MCM CSO AoI W911QY-20-S-C001-A002 COVID-19 Neutralization Assay Services.pdf

U.S. Army Contracting Command – Aberdeen Proving Ground, Natick Division (ACC-APG-Natick) Joint Program Executive Office - Chemical Biological Radiological Nuclear Defense (JPEO-CBRND)

Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA)

Medical Countermeasures (MCM) Commercial Solutions Opening (CSO) Solicitation Number: W911QY-20-S-C001

Area of Interest (AOI) Number A002: Neutralization Assay Services

1. AoI Background:

In December 2019, a novel (new) coronavirus known as SARS-CoV-2 (“the virus”) was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease COVID-19 that has now spread globally. The Secretary of Health and Human Services (HHS) declared a public health emergency on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19. On March 1, 2020, the President of the United States, pursuant to sections 01 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42 U.S.C. 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency.

Under the President’s Operation Warp Speed Mission, HHS is leading a whole of nation effort with the primary goal to execute on a well-defined portfolio of COVID-19 medical countermeasure candidates to maximize probability of having safe and effective diagnostics, therapeutics and vaccines as fast as possible for mass distribution. As such, BARDA has a specific need to complete the following: technology transfer of a qualified or validated SARS- CoV-2 virus specific neutralization assay using a live SARS-CoV-2 virus developed by a third party into a new site with appropriate laboratory biosafety facilities; demonstrate comparability of the established assay to a previously validated assay established by a third party. Additionally, this AoI will seek to provide testing services to analyze serum samples using the validated SARS- CoV-2 virus specific neutralization assay in compliance with GCLP for submission to FDA.

2. AoI Objective:

The government seeks to : 1. Technology transfer a high throughput qualified or validated neutralization assay for SARS-COV-2 in a Biosafety Level 3 (BSL3) laboratory to a new site in compliance with GCLP (Contract Base period) and subsequent validation and 2. Test serum samples from human subjects enrolled in clinical trials of COVID-19 vaccines using the new validated assay in compliance with GCLP.

3. AoI Tasks:

Task 1 – Complete a technology transfer of a qualified SARS-CoV-2 virus specific neutralization assay using a live SARS-CoV-2 virus from a third party to a new site under appropriate biosafety laboratory conditions. Solution Briefs should identify the offerors ability to acquire Bio Safety Level Three (BSL3) Lab space for this effort and provide appropriately trained BSL3 staffing.

Offerors will be required to demonstrate comparability of the transferred assay established at the new site to the original assay established by a third party.

Task 2- Validate the SARS-CoV-2 virus specific neutralization assay using a SARS-CoV-2 virus.

Offerors should demonstrate their previous experience testing clinical trial samples in neutralization assays.

Task 3 - Offerors should demonstrate their capability to provide testing services to analyze clinical trial specimens using the validated SARS-CoV-2 virus specific neutralization assay in compliance with GCLP for submission to FDA. This will require offerors to demonstrate previous experience testing under GLP/GCLP conditions, as well as staffing experienced in cell based live virus neutralization assays.

Task 4- Provide testing services to analyze clinical trial samples using the validated SARS-CoV-2 virus specific neutralization assay and report results in compliance with FDA requirements for phase 3 clinical studies (see References).

Task 5 – Program Management Activities:

The offeror must establish the capacity in compliance with Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations, and Biosafety Level standards if applicable. The offeror must be responsible for management of all activities, subcontractors, etc.

to meet the goals of the contract, including holding routine meetings with USG, and completion of meeting minutes. On a monthly basis, the offeror(s) must provide a monthly report that includes capacity availability and utilization, as well as any issues that affect the operational availability of the reserved capacity.

4. AoI Constraints:

a. Offeror (s) selected to receive an award will be required to be registered in the System for

Award Maintenance (sam.gov). It is critical offerors are registered in the System for Award Management (SAM), https://www.sam.gov/. Companies will be ineligible for an award if not registered in SAM. Additionally, verify that you are registered to receive contracts (not just grants) and that your address matches your proposal and SAM.

b. When registering in SAM.gov, be sure to select ‘YES’ to the question ‘Do you wish to bid on contracts?’ in order to be able to compete for CSO. If you are only registered to compete for grants, you may be ineligible for award.

c. The government is working to move expeditiously to execute contract(s), therefore it is extremely important that all companies double check your CAGE codes and DUNS numbers to ensure they are accurate. If they are not accurate at the time of submission, you may be ineligible for award.

d. If applicable under Food and Drug Administration (FDA or USFDA) guidance addressing the current public health emergency, offerors will be required to comply with the Drug Supply Chain Security Act (DSCSA).

e. The government reserves the right to request clarifying information or not to request clarifying information after receipt and evaluation of proposals.

f. The government reserves the right to enter into discussions or not to enter into discussions.

g. The government intends to issue Firm Fixed Price FAR Part 12 type contract(s).

