Islet Cell Distribution Coordinating Center

SOURCES SOUGHT NOTICE Islet Cell Distribution Coordination Center Market Research This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is conducting a market survey to help determine the availability and technical capability of qualified small businesses, veteran-owned small businesses, service-disabled veteran-owned small businesses and/or HUBZone small businesses capable of serving the needs mentioned below. The NIDDK seeks an organization or an institution to serve as the coordinating center for the distribution of human cadaveric islets for laboratory research. This procurement will support a single coordinating center that subcontracts to qualified islet isolation facilities to prepare and distribute human islets for investigational research. The coordinating center will maintain a roster of investigators approved to receive islets and will assume responsibility to notify investigators and distribute islets when they are available. Contract funds will provide partial cost recovery to islet isolation facilities for islets distributed and investigators that receive them will have cost sharing charges for the islets received. Currently, the National Institutes of Health and NIDDK support a multi-facetted research program to further the development of islet transplantation as a viable therapy including clinical trials, preclinical studies in animal models, fundamental research, and provision of resources to supplement these efforts. This support includes investigator initiated research projects and consortia funded through cooperative agreements and contracts. Of relevance to this notice, the Islet Cell Resource (ICR) program is currently comprised of an interactive consortium of academic clinical islet isolation facilities and a coordinating center (for more information, visit http://icr.coh.org ). These islet isolation facilities have responsibilities for the procurement of human pancreata, purification and quality control of islet cell preparations, and distribution of viable islets for approved research or clinical protocols. They also perform research and development to improve isolation techniques, cellular viability and function, and shipping conditions. To receive research islets from the ICR, investigators must apply to the Administrative and Bioinformatics Coordinating Center (ABCC). Eligibility requires that investigators either have ongoing, peer reviewed grant funding or have obtained protocol approval by an ICR scientific subcommittee. The ABCC maintains a web-based data collection system that archives detailed information about all phases of islet procurement and a sophisticated algorithm that electronically selects prioritized investigator users to receive islets. In the past five years the ICR has distributed more than 100 million islet equivalents for research studies, and growing needs from the research community are projected. The information gained from fundamental islet research should greatly enhance the current understanding of human islet function and enable transplantation and other therapies for treating diabetes. The objective of this forthcoming procurement is to establish a successor coordinating center to the ICR in order to continue providing human islet availability following the conclusion of the ICR project period on July 31, 2009. The NIDDK plans to support a contract for islet distribution for laboratory research to accomplish the following objectives in an efficient and cost effective manner: 1. Receive requests for islet applications, qualify investigator recipients, and process these data to maintain a complete and continuously updated electronic roster of approved investigator users and their projected needs. For purposes of this solicitation, the 2008 roster lists 147 investigators who estimate their annual research needs to exceed 30 million IEQ per year. 2. Solicit and qualify potential islet production centers with respect to cGMP certification, assure quality performance standards of prepared islets, provide training for standardized distribution protocols, subcontract to appropriate facilities to provide islets for laboratory research, and adjust these subcontracts as warranted. Solicitation and Qualification of Islet Production Centers: Islets will be sourced from islet production facilities in two ways. The first method of sourcing will utilize NIH-sponsored clinical islet transplantation trials in North America that include the University of Miami, University of Minnesota, University of Edmonton, University of Pennsylvania, Emory University, University of California at San Francisco, University of Illinois at Chicago, and Northwestern University. These institutions comprise the NIH-funded Clinical Islet Transplantation Consortium (CITR) and are in the midst of initiating a series of clinical islet transplantation protocols. Due to the complexities of the islet production process, it is anticipated that only 50% of the isolations attempted will have suitable yield and quality required for clinical use. Islets purified with the intent of clinical use but not used for clinical transplantation, if sufficiently viable, will be salvaged and shipped for research. The second source will be from one or more subcontract site. Because the timing and quantity of clinical islet transplantation activity is unpredictable, NIDDK anticipates that islet production will also be solicited from one or more specific site to assure an availability continuum. The process by which subcontracted facilities are selected will be open, subject to independent peer review, and will follow a general announcement. The Contractor, in conjunction with the approval of the NIDDK Project Officer and an External Evaluation Committee, shall design and distribute the announcement and organize the review of candidate facilities. 3. Develop and maintain an electronic communication system that will monitor and match islet availability from production sites with user requirements and will notify production sites of need for islets and users of availability. 4. Develop and maintain financial records of reimbursements to the islet production facilities and receivables, and house the consolidated database of approved islet production facilities and investigators. 5. Maintain accurate records of islet shipments from production sites to islet recipients including quantities and batch release characteristics of islets shipped as assessed by production sites and recipients. Establish subcontracts with commercial carriers for overnight shipping of islets between multiple sites, domestic or international, in accordance with Standard Industry Practice, FDA Requirements, approved Standard Operating Procedures, city, state, and/or Federal regulations, and any special instructions given. Analyze trends in demand for islets and project future requirements for islets. 6. Collect information on performance site islet quality and investigator user satisfaction and analyze these respective data so that processes and quality can be improved. 7. Compile evidence of scientific progress attributable to human islet distribution as shown by publications and other tangible results. 8. Maintain an External Evaluation Committee (EEC) of advisors to guide development and improvement of the resource and support the technical and administrative functions including subcontracts as determined by the Project Officer and External Evaluation Committee. It is anticipated that the EEC will have membership of four to six non-Federal members and will conduct direct meetings at least annually. Potential offerors must demonstrate familiarity, capability, and experience working with the medical research community as it relates to islet cell research. This includes: communicating with islet production facilities and research investigators; working with NIDDK to develop, implement, and monitor batch release and quality performance standards used by islet production facilities; providing specifications and training to production facilities in matters of handling, packaging, marking, and shipping islets in accordance with ICR, Federal, and other guidelines and requirements; and developing and maintaining documentation to assess the suitability and success of the islets that are used in the various research investigations. Interested firms responding to this sources sought notice must adhere to the following: (a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain enough sufficient detail for the Government to make an informed decision regarding your capabilities, however, the statement should not exceed 10 pages. (b) The capability statement should include references, key personnel, and any teaming arrangements needed to fulfill the requirements. It must identify the responder's small business type and size. (c) All capability statements must be submitted in writing, five copies, no later than 3:00pm eastern standard time on Tuesday, October 14, 2008 to the following address: Contracting Officer, NIDDK Acquisitions Management Branch, 2 Democracy Plaza, Suite 700W, 6707 Democracy Boulevard, MSC 5455, Bethesda, Maryland 20892-5455 (If using delivery service, use Bethesda, Maryland 20817). Responses will not be accepted via email or fax.