SPECIAL NOTICE
A -- Prototype development of a COVID-19 Pandemic Therapeutic Rapid Advanced Research and Development (ARD) to Large Scale Manufacturing
- Notice Date
- 7/24/2020 1:30:22 PM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W6QK ACC-APG NATICK NATICK MA 01760-5011 USA
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-20-S-0019
- Response Due
- 2/28/2021 8:59:00 PM
- Archive Date
- 03/15/2021
- Point of Contact
- Lawrence E. Mize, Phone: 3016199813
- E-Mail Address
-
lawrence.e.mize.civ@mail.mil
(lawrence.e.mize.civ@mail.mil)
- Description
- Request for Project Proposals (RPP) Contracting Agency: Department of the Army Contracting Office: Army Contracting Command, Natick Contracting Division (NCD) Contracting Office Location: Fort Detrick, MD, USA Program Office: JPEO CBRND and HHS ASPR RPP Number: W911QY-20-S-0019 Prototype development of a COVID-19 Pandemic Therapeutic Rapid Advanced Research and Development (ARD) to Large Scale Manufacturing.� This Prototype project is a combination of an agile development activity, design, and demonstration of the technical and operational utility of a product to move forward to FDA licensure/approval. In accordance with Section III.F of announcement MCS BAA-17-01, the Government is hereby requesting formal submission of preproposals to execute a formal agreement under 10 USC 2371(b), Other Transaction Authority (OTA) for the prototype project described above: Upon receipt of a preproposal submitted in response to this RPP, the next steps are as follows:�� The Government will evaluate the preproposal. Discussions among the parties, whether verbally or in writing, will occur as appropriate. The Government may request a full proposal from the offeror. Additional discussions will occur as necessary. Award may be made after evaluation and selection of a successful proposal.� (Note: Awards are dependent upon the availability of funds.) This Request for Project Proposal (RPP) is issued to request project proposals in compliance with USC 2371(b), and is being issued for planning purposes only.� It is not to be construed as a commitment by the Government to award an agreement, nor will the Government pay for the information solicited. Specific requirements are identified in the Project Description/Statement of Objectives below. Due date: The date and time set for submission of preproposals is shown above. Preproposals received after the set time will not be considered unless the Government, at any time, elects to allot further time for proposal submissions. Preproposals shall be sent by email to: lawrence.e.mize.civ@mail.mil The Government will review/evaluate the submitted preproposals and if there is Government interest, the Agreements Officer may issue a request for full proposal (RFFP) in response to this RPP. The Government may award an agreement based on the proposal submission, or may require submission of additional details. The award of Prototype agreements shall be for the development of prototypes in accordance with 10 U.S.C. 2371b for projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the Armed Forces. A prototype project can generally be described as a preliminary pilot, test, evaluation, demonstration, or agile development activity used to evaluate the technical or manufacturing feasibility or military utility of a particular technology, process, concept, end item, effect, or other discrete feature. Only a warranted Agreements Officer may obligate the U.S. Government to the expenditure of funds for awards under this Announcement.� Evaluation will be performed by JPEO-CBRND and HHS-ASPR-BARDA personnel, other Federal Agency Representatives, outside scientists with diverse expertise, clinicians, consumers, or combinations thereof based on evaluation and selection of the best preproposal submission, and/or subsequent full proposal submission. After evaluation and selection, an award will be made to the successful offeror(s). Subsequent awards depend upon the availability of funds and fulfillment of requirements and priorities determined to exist at the time of award. In some cases, funding priorities may change as certain scientific tasks are addressed and new mission assignments arise. Award may also be dependent upon demonstration by the offeror that they have adequately addressed the requirements. The U.S. Government does not fund preparation of proposals or support work efforts or tasks that are inferred from discussions with technical project officers. The Offeror will not be reimbursed for any costs incurred prior to the effective date of the agreement. There are certain post-employment restrictions on former Federal officers and employees as defined in 18 USC 207 and FAR 3.104-4(c).� If an offeror believes a post-employment restriction or conflict of interest exists, notification should be sent to the Agreements Officer prior to initiating efforts on a full proposal. The Freedom of Information Act (FOIA) (5 USC 552) provides a statutory basis for public access to official U.S. Government records.� �Records� are defined to include documentation received by the U.S. Government in connection with the transaction of public business. Certain types of information submitted to the Government in a process having the potential for award of an OT are exempt from disclosure requirements of FOIA for a period of five (5) years from the date the Government receives the information.