PRODUCTION OF MONOCLONAL ANTIBODY PRODUCT COUNTERMEASURES AGAINST THE TRHEAT COVID-19

****Amendment 0001: Closing date has been extended until 14 July 2020, 11:59PM**** Natick Contracting Division Fort Detrick Request for Project Proposal W911QY-20-S-RPCMO Agency: Department of the Army Office: Army Contracting Command, Natick Contracting Division Location: Fort Detrick, MD, USA Program Office: JPEO CBRND Enabling Biotechnologies RPP Number: W911QY-20-S-RPCMO Date Issued: 30 June 2020 Proposals Due: 7 July 2020 by 11:59 PM This is a Request for Project Proposal (RPP) for the Joint Project Lead, Chemical, Biological, Radioactive and Nuclear Defense - Enabling Biotechnologies (EB). This RPP is for the requirement described in the below Statement of Objectives (SOO). JPEO-CBRND-EB is seeking technical solutions and manufacturing capabilities to rapidly optimize, manufacture and test existing monoclonal antibody (mAb) product candidates to ensure its readiness for the clinical trials and/or emergency use. The proposed approach should assume scaling up the manufacturing to support thousands of doses of monoclonal antibodies. The manufacturing should also occur within the United States. Optimal solutions will balance the goals of rapid mAb development and manufacturing with maintaining the Quality Management System (QMS) ensuring uncompromised process/product quality during emergency response and a full compliance with the FDA regulations and guidance. Any resultant award may be issued as an Agreement under the authority of 10 USC 2373., with the expectation of the purchase of quantities necessary for fielding and testing new capabilities, or authority 10 USC 2371(b) should evaluation of submissions deem it necessary for prototype development. Upon receipt of the proposal submitted in response to this RPP, the next steps are as follows: The Government will evaluate the proposal. Discussions among the parties, whether verbally or in writing, will occur as appropriate. If interested in pursuing it, the Government will send an Agreement to the offeror. Additional discussions will occur as necessary. Award will be made after evaluation and selection of a successful proposal. Note: Award is dependent upon the availability of funds. GENERAL INFORMATION: Any award shall be for the purpose of acquiring chemical activity and medical supplies and designs thereof necessary for experimental or test purposes in the development of the best supplies needed for national defense. Examples of supplies for purposes of an agreement include manufacturing platforms, compounds, drug product, drug substance, conformance lots, optimized products, shakedown/engineering/ development runs, equipment, and materials. These examples are supplies for testing and experimental purposes that are necessary to develop the best supplies for national defense, such as Food and Drug Administration (FDA) licensed vaccines and therapeutics. No purchases shall be made in quantities greater than necessary to perform experimentation, technical evaluation, assessment of operational utility, or safety or to provide a residual operational capability. Only a warranted Agreements Officer with 10 USC 2373 authority may obligate the U.S. Government to the expenditure of funds under this authority. Only a warranted Agreements Officer with 10 USC 2371b authority may obligate the U.S. Government to the expenditure of funds under this authority. The U.S Government may pursue follow-on production pursuant to 10 USC 2371b upon successful completion of the prototype project. 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 modification. 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 postemployment 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 522, 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 agreement are exempt from disclosure requirements 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 contractors 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 SAM. 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. SUBMISSION PROCEDURES: General Formatting Guidelines. Proposals shall be submitted electronically. All applications must be clear, legible, and conform to the following general formatting guidelines: Elaborate proposals with high-gloss paper, vivid colors, detailed artwork, or other embellishments are unnecessary and not desired. Paper: Pages shall be 8.5 x 11 inches, single sided, with each page numbered - X of Y pages. Margins: Minimum of 1 inch on all sides. Type Font: 12 point Times New Roman, single spaced. Acronyms: Spell out all acronyms the first time they are used. One page of the proposal body is allocated to spell out acronyms, abbreviations and symbols. Language: English. Electronic file format: PDF, compatible with Adobe Acrobat Reader v. 11.0. File size less than 20 MB. Proposal Guidelines. Cover Page (1 page) - Proposal for RPP W911QY-20-S-RPCMO. Name of Lead Organization (Company) submitting proposal including Commercial and Government Entity code (CAGE) and Data Universal Number (DUNS). Type of business, selected among the following categories: - Large Business, - Small Disadvantaged Business, - Other Small Business, - HBCU, - MI, - Other Educational, or - Other Nonprofit Contractor's reference number (if