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Overview: NIAAA Medications Development Program

Overview: NIAAA Medications Development Program. Raye Z. Litten, Ph.D. Mark Egli, Ph.D. Co-Leaders Medications Development Team National Institute on Alcohol Abuse and Alcoholism May 26, 2005. Medications Development is a High Priority at NIAAA.

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Overview: NIAAA Medications Development Program

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  1. Overview: NIAAA Medications Development Program Raye Z. Litten, Ph.D. Mark Egli, Ph.D. Co-Leaders Medications Development Team National Institute on Alcohol Abuse and Alcoholism May 26, 2005

  2. Medications Development is a High Priority at NIAAA • One of ten primary research outcome goals of NIH • One of the more highly developed research programs at NIAAA

  3. NIAAA-Supported Clinical Pharmacological Studies to Treat Alcohol Use Disorders • 1 Phase 3 clinical studies • 33 Phase 2 clinical trials • 17 Phase 1 clinical trial

  4. NIAAA-Supported Clinical Studies to Reduce or Prevent Drinking

  5. Promising Targets for Novel Agents • CRF1 antagonists • cannabinoid CB1 antagonists • adenosine A2 antagonists • NPY2 agonists • glutamate mGuR5 antagonists • GABAA alpha 1 and 5

  6. NIAAA-Supported Clinical Pharmacotherapy Trials for Comorbid Alcoholics

  7. NIAAA-Supported Clinical Pharmacotherapy Trials for Comorbid Alcoholics

  8. NIAAA-Supported Clinical Pharmacotherapy Trials for Comorbid Alcoholics

  9. NIAAA-Supported Clinical Pharmacotherapy Trials for Adolescents

  10. NIAAA-Supported Clinical Pharmacotherapy Trials for Adolescents

  11. NIAAA-Supported Clinical Pharmacotherapy Trials for Alcoholic Liver Disease

  12. Creation of a Medications Development Team

  13. Medications Development Team is Multi-Disciplinary Expertise in: • Genomics, proteomics, and metabolomics • Neuroscience • Addiction • Animal models • Clinical pharmacology • Clinical trials • Health services • Psychiatry • Human development • Alcohol liver disease, FAS, AIDS • Technology transfer, patents, and intellectual properties

  14. Team’s Goal To facilitate and accelerate the discovery, development, and delivery of medications to treat high-risk drinking, alcohol abuse and dependence, and alcohol-related medical disorders

  15. Aims of Medications Development Team • Stimulate innovative research and development in support of medications development • Establish internal mechanisms and decision-making protocols for evaluating and advancing lead compounds

  16. Aims of Medications Development Team • Develop collaborative networks among government, academia, and private industry and organizations • Develop evidence-based clinical trials standards with the FDA

  17. The Team developed a medications development plan The plan will: • Accelerate drug development from lab bench to patient to practitioner • Advance interdisciplinary research • Stimulate public private partnerships • Themes of the NIH Roadmap

  18. Extramural Advisory Board (EAB) Review • EAB reviewed the plan and identified the most important priorities for advancing the field of medications development • Fulton Crews will present EAB’s recommendations

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