� The types of information listed above may continue to be exempted, in whole or in part, from disclosure after the expiration of the five (5) year period if it falls within an exemption to the FOIA such as trade secrets and commercial or financial information obtained from a person and privileged or confidential. Offerors should mark business plans and technical information that are to be protected for five years from FOIA disclosure with a legend identifying the documents as being submitted on a confidential basis. The Government is prohibited from soliciting and awarding actions to awardees that have engaged or are suspected to have engaged in criminal, fraudulent, or seriously improper conduct. Prospective awardees shall complete electronic annual representations and certifications at https://beta.sam.gov/.� By submission of an offer, the Offeror acknowledges the requirement that prospective awardees MUST be registered in the System for Award Management (SAM) database prior to submitting an invoice and through final payment of any contract resulting from this RPP.� Offerors that are not registered should consider applying for registration immediately upon receipt of this solicitation.� To remain registered in the SAM database after the initial registration, the Offeror is required to review and update on an annual basis from the date of initial registration (or subsequent updates) its information in the SAM database to ensure it is current, accurate and complete. Data submitted that cannot be disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall be marked on the title page with the below legend and mark each data sheet as follows: TITLE PAGE LEGEND: This Proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part--for any purpose other than to evaluate this Proposal. If, however, an agreement is awarded as a result of--or in connection with-- the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting award. This restriction does not limit the Government's right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets [insert numbers or other identification of sheets]; DATA SHEET MARKING: Mark each sheet of data it wishes to restrict with the following legend: Use or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal. Questions regarding this announcement may be submitted by email to lawrence.e.mize.civ@mail.mil within 2 days of the closing date. In accordance with 10 U.S.C. � 2371b(f), the Government may award a follow-on production contract or Other Transaction (OT) for any OT awarded under this BAA if: (1) that participant in the OT, or a recognized successor in interest to the OT, successfully completed the entire prototype project provided for in the OT, as modified; and (2) the OT provides for the award of a follow-on production contract or OT to the participant, or a recognized successor in interest to the OT. Follow-on production is anticipated to 800,000 treatments per quarter for up to 18 months. Proposals Brochures or other descriptions of general organizational or individual capabilities will not be accepted as a preproposal.� All preproposals will be assigned an identification number and an email will acknowledge receipt of a proposal. Generally, the Project Manager of the submitting organization should receive a decision letter or email upon completion of the evaluation. Administration: The Government will retain comments and information received in response to this RPP. Do not use Government security classification markings. All written responses must be received by midnight of the due date. Submission should be identified with a Subject Line of Responding Organization and RPP Title. Material that is advertisement only in nature is not desired. Requirements: See Attached Project Description Submissions: Preproposals should be limited to six pages (including cover sheet), and include a description of the relevant technology including supporting data, the scope of the proposed effort including a high-level Work Breakdown Structure (WBS), and a description of the proposer�s research, development, manufacturing, past performance, or other special qualifications. The preproposal must also include an anticipated rough order of magnitude (ROM) cost for the efforts described in the preproposal, including a price per dose for both the manufacturing scale quantity and the follow-on production quantity.� Preproposals shall be submitted to the following email address: Lawrence.e.mize.civ@mail.mil. PROJECT DESCRIPTION/STATEMENT OF OBJECTIVES 2.1 OBJECTIVE AREA �Treatment � COVID-19 Pandemic Therapeutic Rapid Advanced Research and Development (ARD) to Large Scale Manufacturing 2.1.1 DESCRIPTION/OBJECTIVE OF THE PROJECT: The Department of Defense and� Department of Health and Human Services (HHS), seeks Offerors to perform at-scale prototype manufacturing and fill-finish of Coronavirus Disease 2019 (COVID-19) Medical Countermeasures (MCM) currently in advanced development, in order to ensure nationwide access. An outbreak of respiratory disease caused by a novel coronavirus, was first detected in China and has now spread worldwide, including the United States. The virus has been named Severe Acute Respiratory Disease Coronavirus-2 (SARS-CoV-2), and causes COVID-19. On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO), declared the outbreak a �Public Health Emergency of International Concern� (PHEIC). On January 31, the United States Department of Health and Human Services Secretary, Alex M. Azar II, declared a Public Health Emergency (PHE) for the United States to aid the nation�s healthcare community in responding to COVID-19. On March 11, WHO publicly characterized COVID-19 as a pandemic. On March 13, the President of the United States declared the COVID-19 outbreak a national emergency. It is critical for the sponsors of COVID-19 therapeutic candidates to initiate at-scale prototype manufacturing to demonstrate the target population capability. As such, the USG will support at-scale manufacturing (through packaging and release testing) of selected MCMs, to ensure timely availability to the US population when needed.