Request for Information (RFI) - Walter Reed Army Institute of Research (WRAIR) - Bioresearch Support to the Lugar Center, The Republic of Georgia
This Request for Information (RFI) is in support of WRAIR for its biomedical research mission to the Lugar Center, Tbilisi, the Republic of Georgia and the Caucuses (Azerbaijan). Specifically U.S. Army Medical Research Unit-Georgia (USAMRU-G) under the command and control of WRAIR, and in partnership with the Georgian Ministry of Defense, Ministry of Labor, Health, and Social Affairs; and Ministry of Agriculture, requires support services for technical clinical research services and operational (management and ancillary) support services.
USAMRU-G will provide subject matter expertise in a broad range of pathogen research methods and technologies, medical product development, grants writing training, and research marketing.
USAMRU-G's bioresearch program includes working on strain characterization of pathogens in this region, antimicrobial resistance, bacteriophage, leishmaniasis, and exploring other emerging and re-emerging diseases posing a potential risk to the Force in the Caucasus region (i.e. Crimean-Congo haemorrhagic fever (CCHF), anthrax, brucellosis, tularemia, etc.). Infectious disease syndromes caused by existing, emerging, or re-emerging viral pathogens, not otherwise identified, is also of interest to USAMRU-G. For example, USAMRU-G has interest in identifying the cause of the 50% of influenza like illnesses which are NOT influenza but that resulted in a medically significant illness. Other syndromes of interest are acute febrile illness/fevers of unknown origin, acute respiratory infection, sexually transmitted infections and military prevalence, global traveler's diarrhea, and central nervous system infection surveillance.
Once specific threats have been determined, USAMRU-G works on those identified threats along a scientific continuum including: 1) epidemiologic disease surveillance and sample collection, 2) basic and exploratory science, 3) translational research, and 4) product research and development. The intent is to license (as applicable) and field medical countermeasures and medical solutions designed to eliminate or mitigate these threats in the most safe, expeditious, cost effective, and high quality manner possible.
In order to facilitate the establishment of USAMRU-G at the Lugar Center, WRAIR's research efforts must be world class quality and adaptive to changes in the Nation's requirements for support of their military services. These tasks may require, but not limited to, the expertise of:
Scientific Support: Clinical Research Principal Investigation Support Services, Microbiological Support Services, Virological Support Services.
Clinical Research Support: Bioinformatics Support Services, Quality Assurance/Quality Control Support Services, Geography Information System (GIS) Technical Support services, Research and Laboratory Technical Support Services, Insectary Support Services.
Operational Support: Support Services Operational Management, Translation Services, Logistics, Biomedical equipment and Supply Support Services, Transportation Support Services, Information Technology Support Services, Safety Support Services, Training, Administrative and Clerical Support Services.
It is anticipated that a single award, IDIQ will provide a vehicle through awarded tasks orders for obtaining services in support of USAMRU-G's bioresearch mission. This RFI describes a requirement for scientific support, clinical research support, and operational (management and ancillary) support. Task orders may be awarded for surveillance and sample collection; basic and exploratory science; translational research; product research and development; and/or operational support to USAMRU-G in terms of logistics support, safety, recruitment, retention, and training, as well as operational IT support. All vendors are provided a fair opportunity to submit a capabilities statement under this request. Only one contract is anticipated to result from this RFI, however the Government reserves the right to withdraw, modify, or eliminate various aspects of the requirement (including contract vehicle type) determined to be too costly or impractical prior to award. A firm, fixed price award is anticipated.
Responses to this RFI are due by 10:00 AM Eastern Time on 30 June 2014. See Section 6.0 for further information.
2.0 CAUTION: This is an active requirement. Contractors are strictly prohibited from discussing this requirement with any member of the identified program office. All discussion shall be with the POC listed below.
This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kinds of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned.
Interested parties are asked to respond to this RFI and submit a capability statement that supports the focus of this RFI. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained. Potential offerors are requested to direct all questions via email to the Point of Contact listed below in item 6.0.
All responses should be complete; in 12-point font; and not exceed 5 pages total, including tables, graphics and appendices.
