SOURCES SOUGHT
A -- Bridge Contract (Dengue Research Closeout)
- Notice Date
- 7/28/2016
- 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
- 10881572
- Archive Date
- 8/19/2016
- Point of Contact
- Sharew Hailu,
- E-Mail Address
-
sharew.hailu.civ@mail.mil
(sharew.hailu.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought (SS) Dengue Vaccine Clinical Research (Closeout of Study) General Information: This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein. This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expense associated with responding to this RFI. An intent to sole source will not be published in accordance with 5.202 (a) (8): "The proposed contract action results from the acceptance of an unsolicited research proposal that demonstrates a unique and innovative concept (see 2.101) and publication of any notice complying with 5.207 would improperly disclose the originality of thought or innovativeness of the proposed research, or would disclose proprietary information associated with the proposal. This exception does not apply if the proposed contract action results from an unsolicited research proposal and acceptance is based solely upon the unique capability of the source to perform the particular research services proposed (see 6.302-1(a)(2)(i))." This requirement is specifically to bridge W81XWH11D0021 Delivery order 2. Approximately 10 months is required to complete the long term follow up and close out the study. Sources Sought Response and Due Date: 8/4/2016 Instructions to Responders: Responses from all capable and qualified sources are encourgaged to respond to this request. White papers should adhere to the following formatting and outline instructions: 1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF. 2. Submissions shall not exceed 8 pages inclusive of the Cover page. 3. Cover Page (1page) •Title •Organization •Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses) •Topic area(s) addressed 4. The response should provide sufficient technical data to determine how you fully meet the requriements as specified in the Performance Work Statement. 5. A draft PWS is attached.This requirement may contain proprietary information. This is a requirement for an active protocol and the tasks to the close out. 6. Please note that responses are due no later than 8/4/2016 at 12 PM EST. The preferred method of submission is via email. The point of contact for this action is Sharew Hailu, Contract Specialist, Sharew.Hailu.civ@mail.mil. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis. Statement of Work (SOW) For Dengue Vaccine Clinical Research (Closeout of Study) Introduction: The USAMRMC is developing medical products intended to mitigate the impact of dengue virus infection on US military operations. These medical products include (but are not limited to) vaccines, diagnostics, therapeutics, and repellents. USAMRMC requires a contractor to provide clinical research/support services for the support of clinical studies aimed at the development of dengue vaccines and other activities as related to this objective as needed. The Government requires support to successfully perform the projects, tasks, and subtasks outlined below designed to support the U.S. Army Medical Research and Materiel Command (USAMRMC) in their dengue vaccine development efforts both within the US and abroad and with a variety of co-development partners. Development and U.S. FDA licensure of a vaccine to prevent dengue is a high priority of the United States Department of Defense. For over 30 years, the U.S. Army Medical Research and Materiel Command (USAMRMC) has committed significant resources to the development of a dengue vaccine. GSK is committed to developing a dengue vaccine for global use and is currently developing a dengue vaccine candidate in collaboration with the USAMRMC that has great potential for meeting U.S. Army requirements. This vaccine candidate, DPIV, is in preclinical testing. The SOW outlined in this TO describes the preparation and conduct of an early phase trial supporting the USAMRMC/GSK clinical development plan for the DPIV candidate. The successful completion of the clinical development plan is anticipated to result in licensure and marketing of the DPIV vaccine in dengue endemic countries and the US. Toward this end, the USAMRMC granted GSK an exclusive license to the technology required to produce the DPIV candidate and executed a CRADA outlining how each party will leverage the other to advance the DPIV candidate towards licensure in dengue endemic countries and in the U.S. for use in adult travelers and the military. The USAMRMC will support the development effort by functioning as the DPIV Sponsor during the initial phase of clinical development, fulfill the responsibilities associated with the same unless otherwise negotiated, provide subject matter expertise in dengue vaccine manufacturing, pre-clinical, and clinical development, provide regulatory support, provide research laboratory assets and expertise as required, provide project management services, provide quality oversight, and work with the contractor to ensure they are successful in executing their duties as described above. In summary, GSK, the USAMRMC, and CRM will work together to plan and execute a high quality, compliant, and safe dengue vaccine clinical trial in Puerto Rico and ensure the biologic samples required to support vaccine safety and define vaccine immunogenicity are properly collected, inventoried, stored, and shipped under cold chain to the laboratories in the US and abroad for testing and ultimate disposition. The Contractor will be provided overall guidance related to the tasks in this SOW from authorized Government staff. DPIV002 is a 100 placebo controlled clinical trial to evaluate a dengue tetravalent purified inactivated vaccine. The vaccine trial completed enrollment and vaccination and has been shown to be safe and immunogentic. Prior to the initiation of the Trial the FDA recommended that the participants be followed for three years following vaccination. The original contract was extended to account for this period of time however phased enrollment (another recommendation) and slower than anticipated enrollment extended the three year follow-up period beyond the life of the money. This statement of work is specifically to bridge W81XWH11D0021 Delivery order 2. Approximately 10 months is required to complete the long term follow up and close out the study. The work items presented herein are associated with the technical and administrative support necessary for the preparation of the study site(s) and finish the execution of clinical study-related activities for the conduct of the DPIV-002 dengue vaccine clinical trial and to close the study out. The period of performance of these activities is anticipated