Example A). Early Testing of Collaborator's Agent
| Contributor Contribution |
- Provides agent for testing
- Files IND with the Food and Drug Administration
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| NIH Contribution |
- Conducts preclinical research and Phase I studies in adult and/or pediatric patient populations at the NIH Clinical Center
- Provides data in support of a new Investigational Drug (IND) application
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| Successful Outcome and/or Product |
- Evaluation of a new agent including safety, tolerability, pharmacokinetics, immunogenicity, etc.
- IND for agent
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Example B). Research Collaborations for Evaluating Devices/Equipment
| Collaborator Contribution |
- Places equipment in an NIH facility for testing by NIH scientists for a limited time
- Offers onsite training sessions and technical support for NIH scientists interested in using the equipment
- May provide equipment upgrades, accessories, reagents/disposables, and maintenance related to technology
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| NIH Contribution |
- Conducts a variety of pilot studies to test the technology and compares results to the other methods
- Assists in validating assays and methods
- Provides data and other feedback for equipment and methods improvements
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| Successful Outcome and/or Product |
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Example C). Research Collaborations for Co-Development of New Antibodies
| Collaborator Contribution |
- Designs and develops antibodies
- Provides agreed upon quantity of product to NIH
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| NIH Contribution |
- Chooses target proteins for antibody development
- Validates using a wide variety of available cell systems
- Provides validation data to company
|
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| Successful Outcome and/or Product |
- Develops custom antibodies
- Publish information about new antibodies
- Create new antibody product
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Example D). Clinical Testing of Agents Leading to New Therapeutics
| Collaborator Contribution |
- Provides or synthesizes the agent
- Conducts preclinical and clinical studies in collaboration with NIH and other institutions
- Works with NIH to develop data needed for FDA approval
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| NIH Contribution |
- Provides or synthesizes the agent
- Conducts preclinical studies for the agent
- Develops or contributes to better formulation or alternative administration methods
- Conducts clinical trials through its network of clinical centers including NIH Clinical Center
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| Successful Outcome and/or Product |
- FDA approval of agent
- Product on the market
- Other clinical trials for additional indications
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