NINDS is offering the CREATE Bio Development Track grant for the development of therapeutic Biotechnology Products and Biologics targeting disorders within the NINDS mission. This grant supports IND-enabling studies for a therapeutic candidate with the goal of submitting an IND application to the FDA. The optional inclusion of a small delayed-onset Phase I clinical trial is also supported. Applications must have a clinical candidate demonstrating necessary bioactivity, stability, and efficacy for desired clinical applications. The closing date for applications is May 07, 2021.
Opportunity ID: 299549
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-543 |
| Funding Opportunity Title: | CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 20, 2017 |
| Last Updated Date: | Apr 28, 2020 |
| Original Closing Date for Applications: | Sep 07, 2020 |
| Current Closing Date for Applications: | May 07, 2021 |
| Archive Date: | Jun 06, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-543.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| updated close date as per NOT-NS-20-056 | Apr 28, 2020 | |
| Dec 20, 2017 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-543 |
| Funding Opportunity Title: | CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 20, 2017 |
| Last Updated Date: | Apr 28, 2020 |
| Original Closing Date for Applications: | Sep 07, 2020 |
| Current Closing Date for Applications: | May 07, 2021 |
| Archive Date: | Jun 06, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-543.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-543 |
| Funding Opportunity Title: | CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 20, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 07, 2020 |
| Archive Date: | Oct 13, 2020 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-543.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-E | Use for due dates on or before May 24, 2020 | PKG00237189 | Jan 20, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00260218 | Jan 20, 2018 | May 07, 2021 | View |
Package 1
Mandatory forms
299549 RR_SF424_2_0-2.0.pdf
299549 PHS398_CoverPageSupplement_4_0-4.0.pdf
299549 RR_OtherProjectInfo_1_4-1.4.pdf
299549 PerformanceSite_2_0-2.0.pdf
299549 RR_KeyPersonExpanded_2_0-2.0.pdf
299549 RR_Budget_1_4-1.4.pdf
299549 PHS398_ResearchPlan_4_0-4.0.pdf
299549 SBIR_STTR_Information_1_2-1.2.pdf
Optional forms
299549 RR_SubawardBudget30_1_4-1.4.pdf
299549 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
299549 RR_SF424_2_0-2.0.pdf
299549 PHS398_CoverPageSupplement_5_0-5.0.pdf
299549 RR_OtherProjectInfo_1_4-1.4.pdf
299549 PerformanceSite_2_0-2.0.pdf
299549 RR_KeyPersonExpanded_2_0-2.0.pdf
299549 RR_Budget_1_4-1.4.pdf
299549 PHS398_ResearchPlan_4_0-4.0.pdf
299549 SBIR_STTR_Information_1_3-1.3.pdf
299549 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
299549 RR_SubawardBudget30_1_4-1.4.pdf
299549 PHS_AssignmentRequestForm_3_0-3.0.pdf
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