This grant seeks to advance analytical methods crucial for characterizing complex generic drug products, particularly focusing on their quality, safety, and efficacy. The primary objective is to develop sophisticated techniques for analyzing diastereomer compositions in phosphorothioate (PS) oligonucleotides, using TEGSEDI (inotersen) or SPINRAZA (Nusinersen) as model products. Research will investigate the diastereomer makeup in these drugs and assess how manufacturing processes influence their distribution. The methods developed will have broad applicability, significantly facilitating the development and evaluation of other synthetic oligonucleotide generic drug products. Ultimately, this research will enhance quality control for oligonucleotide drugs, streamlining their generic development and market assessment.
Opportunity ID: 336282
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-22-013 |
| Funding Opportunity Title: | Development of advanced analytical methods for the characterization of complex generics |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 12, 2022 |
| Last Updated Date: | Jan 12, 2022 |
| Original Closing Date for Applications: | Mar 07, 2022 |
| Current Closing Date for Applications: | Mar 07, 2022 |
| Archive Date: | Apr 06, 2022 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | Special district governments Small businesses State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses City or township governments County governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Section III. Eligibility Information1. Eligible ApplicantsEligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs)o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
Advanced analytical methods for characterization and comparative analysis of complex products, which help to link product attributes to product quality, safety and efficacy, are useful for facilitating the development of generic complex products. The purpose of this study is to develop advanced analytical methods for analyzing the diastereomer compositions in phosphorothioate (PS) oligonucleotides using either TEGSEDI (inotersen) or SPINRAZA (Nusinersen) as the model product. The proposed studies will focus on 1) understanding the diastereomer composition in TEGSEDI or SPINRAZA (Nusinersen), and 2) determining whether and how the manufacturing process may affect the diastereomeric distributions in the drug product. Methods developed through this research may also be applied in cases of other synthetic oligonucleotides, and could greatly facilitate the development and assessment of generic oligonucleotide drug products. Knowledge gained from this research may also contribute to quality control of oligonucleotide drugs. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-22-013 | FORMS G | PKG00271056 | Dec 07, 2021 | Mar 07, 2022 | View |
Package 1
Mandatory forms
336282 RR_SF424_5_0-5.0.pdf
336282 PHS398_CoverPageSupplement_5_0-5.0.pdf
336282 RR_OtherProjectInfo_1_4-1.4.pdf
336282 PerformanceSite_4_0-4.0.pdf
336282 RR_KeyPersonExpanded_4_0-4.0.pdf
336282 RR_Budget_3_0-3.0.pdf
336282 PHS398_ResearchPlan_4_0-4.0.pdf
336282 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336282 RR_SubawardBudget30_3_0-3.0.pdf
336282 PHS_AssignmentRequestForm_3_0-3.0.pdf
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