PREPARE-BAA-Attachment_2_Program_Plan.xlsx
XLSX spreadsheet 14 KB Posted
- Attached to
- PReemptive Expression of Protective Alleles and Response Elements (PREPARE) Federal contract opportunity
- Solicitation number
- HR001118S0037
About this file
Not Listed
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| HR001118S0037-Amendment-01.pdf | ||
| PREPARE-BAA-Attachment_1_Executive_Summary.pptx | PPTX presentation | |
| PREPARE-BAA-Attachment_3_SOW.docx | DOCX document | |
| HR001118S0037.pdf | ||
| PREPARE-BAA-Attachment_4_Budget.xlsx | XLSX spreadsheet |
On GovTribe
Work with this file on GovTribe
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
SPP
Guidance for completing the PREPARE Specific Program Plan (SPP):
--Provide key proposal details already described in the full proposal. (Replace existing text below with answers) --Provide concise answers (no more than 1-3 sentence answers) to each and every Program Detail requested.
--Submit in excel format
| Title | |||
| Lead PI | |||
| Institution | |||
| Phase | Item | Topic | Program Detail |
| 1 | 1 | TA1 (Gene Target Identification) | Bioinformatics tools: software, uses, and rationale |
| 1 | 2 | Months 1 - 12 | Cell line(s), organoid model(s), and/or animal model(s) used |
| 1 | 3 | Threat(s) screened | |
| 1 | 4 | Experimental design (e.g. screen, reporter system, controls) | |
| 1 | 5 | Method(s) for determining baseline expression state(s) in target tissue(s) | |
| 1 | 6 | Criteria for selection and prioritization of protective gene targets (tissue location, viability for activity modulation, etc) | |
| 1 | 7 | Quantitative metrics for Efficacy | |
| 1 | 8 | Quantitative metrics for Safety | |
| 1 | 9 | Quantitative metrics for Specificity | |
| 1 | 10 | TA2 (Programmable Gene Modulator Development) | Bioinformatics tools: software, uses, and rationale |
| 1 | 11 | Cell line(s), organoid model(s), and/or animal model(s) used | |
| 1 | 12 | Months 1 - 12 | List programmable gene modulation approaches (e.g. epigenetic, RNA degradation, etc) and justification for downselection to modulation type(s) selected for investigation |
| 1 | 13 | Experimental design (e.g. screen, reporter system, controls) | |
| 1 | 14 | Quantitative metrics for Efficacy | |
| 1 | 15 | Quantitative metrics for Safety | |
| 1 | 16 | Quantitative metrics for Specificity | |
| 1 | 17 | Quantitative metrics for Multiplexability & Generalizability | |
| 1 | 18 | Plan to support downstream PGM Manufacturability | |
| 1 | 19 | Criteria for prioritization of successful PGM(s) | |
| 1 | 20 | Description of how PGM can be adapted to threats not addressed by proposer | |
| 1 | 21 | TA3 (Clinical Formulations) | Cell line(s), organoid model(s), and/or animal model(s) used |
| 1 | 22 | Months 1 - 12 | List clinical formulation(s), respective cell/tissue target(s), and mode of administration in vivo |
| 1 | 23 | Experimental design (e.g. screen, reporter system, controls) | |
| 1 | 24 | Quantitative metrics for Efficacy | |
| 1 | 25 | Quantitative metrics for Capacity | |
| 1 | 26 | Quantitative metrics for Safety | |
| 1 | 27 | Quantitative metrics for Specificity | |
| Plan to support downstream Clinical Formulation Manufacturability | |||
| 1 | 28 | Methods to address failure modes (e.g., immunogenicity, toxicity, suboptimal ADME, cargo size, off-tissue effects) | |
| 1 | 30 | Capability Demonstration 1 | List threat(s), animal model(s), and relevancy of animal model(s) used |
| 1 | 31 | By Month 22 | Experimental design for Capability Demonstration 1 |
| 1 | 32 | Describe SoA MCM(s) that provide a basis for comparing performance of PGM-MCM(s) | |
| 1 | 33 | Quantitative metrics for Efficacy (must indicate performance category(s) targeted, e.g., level of, duration of, and/or time to protection and/or breadth of threats covered, etc). Minimum is 2× over SoA. | |
| 1 | 34 | Quantitative metrics for Safety. | |
| 1 | 35 | Quantitative metrics for Specificity. | |
| Quantitative metrics for Transience. | |||
| 1 | 37 | Markers of and method(s) for determing Mechanisms of Protection (MoPs) | |
| 1 | 38 | Method(s) for characterizing PGM-MCM components in vivo, e.g. target expression, immunogenicity, toxicity, ADME, etc. | |
| 1 | 39 | Informatics & Data Sharing | List steps and potential platform for data sharing during Phase I |
| 1 | 40 | Regulatory Engagement | List necessary steps and plan for regulatory engagement during Phase I |
| 2 | 41 | Capability Demonstration 2 | List threat(s), animal model(s), and relevancy of animal model(s) used |
| 2 | 42 | By Month 32 | Experimental design for Capability Demonstration 2 |
| 2 | 43 | SoA MCM(s) to be tested | |
| 2 | 44 | Quantitative metrics for Efficacy (must indicate performance category(s) targeted, e.g., level of, duration of, and/or time to protection and/or breadth of threats covered, etc). Minimum is 10× over SoA. | |
| 2 | 45 | Quantitative metrics for Safety. Must display advanced performance or improved characterization over CD1 metrics. | |
| 2 | 46 | Quantitative metrics for Specificity. Must display advanced performance or improved characterization over CD1 metrics. | |
| 2 | 47 | Quantitative metrics for Transience. Must display advanced performance or improved characterization over CD1 metrics. | |
| 2 | 48 | Markers of and method(s) for determing Mechanisms of Protection (MoPs) | |
| 2 | 49 | Method(s) for characterizing PGM-MCM components in vivo. Characterization must be more comprehensive than CD1 metrics. | |
| 2 | 50 | Capability Demonstration 3 | List threat(s), animal model(s), and relevancy of animal model(s) used |
| 2 | 51 | By Month 40 | Experimental design for Capability Demonstration 3 |
| 2 | 52 | SoA MCM(s) to be tested | |
| 2 | 53 | Plan for testing with live agent (include facility, agent, containment/safety level) | |
| 2 | 54 | Quantitative metrics for Efficacy (must indicate performance category(s) targeted, e.g., level of, duration of, and/or time to protection and/or breadth of threats covered, etc). Minimum is 100× over SoA. | |
| 2 | 55 | Quantitative metrics for Safety. Must display advanced performance or improved characterization over CD2 metrics. | |
| 2 | 56 | Quantitative metrics for Specificity. Must display advanced performance or improved characterization over CD2 metrics. | |
| 2 | 57 | Quantitative metrics for Transience. Must display advanced performance or improved characterization over CD2 metrics. | |
| 2 | 58 | Markers of and method(s) for determing Mechanisms of Protection (MoPs) | |
| 2 | 59 | Method(s) for characterizing PGM-MCM components in vivo. Characterization must be more comprehensive than CD2 metrics. | |
| 2 | 60 | Informatics & Data Sharing | List steps and potential platform for data sharing during Phase II |
| 2 | 61 | Regulatory Engagement | List necessary steps and timing for successful IND/EUA submission |
| 2 | 62 | Final Deliverable | In one sentence, describe the final expected PGM-MCM for regulatory submission. (include PGM-MCM type, threat(s), degree of protection over SoA, manufacturability, and duration of protection). |
File details come from the government source that posted it.