SOW_NMCI_FBO.pdf

STATEMENT OF WORK

FOR

DEPARTMENT OF THE ARMY

RESEARCH, DEVELOPMENT AND ENGINEERING COMMAND

INTERNATIONAL TECHNOLOGY CENTER-PACIFIC

(ITC-PAC)

Establishment of Clinically Feasible Direct Reprogramming Procedures

Leading to a Cell-based Therapy for Bone Injury (Document No. W90GQZ73360005)

1. DESCRIPTION OF SERVICE.

The proposal is to develop technologies for the establishment of clinically feasible direct reprogramming procedures leading to cell-based therapy for bone injury.

The aim of this project is to use novel cellular reprogramming technologies to realize the generation of functional human osteoblasts from normal fibroblasts leading to establishment of feasible regenerative therapy of bone injury. The objective in this project is to improve non-viral methods for direct conversion of fibroblast cells into osteoblasts by transducing genes for some defined factors. The Principal Investigator (PI) will improve the direct conversion procedure by means of plasmid vectors to elevate the efficiency of conversion and to obtain directly converted osteoblasts (dOBs) that would massively produce bone matrix. The phenotype of the dOBs will be analyzed in detail, including genome-wide gene expression profile and bone forming activity.

Instead of the four factor combination (RXOL), various other combinations of transcription factors will also be tested and optimized, to induce functional dOBs by a combination of a smaller number of factors. Moreover, chemical direct conversion procedure will also be improved to increase efficiency of induction and to generate functional dOBs that abundantly express osteoblast-specific genes.

Duration of this Research and Development is for a 9-month period.

1.2. DELIVERABLES.

1.2.1. First Deliverable - Project Proposal.

Prior to commencement of work, the contractor shall submit ITC-PAC a Project Proposal which is to measure the progress of the Project, for ITC-PAC’s acceptance.

Project Proposal shall include, at a minimum, the following information:

Project title Investigators

- Name

- Position title

- Organization name

- Address

- Telephone number

- Fax number

- Email address

Concise summary Abstract Objectives Relevance to DoD Background Summary of project plan, expected project result and expected project benefit Project duration Budget details (materials and supply, personnel, travel, etc.)

References

1.2.2. Midterm Deliverable – Interim Report.

The contractor shall submit an interim report detailing the progress of the completed segments of the project to ITC-PAC at the end of the 4-month stage after commencement of work.

Interim Report shall include, at a minimum, the following information:

Status of project plan.

Progress made in the first 4 months.

Projected progress to be made in the next 5 months.

1.2.3. Final Deliverables

1.2.3.1. Final Report

The contractor shall submit the Final Report to ITC-PAC with all the results, problems and/or discoveries encountered during the project phases within 30 days after the performance period ends.

The Final Report shall include, at a minimum, the following information;

Project title Investigators

- Name

- Position title

- Organization name

- Address

- Telephone number

- Fax number

- Email address

Summary (or Abstract) of the Project

Introduction (or Background) Experiment Result & Discussion Conclusion Acknowledgement Reference

1.2.3.2. Financial Report

Together with the Final Report, the contractor shall deliver the Financial Report of this Project to

ITC-PAC.

The Financial Report shall include the cost spent for the Project in the following category: Labor Cost, Material and Supplies, Travel Cost, Indirect Cost.

1.3. PAYMENTS.

1.3.1. First Payment.

After ITC-PAC’s acceptance of a Project Proposal mentioned above, the contractor shall submit the first invoice to ITC-PAC. The first payment will be made upon ITC-PAC’s certification of the invoice.

1.3.2. Second Payment.

After ITC-PAC’s acceptance of an interim report mentioned above, the contractor shall submit the second invoice to ITC-PAC. The second payment will be made upon ITC-PAC’s certification of the invoice.

1.3.3. Final Payment.

After ITC-PAC’s acceptance of the Final Deliverables mentioned above, the contractor shall submit the final invoice to ITC-PAC. The final payment will be made upon ITC-PAC’s certification of the invoice.

2. GOVERNMENT FURNISHED PROPERTY. None.

3. GENERAL INFORMATION.

3.1. Contractor Employees. Personnel shall meet or exceed the following requirement:

3.1.1. The contractor shall not hire employees of the United States Government and/or employees otherwise under contract for service to the United States Government if employing such persons would create a conflict of interest, or appearance of a conflict of interest as determined by the contractor. The contractor shall not employ any person who is an employee of DoD, unless such person seeks and receives approval according to DODR 5500.7, Standards of Conduct.