to take place beginning August 2016. For this Project, the Viral Diseases Branch, Walter Reed Army Institute of Research (WRAIR), USAMRMC is the lead agent. The contractor will assume responsibility for completing work items including (but not limited to): •retaining and managing the DPIV-002 Principal Investigator(s) (PI), Associate Investigator(s) (AI), and study support personnel; •procurement of any remaining clinical research support services, supplies and equipment; •contracting any remaining clinical laboratory testing services; •transportation and communications services for study staff and participants; •providing clinical monitoring services during the execution of the trial; and •providing quality control for activities related to the preparation and execution of DPIV-002. •The contractor will: provide monthly technical reports to the Contracting Officer's representative (COR), work/coordinate with designated quality control and quality assurance personnel from USAMRMC Project:: Completion DPIV-002 and study close out. Task 1. Administrative Support: Note: Subtasks in task 1 are expected to be conducted throughout the duration of the award. Project Management - Manage and provide oversight of the overall activities conducted under the contract, including: generation of monthly reports, facilitation of teleconferences, preparation of meeting agendas and minutes, and issue identification and resolution. Maintain files (electronic and hardcopy) for work products (including all clinical protocol-associated documents), associated reference materials, and data for the duration of the contract. Provide teleconferencing capabilities. Teleconferencing will include access to international teleconference capabilities that will enable up to 15 teleconference attendees to dial-in to conference toll free. Arrange/coordinate travel as needed, for non-government staff members and/or collaborators, both Continental United States (CONUS) and Outside the Continental United States (OCONUS). All travel must be in relation to the items identified in this PWS. All travel shall be in accordance with Joint Travel Regulations. Task 2. Clinical Site Preparations and Study Support 1)Complete activities related to participant study visits including. a.Scheduling and Telephone Call reminders of all DPIV -002 Study Visit #15 (DPIV-002 Final Study Visit) b.Completion of DPIV -002 Study Visit #15 (DPIV-002 Final Study Visit) for all ENROLLED, ACTIVE SUBJECTS. Completion of study visits is currently projected for January 2017. c.An auditable accounting of volunteer compensation for participants to include by subject code the amount, Study Visit and date must be delivered at the end of the contract. 2)Data management activities to include: a.Completion of all case report forms (CRF's) related to Visit #15 for all participants. b.Completion of data entry into the remote data entry (RDE) system for all of Visit #15 variables c.Data cleaning and response to all queries issued in the RDE system. 3) Complete study monitoring and close out activities, including: a.Interim and close out monitoring visits - Schedule visits; attend visits, and respond to requests from the EMMES monitor b.Attend all study related teleconferences and meetings c.Complete all study closure related reports as required d.Submit all regulatory documents to Western Institutional Review Board (WIRB), including amendments, renewals, and study closure related reports 4) Complete shipment of biologic samples (i.e. blood) collected during the conduct of the study to designated laboratories, if needed. 5) Maintain current training of study site personnel in duties related to conduct of the study; including but not limited to; •Good Clinical practices (GCP) •ICH guidelines, •DPIV-002-specific procedures •GLP •GCLP •Specimen Management Note: Initial training will be required if contractor experiences any turnover during the period of performance. 6) Provide technical, administrative, and financial support necessary to support daily operation of clinical study site; to include maintenance of any office equipment, installation/qualification/calibration of any laboratory/analytical equipment, clinical study and administrative supplies, and maintenance services; as required for the performance of DPIV-002. Complete activities related to participant study visits, including: Task 3. DPIV-002 Execution and Timelines. Performed throughout duration of the award. Complete preparations of clinical site(s), related facilities, and training of study-related staff for the performance of DPIV-002 in accordance with the DPIV-002 protocol. Execute protocol-related duties in compliance with the DPIV-002 protocol, Task 3, and US Code of Federal Regulations (CFRs) as applicable to the conduct of clinical studies aimed toward US FDA Licensure of vaccine products, including (but not limited to) Good Clinical Practice Regulations (Title 21 CFR Parts 11, 50, 54, 56), the Health Insurance Portability and Accountability Act (HIPPA) of 1996 (Pub.L. 104-191, 110 Stat. 1936, enacted August 21, 1996), and International Conference on Harmonisation Guidelines for Good Clinical Practices (GCPs) (ICH Guidelines for Good Clinical Practice (E6), Published May 9, 1997).. Collaborate with USAMRMC and applicable regulatory authorities to execute DPIV-002 in Puerto Rico. Complete scheduled long term follow up study visits expected 31 Jan 2017. Continue surveillance activities for unscheduled study visits Conduct close out activities The contractor shall submit the report using the format outlined in Contract Data Requirements List (CDRL) Data Item Description (DID), DID # DI-TCSP-82040. The contractor shall submit the Clinical Trial Monthly Progress Reports using the format outlined in CDRL DID #DI-MGMT-80555A. Deliver invoice once per month Maintain clinical site(s), related facilities, and training of study-related staff for the performance of DPIV-002 in accordance with the DPIV-002 protocol. Execute protocol-related duties in compliance with the DPIV-002 protocol, Task 3, and any local, regional, national, US FDA, ICH regulations and guidance, and other regulations and guidance, as necessary. Collaborate with the Government and applicable regulatory authorities to execute DPIV-002 in Puerto Rico. Place of Performance. Sites of operation will preferably be in or near San Juan, Puerto Rico for DPIV-002. Period of Performance. The period of performance for this task will start 17 August 2016 and will end on 17 June 2017. Travel. CRM employees / representatives may be required to travel throughout the duration of this award to meet the goals and objectives of this study. Projected costs should be outlined in the cost proposal. Government Furnished Information and Materiel: None
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