P03 - JA over SAT below 750k_Vaccine Research Services Waisman_ams_sjc.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C24E-22-AP-0248

1. Contracting Activity:

Department of Veterans Affairs Regional Procurement Office (RPO) East 1010 Delafield Road Pittsburgh PA 15215-1802

Requiring Activity:

Department of Veterans Affairs, VISN 2 James J. Peters VA Medical Center, R&D Service Bronx, NY 10468

Purchase Request 2237 Number: 526-23-1-1912-0011

2. Nature and/or Description of the Action Being Processed:

This request is for Other Than Full and Open Competition for the procurement of a new, Firm Fixed Price contract with the University of Wisconsin System (Waisman Biomanufacturing Center) for the acquisition of the production of current Good Manufacturing Practice (cGMP)-grade E. coli bacteria cell bank and cGMP-grade HEK293 mammalian cell bank for producing the components for HIV-1 vaccine materials that are suitable for use in the human phase I clinical trials. The estimated price is $255,000.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

This is a new requirement for the investigator at the James J. Peters VA Medical Center. The investigator at the JJP VAMC is conducting HIV vaccine research. As part of this study, the investigator requires the production of DNA and protein in accordance with cGMP (current Good Manufacturing Practice) specifications in support of proof of concept studies. The Waisman Biomanufacturing Center at the University of Wisconsin – Madison is the only known vendor able to produce the necessary specific DNA and specific protein under cGMP standards, and the Waisman Biomanufacturing Center has experience manufacturing cGMP-grade DNA and protein vaccines for a phase I clinical trial run by the HIV Vaccine Trials Network.

4. Statutory Authority Permitting Other than Full and Open Competition:

( x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Waisman Biomanufacturing Center is a highly specialized cleanroom facility that is located at the University of Wisconsin-Madison. Waisman is specifically designed and constructed to meet requirements for facilities that are involved in the manufacture of plasmid DNA and other biologics for phase I/II human clinical trials. Waisman currently possesses all of the features that will be critical to meeting the requirements of this project, and is the only known vendor able to produce the necessary specific DNA and specific protein under cGMP standards. The Waisman Biomanufacturing facility has dedicated and separate microbial and cellular products suites that are equipped to produce multi-gram lots of clinical-grade plasmid DNA, human or other mammalian cell banks, and ultimately recombinant proteins manufactured in mammalian systems.

The facility includes other critical features such as Raw Materials Quarantine and Release, a Quality Control Lab, Vial Labeling & Inspection, and Product Quarantine. Waisman staff consists of personnel that are experienced in CGMP production and testing of a range of biologics including plasmid DNA, cell therapeutics, recombinant proteins, and viral vectors. An independent Quality Assurance staff is responsible for reviewing all CGMP manufacturing operations, maintaining all manufacturing and testing documentation, and reviewing test results for product release. In addition, Waisman has a Facility Master File on file with CBER and can provide full support for the Chemistry, Manufacturing, and Control (CMC) section of the Investigational New Drug (IND) application. Lastly, Waisman can support tech transfer of our process to larger scale commercial manufacturers as the program progresses to commercialization.

Market research indicates that there are not at least two VIP verified eligible SDVOSB/VOSBs or other SB concerns that can fulfill this requirement. An intent to sole source under notice ID 36C24E22Q0306 was issued from 9/14/2022 to 9/19/2022 to inform industry that a requirement for vaccine research services would be solicited. That notice yielded no responses. No SB concerns in any socioeconomic category responded to the notice, nor appears capable of fulfilling this requirement. Market research supports that this requirement can only be fulfilled by the University of Wisconsin System (Waisman Biomanufacturing Center).

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Notice ID 36C24E22Q0306 was posted to the GPE from 9/14/2022 to 9/19/2022. The Contracting Specialist/Contracting Officer did not receive any expressed interest from any other source than the University of Wisconsin System (Waisman Biomanufacturing Center). No SB concerns in any socioeconomic category responded to the posted notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Price is expected to be fair and reasonable and will be evaluated against prices in the current market for similar services, comparison of proposed prices found reasonable on previous purchases, current price lists the University of Wisconsin Systems charge the public and other Government entities for the same item, and comparison to the Independent Government Estimate. Market research prices indicate that comparable vaccine research/DNA synthesis prices from contract HHSN26100006 awarded in September 2014 for $407,260 for a phase I/II trial of a therapeutic DNA vaccine for Hepatitis C Virus and contract 75N93019P01206 awarded in September 2019 for $249,943.63 for DNA synthesis, plasmid and protein production have been determined fair and reasonable by NIH NCI and NIAID Contracting Officers. Furthermore, since this contract will be issued on a sole source basis, negotiations and discussions with the contractor may be required to establish price reasonableness, as further determined by the scope and requirements of the project. All these steps will be taken by the Contracting Officer to ensure fair and reasonable pricing.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

As described above, market research, in accordance with FAR Part 10, was conducted by advising industry of the pending acquisition and soliciting inquiries from interested parties. No interested parties submitted capability statements. A review of the Vendor Information Page (VIP) was conducted as required and zero (0) possible vendors were identified such that there is no reasonable expectation that an SD/VOSB could fulfill VA’s requirement. Based on the information above, only University of Wisconsin System (Waisman Biomanufacturing Center) can provide the service described.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The statement of work is part of a unique proof-of-concept vaccine study, pre-clinical trials, using VA intellectual property. As such, the Waisman Center’s experience manufacturing cGMP-grade DNA and protein vaccines for a phase I clinical trial run by the HIV Vaccine Trials Network, in addition to being the only known vendor able to produce the necessary specific DNA and specific protein under cGMP standards supports the Use of Other than Full and Open Competition.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

The only source which has expressed an interest in this Acquisition:

University of Wisconsin System (Waisman Biomanufacturing Center) 21 N Park Street Ste 6230 Madison, WI 53715-1218

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

There are no actions to be taken to remove or overcome barriers to competition. While other contractors supply sequencing systems, only Illumina, Inc. is able to meet the requirement identified.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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.

15:22:03 -04'00'__ ____03/17/2023______________ Date

___________________160818 __________ Name Toy Mordiglia Title AO/R&D Facility JJP VAMC

Mordiglia Digitally signed by Toy S. Mordiglia 160818 Date: 2023.03.17

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date

Contracting Officer RPO East, VHA

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Seth J. Custer Date Division Chief VHA R&D Contracting Division RPO East, VHA

03/20/2023

VHALEBCUSTES

Typewritten Text 3/24/2023