SOLICITATION NOTICE
A -- Production Assistance for Cellular Therapies (PACT) – Coordinating Center (CC)
- Notice Date
- 3/27/2015
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-ECB-HB-2016-08-JB
- Archive Date
- 4/26/2015
- Point of Contact
- Justin M. Borden, Phone: 3014350348, Jeffrey A Williams, Phone: (301) 435-0338
- E-Mail Address
-
justin.borden@nih.gov, williamsja2@nhlbi.nih.gov
(justin.borden@nih.gov, williamsja2@nhlbi.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Coordinating Center (CC) for a five year renewal of the program entitled "Production Assistance for Cellular Therapies (PACT). The purpose of this announcement is to provide a Pre-Solicitation Notice for the release of Solicitation NHLBI-ECB-HB-2016-08-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 Objectives THIS IS A TOTAL SMALL BUSINESS SET ASIDE. The 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, and 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 cellular products manufactured by the CPFs are intended for non-clinical use within the United States. The CC shall be the monitor and coordinator for organizational and regulatory aspects of the PACT Program The CC shall be responsible for: 1) the management and coordination of the NHLBI Production Assistance for Cellular Therapy (PACT) program working cooperatively with NHLBI and up to eight (8) Cell Processing Facilities (CPFs); 2) coordinating study activities; 3) participating in steering committee and subcommittee meetings; 4) serving as a resource for new and existing NHLBI cellular therapy programs and investigators; 5) implementing plans to achieve program objectives; and 6) monitoring and coordinating the organizational and regulatory aspects of the PACT Program. PACT Steering Committee, Expert Evaluation Panel, Scientific Review Board, and RSA Review Process The PACT Steering Committee (SC) shall guide the development, oversee the operations of the PACT program, and monitor the progress on approved and funded projects. The SC Chair will be an investigator that is not directly associated with any of the PACT contractors. Each of the PACT contractors shall have one (1) representative on the SC. The committee shall consist of up to nine (9) PACT contractor members (one from the CC and each CPF) plus the Chair and representatives from NHLBI. The CC shall provide honoraria to the SC chair, administrative and logistics support for the SC meetings and prepare meeting minutes. The CC shall arrange and coordinate SC teleconferences, which will be held as needed and average less than four per month. The SC shall develop and implement a Manual of Procedures (MOP). The MOP shall describe the operation of the CC and the CPFs and shall include procedures for the evaluation, prioritization, and processing of Requests for Services Applications (RSAs) from investigators. The MOP shall be completed and approved before any RSAs will be accepted by the PACT program. Subcommittees may be formed to address and oversee programmatic activities such as education and publications. Membership of the subcommittees will consist of at least one key personnel from each CPF and the CC. The NHLBI shall establish a five member external PACT Expert Evaluation Panel (PEEP) to evaluate the goals and progress of the PACT program. The overall objective of the PEEP shall be to determine if the PACT program is meeting the needs of the scientific community and if so, how effectively. The CC shall assist the NHLBI Contracting Officer's Representatives (CORs) with the selection and invitation of the PEEP and provide honorarium support to its members. The PEEP shall meet once a year in Bethesda, MD. The CC shall develop metrics in collaboration with the SC and NHLBI to track and monitor program progress including, but not limited to, the timeliness and quality of services and success in meeting program goals. The CC shall prepare potential metrics for discussion at the first SC meeting and shall collaborate with the SC to finalize the metrics within six (6) months of contract initiation. The metrics shall be included in the MOP and revised as needed throughout the contract period. The CC, in collaboration with NHLBI, shall identify scientists for the PACT Scientific Review Board (SRB) who will be able to provide a merit evaluation of the RSAs. These scientists, who are not directly associated with any of the PACT contractors, shall form the SRB from which three (3) members will be selected to submit an electronic review for each RSA. The CC shall prepare and send the invitations and provide honorarium support to SRB members. The CC shall develop the RSA review process which will include the electronic distribution of applications and evaluations. The CC shall coordinate and conduct all interactions with the SRB regarding the review of RSAs. The CC shall provide written summaries of the reviewer's scores and critiques to NHLBI CORs. NHLBI CORs shall be responsible for making the determination of which RSA will be selected for PACT support. Approximately 90 RSAs are anticipated to be reviewed during the five (5) year program. Under this solicitation, the Government anticipates the award of one (1) Cost-Reimbursement options contract for a period of approximately five years with an estimated award date of July 1, 2016. The period of performance of the options contract will be for a total of five (5) years, including three (3) phases. Phase I "Planning Phase" will consist of a base of six (6) months, Phase II "Operational Phase" will consist of five (5) ten (10) option periods, and Phase III "Closeout Phase" will consist of one (1) four (4) month option 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 program phases shall total 60 months. The corresponding phases are as follows: Program Phase Number of Months 1. Planning Phase 6 2. Operational Phase 50 3. Closeout Phase 4 Project Requirements The important overall technical requirements associated with the Production Assistance Cell Therapy (PACT) program Coordinating Center (CC) include the following: • Design a Manual of Procedures (MOP) to achieve program objectives. • Coordinate PACT activities and participate as a member of the SC and subcommittees. • Establish the PACT Expert Evaluation Panel (PEEP) to evaluate the goals and progress of the PACT program. • Promote communication between the CPFs and NHLBI. • Develop a public and private PACT website. • Monitor, assess, and provide reports on the PACT CPFs' program status. • Provide assistance to PACT CPFs and NHLBI staff on regulatory issues related to the production of cellular therapy products. • Facilitate and coordinate the PACT program with relevant NIH/NHLBI programs. • Provide coordination for PACT training and educational activities and programmatic publications. • Develop and implement an outreach plan for the PACT program. • Maintain a Manual of Procedures (MOP). • Coordinate PACT activities and participate as a member of the SC and subcommittees to develop and implement a coordinated plan to achieve program objectives. • Convene and monitor the PACT Expert Evaluation Panel (PEEP). • Promote communication between the CPFs and the NHLBI. • Maintain a public and private PACT website. • Manage a process to review applications for PACT services including a scientific review component. • Monitor, and assess the PACT CPFs program status. • Provide assistance to investigators, PACT CPFs, and NHLBI staff on regulatory issues related to the production of cellular therapy products. • Provide bio statistical assistance with preclinical study design and early phase clinical trial design as necessary. • Perform the following for translational service projects performed by the CPFs: • Facilitate and coordinate the PACT program with relevant NIH program and external government staff. • Provide coordination for PACT training and educational activities and programmatic publications. • Develop and implement an outreach plan for the PACT program. • Coordinate PACT activities and participate as a member of the SC and subcommittees to develop and implement a coordinated plan to achieve program objectives. • Promote communication between the CPFs and the NHLBI. • Maintain a public and private PACT website. • Monitor, and assess the PACT CPFs program status. • Facilitate and coordinate the PACT program with relevant NIH program and external government staff. • Closeout 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-ECB-HB-2016-08-JB/listing.html)
- Record
- SN03682346-W 20150329/150327235652-01f4716c854a35c17a88c7d7cf508963 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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