� 2.1.2 STATEMENT OF OBJECTIVES (SOO): 1)�������� Project Objectives: The objective of this prototype project is to initiate an advanced development SARS-CoV-2 MCM prototype for clinical/non-clinical development and/or manufacturing scale-up to demonstrate the capability to support sustained large scale manufacturing necessary to meet surge requirements with little advance notification, under the conditions for which the MCM is being developed. Candidate MCMs will either be direct acting antivirals or host directed therapeutics, which indirectly inhibit the coronavirus lifecycle.� Prior in vitro and in vivo demonstration of efficacy against SARS-CoV-2 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 December 31, 2020.� Fill and release of drug product should be included within the proposed scope but can be completed in Q1/Q2 2021.� A treatment course is defined by the highest dose proposed for Phase 2 clinical trials.� Optional line items associated with full scale Follow-On production quantities to treat up to 800,000 people per quarter may be included in the negotiated project agreement.� These option line items may be exercised at the Government's sole discretion in accordance with paragraph 2.1.4.3.��� 2)�������� Performance Objectives (Required Results): The U.S. Government, in support of Operation Warp Speed, seeks Offerors to perform at-scale prototype manufacturing and fill-finish of a SARS-CoV-2 MCM. Initially at the minimum, fill/finish manufacturing shall take place in a US-based facility.� 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 December 31, 2020, 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�. Demonstration of efficacy should be included in the performance plan with support for platform clinical trial conduct. The Offeror�s proposal should include a validation plan and associated timelines. The project shall be accomplished using aggressive risk management and taking advantage of any regulatory flexibilities. A description of the manufacturing facility, quality assurance, and regulatory acceptance, including quality systems and regulatory milestones towards facility approval, is required. To assist with facility assessment, the chemical synthesis and process description should be included. It is desired that the drug substance manufacturing be US based.� If this is not initially possible, a mitigation strategy including a reasonable timeline is required for transfer to the future at-scale drug substance US based manufacturing facility. The supply of and manufacture of regulatory starting materials including key chemical reagents and raw materials must be sustainable and desirably US sourced. If foreign sourced a mitigation plan is needed.� 3)�������� Regulatory Objectives: Candidate MCMs shall have at a 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. 4)�������� Project Management Objectives: Mandatory reporting requirements are described in the base agreement: Monthly progress reports should include both technical and financial status and expenditure forecast; final prototype project report; patents reports, work breakdown structure; integrated master schedule; regulatory documents, including communications with the FDA, all submissions, and the PL 115-92 Sponsor Authorization Letter. Project management oversight will be comprised of an Agreements Officer�s Representative (AOR) and USG Project Coordination Team (PCT), which will perform ongoing technical reviews and approvals of milestones. The Offeror shall invite the government to attend all FDA meetings with regard to this project. 5)�������� Logistics Objectives: The USG seeks at-scale prototype manufacturing and fill-finish of a SARS-CoV-2 MCMs currently in advanced development. Production shall occur using an established manufacturing process for bulk drug substance and fill and finished drug product, with a plan that provides up to 100,000 treatment courses of drug product for a targeted US population by December 31, 2020. A treatment course is defined by the highest dose proposed for Phase 2 trials.� Initially it may be considered acceptable for the drug substance and the 100,000 treatment courses to manufacture at a smaller scale provided that the scale is of sufficient manufacturing scale to properly demonstrate the process.� This scale must use the same synthesis, targeted, scalable, validated process, possessing the needed potential ramp-up capacity for the at-scale manufacturing. The at-scale development and manufacturing must occur in parallel. Once finished drug product is accepted by the US Government, product will be stored and distributed by the Offeror. 