A03-Sanaria_Inc_J_and_A_FBOa_Redacted.pdf

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Control No.

Justification and Approval For Other Than Full and Open Competition

For actions over $650,000 but not exceeding $12.5M

Program/Equipment: Improving Manufacturing Process for PfSPZ Malaria Vaccine in

Authority:10 U.S.C. 2304(c)(1) Amount $ 3,500,000.00

Prepared By:

Typed Name:

DSN:

Title: PM Advanced Medical Development

Date: 7/7/15

Contracting Officer:

Typed Name:

DSN:

Date Reviewed: 14 July 2015

Technical Representative:

Typed Name:

DSN:

Title: PM Advanced Medical Development

Date: Reviewed: 7/7/15

Requirements Representative:

Typed Name:

DSN:

Title: PM Advanced Medical Development

Date: Reviewed: 7/7/15

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Reviews:

I have reviewed this justification and find it adequate to support other than full and open competition.

Director (GS-15 equivalent), Program Manager or PEO (PEO signature required if program managed be PEO):

Typed Name:

DSN:

Signature:

Date: 7 July 2015

Legal Counsel:

Typed Name:

DSN:

Signature:

Date: 14 July 2015

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Justification and Approval

For Other Than Full and Open Competition

1. CONTRACTING ACTIVITY

Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, ATTN: CCAP-SCN, Kansas Street, Natick, MA 01760

2. DESCRIPTION OF ACTION

Approval is requested to solicit on the basis of other than full and open competition for a new contract.

The contract is in support of:

Naval Medical Research Center Advanced Medical Development Type of contract contemplated: Cost No Fee.

Reason for type of contract:

Effort is R&D in nature and lacks precise specifications in order to accurately estimate costs Funding information:

Fiscal Year:

Type of Money to be used:

Research Development Test and Evaluation.

3. DESCRIPTION OF SUPPLIES/SERVICES

Approval is requested to award a contract to develop an improved manufacturing process of an irradiated sporozoites-based malaria vaccine to support large scale manufacturing for use in Phase 3 clinical trials, and ultimately enabling production of a vaccine that will prevent malaria infection of United States service members. The large scale automated manufacturing process must be in compliance with current Good Manufacturing Practices (cGMPs) that will produce large amounts of malaria vaccine to be utilized in future Phase 3 clinical trials. The vaccine would be administered intravenously and must utilize irradiated aseptic, purified, cryopreserved, attenuated (non-replicating), metabolically active Plasmodium falciparum (Pf) sporozoites (SPZ) extracted from mosquitos that are grown and incubated.

Why irradiated? Irradiation causes the non-replication (attenuation) - or therefore the "weakened" version of the sporozoites to initiate the immune response without full blown malaria but allowing for a more immediate response in the future. If the mosquitos (and in the turn the sporozoites) are not irradiated, they will cause a malaria infection in the individual.

Why metabolically active? There is no produced immune response when the sporozoites are not metabolically active because it will not bury itself in the liver to initiate an immune response.

Why cryopreserved? The Malaria vaccine is a eukaryotic vaccine unlike most vaccines.

Eukaryotic cells require storage at less than -150 degrees centigrade.

Why purified and aseptic? Vaccines need to follow cGMP practices. The same for the grown mosquitos, we need clean mosquitos where we can estimate the viral load and the dose.

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Estimated value for this effort is $3,500,000.00 for a twenty-four month period of performance.

4. AUTHORITY CITED

The statutory authority permitting other than full and open competition is 10 U.S.C.

2304(c)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. REASON FOR AUTHORITY CITED:

Market research has determined that Sanaria Inc. of Rockville, MD is the only company that has produced the PfSPZ vaccine via irradiated sporozoites and there are no other such companies that have shown any part of this capability. Other malaria vaccines are in development but none utilize irradiated PfSPZ sporozoites as required by the Government.

The potential benefits to the Government if this effort is successful are substantial. Specifically, the effort will result in enabling production of a vaccine that will prevent malaria infection of US service members as well as civilians world-wide. This technology will enhance efficiency and synergy within the US Government's vision of assisting in the reduction of pandemic infectious disease and biological threats, global surveillance efforts and bio-defense. No other organization besides Sanaria Inc. has the extensive breadth and depth of technical expertise with the irradiated PfSPZ sporozoites required to perform the work.

6. EFFORTS TO OBTAIN COMPETITION:

Market research was conducted to identify sources of malaria vaccine developers. While a number of malaria vaccines are under development, including those based on the Plasmodium faciparum reticulocyte-binding protein homologue 5 (PfRH5) antigen as well as recombinant vaccines consisting of the Plasmodium faciparum circumsporozoite protein from the pre-erythrocytic stage. However, market research could only identify one source utilizing irradiated PfSPZ sporozoites to meet the Government requirement.

