency – making important medical discoveries that i...
NIMH Mission:   To reduce the burden of mental illness and behavioral disorders through research on mind, brain, and behav...
Center for Mental Health Research on AIDS (CMHRA) <ul><li>Supports domestic and international studies to:   </li></ul><ul>...
CMHRA <ul><li>HIV Pathogenesis, Neuropsychiatry, and Treatment Branch:  </li></ul><ul><li>  Contact: Dianne M. Rausch, Ph....
HIV Infection   Neurological Complications  Psychiatric Complications  HIV dementia Cognitive disorders CNS infections Pol...
Antiretroviral Agents  Neurological  Complications  Psychiatric  Complications  Raines, Radeliffe, and Treisman, 2005
Raison et al., 2005 Bi-Directional Communication Immune system “talks” to the brain –  releases cytokines, causes behavior...
Currently there is no single best approach to the CNS-related consequences of HIV  <ul><li>NNRTIs  (e.g., efavirenz): can ...
Preclinical Therapeutics Development  for NeuroAIDS   <ul><li>R21 (PA- 07- 528) </li></ul><ul><li>http://grants1.nih.gov/g...
<ul><li>Novel assays, in vitro/vivo models (rodent or SIV in particular) useful for drug screening.  </li></ul><ul><li>Stu...
“ Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders” <ul><li>SBIR:  PA-06-432   http ://grants...
<ul><li>Small Business Innovation Research (SBIR)   </li></ul><ul><li>Set-aside program for small business </li></ul><ul><...
SBIR/STTR: 3-Phase Program <ul><li>PHASE I </li></ul><ul><ul><li>Feasibility Study   </li></ul></ul><ul><li>PHASE II </li>...
“ Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders ”   SBIR (R43/44) and STTR (R41/42) <ul><l...
“ Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders ” (SBIR/STTR) <ul><li>Phase I: $250,000/ye...
National Institutes of Health/ NIMH Funding Opportunities  For Pre-clinical and Clinical Therapeutics Development for Neur...
Contacts <ul><li>Kathy L. Kopnisky, Ph.D.  </li></ul><ul><li>  301.443.7726 </li></ul><ul><li>  [email_address] </li></ul>...
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NIH / NIMH Funding Opportunities for NeuroAIDS Treatment

  1. 1. 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 20th International Conference on Antiviral Research April 29 - May 3, 2007 Westin Mission Hills Resort Palm Springs, California
  2. 2. National Institutes of Health (NIH) <ul><li>Nation's medical research agency – making important medical discoveries that improve health and save lives </li></ul><ul><li>A part of the U.S. Department of Health and Human Services , the primary Federal agency for conducting and supporting medical research </li></ul><ul><li>Composed of 27 Institutes and Centers </li></ul><ul><li>Provides leadership and financial support to researchers in every state and throughout the world </li></ul>
  3. 3. NIMH Mission: To reduce the burden of mental illness and behavioral disorders through research on mind, brain, and behavior <ul><li>Division of Adult Translational Research </li></ul><ul><li>Division of AIDS and Health & Behavior Research </li></ul><ul><ul><li>Center for Mental Health Research on AIDS </li></ul></ul><ul><ul><li>Director: Ellen Stover, Ph.D. </li></ul></ul><ul><li>Division of Services and Interventions Research </li></ul><ul><li>Division of Pediatric Translational Research </li></ul><ul><li>Division of Neuroscience and Basic Behavioral Science </li></ul><ul><li>Division of Extramural Activities </li></ul>
  4. 4. Center for Mental Health Research on AIDS (CMHRA) <ul><li>Supports domestic and international studies to: </li></ul><ul><li>develop behavioral change and prevention strategies to reduce the transmission of HIV and other sexually transmitted diseases (STDs) </li></ul><ul><li>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 </li></ul><ul><li>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 </li></ul><ul><li>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 </li></ul>
  5. 5. CMHRA <ul><li>HIV Pathogenesis, Neuropsychiatry, and Treatment Branch: </li></ul><ul><li> Contact: Dianne M. Rausch, Ph.D. (Deputy Director CMHRA) </li></ul><ul><ul><li>Mechanisms of Neuropathogenesis Program (9A-ASNP) Contact: Jeymohan Joseph, Ph.D. </li></ul></ul><ul><ul><li>Viral/Host Genetics Program (9A-ASNG) Contact: Jeymohan Joseph, Ph.D. </li></ul></ul><ul><ul><li>Neuropsychology/Neuropsychiatry of HIV Infection Program (9A-ASNM) Contact: David M. Stoff, Ph.D. </li></ul></ul><ul><ul><li>HIV-Therapeutics/Clinical Trials & Psychiatric Pathogenesis Program (9A-ASNK) Contact: Kathy Kopnisky, Ph.D. </li></ul></ul><ul><ul><li>Pre Clinical Therapeutics Development Program (9A-ASNK1) Contact: Jing Bao, M.D., Ph.D. </li></ul></ul>
  6. 6. HIV Infection Neurological Complications Psychiatric Complications HIV dementia Cognitive disorders CNS infections Polyneuropathies Mood disorders Depression Mania Psychosis Raines, Radeliffe, and Treisman, 2005
  7. 7. Antiretroviral Agents Neurological Complications Psychiatric Complications Raines, Radeliffe, and Treisman, 2005
