Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) Capability

The Army Contracting Command -Aberdeen Proving Ground (ACC-APG) Contracting Center, Natick Contracting Division, Natick, MA, in support of the Joint Program Executive Office-Chemical and Biological Defense (JPEO CBD), Joint Project Manager - Medical Countermeasure Manufacturing Advanced Development Manufacturing (JPM-MCM ADM), intends to issue a Request for Proposal (RFP) on the basis of full and open competition on or about 26 August 2011 for the Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) Capability. The Government intends to award a contract to provide the DoD with an enduring capability and infrastructure to meet DoD requirements/demands for advanced development and manufacturing of Medical Countermeasures (MCMs).

The overall goal for the contractor is to collaborate, and work with Government (to include the Food and Drug Administration), academia, and industry to reduce the overall time and cost associated with the development and manufacturing of Food and Drug Administration (FDA) approved MCMs, and provide the DoD, and by extension the United States Government (USG), the capability for agile and flexible advanced development and manufacturing. The ADM capability shall integrate flexible, modular (single use, disposable), adaptable and scalable processes and equipment that can provide:
- Capability that allows third parties to develop candidates and provide products to the USG by leveraging ADM's core competencies and facilities while ensuring Intellectual Property is protected
- Streamlined advanced development capability that reduces risk (cost and schedule)
- Manufacturing and warm-base capabilities to rapidly respond to CBRN events and emerging and genetically engineered infectious disease outbreaks by producing FDA approvable products or expand (surge) manufacturing of existing FDA approved products without requiring additional regulatory approvals
- Strategies for using the ADM capability to support and facilitate transition of processes, technologies, and individual MCM candidates from Science and Technology efforts and/or novel industry innovations. The type of requirements would include, but not limited to: novel platform/expression systems for MCMs, advancements in regulatory science, and advancements in flexible manufacturing enabling technologies for MCMs.
- Assistance and training for workforce development in the areas of drug development and manufacturing including the use of the ADM capabilities

The MCM ADM capability may be centralized or distributed within the United States and its territories, and may include international participation. The contractor will establish, own and operate the MCM ADM capability within the United States. This project supports only the establishment and commissioning of the MCM ADM capability and the sustainment of the capability to enable the advanced development of vaccines, and/or drugs, and the rapid response to advanced development and manufacturing needs as they arise. All activities related to specific MCM advanced development and manufacturing requirements will be executed as separate contracts with third-party entities that will use this capability as a directed source.

The USG will evaluate proposals in accordance with FAR 15, Contracting by Negotiation, and intends to make a single award to the offeror whose proposal represents Best Value to the USG. The resulting contract will be a ten (10) year contract with a base period of two (2) years and four (4) two-year option periods. Contract type will be Cost Reimbursement. The NAICS code assigned to this acquisition is 325412 with applicable Small business size standard of 750 average number of employees.

The RFP will be posted to the Federal Business Opportunities (FedBizOpps) website on or about 26 August 2011. All interested parties may access the website at https://www.fbo.gov. Program information and solicitation documents will also be posted to the Natick Contracting Division Website link provided below. The announcement number W911QY-11-R-0023 will be the controlling document for preparation and submission of proposals. All responsible sources may submit a proposal to be considered by this agency. The USG is in no way liable to pay for or reimburse companies or entities that respond to this RFP.

No hard copy of this solicitation will be issued. Amendments, if any, will be posted at the same location as the RFP. It is the responsibility of those respondents to obtain all amendments and applicable documents. The actual closing date for submission of proposals will be stated in the solicitation when issued. Award of the proposed contract is subject to the availability of funds.
The Government plans to conduct a pre-solicitation conference with interested parties after the release of the RFP. Details regarding this conference will be forthcoming.

This is a pre-solicitation synopsis announcement, prepared in accordance with FAR 5.204.