any) Proposal Title, which should correspond to the SOO. Technical point of contract to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax (if available), and electronic mail address (if available) Administrative point of contact to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax (if available), and electronic mail address (if available) Date proposal was submitted Technical Section. Acronyms, Abbreviations, and Symbols Project objective. Describe the project and what will be accomplished if the U.S. Government funds the proposal. Background data. Include, for example, data supporting the safety and efficacy of the proposed technology, the validity of models used to test and evaluate the technology, and Offeror compliance with GLP, current Good Manufacturing Practices (cGMP), and/or Good Clinical Practices (GCP) compliance, as appropriate. Proposed technical approach. Describe in a comprehensive manner the technical approach proposed to accomplish the project objective. Describe the proposed technical approach in sufficient detail so that the U.S. Government may determine that the proposed approach is of acceptable risk. The proposal shall indicate at which Technology Readiness Level (TRL) the proposal will be at per the attached TRL level descriptions. Project Management Section. Statement of Work (SOW). The Offeror shall submit a statement of work that formally captures and defines the work activities, deliverables, and timeline, for the prime contractor and any subcontractors, necessary to execute the SOO. WBS and WBS dictionary. The offeror may submit a Work Breakdown Structure (WBS) and use extended WBS elements as needed to define the contract scope and to accurately describe the proposed effort. The WBS should correlate with the SOW and Agreement Line Items (ALINs). Integrated Master Schedule (IMS). The IMS should document the critical path, major milestones, tasks/activities, duration, lead/lag/slack time, and schedule relationships. The IMS should be directly traceable to each SOW, ALINs, and the WBS. The IMS is intended to be used as a tool for day to day tracking of the program/project. Tasks/activities should roll-up to increasingly higher summary levels. All tasks/activities in the IMS should be logically linked together showing predecessor/successor relationships. The tasks/activities should be sufficient to account for the entire program/project under the agreement. Dates delineated in the IMS will become legally binding, and will be adjusted accordingly, based on the actual award date. The IMS should be submitted electronically in - Read Only format that shows all formulas and links for review. The data file shall be in the native format of the commercially off the shelf software. Project Management Approach. The approach to managing and integrating the various aspects of the required work shall be described in sufficient detail so that the U.S. Government may assess associated risks. The Offeror shall identify significant milestones, decision points, and the processes that will be used to evaluate program status and progress. The Offeror shall include a description of any functional oversight. The Offeror shall present mechanisms for interactions/communications between Program Management and the U.S. Government, to include how processes will be updated (e.g., managing and interfacing with key Subcontractors and the U.S. Government). The Offeror shall include a description of management relationships or techniques that will be used to supplement day-to-day processes and procedures. Risk Management Plan. The Offeror shall identify potential risks and describe the implementation of an integrated and proactive risk management plan as part of an overall management scheme (e.g., risk planning, risk assessment, risk handling, risk monitoring and documentation). The risk management plan shall discuss integrated methods for identifying, analyzing, prioritizing, and tracking risk drivers and include plans for adequate resources for risk mitigation. The Offeror shall describe tools or methodologies used in the integrated risk management and risk assessment processes. Cost or Pricing Section. Submit a separate cost or pricing section. Proposals may be submitted on an expenditure (cost) plus fixed fee or firm fixed price basis. All costs and pricing shall be submitted on a separate unprotected Microsoft Excel file, showing all formulas and links. The depth and breadth of the cost proposal shall be determined based on the complexity of the requirement. Security Requirements. Although not to be evaluated, the Offeror shall identify existing or describe capability of obtaining personnel/facilities security clearances. DoD security management and handling requirements outlined in regulations such as DoD 5200.1-R and DoD 5400.7-R will apply. Subcontractor Management. The Offeror shall propose a subcontracting management approach to include analysis of subcontractor selection (i.e. list selection criteria), choice of subcontract types, and the plan for incentivizing contractors and assuring subcontractors meet cost, schedule, and performance requirements. The Offeror shall describe how subcontract competition will be sought, promoted, and sustained throughout the course of the cost reimbursement