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Integrated Preclinical / Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed)

List of required information for application:

1. Project Title

2. Abstract/Summary of the project

3. Project Timeline

4. Detailed budget breakdown

5. Project Team and their qualifications

6. Description of the advanced HIV-1 vaccine candidate

7. Rationale for translation of the vaccine candidate from pre-clinical studies to clinical testing

8. Plan for technology transfer and collaboration with Pharma/Biotech/Contract Manufacturing Organizations (CMO)

9. Preclinical immunogenicity and optimization studies plan

10. Process development plan

11. Analytical assay development plan

12. Qualification and validation plan for manufacturing processes

13. Small scale pilot or engineering runs plan

14. CGMP manufacturing plan

15. Quality assurance/quality control oversight plan

16. Fill-finish activities plan

17. Product release and storage plan

18. Reference standard, drug substance, and drug product stability testing program plan

19. Investigational New Drug (IND)-enabling studies plan

20. Regulatory submission preparation plan

21. Any additional supporting documentation or data related to the project.

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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%

Average time savings to our clients, compared to
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