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Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)

List of required information for application:

1. Name of the applicant institution or organization.

2. Contact information for the primary point of contact for the application.

3. Project title.

4. Project summary or abstract.

5. Detailed description of the proposed research plan for biologic-based therapeutic discovery and development.

6. Significance and innovation of the proposed project.

7. Clear objectives and milestones for the project.

8. Approach and methods for lead optimization through phase I clinical testing.

9. Description of the potential therapeutic biotechnology products and biologics to be developed.

10. Description of the large biologic macromolecules, gene-based therapies, cell therapies, and novel emerging therapies to be explored.

11. Explanation of how the proposed project aligns with the objectives of the Blueprint Neurotherapeutics Network for Biologics.

12. Demonstration of collaboration with NIH-funded consultants.

13. Plans to work with NIH contract research organizations (CROs) for manufacturing, scaling, pharmacokinetics, toxicology, and Phase I clinical testing.

14. Statement of the applicant institution's retention of assignment of intellectual property (IP) rights.

15. Explanation of how the applicant institution will gain assignment of IP rights from the BPN-Biologics contractors.

16. Description of the applicant institution's capability to control patent prosecution and licensing negotiations for biotherapeutic candidates developed in this program.

17. Budget justification, including proposed funding amount and breakdown of costs.

18. References to support the proposed research plan and approach.

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Funding Amount

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Eligible Applicants

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Eligible Activities

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Deadline to Apply

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88%

Approval rating across all Canadian funding programs

93%

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