SOLICITATION NOTICE
A -- Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases
- Notice Date
- 5/27/2011
- 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 Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIAID-DMID-NIHAI2010107
- Archive Date
- 6/28/2011
- Point of Contact
- Nicole Gordon, Phone: (301) 402-0972, Deborah Anderson, Phone: 301-402-2234
- E-Mail Address
-
gordonn@niaid.nih.gov, andersondj@niaid.nih.gov
(gordonn@niaid.nih.gov, andersondj@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement for a contractor to provide a suite of product development services. While the overall suite of services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine and other biologics product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services have helped a wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter a Phase I trial. Description Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to study control and prevent diseases caused by all infectious agents (except HIV). Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts. DMID also supports an array of research resources and services to assist investigators, including programs that provide or make available genomic data and technologies; organisms and state-of-the-art reagents; biocontainment facilities; and preclinical and clinical translational research services. (http://www3.niaid.nih.gov/research/resources/dmid). The development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requires a product development-oriented program to provide preclinical development support for multiple vaccine and biologic candidates that emerge from academia, the private sector, or other sources. The suite of services will encompass those activities commonly associated with the development of vaccine and biologic products for infectious disease required for Investigational New Drug (IND) application and/or Biologic License Application (BLA). Consequently, DMID recognizes that to obtain the full spectrum of expertise or facilities required to perform all activities set forth in this solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants. The Contractor shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order. Purpose and Objectives: The purpose of this solicitation is to establish a NIAID resource entitled "Manufacture and Characterization Services (MCS) for the Development of Vaccines and Other Biologics for Infectious Diseases" that provides a suite of product development preclinical services from early feasibility studies through manufacture and release of Phase I/II material. While the overall suite of services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine and biological product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II trials. Project Requirements: The Contractor shall provide DMID with a broad and flexible range of development-oriented capabilities to provide preclinical development support for multiple vaccine and biologic products when such products emerge from investigator-initiated research studies or other sources identified by DMID Program staff. These capabilities span early feasibility studies through manufacture of Phase I/II material to more rapidly and efficiently close development and production gaps, increase the government's response to emerging disease threats, and improve surge manufacturing capabilities. The Contractor shall also provide appropriate documentation and support for pre-IND and IND submissions for Phase I and II clinical testing. DMID will issue a Task Order Request for Proposal after determination of a specific need that is appropriate to the Statement of Work. The Contractor shall be prepared to develop a response in which the Contractor specifies the methods it will employ in accomplishing the key components of each Task Order and the associated costs. The needs, funding, product maturity and timelines of the product as specified in the Task Order establishes requirements for compliance with current Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) [21 CFR Parts -11, -58, -210, -211, -600]. For the purposes of this contract, the following definitions shall apply: •Vaccines - An antigenic preparation used to render an organism immune to an infectious disease by inducing or increasing immunity for prophylaxis and/or therapy. Vaccine product include but are not limited to synthetic peptides, recombinant proteins, nucleic acids, viral-like particles, vector-based vaccines, as well as live, modified, and/or attenuated organisms. •Vaccine Components - An antigen-enhancing substance (i.e. adjuvant) or a delivery system (i.e. needle free dermal patch) that is used during dose administration to enhance the immune response of a vaccine. •Other Biologics - Therapeutic preparations made from living organisms or the components of living organisms and are most likely regulated by CBER. Biologics include but are not limited to allergenics; antitoxins; blood and blood products; and cellular and gene therapy products. For the purposes of this contract, challenge material for non-clinical, preclinical, and clinical trials will also be added to the definition of biologics. The services shall be directed at the following: •diseases caused by pathogens and toxins on the National Institute of Allergy and Infectious Diseases (NIAID) Category A, B, and C Priority Pathogens list (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/Pages/CatA.aspx) •emerging and re emerging infectious diseases; •antimicrobial resistant and multi drug resistant infections; •other bacterial infections; •fungal infections; •viral infections; and •parasitic diseases. The Contractor shall be required to carry out the Scope and Activities defined in the following five Task Areas: (1) Administrative, Management and Technical Support: It is estimated that one Task Order will be assigned under this Task Area. The Task Order will be a cost-reimbursement, term (level of effort) type contract with a Base Period of 12 months and multiple Options to extend the Base Period of Performance in 12-month increments up to a total of 10 years to continue the same requirement. The contractor is REQUIRED to provide a total level of effort of 307 total direct labor hours per year based on a Work Year of 1920 productive work hours (excluding vacation, holiday, sick leave) for a period of performance of 10 years (Base period plus nine, one-year Options). The scope of this Task Area's activities includes the ability to facilitate ad hoc meetings and provide ad hoc reporting as part of general administrative, management, and technical support activities that are not Task Order specific. (2) cGMP Manufacture and Related Activities: The scope of Task Area 2 includes producing cGMP vaccine and biologic products in accordance with relevant FDA guidelines and the performance and documentation of all other related activities including product release assays required for human clinical use. The Contractor shall be responsible for directing and ensuring the successful technology transfer of all materials, assays, methods and procedures as required for the successful performance of the activities. The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations. (3) Process Development and Related Activities: The scope of Task Area 3 includes development and performance of production and purification processes amendable to scale-up for the manufacture of vaccine and biologic products; the production of research-grade products and cGMP materials; performance of product characterization tests required for in-process testing and subsequent lot release of produced materials; developing and performing animal immunogenicity and potency assays; and perform non-clinical animal testing. Activities may also include technology transfer of processes to/from other facilities. The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations. (4) Feasibility Assessments and Audits: The scope of Task Area 4 includes assessing and advising via documented communications (e.g., reports) on products for feasibility of design, development, manufacture, assay development and stability for the development of Phase I and II clinical trial materials; developing and writing Preclinical and/or Product Development Plans for specified products; performing risk/gap analysis for incoming projects and materials; and conducting, reviewing and evaluating audits of potential vendors. Audit types include technical and/or facilities audits. (5) Regulatory Activities and Documentation: The scope of Task Area 5, for products produced and/or tested for use in NIAID-sponsored research in collaboration with the product supplier, includes developing a Manufacturing Report; Chemistry, Manufacturing and Controls (CMC) Information; a Master File; and other regulatory documents 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).] The Contractor shall obtain and compile, in consultation with the COTR, product sponsors, subcontractors and/or consultants, the nonclinical data, CMC, and other appropriate documentation for submission to either the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER), FDA, or non-domestic regulatory authorities, as applicable. Task Order(s) may be comprised of only one Task Area or may be a combination of multiple Task Areas. Agency Contracting Officer's Technical Representative (COTRs) and scientists will collaborate with the Contractor in all awarded Task Orders. Technical Requirements will be defined in the individual Task Orders. The list below represents the average number of specific tasks offerors should assume to perform each year under the contract. This list is provided to indicate the general scope of work of this contract. Assume that the period of performance of task orders may range from less than one year to multiple years. 1 task order/year -- Administrative, Management, and Technical Support (Area 1) 6 task orders/year -- cGMP Manufacture and Related Activities (Area 2) 6 task orders/year -- Process Development and Related Activities (Area 3) 8 task orders/year -- Feasibility Assessments and Audits (Area 4) 6 task orders/year -- Regulatory Activities and Documentation (Area 5) NIAID anticipates awarding a single 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 will be issued after the award of the IDIQ contract for an ordering period of seven years beginning on or about June 21, 2012. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about June 23, 2011, and may be accessed through FedBizOpps http://www.fbo.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
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