OTSBSSN No.: BARDA-2021-Filovirus Therapeutic(01B)

Other Than Small Business Sources Sought Notice OTSBSSN No.: BARDA-2021-Filovirus Therapeutic (01B) I. INTRODUCTION The purpose of this Other Than Small Business Sources Sought Notice (01B) is to seek declarations of technical capabilities, data, and materials from qualified other than small business concerns relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The proposed NAICS for this proposed requirement is 541714. Please note that a Small Business Sources Sought Notice (01A) has also been posted regarding this possible requirement and is intended solely for prospective Offerors that are considered to be a Small Business. Prospective Offerors shall respond to the appropriate notice relative to their business size standard. THIS NOTICE IS STRICTLY FOR MARKET RESEARCH. II. AUTHORITY The Office of Contracts Management Acquisition (CMA) issues this Other Than Small Business Sources Sought Notice (OTSBSSN) on behalf of the Biomedical Advanced Research and Development Authority (BARDA) pursuant to FAR paragraphs 5.205(c), 15.201(e) and FAR parts 10, 19. III. ACRONYM - ASPR means Assistant Secretary for Preparedness and Response - BARDA means Office of the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services - BDS means Bulk Drug Substance - CBRN means Chemical, Biological, Radiological, and Nuclear - CDC means Centers for Disease Control and Prevention - CMA means Contracts Management and Acquisition - CONOPs means Concepts of Operations - cGXP means any of cGMP, current Good Manufacturing Practices; cGLP, current Good Laboratory Practices; cGTP, current Good Tissue Practices; or cGCP, current Good Clinical Practices - EBOV means Zaire ebolavirus - FAR means Federal Acquisition Regulation - FDA means the U.S. Food and Drug Administration - FDP means Final Drug Product - HHS means the U.S. Department of Health and Human Services - Licensed means approved for use by a regulatory authority - MARV means Marburg virus - MCM means Medical Countermeasure - Notice means this Sources Sought Notice - PEP means Post Exposure Prophylaxis - PHEMCE means the Public Health Emergency Medical Countermeasures Enterprise - RFI means Request for Information - SNS means Strategic National Stockpile - SSN means Sources Sought Notice - SUDV means Sudan ebolavirus - USG means United States Government - VHF means Viral Hemorrhagic Fever IV. PURPOSE The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use responses to this Other Than Small Business Sources Sought Notice (OTSBSSN) for planning potential future acquisitions. BARDA seeks pertinent marketplace data on availabilities and capabilities for procuring, stockpiling, and investing in the late stage development of therapeutics targeting filovirus disease caused by Ebola virus (EBOV), Marburg virus (MARV), or Sudan virus (SUDV). BARDA seeks information on availabilities, capabilities, and other pertinent marketplace data to support late-stage activities required for Food and Drug Administration (FDA) approval of therapeutics targeting filovirus disease. This information is intended to strengthen BARDA's understanding of the current and future marketplace and enhance its ability to obtain quality services economically, and to efficiently and lawfully establish potential vendor source files and listings. BARDA will not award any contracts under this notice. V. BACKGROUND The Office of the Biomedical Advanced Research and Development Authority intends to use responses to this OTSBSSN for planning purposes towards the possible procurement of filovirus therapeutics for use in civilian populations in the event of an outbreak of Ebola virus (EBOV), Marburg virus (MARV), or Sudan virus (SUDV). Within the Federal Government, the U.S. Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective Medical Countermeasures (MCMs) to treat the adverse health effects resulting from intentional release leading to exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemics, and emerging infectious diseases. Response and recovery were identified as key elements of national defense in the National Strategy to Combat Weapons of Mass Destruction issued in 2002 (National Security Presidential Directive-17/Homeland Security Presidential Directive-4, NSPD-17/HSPD-4) and in the National Military Strategy to Combat Weapons of Mass Destruction (NMS-CWMD), released in 2006. This procurement is also aligned with the Project Bioshield Act of 2004 (Pub. L. No. 108-276, www.gpo.gov/fdsys/pkg/PLAW-108publ276/pdf/PLAW-108publ276.pdf), which established the processes by which MCMs are procured for the Strategic National Stockpile (SNS).The lead role of HHS in the medical and public health response, including development and availability of MCMs, was emphasized in 2004 in Biodefense for the 21st Century (HSPD-10) and in 2007 in Medical Countermeasures against Weapons of Mass Destruction (HSPD-18). The importance of an effective MCM enterprise for development and provision of medical countermeasures was emphasized in 2009 in the National Health Security Strategy (NHSS). These documents represent the foundation for addressing the Nation's CBRN MCM needs. Filovirus Threat and Filovirus Therapeutics EBOV, SUDV, and MARV viruses are single-stranded, negative sense RNA viruses of the Filoviridae family. Infections by these viruses result in a highly lethal Viral Hemorrhagic Fever (VHF); mortality has ranged from 25-90 percent depending on the outbreak and the virus species by which it was caused. MCMs against filoviruses are urgently needed should future outbreaks of this virus occur, similar to the 2014-2015 epidemic in West Africa. In 2006, the Department of Homeland Security (DHS) determined that Ebola and Marburg viruses are material threats to national health security. The threat of filovirus agents being used as biological/bioterror weapons led the DHS to issue a Material Threat Determination (MTD) based on its Material Threat Assessment (MTA) for Ebola virus and Marburg virus. Based on the assessment by DHS and medical consequence modeling by the Department of Health and Human Services (HHS), the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) determined that up to 753,000 therapeutic treatment courses would be needed for Ebola virus and up to 2.09 million therapeutic treatment courses would be needed for Marburg virus. At present, only a small fraction of this requirement has been fulfilled in terms of delivery to the SNS, or management of MCMs as vendor-managed inventory (VMI). The Pamoja Tulinde Maisha (PALM) randomized, controlled trial (RCT) conducted during the 2018-2020 EBOV outbreak in North Kivu and Ituri provinces in the Democratic Republic of the Congo (DRC) evaluated efficacy of mAb114, EB3 and Remdesivir to treat patients infected with EBOV relative to a ZMapp control arm. The study was closed early due to EB3 meeting predefined early termination criteria. Subsequent analysis of the final study data has shown that both mAb114 and EB3 were superior to the ZMapp control arm and that there is no significant difference in mortality between the mAb114 and EB3 arms. Remdesivir failed to show superiority to ZMapp. As such, use of ZMapp and Remdesivir was immediately discontinued. In 2020, EB3 (Inmazeb) and mAb114 (Ebanga) were approved by the FDA for the treatment of individuals infected by EBOV. In addition, while there are no currently approved interventions for MARV infection or SUDV infection, there are products in development that may be submitting investigational new drug (IND) applications in the near future. It is critical that the United States Government (USG) initiate a mechanism to support the advanced development, licensure, and procurement of filovirus therapeutics. VI. PROJECT REQUIREMENTS This notice seeks information from Other Than Small Businesses (OTSB) with regard to their qualifications, experience and capability to develop and manufacture filovirus therapeutics against EBOV, SUDV, and MARV. Any proposed therapeutic/Sponsor should meet the following criteria: The Offeror must have submitted an investigational new drug (IND) application related to the intended operational use of a product as a filovirus therapeutic; The Offeror must have documented FDA concurrence on the proposed regulatory path leading to approval of the product as a filovirus therapeutic. Proposed capability should include the ability to procure the therapeutic product as Final Drug Product (FDP) under any of the following mechanisms: 1) delivered as FDP to the SNS, or 2) purchased and maintained as FDP by the sponsor as VMI which may be delivered to the SNS at the later date. VII. CAPABILITY STATEMENT/INFORMATION SOUGHT Respondents are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability in line with this notice. Respondents must submit separate Business and Technical Representation, and both shall each not exceed 10 single sided pages (including all attachments, resumes, charts, etc.) in 11pt Arial font. Content contained in excess of the stated limit per section will not be reviewed. Respondents are asked to state in their capability statement, whether they are responding to the Small Business Sources Sought Notice or the Other Than Small Business Sources Sought Notice. 1. Business Representations Respondents must make business representations to ASPR/BARDA in the following order: a) Business Information Provide potential respondent name, principal place of business, DUNS number, taxpayer identification number, number of employees, annual revenue of company, point of contact, and email address. b) NAICS Codes Provide your applicable NAICS Code. c) Compliance Statement Provide a statement assuring compliance with all applicable laws and this notice. d) Capability Statement Provide relevant business information on capability, prior experience, and business interests to provide the type of product(s) specified under Section VI, above. 2. Technical Representations Respondents shall submit the technical representations to ASPR/BARDA in the order listed below as separate sections. (Note: sections not relevant to the respondent may be left without information by marking it - NA/Reserved, to maintain the section numbering). a) Response Specification In response to this notice, clearly describe the capability and experience that meets the requirements specified in Section VI. b) Technical Information: All sponsors responding to this notice are required to provide the information on their products and capabilities by providing a short narrative and summarizing the stage of development, non-clinical and clinical studies completed to date, stability data, manufacturing accomplishments, and FDA interactions. The short narrative may include figures, schematics, diagrams, photographs, etc. and shall describe the proposed final products under consideration. NARRATIVE SECTIONS: Product Name: As marketed or published. Provide the product insert included in the package. (Note: Do not include any product brochures and promotional marketing material). Intended indication for use as a therapeutic capable of meeting product requirements outlined in Section VI. Regulatory Status or Stage of Development: Provide summaries of communications with the FDA describing current state of medical product development according to the FDA pathways. Clinical Development: Provide a summary of preclinical and clinical development. The Offeror must also provide evidence of non-clinical efficacy. Current Manufacturing Capacity: Provide a summary of manufacturing achievements, completed manufacturing runs, and manufacturing capacity. Shelf Life and Storage Conditions: Provide a summary of stability and storage as measured by time and temperature. 3. Other Information ASPR/BARDA encourages all respondents to submit currently available marketing or extant information, or to notify ASPR/BARDA of the publicly available location; thereof to the maximum extent consistent with this notice's requirements and limitations. Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. ASPR/BARDA will presume that any unmarked information, data, and materials were furnished with an - unlimited rights license, as FAR subpart 27.4 defines that term, and ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials. 4. Response Format, Transmission, and Closing Date Respondents shall provide declarations of capability and all information, data, and materials in Microsoft Office , or Adobe Acrobat format, and furnish responses electronically (via email) to Sabrina.McIntyre@hhs.gov for receipt by 5:00 P.M. ET on March 21, 2021. Any questions, comments, or concerns regarding this notice shall be written and transmitted via email to Sabrina.McIntyre@hhs.gov. VIII. DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on beta.SAM.gov under Contract Opportunities in accordance with FAR part 5. However, responses to this notice will not be considered adequate responses to a solicitation. IX. CONFIDENTIALITY Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. ASPR/BARDA will presume that any unmarked information, data, and materials were furnished with an - unlimited rights license, as FAR subpart 27.4 defines that term, and ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.