SSJ_FBO.pdf

Single Source Justification (Simplified Acquisition)

Section A: General Contract Information

Contracting Activity: U.S. Army International Technology Center Pacific (ITC-PAC)

Purchase Request/ Identification Number: W90GQZ-73360005

Project/Program Name: Establishment of clinically feasible direct reprogramming procedures leading to a cell-based therapy for bone injury

Estimated Contract Cost: $125,000

Section B: Description of the Supplies/Services Required

This requirement is to provide financing in support of the research project titled “Establishment of clinically feasible direct reprogramming procedures leading to a cell-based therapy for bone injury” lead by Dr. Osam Mazda, MD.PhD., of Nippon

Medical and Chemical Instruments Co., Ltd.

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

This acquisition will be a firm-fixed price purchase order in the amount of $125,000, for 9 months.

The proposed contractor is

Osam Mazda, MD.PhD

Title: Research Conductor

Nippon Medical and Chemical Instruments Co., Ltd.

Address: 1-22-38, Edobori, Nishiku, Osaka 550-0002, Japan

E-mail : omazda@gmail.com

FAX: +81-6-6445-7641

Section C: Justification for Soliciting from a Single Source

ITC-PAC Director of Biotechnology and Nanotechnology, Dr. Tommy Wong, found this project while searching areas of expertise for potential sources of basic research. He searched for all sources that they identified as technically capable and promising. He found that the primary/lead organization for this project is Dr. Osam Mazda, MD, PhD, of the Nippon Medical and Chemical Instruments Co.,Ltd., who is considered the leading research scientist in the field of cell and tissue regeneration, especially in the area of bone therapy. Indeed, Dr. Mazda and his team are recognized for their research in bacterial adaptation, as evidenced by a recent publication on this topic in a prestigious journal (Yamamoto,K., Kishida,T., Sato,Y., Nishioka, K., Ejima,A., Fujiwara,H., Kubo,T., Yamamoto,T., Kanamura,N., and Mazda O. (2015). Direct conversion of human fibroblasts into functional osteoblasts by defined factors. Proc. Natl. Acad. Sci. USA. 112, 6152-6157), and invitations to present his work at international forums. Dr. Mazda is the only expert who could conduct such a project and who expressed interest in developing proof of concept studies on this research and development project.

This fund is for the research and development project titled “Establishment of clinically feasible direct reprogramming procedures leading to a cell-based therapy for bone injury”. Because this project will feature the latest scientific innovation in this field, there is no parallel value to be found in the commercial sector. ITC-PAC certifies the price of $125,000 is fair and reasonable for this type of project to compare similar projects of other Government agencies. This certification is based on the following facts:

The funds will be used to support research and development efforts at the Nippon Medical and Chemical Instruments Co.,Ltd., Osaka, Japan, by Dr. Osam Mazda. Cost estimates are as follows:

Material and supplies $ 84,460 Personnel cost $ 19,540 Travel cost $ 8,500 Indirect Cost $ 12,500 Total: $125,000

The above mentioned cost is based on the detailed itemized expenditures in the budget (please see the attached “Supplement to Single Source Justification, Proposed Contractor is Dr. Osam Mazda”. This budget is considered fair and reasonable.

The Government will receive deliverables such as:

Project Proposal

Project Interim Report

Project Final Report

Section D: Efforts to Obtain Competition

ITC-PAC Director of Biotechnology and Nanotechnology, Dr. Tommy Wong, found this project while reviewing recent studies conducted by the other researchers. This group (Dr. Osam Mazda’s group) succeeded in the development of a variety of methodologies in the transformation of somatic cells to stem cells. Dr. Mazda has published many papers in this field and is attested by the high-impact journals that have published much of his work. This research is the only direct source associated with a collaboration effort among ITC-PAC, MRMC, and Dr. Mazda of the Nippon Medical and Chemical Instruments Co.,Ltd., Osaka, Japan, in the area of cell transformation for bone therapy.

Section E: Steps to Preclude Future Single Source Awards

This is a one-time purchase action, but ITC-PAC keeps searching areas of expertise for potential sources of basic research.

Section F: Determination

Technical/Requirements Personnel’s Certification:

As evidenced by signature below, the technical and/or requirements personnel have certified that any supporting data contained herein which is their responsibility is both accurate and complete.

Date

11 Jan 2017

Typed Name and Rank/Grade of Certifying Official

KENNETH EVENSEN

Director, US ARMY ITC-PAC

Signature of Cert i fy ing Off ic ial

Contracting Officer's Determination: I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Date Typed Name and Rank/Grade of Contracting Officer Signature of Contracting Officer