FINAL_Attachment-15-Additional_Business_Proposal_Instructions_REVISED.pdf
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- Attached to
- Preclinical PREVENT Cancer Program for Preclinical Efficacy and Intermediate Endpoint Biomarkers
- Solicitation number
- N01-CN55003-47
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Revised Attachment 15. This also goes with Amendment 2
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Additional Business Proposal Instructions Attachment 15 (October 2014) Page 1 of 2
ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS
BUSINESS PROPOSAL
SECTION 1 – PROPOSAL COVERSHEET – Form NIH-2403 – PROPOSAL SUMMARY
AND DATA RECORD
SECTION 2 – COST OR PRICE SUPPORT
Section L of the RFP specifies the minimum documentation requirements for cost data and all cost related support. All related documentation should be included in the proposal in a clearly marked section. Cost and Pricing support should be provided for all proposed subcontractors.
1. Sample Task Order Budget:
The Sample Task Order entitled, “Use Small Molecule Inhibitor(s) of MDM2/MDMX to Prevent Cancer”, which is provided as Appendix A to Attachment 9, Additional Technical Proposal Instructions, is comprised of two (2) Task Areas.
Task Area 1: In vivo dose selection and initial safety assessment studies following identification of Chemopreventive agents.
Task Area 2: Pharmacokinetics and pharmacodynamics in experimental animals.
2. Cost Assumptions for Sample Task Order Budget Preparation:
Task Area 1: Assume that approximately 250 rodents (mice and rats) will be used/per year. The Offeror shall nominate at least one novel and specific inhibitor of
Mdm2/MdmX from literature for initiating a dose finding in vivo study. In addition, the
Offeror shall conduct an initial PK study to demonstrate blood levels of the molecule over 24-hour period.
Task Area 2: Assume that approximately 400 rodents (mice and rats) will be used/per year. The Offeror shall choose one preclinical efficacy model and conduct detailed pharmacodynamic study to demonstrate such molecule’s effectiveness in preventing carcinogenesis. In addition, The Offeror shall explore and delineate the connection of
In addition to the instructions and format requirements for the Business Proposal that are contained in Section L of the solicitation, the information presented in this attachment is intended to provide uniform cost assumptions that apply to the solicitation.
Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the technical evaluation criteria, and, the RFP as a whole, in the development of your proposal. The information requested here should be used as further guidance for the development of your Business Proposal.
Additional Business Proposal Instructions Attachment 15 (October 2014) Page 2 of 2 pharmacodynamic endpoints, such as tumor multiplicity, incidence, and pathway-mediated intermediate endpoints.
Travel Requirements (Include in Task Area 2): Assume one (1) staff member/PI will be allowed to travel to a scientific meeting one (1) time in the final year of the Task Order. Assume costs for (1) traveler, three (3) night stay and travel must be within the United States. Travel to scientific meetings will only be allowable based on presentation of the results for the specific Task Order. Assume the meeting is in Chicago, Illinois.
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