Coordinating Center to Administer the NHLBI Production Assistance for Cellular Therapies (PACT) Program and Support NHLBI Translational Research in Cell Therapies

The National Heart, Lung, and Blood Institute (NHLBI) is conducting a market survey to assess the availability and potential technical capability of small business firms as defined by NAICS Code 541711, size standard 500 employees, to perform as a Coordinating Center for the competitive renewal of the Production Assistance for Cellular Therapies (PACT) Program. The objective of this initiative is to continue to advance cellular therapy research in the areas of regeneration of damaged/diseased tissues, organs, and biologic systems, and targeted treatments for serious diseases without effective therapies. It is anticipated that up to six Cell Processing Facilities will also be established through competitive acquisition. This is a five-year requirement for a Coordinating Center that will be responsible for the management and coordination of the NHLBI Production Assistance for Cellular Therapy (PACT) program working cooperatively with NHLBI and up to six (6) Facilities; coordinating study activities, participating in steering committee and subcommittee meetings, serving as a resource for new and existing NHLBI cellular therapy programs and investigators, and implementing a plan to achieve program objectives. Information on the current PACT program may be viewed at http://www.pactgroup.net/. The successful Coordinating Center shall be responsible for performing the following tasks: 1. Design and maintain a Manual of Procedures. 2. Coordinate PACT activities and participate as a member of the Steering Committee and subcommittees to develop and implement a coordinated plan to achieve program objectives. 3. Monitor and convene the PACT External Review Panel. 4. Promote communication between Facilities and NHLBI. 5. Manage PACT programmatic funds for data collection in qualified clinical trials using PACT products. 6. Develop a web-based application and monitoring system to collect, review, and monitor applications for translational services. 7. Develop and maintain public and private PACT websites including maintenance of a web-based catalogue of PACT cellular therapy products, and a data base of PACT funded clinical research with online data entry. 8. Establish and manage a process to review applications for PACT products including a peer review component. 9. Monitor the PACT program and assist with the development of metrics and reports to monitor other NHLBI programs in novel cell therapies. Perform annual site visits to PACT Cell Processing Facilities to audit program for regulatory compliance and provide written reports detailing the findings from the site visits. 10. Monitor, assess and provide reports on the PACT Facilities program status. 11. Provide assistance to NHLBI investigators, PACT Facilities, and NHLBI staff on regulatory issues related to the production and administration of cellular therapy products. 12. Provide biostatistical support for phase I/II clinical trials on an ad hoc basis and provide assistance with preclinical study design and early phase clinical trial design as necessary. 13. Provide data management and analytical services for manufactured products. 14. Monitor the reporting of adverse events associated with products manufactured by the Facilities. 15. Facilitate and coordinate the PACT program with relevant NIH/NHLBI programs. 16. Provide coordination for PACT training and educational activities and programmatic publications. 17. Develop and implement a marketing plan for the PACT program. 18. Ensure an orderly transition of PACT resources to a successor contractor at contract expiration. This notice is not a request for a competitive competition. However, if an interested party believes it can perform the above requirements, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must demonstrate: 1) Adequacy of plans for fulfilling the Coordinating Center functions, including methods for coordination, monitoring, and central management of all activities required for collaborative development of cell processing protocols; 2) Evidence of ability to perform and experience in performing the tasks described above; 3) Qualifications and availability of proposed personnel, with experience pertinent to the operation of an administrative center for a multicenter program including expertise in preparing regulatory submissions to the FDA, data collection and analysis, monitoring, standardization, quality assurance, quality control, preparation of scientific reports and manuscripts. Offerors should demonstrate a labor mix that has the necessary flexibility to meet the stages of the program from SOP and protocol development to product manufacture and clinical study review and oversight; 4) Adequacy of the organizational and administrative structure of the proposed program and institutional commitment to the program. Prior successful participation by the institution in multicenter studies related to cellular therapies, transfusion medicine or hematopoietic transplantation, both in the collection of data from multiple clinical and laboratory sites, as well as experience in monitoring the quality and timeliness of such data. Availability and adequacy of proposed Facilities, equipment, and space; 5) Demonstrated experience in administrative and scientific leadership and coordination necessary for soliciting cooperation from the cell processing Facilities and exercising appropriate leadership in matters of data acquisition, management, and analysis. Demonstrated ability to recruit and engage scientific expertise in the areas of heart, lung, and blood diseases as required by products or services requested; 6) Evidence of leadership in authoring and publishing scientific papers in pre-clinical research and Phase I and I/II clinical trials; 7) The firms status as a small business under NAICS code 541711. The Government is not responsible for costs associated with preparing capability statements in response to this announcement. Three copies of the material requested above should be submitted in writing and must contain material in sufficient detail to allow NHLBI to determine if the party can perform this requirement. Statements of capability must be received at the following address (or email of word document acceptable) no later than 4:00pm local time, December 3rd, 2008: National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions, Rockledge II - Room 6102, 6701 Rockledge Drive - MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Lisa A. Hill, Contracting Officer, hilll1@mail.nih.gov.