SOURCES SOUGHT
A -- NIAID PRECLINICAL DEVELOPMENT SUPPORT
- Notice Date
- 10/1/2015
- 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 Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHSN-NIH-NAID-RDSS-NIHAI2015035
- Archive Date
- 10/31/2015
- Point of Contact
- Kishan Patel, Phone: 240-669-5157, Michelle L Scala, Phone: 240-669-5156
- E-Mail Address
-
patelki@niaid.nih.gov, mscala@niaid.nih.gov
(patelki@niaid.nih.gov, mscala@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice Information Introduction 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 the applicable NAICS code should not submit a response to this notice. Background The development of vaccines and any other mucosally/systemically deliverable entities to prevent the spread of HIV infection is among the National Institute of Allergy and Infectious Diseases (NIAID) highest priorities. In addition, vaccines administered to infected individuals have potential for inducing immune control of the infectious agent. While advances in immunology and molecular biology continue to offer an expanding array of approaches for the development of new vaccines/products, there is limited capacity to move promising concepts through the development process. In order to supplement limited industry involvement in developing vaccines, NIAID requires a nontraditional, proactive and developmentally-oriented program to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. NIAID will use this contract to more rapidly and efficiently close development and production gaps. These functions support the fundamental goals of the Vaccine Translational Research Branch (VTRB) under the Vaccine Research Program (VRP), Division of AIDS (DAIDS). We anticipate awarding an Indefinite Delivery/Indefinite Quantity (IDIQ) contract to one organization that meets the overall qualifications needed to fulfill the technical requirements of the solicitation, providing a guaranteed minimum award. Task orders for specific tasks requiring specialized expertise shall be issued after the award of the base contract. This is a recompetition of an existing contract entitled "Preclinical Development Support" with Advanced BioScience Laboratories, Inc., under contract number HHSN272201100021I. Purpose and Objectives The Contractor shall provide preclinical development support for promising candidates when such candidates emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. Project Requirements The Contractor shall manage a preclinical research program that identifies and develops potential HIV products by providing scientific, technical, and management expertise. The Contractor shall assist in identification, testing, and development of products; participate in and manage preclinical testing including in vitro laboratory testing, immunogenicity testing, efficacy studies, and toxicology testing using laboratory animals; and utilize GMP production protocols to produce promising products. Furthermore, the Contractor shall also maintain inventories of products, provide quality assurance and quality control, provide the appropriate regulatory documentation, and provide document management that tracks the preclinical development of the products. The Contractor shall carry out, either directly or through subcontractors and/or consultants, tasks in the following areas: 1.Essential Core Activities: Upon award of the base contract Task Order A-1 will be issued for this task area and will be renewed annually for a total of 7 years. This task area includes essential activities that shall be performed by the Contractor on a regular basis and consists of the following: a.Project Management: Provide overall project management; subcontract solicitation, award and administration; organize and coordinate meetings. b.Quality Assurance/Quality Control: Provide a Quality Assurance Unit; establish a quality system for each task order; provide Quality Assurance/Quality Control oversight for Contractor and subcontractors. c. Document Management: Develop, maintain and submit documents (e.g., reports, protocols, meeting agendas, meeting minutes, project timelines, etc.) d. Storage and Shipping: Provide secure storage of products, materials, reagents, and specimens under controlled temperatures; retrieve, package and ship materials under CGMP conditions. e.Personnel and Physical Infrastructure: Provide personnel, facilities and equipment to carry out the requirements of the contract at the time of Task Order award including IT systems, document management, storage areas, office space, etc. f.Transition: Provide an initial transition plan. 2.Feasibility Assessments: Under this task area, the Contractor shall assess products for feasibility of design, development, manufacture, potency assay development and stability for the development of phase I-III clinical trial materials. Assume performance of 1 feasibility assessment/year for 7 years. 3.Audits: Under this task area the Contractor shall conduct, review and evaluate audits. Types of audits to be conducted include, but are not limited to, technical and/or facilities audits. Assume performance of 4 audits per year for 7 years. 4.Regulatory Documentation: Under this task area, for products produced and/or tested for use in NIAID-sponsored research, in collaboration with the product supplier, the Contractor shall develop a Master File, Investigator's Brochure, and compile an IND application, including a clinical trial protocol (provided by NIAID) appropriate for submission to the U.S. Food and Drug Administration (FDA). [Guidance on regulatory requirements can be obtained through the FDA Center for Biologics Evaluation and Research website (www.fda.gov/cber).] Assume development of documents for 1 Pre-IND and 1 IND per year for 7 years. 1.Process Development and CGMP Manufacture: Under this task area the Contractor shall produce vaccines and any other mucosally/systemically deliverable entities and research-grade products as requested by the Contracting Officer's Representative (COR), including process development and production of CGMP products suitable for human clinical trials, and perform the necessary characterization tests required for release for clinical use. Transient transfection is one of the required methods for CGMP manufacture of HIV-1 proteins. This includes electroporation and other forms of transient transfection, and the CGMP expansion and harvest of cell substrates produced by such means for use in the manufacture of HIV-1 protein vaccines. Assume the initiation of 1 CGMP manufacturing project each year for 7 years. 6.Safety and Immunogenicity Testing: Under this task area the Contractor shall perform pre-clinical testing of products as required for regulatory compliance prior to initial human clinical trial evaluation. Assume performance of 3 safety studies per year for 7 years. Anticipated Period of Performance The anticipated period of performance is for 7 years beginning January 10, 2017 through January 9, 2024. Capability Statement/Information Sought Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Respondents should have scientists, laboratories, CGMP facilities, and fill-finish facilities to allow production of prototype or intermediary components for vaccines. Interested contractors should have the capacity and experience to perform CGMP manufacturing including protein manufacture through transient transfection (electroporation) in CHO cells and be able to scale up CGMP protein upstream processes to produce sufficient materials for clinical trial use. Essential personnel include project managers, scientists, quality assurance, quality control, manufacturing, auditing, regulatory, and business contracting staff. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: a.DUNS number b.Company Name c.Company Address d.Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e.Current GSA Schedule appropriate to this Sources Sought f.Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g.Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) As validated via the Central Contractor Registration (CCR). All offerors must be registered in the CCR, located at http://www.ccr.gov/ Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Kishan V. Patel, Contract Specialist, at Patelki@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify Sources Sought Reference Number HHSN-NIH-NAID-RDSS-NIHAI2015035. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM (Eastern Prevailing Time) on 10/16/2015. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award an IDIQ contract or Task Order or otherwise pay for the information provided in 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 a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
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