  8. 8. Raison et al., 2005 Bi-Directional Communication Immune system “talks” to the brain – releases cytokines, causes behavioral changes the brain “talks” to the immune system - releases hormones, etc. that regulate immune responses
  9. 9. Currently there is no single best approach to the CNS-related consequences of HIV <ul><li>NNRTIs (e.g., efavirenz): can penetrate CNS but cause significant side effects </li></ul><ul><li>NNTIs (e.g., zidovudine): effective in suppressing CNS viral load and symptoms but can cause neuropsychiatric side effects </li></ul><ul><li>PIs less likely to produce depression but have lower CNS penetration and more interactions with psychotropics </li></ul><ul><li>Need: Novel agents that are effective and </li></ul><ul><li>tolerable for HIV CNS disease </li></ul>
  10. 10. Preclinical Therapeutics Development for NeuroAIDS <ul><li>R21 (PA- 07- 528) </li></ul><ul><li>http://grants1.nih.gov/grants/guide/pa-files/PA-07-528.html </li></ul><ul><li>R03 (PA- 07- 529) </li></ul><ul><li>http://grants1.nih.gov/grants/guide/pa-files/PA-07-529.html </li></ul>
  11. 11. <ul><li>Novel assays, in vitro/vivo models (rodent or SIV in particular) useful for drug screening. </li></ul><ul><li>Studies that ameliorate HIV or HAART-related neurotoxicity </li></ul><ul><li>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 </li></ul>Preclinical Therapeutics Development for NeuroAIDS R21 (PA- 07- 528) and R03 (PA- 07- 529)
  12. 12. “ Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders” <ul><li>SBIR: PA-06-432 http ://grants1. nih.gov / grants / guide / pa -files/PA-06-432. html </li></ul><ul><li>STTR: PA-06-433 http://grants1.nih.gov/grants/guide/pa-files/PA-06-433.html </li></ul>
  13. 13. <ul><li>Small Business Innovation Research (SBIR) </li></ul><ul><li>Set-aside program for small business </li></ul><ul><li>concerns to engage in federal R&D -- </li></ul><ul><li>with potential for commercialization </li></ul><ul><li>Small Business Technology Transfer Research (STTR) </li></ul><ul><li>Set-aside program to facilitate cooperative </li></ul><ul><li>R&D between small business concerns and U.S. research institutions – with potential for commercialization </li></ul>Program Descriptions 2.5% 0.3%
  14. 14. SBIR/STTR: 3-Phase Program <ul><li>PHASE I </li></ul><ul><ul><li>Feasibility Study </li></ul></ul><ul><li>PHASE II </li></ul><ul><ul><li>Full Research/R&D </li></ul></ul><ul><li>PHASE III </li></ul><ul><ul><li>Commercialization Stage </li></ul></ul><ul><ul><li>Use of non-SBIR/STTR Funds </li></ul></ul><ul><ul><li>CAP (Commercialization Assistant program) </li></ul></ul>
  15. 15. “ Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders ” SBIR (R43/44) and STTR (R41/42) <ul><li>Novel agents, methods, biomarkers, and drug delivery technologies that can directly or indirectly eliminate/eradicate HIV reservoirs in the brain </li></ul><ul><li>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 </li></ul><ul><li>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 </li></ul><ul><li>Development of adjunctive therapies against the consequences of HIV in the CNS and/or mental illness comorbidity </li></ul><ul><li>Phase I & II clinical trial studies </li></ul>
  16. 16. “ Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders ” (SBIR/STTR) <ul><li>Phase I: $250,000/year for 2 years </li></ul><ul><li>Phase II:$450,000/year for 3 years </li></ul><ul><li>Receipt dates: May 7, Sep 7, January 7 </li></ul>
  17. 17. 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 ) <ul><li>Novel agents, methods, biomarkers, nanoparticles, and drug delivery technologies to eradicate HIV reservoirs in the brain </li></ul><ul><li>Novel in vitro/vivo models of neurotoxicity and treatment efficacy measures </li></ul><ul><li>Novel therapeutics and adjunctive agents that attenuate the long-term side effects of antiretroviral agents </li></ul><ul><li>Drug-drug interactions between ARVs and psychotropics </li></ul><ul><li>Development of IND applications </li></ul><ul><li>Phase I and II clinical studies </li></ul><ul><li>$275K for the two-year period (R21) $50K per year for two years (R03) </li></ul><ul><li>$250K for phase I for up to two years and $450K for phase II for up to three years may be requested (SBIR/STTR) </li></ul>NIMH supports the development of innovative technologies /approaches for the treatment of HIV/AIDS-associated mental and neurological disorders, including but not limited to:
  18. 18. Contacts <ul><li>Kathy L. Kopnisky, Ph.D. </li></ul><ul><li> 301.443.7726 </li></ul><ul><li> [email_address] </li></ul><ul><li>Jeymohan Joseph, Ph.D. </li></ul><ul><li> 301.443. 6100 </li></ul><ul><li>[email_address] </li></ul><ul><li>David M. Stoff, Ph.D. </li></ul><ul><li>301.443.4625 </li></ul><ul><li> [email_address] </li></ul><ul><li>Jing Bao, MD, Ph.D. </li></ul><ul><li>301.443.8542 </li></ul><ul><li>[email_address] </li></ul>

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