Cell Processing Facilities in support of the NHLBI Production Assistance for Cellular Therapies (PACT) Program and Support of 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 is 500 employees, to perform as a Cell Processing Facility for the competitive renewal of the Production Assistance for Cellular Therapies (PACT) Program. The objective of this program 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 be established through competitive acquisition along with One Coordinating Center. This is a five-year requirement for Cell Processing Facilities to support translational research in novel cell therapies, to advance the field of cellular therapy, and to enable scientifically meritorious basic science research to reach the clinical trial stage even if the investigator lacks the internal resources or infrastructure needed. Information on the current PACT program may be viewed at http://www.pactgroup.net/. The successful Cell Processing Facility shall be responsible for performing the following tasks: 1) Participate in developing a Manual of Procedures. 2) Provide investigators with requested translational study support or cellular therapy products. 3) Work cooperatively with Coordinating Center to implement procedures for evaluating, prioritizing and processing requests for service. 4) Assure prompt accumulation, entry, and editing of product related data in accordance with protocols. 5) Implement and maintain quality control and quality assurance plans for all products. 6) Design and implement monitoring plans for products including production, compliance, with regulatory requirements, and assistance in designing clinical studies. 7) Report adverse events. 8) Process, store, ship and analyze products produced. 9) Participate in yearly site visits conducted by the Coordinating Center. 10) Implement programs or mechanisms to train interested investigators in the conduct of translational research and manufacturing procedures. 11) Maintain a laboratory that meets all requirements for the production of clinical grade reagents. 12) For each manufactured product, the Cell Processing Manufacture shall provide protocol information, participate in analysis and writing of manuscripts and prepare archival samples from each lot manufactured. 13) Establish and implement a plan to work with institutional technical transfer offices to facilitate completion of material transfer agreements required to ship biological materials from one institution to another. 14) Work with PACT Coordinating Center to develop educational activities and partnerships with professional societies related to cellular therapies. 15) Establish and maintain working relationships with relevant NIH/NHLBI programs. This notice is not a request for proposal. 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) Ability to perform and experience in performing the tasks described above including documentation of the production of clinical grade cellular therapy products, the suitability of the quality control and quality assurance plans; and documentation of the facility's participation in early phase clinical trials of cellular therapy products. 2) Documented training, experience, expertise, and availability of the Principal Investigator for planning and directing the proposed cell processing facility. Adequate plans describing the synergy of your proposed team. Documented training, experience, and availability of personnel in conducting the proposed services; including evidence of leadership in authoring and publishing scientific papers in pre-clinical research and Phase I and I/II clinical trials; 3) Adequacy of the organizational structure of the cell processing facility. Availability and adequacy of the facilities and resources necessary to meet the objective of the proposed cell processing facility, including institutional commitment to the PACT program; and 4) the firm's 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 6124, 6701 Rockledge Drive - MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Kristiane E. Cooper, Contracting Officer, cooperke@nhlbi.nih.gov.