Background WRAIR's mission is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers life saving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the war fighter. WRAIR's focus on research for the Soldiers affects all aspects of its operations as military medical research priorities differ from those of the civilian sector. WRAIR scientists have a unique understanding of military operations and environments, including the stresses and exposures troops encounter and the performance requirements of a deployed military force. Despite WRAIR's focus on the military, its research has been used to solve nonmilitary medical problems around the world. Its history is filled with the lifesaving or life-enhancing discoveries of distinguished scientists.
In 2009, the Cooperative Biological Engagement Program (CBEP) engaged the United States Army Medical Research and Material Command (USAMRMC), following a request from the Government of Georgia (GoG) to establish a long-term U.S. presence at the Richard G. Lugar Center for Public Health Research (Lugar Center), which will serve as the cornerstone of the Georgian National Disease Surveillance Program. In January 2011, WRAIR, through its command channels, was tasked by the Deputy Secretary of Defense as the Executive Agent, to establish a medical research unit at the Lugar Center in Tbilisi, Georgia. The new U.S. Army Medical Research Unit-Georgia (USAMRU-G) under the command and control of WRAIR, and in partnership with the Georgian Ministry of Defense, Ministry of Labor, Health, and Social Affairs; and Ministry of Agriculture, will build partnerships in global health and meet DoD overseas medical research laboratory mission requirements.
The USAMRU-G mission statement is to promote global health security, identify infectious disease threats to global health security, and develop interventions to mitigate those threats. USAMRU-G shall collaborate and assist the Government of Georgia in its efforts to combat endemic disease threats of military importance as well as to participate in cooperative surveillance and research projects addressing military and public health issues in the region. Its mission shall also provide for extensive capacity building to train Georgian scientists, physicians, students, and technicians in a wide range of bioresearch-related topics. The incorporation of the United States-led medical research and development program, along with the experience of the DoD Global Emerging Infectious Disease program, will provide an opportunity to integrate the Georgian laboratory platform into an international site for infectious disease surveillance and research.
Through this RFI the Government is looking for capability statements addressing the following requirements:
A. Scientific Support 1) Surveillance and sample collection a) Conduct surveillance of multiple syndromes, diseases, and pathogens b) Collaborate with the CONUS and OCONUS DOD research labs across a broad range of surveillance activities c) Develop and maintain a repository of biologic samples for future experiments d) Conduct pathogen discovery activities
2) Basic and exploratory science a) Immunologically characterize human responses to natural infection and immunization b) Complete full genome characterization of pathogens collected during surveillance and pathogen discovery activities
3) Translational Research a) Assess diagnostic assays developed within and outside of DOD designed to detect and identify infectious diseases of military importance b) Complete modeling exercises exploring how infectious disease transmission and prevention respond to changing a variety of changing factors c) Test virus isolates and other pathogens for susceptibility of resistance to currently available therapeutics
4) Product Research and Development a) Conceptualize, design, and develop vaccine or drug constructs and candidates b) Complete pre-clinical drug or vaccine characterization assessing safety and immunogenicity c) Execute phase 1 and early phase 2 clinical trials in humans.
B. Clinical Research support a) Prepare and maintain data in a searchable and analytic format (Bioinformatics), b) Prepare and maintain data in accordance with the Food and Drug Administration (FDA) regulations, i.e. Codification of Federal Regulations (CFR) Quality Assurance/Quality Control Support Services, c) Geography Information System (GIS) Technical Support services, d) Provide bioresearch support personnel (Research and Laboratory Technical), e) Provide Insectary Support Services.
C. Operational Support a) Management support of day to day operational requirements in IT services, scientific recruitment, retention, training, quality assurance, logistics support, safety services, local transportation services, translation services.
6.0 CONTACT INFORMATION
The following is the Point of Contact for this RFI:
Andrew Green, Contract Specialist United States Army Medical Research Acquisition Activity 820 Chandler Street Ft. Detrick, MD 21702-5014
Please submit written responses via email in Microsoft Office 2000 or 2007 format by 10:00 AM, 30 June 2014, to the following email address: firstname.lastname@example.org. No hardcopies will be accepted. No inquiries on any potential future acquisition activities or timelines will be entertained.