Benefits of a Collaboration
NIAAA is dedicated to providing leadership in the national effort to reduce alcohol related problems. Institute staff have multidisciplinary training and experience in alcohol treatment and preclinical and clinical research. Not only can NIAAA provide technical advice on the design and execution of a clinical trial, we also have access to a network of academic researchers whom can provide assistance throughout every step in the medication development process. Establishing public-public partnerships will create opportunities to develop and facilitate use of effective medications, coordinate activities more efficiently, and focus on activities not performed by other entities. NIAAA is working to develop evidence-based clinical trial outcome standards and share these analyses with the FDA.
For additional information please contact NIAAA:
Megan Ryan, Contractor, Study Coordinator, 5635 Fishers Lane Bethesda, MD 20952 Phone 301-443-4225 Fax 301-480-5790
For additional information please contact NIAAA:
Megan Ryan, Contractor, Study Coordinator, 5635 Fishers Lane Bethesda, MD 20952 Phone 301-443-4225 Fax 301-480-5790
Opportunities for Pharmaceutical Companies
· SBIR/STTR Funding - Companies under 500 employees have an opportunity to obtain SBIR/STTR funding. Topics include drug discovery, preclinical development (animal models, toxicology), and early human testing.
· Collaborative Agreements - These offer the potential to establish formal collaborations such as a Clinical Trial Agreement or a CRADA to test promising medications.
· Animal Models - NIAAA supports contracts to evaluate novel medications for AUD in animal models that represent different aspects of alcoholism.
· Human Lab Models - NIAAA is supporting human laboratory paradigms to screen medications to treat AUDs. Reactivity and self-administration paradigms are being used to test several promising medications for alcohol use disorders.
· Early Phase 2 Clinical Trials—NIAAA is conducting early Phase 2 trials to test efficacy and safety of promising compounds.
· Technical Assistance - NIAAA provides pharmaceutical companies with the status of medications development for the treatment of AUDs. Topics of interest include molecular targets, animal and human screening models, and methodology and design of conducting clinical trials.
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