SOURCES SOUGHT
A -- Production Assistance for Cellular Therapies (PACT) – Coordinating Center
- Notice Date
- 10/31/2014
- Notice Type
- Sources Sought
- 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
- HHS-NIH-NHLBI-SBSS-HB-16-08
- Archive Date
- 12/2/2014
- Point of Contact
- Justin M. Borden, Phone: 3014350348, Jeffrey A Williams, Phone: (301) 402-1677
- E-Mail Address
-
justin.borden@nih.gov, jeffrey.williams@nih.gov
(justin.borden@nih.gov, jeffrey.williams@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Contracting Office Address 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 Drive RKL2/6016, MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES Inroduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under NAICS code 541712 should not submit a response to this notice. Background 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. The current segment of the Production Assistance for Cellular Therapies (PACT) program (2010-2015) includes five Cell Processing Facilitates (CPFs) and one Coordinating Center (CC). The five CPFs provide production assistance in areas ranging from translational development to the scale-up of a product to the manufacture and delivery of clinical grade cellular therapy products for animal safety studies and Phase I/II clinical trials. Applications for product manufacture are received via a web portal and managed by the CC. Applications that are found to be of programmatic interest to the Institute and associated with a funded clinical study are considered for manufacture by the program. In addition, the CPFs and the CC provide education and regulatory support through active assistance with product regulatory materials, cell processing workshops, presentations at scientific meetings, peer reviewed publications, and educational web seminars. For more information on the 2010-2015 PACT programs, see http ://www.pactgroup.net/. The National Heart, Lung, and Blood Institute (NHLBI) is planning a 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. This program will fund up to eight (8) geographically dispersed Cell Processing Facilities (CPFs) and one (1) Coordinating Center (CC) within 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 CC shall be the monitor and coordinator for organizational and regulatory aspects of the PACT Program. The PACT CPFs shall be established to serve investigators as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. (Refer to Sources Sought Notice HHS-NIH-NHLBI-SBSS-HB-16-09 for the PACT CPFs). The services of the PACT renewal 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 shall include support for IND-enabling translational research and diversifying the cell therapy expertise within the program by increasing the number of manufacturing CPFs up to eight. The PACT program shall no longer provide cellular products for Phase I/II clinical trials; however, it shall reflect operational changes in the review and selection of applications for services. Project Requirements The NHLBI is seeking a small business with the ability to serve as the CC for a five-year renewal of the NHLBI PACT program. The CC is expected to fulfill the following: 1. Design and maintain a Manual of Procedures (MOP). 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. Promote communication between the CPFs and NHLBI. 4. Develop and maintain a public and private PACT website. a. Develop and maintain an interactive, secure, scalable and robust web-based information and data management platform, in collaboration with the NHLBI CORs and Steering Committee. b. Design a platform that is flexible to meet changing needs of the PACT program and NHLBI activities in cellular therapy translational research. c. Provide a secure environment and the necessary data management system(s) and informatics support to acquire, store, catalogue, query, and distribute documents and materials. d. Maintain computer programs, databases, and other resources used or developed that are compliant with terminology and data standards established by NHLBI. e. Ensure that the PACT computer hardware and software procedures comply with all Federal and State regulations. The website designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http ://www.access-board.gov/508.HTML 5. Establish and manage a process to review applications for PACT services including a peer review component. 6. Monitor, assess, and provide reports on the PACT CPFs program status. 7. Provide assistance to investigators, PACT CPFs, and NHLBI staff on regulatory issues related to the production of cellular therapy products. a. Propose strategies to ensure consistency among the CPFs in their operations and perform oversight functions. b. Develop a Section 508 compliant web based data management system to assist investigators with the development and preparation of Phase I or I/II clinical trial protocols, Chemistry Manufacturing and Controls (CMC) sections of the Investigational New Drug (IND) applications and Standard Operating Procedures (SOPs). c. Serve as the gatekeeper for regulatory compliance issues d. Possess knowledge of current Food and Drug Administration (FDA) regulations for cellular and gene therapy products. e. Provide regulatory assistance to NHLBI funded investigators or to investigators submitting applications to the NHLBI related to translational research in cellular therapies, at the request of the NHLBI COR. Assistance shall include, but is not limited to: i. Preparation of an IND, study design for a Phase I or I/II clinical trial, ii. Preparation of feasibility data and coordination with NIH-funded Clinical and Translational Science Award (CTSA) programs. Information about the CTSA program is available at http://www.ncats.nih.gov/research/cts/ctsa/about/about.html f. Assist the CPFs in developing, and assisting the investigator, of a PACT program approved project, to obtain an IND for a manufactured cellular therapy. These activities shall be conducted in accordance with current regulatory guidelines from the FDA and professional societies 8. Facilitate and coordinate the PACT program with relevant NIH/NHLBI programs. 9. Provide coordination for PACT training and educational activities and programmatic publications. 10. Develop and implement an outreach plan for the PACT program. 11. Provide biostatistical assistance with preclinical study design and early phase clinical trial design as necessary. 12. Perform the following for all translational service projects performed by the CPFs: a. Provide data management and analytical services for all approved projects. b. Analyze data collected. c. Participate in the analysis and writing of study manuscripts and reports for publication and presentation. d. Prepare and analyze data that will be used for specific manuscript preparation. e. Develop and obtain customer satisfaction data from the requesting investigator to address the quality and acceptability of the product and/or support for translational services 13. Ensure an orderly close out of the program or transition of PACT resources to a successor contractor at contract expiration. Anticipated Period of Performance March 1, 2016 - February 28, 2021 Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement and any furnished documents shall clearly address each of the following items separately and demonstrate: 1. Evidence of ability to perform and experience in fulfilling Coordinating Center functions, including methods for coordination, monitoring, and central management of all activities required for the collaborative development of cell processing protocols; 2. Evidence of ability to perform and experience in performing the project requirements described above; 3. Qualifications and availability of proposed personnel, with experience pertinent to the operation of an Coordinating 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. Potential Offerors shall include information to support that it has the necessary staffing and flexibility to meet the stages of the program from SOP and protocol development to product manufacture; 4. Evidence of the organizational and administrative structure capable of meeting the needs of the proposed program. Potential Offerors shall include information on: a) prior successful participation in multicenter studies related to cellular therapies, transfusion medicine or hematopoietic transplantation, both in the collection of data from multiple laboratory sites, as well as experience in monitoring the quality and timeliness of such data and availability; and b) facilities, equipment, and space; 5. 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. 6. Ability to recruit and engage scientific expertise in the areas of heart, lung, and blood diseases as required by products or services requested; 7. Evidence of leadership in authoring and publishing scientific papers in pre-clinical research; 8. The firm's status as a small business under NAICS code 541712. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Jeffrey Williams, Contracting Officer, at Jeffrey.Williams@nih.gov and Justin Borden, Contract Specialist, at Justin.Borden@nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate one (1) cost-reimbursement Options Contract, for a period of five years with an approximate award date of March 1, 2016. Original Point of Contact Jeffrey Williams, Contracting Officer, NHLBI Extramural Contracts Branch, Phone (301) 435-0335, Fax (301) 480-3338, Email: Jeffrey.Williams@nih.gov Justin Borden, Contract Specialist, NHLBI Extramural Contracts Branch, Phone (301) 435-0348, Fax (301) 480-3338, Email: Justin.Borden@nih.gov 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 RKL2/6016 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES.
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