SPECIAL NOTICE
65 -- Program Announcement: JPEO-CBRND & BARDA Commercial Solutions Opening (CSO) Area of Interest (AoI) W911QY-20-S-C001-A003 SARS-CoV-2 Medical Counter Measures (MCM) Therapeutics
- Notice Date
- 7/24/2020 5:13:30 PM
- Notice Type
- Special Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- W6QK ACC-APG NATICK NATICK MA 01760-5011 USA
- ZIP Code
- 01760-5011
- Response Due
- 8/14/2020 9:00:00 AM
- Archive Date
- 08/29/2020
- Point of Contact
- Sean G. Auld, Phone: 5082062083, Maria C. Dunton, Phone: 5082062114
- E-Mail Address
-
sean.g.auld.civ@mail.mil, maria.c.dunton.civ@mail.mil
(sean.g.auld.civ@mail.mil, maria.c.dunton.civ@mail.mil)
- Description
- Program Announcement: JPEO-CBRND & BARDA Commercial Solutions Opening (CSO) Area of Interest (AoI) W911QY-20-S-C001-A003 SARS-CoV-2 Medical Counter Measures (MCM) Therapeutics Contracting Office: U.S. Army Contracting Command � Aberdeen Proving Ground, Natick Division (ACC-APG-Natick) Program Office: Joint Program Executive Office - Chemical Biological Radiological Nuclear Defense (JPEO-CBRND) and Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS). A. Background: This is a Program Announcement for a potential new Area of Interest (AoI) against the U.S. Army Contracting Command � Aberdeen Proving Ground, Natick Division�s (ACC-APG-Natick) Commercial Solutions Opening (CSO) W911QY-20-S-C001 on behalf of Joint Program Executive Office - Chemical Biological Radiological Nuclear Defense (JPEO-CBRND) and Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services.� The potential AoI is being prepared in support of Operation Warp Speed in response to the Corona Virus 2019 (COVID-19) Pandemic. The anticipated AoI will utilize the non-Federal Acquisition Regulation (FAR) based solicitation authority for acquiring innovative and commercial solutions. Section 879 of the National Defense Authorization Act (NDAA) for Fiscal Year 2017 (Pub. L. 114-328) authorizes ACC-APG-Natick to implement a pilot program to competitively procure innovative commercial items, technologies, and services using CSO procedures. CSO is new acquisition mechanism that provides a streamlined acquisition process and simplified contract terms that is designed to attract start-up companies and others who have not previously worked with U.S. Government. Under the CSO and resulting AoI�s ACC-APG-Natick seeks proposals for innovative, commercial items, technologies and services currently in the production/commercialization phase as well as adaptations of existing commercial products to combat the current COVID-19 pandemic as well as future pandemics or medical emergencies. The current ACC-APG-Natick CSO solicitation is open and available through 30 September 2022. This is an advance notice of a potential technical AoI posting for validated SARS-CoV-2 MCM therapeutics. The CSO solicitation process will include a multi-phased solicitation and evaluation approach: Phase 1 � Submission of the Written Solution Brief, Phase 2 � presentations/pitches (if applicable), and Phase 3 � Request for Commercial Solution Proposal. The CSO is considered a competitive process, intended to ensure that competitive procedures are used to the maximum extent practicable. B. Potential Opportunities:� �BARDA has a potential Area of Interest (AoI) to complete the following: perform therapeutics manufacturing and fill-finish of advanced SARS-CoV-2 MCMs. Therapeutics manufacturing is expected to meet the necessary US Food and Drug Administration (FDA) requirements for beginning a Phase 3 clinical trial, and the product be granted licensure by the FDA. �Manufacturing shall occur using cGMP validated manufacturing processes for bulk drug substance and fill and finished drug product. The ramp-up capacity provides up to 100,000 treatment courses for a targeted US population by March 31, 2021, to treat the US population indicated in the Offeror�s target population. A treatment course is defined by the highest dose proposed for Phase 2 clinical trials. A minimum quantity is not defined; however, the intent is �Large Scale production capability in a short period of time with little to no advance notice under the conditions for which the MCM is required.� Candidate MCMs shall have at minimum, capability of obtaining Emergency Use Authorization (EUA) and/or a reasonable chance of moving to Phase 3 clinical trials by 4Q 2020 including all development plans and efforts, manufacturing, all done in support of the goal of achieving FDA approval/licensure in 2021. Offerors must have started, or have completed, a Phase 1 clinical study no later than August 31, 2020. The Offeror will need to demonstrate large scale manufacturing capability by completing the manufacture, release, stockpiling and distribution of up to 100,000 drug product treatment courses by March 31, 2021.� A treatment course is defined by the highest dose proposed for Phase 2 clinical trials.� Manufacture of the therapeutic product shall occur using an established manufacturing process for bulk drug substance and fill and finished drug product, with a ramp-up capacity plan that provides enough doses to meet the desired treatment course. Interested parties are hereby advised of the following: The potential AoI is expected to be posted on or about July 31st 2020. The government reserves the right to release or not to release the potential AoI as a result of this program announcement. A solicitation for solution briefs, presentations/pitches and requests for proposals are not a guarantee that award and obligation of funds will be made.� The costs incurred by companies in the preparation and submission of their solution briefs, presentations/pitches and requests for proposals in response to solicitations will not be paid by the government and are not allowable as a direct charge to any government contract. �C. Reference(s): �The Commercial Solutions Offering solicitation is currently open until 30 September 2022.� �MCM CSO Solicitation W911QY-20-S-C001
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/b05b5b77230c4da8a025bf90dc29e77a/view)
- Place of Performance
- Address: Natick, MA 01760, USA
- Zip Code: 01760
- Country: USA
- Zip Code: 01760
- Record
- SN05732694-F 20200726/200724230143 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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