6)�������� Performance Requirements: 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. The Offeror�s proposal should include a validation plan and associated timelines. The project shall be accomplished using aggressive risk management and taking advantage of any regulatory flexibilities. A description of the manufacturing facility quality assurance and regulatory acceptance, including quality systems and regulatory milestones towards facility approval is required. 7)�������� Operational Constraints/Limitations/Restrictions: Fill/finish manufacturing operations shall be based in the US. 2.1.3 PERIOD AND PLACE OF PERFORMANCE:� The anticipated Period of Performance for this effort is up to two (2) years from the date of award (including options). Specific dates to be negotiated.� It is anticipated that the primary place of performance will be the contractors� or subcontractors� facilities. However, this aspect can be negotiated as part of each Offerors� submission. 2.1.4 DELIVERABLES: 2.1.4.1 DATA DELIVERABLE(S):� Data Deliverables required include: �� Meeting minutes from all scheduled and ad-hoc meetings with the Program Office and AOR. �� Monthly financial reports required for invoice approval. �� All FDA communications, including minutes and submissions. �� Detailed Work Breakdown Structure that enables the proposed Statement of Work. �� The Offeror shall have a comprehensive Supply Chain Resiliency Program that provides for identification and reporting of critical components associated with the secure supply of drug substance, drug product, and work-in-process through to finished goods. �� FDA Form 483 and the Establishment Inspection Report (EIR) if applicable �� Bi-Weekly Performance meeting agendas, meeting minutes, and briefings �� All required reports and documents (in contractor format) set forth in Addendum 1 to this Project Description Note: Technical data deliverables described herein shall be delivered to the Government with a minimum of Government Purpose Rights 2.1.4.2����������� PROTOTYPE DELIVERABLE(S): The prototype Deliverable includes the fill/finished therapeutic drug product authorized for use by the FDA, and/or demonstrated manufacturing capability meeting the performance objectives. Drug product must be delivered by December 31, 2020, in the US; drug product will not be accepted until it is physically located in the US.� 2.1.4.3 Follow-on Production: In accordance with 10.U.S.C. 2371b(f), and upon a determination that the prototype project for this transaction has been successfully completed, any competitively awarded prototype OTA as a result of this RPP may result in the award of a follow-on production contract or transaction without the use of competitive procedures.� The Government intends to purchase sufficient quantities to treat an estimated 800,000 people per quarter with the selected MCM therapeutic for the duration of 2021.� The Offeror�s proposal shall include production option(s) to purchase the fill/finished drug product, based on maximum production capability, providing quantity per month, price per dose and per gram, inclusive of all direct and indirect costs, storage, and distribution to US Government designated facilities.�� The manufactured prototype will be successful if: �� The prototype is safe and effective, as agreed to by the FDA either by licensure or under an EUA or, �� The Offeror demonstrates capability of delivering up to 100,000 treatment courses of drug product for a targeted population by December 31, 2020 in the US. 2.1.5 SPECIAL REQUIREMENTS: 2.1.5.1 Export Control: Export Controls shall be in accordance with the Base Agreement. 2.1.5.2 Security and Classified Data: This project is Unclassified. 2.1.5.3 Acceptance of Deliverables: The Government will provide acceptance of all data deliverables within ten (10) calendar days of delivery. The Government will provide acceptance of all therapeutic prototype deliverables within thirty (30) calendar days of delivery and physical delivery to US soil. 2.1.5.4 Travel: The following travel situations may be approved by the Government upon request: �� Travel for Face-to-face meetings with Government personnel and/or sub-contractors. �� Travel to provide oversight, audits, and/or data reviews with sub-contractors. �� Travel for Program review meetings or Integrated Product Team (IPT) meetings, as requested by the Government. �� Travel to complete in-person FDA requested meetings. Additional non-directed travel, necessary for the completion of the contracted work, may be permitted.� The Offeror shall provide a breakout of expected travel in their proposal. 2.1.6 GOVERNMENT FURNISHED PROPERTY:� Government Furnished Equipment, Contractor Acquired Government Furnished Property, and Contractor Acquired Government Owned Property are subject to negotiations during the award process. The contractor should identify necessary equipment and property in white paper submissions to this RPP. 2.1.7 FUNDING CONFIDENCE LEVEL: CL-1 Highly Confident funds will be available. 2.1.8 AGREEMENTS OFFICER�S REPRESENTATIVE (AOR): Name: Kristen Herring Telephone: 202-260-1388 E-mail: kristen.herring@hhs.gov Office Symbol: HHS/ASPR/BARDA 2.1.8.1����������� ALTERNATE AOR: Name: Nellie Byun Telephone: 202-774-2303 E-mail: Nellie.byun@hhs.gov Office Symbol: HHS/ASPR/BARDA 2.1.9 Requiring Activity: Joint mission between the Department of Health and Human Services and Department of Defense to combat COVID-19
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