7. ACTIONS TO INCREASE COMPETITION:

Upon conclusion of this effort, should the Government determine that procurement of an irradiated sporozoites-based malaria vaccine is necessary to support Phase 3 clinical trials, a market survey will be conducted at that time to identify capable vendors that can supply such a vaccine meeting those specifications.

8. MARKET RESEARCH

Market research was conducted by PM Advanced Medical Development (AMD). AMD has a requirement for the development of an enhanced manufacturing process for an irradiated sporozoites-based malaria vaccine to support large scale manufacturing for use in Phase 3 clinical trials that meets the following requirements:

- Ability to produce large scale automated manufacturing process that is in compliance with current Good Manufacturing Practices (cGMPs) that will produce large amounts of irradiated PfSPZ malaria vaccine to be utilized in future Phase 3 clinical trials.

- Must already have in place an established manufacturing process for PfSPZ vaccine, using irradiated sporozoites, under cGMPs that proved to be successful during Phase 1 and Phase 2 clinical trials.

- Must have the capability to develop a semi-automated process for the dissection and collection of infected mosquito salivary glands containing PfSPZ.

- PfSPZ vaccine must be able to be administered intravenously (IV).

- PfSPZ malaria vaccine must utilize irradiated aseptic, purified, cryopreserved, attenuated (non-

Page 5 of 720120507 replicating), metabolically active Plasmodium falciparum (Pf) sporozoites (SPZ) extracted from infected mosquitoes that are grown and incubated.

Based on current market research via internet searches using keywords, PfSPZ vaccine, Sanaria, Inc. is the only vendor that comes up in the search results:

1. http://en.wikipedia.org/wiki/PFSPZ_vaccine

2. http://www.sanaria.com/

3. http://www.niaid.nih.gov/news/newsreleases/2013/Pages/PfSPZ.aspx

4. http://www.makingmalariahistory.org/initial-trials-of-sanaria-vaccine-provide-complete-protection-against-malaria/

5. http://www.nature.com/news/zapped-malaria-parasite-raises-vaccine-hopes-1.13536

6. http://www.malariavaccine.org/files/MVIfactsheet_Sanaria_110106_000.pdf

A SBA “Dynamic Small Business Search” was conducted on 22 May 2015 under NAICS code 325413, using the relevant key words “PfSPZ vaccine”, yielding no results. A SAM search was also conducted on 22 May 2015 using relevant key words “PfSPZ vaccine”, yielding no results.

Results indicate that Sanaria is the sole company that has the capability to produce the PfSPZ vaccine using irradiated Pf sporozoites. There is no such other company out there in the world that demonstrates this unique and innovative concept and capability to provide this particular research services to the government. According to Sanaria’s SAM registration, it is a veteran-owned small business concern. The Sanaria PfSPZ malaria vaccine won the 2014 Vaccine Industry Excellence Award for “Best Prophylactic Vaccine”.

identified Sanaria Inc. as the only company in the world that currently produces irradiated PfSPZ vaccines that is in compliance with cGMPs. She indicated that there are other companies out there working on developing malaria vaccines but none that uses irradiated PfSPZ sporozoites. She also noted that Sanaria has collaborated with the Naval Medical Research Center (NMRC) and the Center for Disease Control (Malaria Epidemiology Branch) under Cooperative Research and Development Agreements.

Based on the above findings, it has been ascertained that of the products identified in the current market survey, only one (Sanaria, Inc.) meets all of the basic requirements. It has been ascertained then that there is a reasonable expectation of obtaining from Sanaria, Inc. the best scientific and technological source consistent with the demands of the proposed acquisition for the best mix of cost, performance, and schedule.

9. INTERESTED SOURCES:

A notice of intent to award this sole source contract to Sanaria Inc. was issued 8 Jun 2015 on FedBizOpps. No responses were received from other sources.

10. OTHER FACTS:

Discuss any other facts supporting use of other than full and open competition, such as the following:

a. Procurement History The Naval Medical Research Center (NMRC) and the Center for Disease Control (Malaria Epidemiology Branch) has previously collaborated with Sanaria Inc. under Cooperative Research and Development Agreements.

b. Acquisition Data Availability

N/A

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c. Unusual and Compelling Urgency

N/A

d. Subcontracting Competition

N/A

e. Follow-on Contracts

N/A

11. TECHNICAL CERTIFICATION:

I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Date: 7/7/15

Title: PM Advanced Medical Development

Signature:

12. REQUIREMENTS CERTIFICATION:

I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Date: 7/7/15

Title: PM Advanced Medical Development

Signature: