SOURCES SOUGHT
A -- Advanced Development for HIV Vaccine - Attachment A: MHRP Slide Deck
- Notice Date
- 10/21/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-16-R-0006
- Point of Contact
- Andrew W. Green, Phone: 3013199279
- E-Mail Address
-
Andrew.w.green17.civ@mail.mil
(Andrew.w.green17.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Attachment A: MHRP Slide Deck, gives a summary of the program efforts. Purpose The HIV Vaccine Program Management Office (HIVV PMO) and Walter Reed Army Institute of Research (WRAIR) are seeking information from companies, organizations, educational institutions and consortia (hereafter referred to as companies) with capabilities to support and perform vaccine clinical research activities primarily at its facilities in the US, Uganda, Tanzania, Nigeria, Kenya, Mozambique, and Thailand. The information being gathered will be used to assess the opportunity to issue a solicitation with the intent of completing clinical trials and supporting laboratory analysis in support of critical path studies leading to licensure of candidate vaccines. The primary focus of this Sources Sought is to gather information about organizations capable of conducting research and development of vaccines that can advance intramural HIV vaccine candidates from its Tech Base (safety and immunogenicity) to Advanced Development (efficacy and immunogenicity) programs. WRAIR is interested in companies with the capacity to support and conduct vaccine trials utilizing heterologous prime-boost vaccination strategies comprising combinations that can include, but are not limited to: (a) recombinant viral vectors (e.g. MVA, Ad26, Pox viruses, etc.); (b) recombinant protein immunogens + adjuvant; and (c) HIV DNA plasmids. A secondary focus of this Sources Sought is to seek information about potential HIV vaccine technological enhancements. Examples of vaccine technological enhancements include but are not limited to any of the following: optimization of a protective immune response, innovations in formulation that improve stability and shelf life, efficacy of novel adjuvants, novel routes of delivery and identification of novel immunologic markers as correlates of protection. Background In 1985, the United States military recognized the emerging HIV epidemic as a new threat to U.S. and allied forces worldwide. A military directive emerged to develop effective preventive measures to include prevention education, vaccine development and implementation of novel anti-viral therapies, and clinical management tools for the Department of Defense (DoD). Congress mandated the formation of an Army-led HIV/AIDS research unit in 1986. The HIV research program, centered at WRAIR, includes affiliated research sites in Kenya, Tanzania, Uganda, Nigeria, Mozambique, and Thailand and collaborates with a wide variety of national and international research groups. The overarching program is collectively known as the U.S. Military HIV Research Program (MHRP). Attachment A: MHRP Slide Deck, gives a summary of the program efforts. Additional program and organization information can be accessed at www.hivresearch.org. MHRP has become an important and strategic partner in the international effort to develop a HIV vaccine. From its inception, MHRP has focused vaccine development efforts on the HIV variants that circulate in the developed (subtype B) and developing (non-subtype B) world, given its dual mission to develop a preventive HIV vaccine for U.S. military personnel and for the global community. Since 1988, the U.S. Army has executed the vast majority of its diverse HIV research and development portfolio under a single cooperative agreement with a congressionally authorized non-profit organization. The U.S. Army anticipates transitioning this work to a contract vehicle within calendar year 2016. Information Requested The Government requests capabilities statements which shall be used to assess potential offerors with strong capabilities in developing and performing OCONUS clinical trials and HIV-vaccine specific research. Time permitting and based upon the capabilities statements, the Government may elect to conduct an industry day with the purpose of further honing the PWS. Companies are invited to describe their experience and any on-going research efforts involving HIV vaccines, or similar products. Your responses should include but are not limited to: 1.Company Information 2.Describe any vaccine platforms and antigen components you have directly supported. Include a brief synopsis of design and results of any Phase II and III trials. 3.Describe your experience operating/working outside the continental United States (OCONUS) to conduct clinical trials and vaccine R&D: a.Working in resource-limited countries including Africa and Asia b.Working with foreign governments to conduct clinical trails c.Working/collaborating with educational institutions OCONUS d.Coordinating and executing agreements with the above-mentioned entities e.Working with advocacy groups, Community Advisory Boards, and Non-Governmental Organizations (NGOs) in the context of conducting clinical trials OCONUS f.Working with foreign Institutional Review Boards (IRBs) in executing vaccine clinical trials 4.Describe OCONUS laboratory capabilities (or experience in developing these capabilities) to support clinical trials and conduct protocol related R&D to determine biological basis for efficacy (e.g. immunological assays to determine correlates of protection, -omics to assess pathogen and host dynamics that influence protection, etc). 5.Describe your experience in supporting US-based management and oversight required to conduct complex international multi-site clinical trials. Include regulatory support, protocol development support, clinical monitoring, data analysis, project management support, IT support, financial analysis and reporting support. 6.Describe your experience in building capacity, technology transfer, and empowering international sites in host nations, particularly in resource-constrained countries. 7.Describe your experience obtaining specimens from clinical trials and the general nature of experiments your organization has conducted from those specimens. Please include any comments relative to critical factors that your organization feels the government should consider for this effort. Submitting a Response This is a Sources Sought only and does not constitute a commitment, implied or otherwise, that the DOD will take procurement action in this matter. This is NOT a solicitation for proposals, applications, proposal abstracts or quotations. The purpose of this Sources Sought is to obtain knowledge and information to assess the current state of the science. Further, neither DOD nor any other governmental agency will be responsible for any cost incurred in furnishing this information. Responses are limited to 11 pages, not including cover page, cover letter, and table of contents. Responses should include: 1.Executive Summary - 1 page 2.Company information - 1 page to include a) name and title of the primary point of contact for the response; b) name and address of the institution or company; c) DUNS number 3.OCONUS clinical trial experience - 3 pages 4.OCONUS laboratory infrastructure development, support, and maintenance experience- 2 pages 5.US Based Management support experience - 2 pages 6.OCONUS Capability building and technology transfer experience - 1 page 7.Specimen Management experience - 1 page Page limits above are intended as guidelines only. You may use more or fewer pages for individual sections, provided that the total response does not exceed 11 pages. Any proprietary information should be clearly identified as such and will be kept confidential as allowed by relevant federal law. Submitted data and information will not be returned. Responses are due in electronic format, preferably pdf format, by 12:00pm ET 2 November 2015. Responses should be sent to the United States Army Medical Research Acquisition Activity, Primary Point of Contact (POC): Andrew Green, at andrew.w.green17.civ@mail.mil.
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