5. AoI Solution Brief Submission Requirements:

Solution Briefs should not exceed five (5) single-sided written pages using 12-point font or, alternatively, Solution Briefs may take the form of briefing slides which should not exceed fifteen (15) slides.

Regardless the format chosen, Briefs must be sent as PDFs. Solution Briefs must be submitted no later than 1200 on 31 July 2020. The government reserves the right to or not to evaluate Solution Briefs received after the submission deadline. All submissions must be sent to the points of contact (POC) listed in the POC section of this AoI. Due the urgent nature surrounding the President’s Operation Warp Speed Mission CSO, the government does not intend to enter into CSO Phase 2 procedures, but reserves the right to do so based on the evaluation results.

Solution Briefs must include the following:

a. Company Name, CAGE code, DUNS number, Title, Date, Point of Contact Name, E-Mail

Address, Phone, and Address. Specifically identify the AoI for which the Solution Brief is submitted.

b. Executive Summary: Provide an executive summary of the technology. (This should be included in the 5 written page limit).

c. Technology Concept: Show and/or describe how your proposed solution or potential new capabilities fulfill innovative, commercial products, commercial technologies and services or adaptations/modifications of existing commercial product technologies and services to manufacture products used to combat the current COVID-19 pandemic, as well as address future pandemics or medical emergencies. Describe the unique aspects of your technology and the proposed work as it relates to the AoI. Identify whether the effort includes the pilot or demonstration of existing commercial technology (identified as commercially ready and viable technology), or the development of technology for potential defense application. If development or adaptation is proposed, identify a suggested path to mature the technology.

Identify aspects of your proposal, to include date and software, which may be considered proprietary.

d. Price: Provide a Rough Order of Magnitude (ROM) estimate for the level of effort and cost to complete the proposed solution, and include desired payment terms. The ROM shall provide enough detail for the government to understand the costs associated with the proposal.

6. AoI Request for Commercial Solutions Proposal (CSP) Submission Requirements:

Proposals must include separate technical and price volumes. Submissions should try to adhere to 10 pages (12-point font) per volume not including the cover page and table of contents. Based on the government’s market research and previous efforts the government anticipates selecting multiple offerors to submit proposals as a result of Solution Brief evaluations. The government reserves the right to request proposals from “all, some, or none” of the offerors who submitted Solution Briefs based on the evaluation and individual merits.

If an offeror(s) receives a request to submit a proposal from the government proposals must be submitted no later than the date and time identified in the request for proposal. The government anticipates that proposals will be required to be submitted within seven (7) days after receipt of the request for proposal, but reserves the right to define the specific due date and time that may be less or more than seven (7) days based on the urgency of the requirement. The government reserves the right to or not to evaluate proposals received after the submission deadline. All proposal submissions must be sent via e-mail, with subject line stating “(Insert Company Name) COVID-19 Neutralization Assay Services A002” to the POCs listed in the POC section of this AoI. Due the urgent nature surrounding the President’s Operation Warp Speed Mission the government may execute awards against this AoI at any time after the receipt of proposals.

Proposals must include the following:

a. The technical volume that includes a detailed work plan indicating how each aspect of the objectives are to be accomplished. CSP’s technical volumes must be in as much detail as considered necessary to fully explain the proposed technical approach or method including all assumptions utilized to develop the reservation plan and associated costs. The technical volume must reflect a clear understanding of the nature of the work being undertaken. The technical volume must include information on how the project will be organized, staffed, and managed, including a monthly breakdown of capacity available and all technical assumptions made in determining the scope of the reservation cost including (i.e. technology transfer, formulation, in-house vs out sourced, etc.). Information must be provided that demonstrates an understanding and management of important events or tasks. The technical volume must include a list of suggested deliverables and deliverable dates.

b. The price volume must contain sufficient information to allow the government to perform a basic analysis of the proposed cost or price of the work. The government reserves the right to request any other price data or supporting cost information the government deems necessary to determine the total overall price is fair and reasonable. This can include but is not limited to commercial price catalog(s), previous commercial sales receipts, and/or other proprietary information to help the government determine reasonableness and future budgetary cost estimates.

7. Points of contact:

Contracting Officer: Sean Auld, sean.g.auld.civ@mail.mil Procurement Analyst: Maria Dunton, maria.c.dunton.civ@mail.mil.

8. General Note:

This AoI does not commit the government to pay the costs associated with your proposal preparation or transmission. The Contracting Officer is the only individual who can legally commit the government to the expenditure of public funds on any resultant contract.