Production Assistance for Cellular Therapies (PACT) - Cell Processing Facilities (CPFs)
Added: Mar 27, 2015 7:25 am
The National Heart, Lung, and Blood Institute (NHLBI) is seeking cell processing facilities for a five year renewal of the program entitled "Production Assistance for Cellular Therapies (PACT)-Cell Processing Facilities (CPFs)". The purpose of this announcement is to provide a Pre-Solicitation Notice for the release of Solicitation NHLBI-ECB-HB-2016-09-JB. The intended procurement is classified under NAICS code 541712 with a Size Standard of 500 employees. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.Background and Program ObjectivesThe National Heart, Lung, and Blood Institute (NHLBI) is planning a second competitive renewal for the Production Assistance for Cellular Therapies (PACT) program for the development of clinical manufacturing protocols and production of novel somatic (biological) cell therapies for use in pre-clinical studies to be used in support of Investigational New Drug (IND) applications. The objective of this program is to continue to advance cellular therapy research in the areas of regeneration of damaged/diseased tissues, organs, biologic systems, and targeted treatments for serious diseases without effective therapies. This program will fund up to eight (8) geographically dispersed Cell Processing Facilities (CPFs) and one (1) Coordinating Center (CC) in the U.S. with the capacity to provide consulting, manufacturing, preclinical study, administrative, and regulatory expertise necessary for the development of novel cellular therapies in the area of heart, lung, and blood cellular therapy research. The PACT CPFs shall serve investigators within the scientific community as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. PACT CPFs shall manufacture cellular therapy products for investigators from academia and industry needing manufacturing support. The cellular products manufactured by the CPFs are intended for non-clinical use within the United States.Under this solicitation, the Government anticipates the award of eight (8) Indefinite Delivery, Indefinite Quantity (IDIQ) contracts with cost-reimbursement and fixed-price task orders for a period of approximately six years with an estimated award date of July 1, 2016.The period of performance of the IDIQ will be for a total of six (6) years: Five fiscal years of funding (from FY 2016 through 2020) shall be used to obligate amounts on all new task orders awarded within the five year ordering period (Years 1 through 5). No new task orders will be awarded and no funds will be obligated on existing task orders after the ordering period ends in Year 5. Up to one additional year (Year 6) shall be used to complete all unfinished work on any existing task orders awarded before the end of the ordering period.The second competitive renewal of the PACT program shall continue to provide the services that were identified as essential for the advancement of cellular therapy research by the previous PACT External Advisory Panel, investigators using PACT services, NIH working groups, and NHLBI staff. These services include providing support for IND-enabling translational research, and diversifying the cell therapy expertise within the program by increasing the number of manufacturing CPFs. The PACT program will no longer provide cellular products for Phase I/II clinical trials. The Statement of Work for the second renewal also reflects operational changes in the review and selection of applications for services. The anticipated number of awards to Cell Processing Facilities was established to meet the needs of the program by diversifying the cell therapy expertise and permits the capability to manufacture and ship cell therapy products that are not feasible over lengthy distances between the facility and the requesting investigator. The program phases shall total 60 months. The corresponding Task Area(s) for each phase shall be as follows: Program Phase Task Area(s)Number of Months1. Planning Phase1. Administrative and Regulatory Support 62. Accepting Service and Manufacturing Request1. Administrative and Regulatory Support 2. Cell Manufacturing and Process Development Services503. Requesting Closeout and Termination of Service Agreements1. Administrative and Regulatory Support 2. Cell Manufacturing and Process Development Services3. Program Closeout and Transition4Project RequirementsThe important overall technical requirements associated with the Production Assistance Cell Therapy (PACT) program include the following:• In conjunction with the CC and the other CPFs, participate in developing and maintaining a Manual of Procedures (MOP). • Participate as a member of the Steering Committee (SC) and subcommittees as necessary to achieve program objectives. • Work with the CC to implement procedures for evaluating and prioritizing Requests for Services Applications (RSAs). • Establish and implement a plan to work with institutional technical transfer offices to facilitate the development of a PACT material transfer agreement (MTA) template and other program specific templates. • Work cooperatively with the PACT CC to develop educational activities and partnerships with professional societies related to advancing cellular therapies.• Establish and maintain working relationships with relevant NIH ICs (Institutes and Centers) and NHLBI program officials. • Ensure effective program administration and orderly close-out of task order activities. • Provide and successfully deliver requested translational study support or cellular therapy products to investigators. • Facilitate the completion of site visits to be conducted by the CC.• Ensure an orderly close-out of task order activities. • Ensure an orderly and efficient closeout and transition of the program upon contract expiration.This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. This advertisement does not commit the Government to award a contract. The RFP will be available on the FedBizOpps Web page at http://www.fedbizopps.gov. Prospective offerors are responsible for downloading the RFP and all attachments. The offeror is responsible for monitoring the FedBizOpps Web page for the release of the solicitation and any amendments. The RFP will be available from the FedBizOpps on or about April 13, 2015.
NHLBI-ECB-HB-2016-09-JB Department of Health and Human Services National Institutes of Health
3/27/15, 7:25 AM