component of the acquisition, identify any known barriers to increasing subcontract competition and how to overcome any such barriers. Prior to Agreement execution, the Offeror shall submit with its proposal the first tier subcontractors letter(s) of consent allowing the Government to disclose the subcontractors past performance to the Offeror during negotiations. Reports / Meetings / Knowledge Dissemination. Reports are necessary for continuation of funding. The Offeror must identify all reports and deliverables. Below is a list of anticipated reports: Biweekly teleconferences and communications Quarterly progress/financial reports Final reports Adhoc meetings Regulatory meetings/documentation Integrated master schedule EVALUATION FACTORS: The following factors will be considered during evaluation (in no particular order): Relevance. Projects must be directly relevant to the ultimate purpose of acquiring chemical activity and medical supplies and designs thereof necessary for experimental or test purposes in the development of the best supplies needed for national defense. Funds Availability. The Government must have funds available to support the proposed work. Project Objectives. The stated objectives must be clear, valid and logical. Projects that demonstrate an innovative approach are desired. Facilities. Describe the proposed facilities and equipment, or unique combinations of these, in detail to demonstrate that the organization has, or may access, the necessary facilities required for the accomplishing the proposed objectives. Budget/Cost. The budget must reflect the actual needs of the proposed work and be fully justified so that the U.S. Government can evaluate and determine the cost to be fair and reasonable and commensurate with the complexity and nature of the work proposed. SELECTION FOR AWARD: Subject to availability of funds, if agreeable terms are reached after evaluation of the proposal and negotiations, an award will be made. DUE DATE: Submit the proposal by email to contact@example.gov no later than 7 July 2020 at 11:59PM. ATTACHMENT 1 STATEMENT OF OBJECTIVES STATEMENT OF OBJECTIVES (SOO) PRODUCTION OF MONOCLONAL ANTIBODY PRODUCT COUNTERMEASURES AGAINST THE TRHEAT COVID-19 Introduction In response to a dynamically changing chem/bio weapons threat landscape and increasing potential for novel pathogens outbreaks, the Joint Program Executive Office for Chemical, Biological, Radioactive, and Nuclear Defense Enabling Biotechnologies (JPEO-CBRND-EB) has been established to rapidly develop, manufacture and deliver Medical Countermeasures (MCM) for the emergency use. 2. Scope JPEO-CBRND-EB is seeking technical solutions and manufacturing capabilities to rapidly optimize, manufacture and test existing monoclonal antibody (mAb) product candidates to ensure its readiness for the clinical trials and/or emergency use. The proposed approach should assume scaling up the manufacturing to support thousands of doses of monoclonal antibodies. The manufacturing should also occur within the United States. Optimal solutions will balance the goals of rapid mAb development and manufacturing with maintaining the Quality Management System (QMS) ensuring uncompromised process/product quality during emergency response and a full compliance with the FDA regulations and guidance. 3. Objectives The primary objective of this SOO is to rapidly supply mAb drug substance material(s) ready to support late stage clinical evaluation. In order to ensure the most accelerated timeline for mAb products generation, objectives of this SOO include (1) the ability to manufacture a CHO-based mAb drug product (2) the ability to manufacture at a large scale (>500L) of mAb drug substance; (3) Late stage appropriate quality assurance and quality management system for drug substance manufacturing and drug product. 4. Performance Requirements Deliverables under the Agreement include: cGMP drug substance and drug product manufacturing: The drug substance and drug product manufacturing approach is expected to leverage the existing monoclonal antibodies candidates for large scale manufacturing. The subset of the manufactured final drug product will be the deliverable to be delivered to the USG for use by DoD personnel in late stage clinical evaluation or under Emergency Use Authorization. The JPEO-CBRND-EB seeks rapid assessment and optimization, where applicable, of manufacturing processes, in-process, release and stability testing in order to streamline drug substance manufacturing and release for drug product fill finish, while maintaining product safety and efficacy, and conforming to regulatory requirements. 5. Proposal Submission Requirements In response to the above requirements, proposal submissions must include the following information: A staged proposal with appropriate go/no-go decision points based on achieving aggressive technical milestones defined by projected success metrics. A discussion of the anticipated approaches for streamlining product development timelines, and the anticipated end state including preliminary schedule and projected manufacturing yields. An analysis of the costs and timeline associated with an emergency response event a manufacturing campaign of up to 12 cGMP drug substance runs at the large scale (>1000L)