RFP ANNOUNCEMENT:  Preclinical Services for the Development of Biopharma-Ceutical Products for Infectious Diseases - NIH-NIAID-DMID-NIHAI2010102CODE)


Notice Number:  NOT-AI-11-021

Key Dates

Release Date:   December 20, 2010

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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 biopharmaceutical 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.

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 therapeutics 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 nontraditional, proactive, and product development-oriented program to provide preclinical development support for promising biopharmaceutical therapeutic 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 biopharmaceutical 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.

Project Requirements: The Contractor shall provide DMID with a broad and flexible range of nontraditional, proactive and development-oriented capabilities to provide preclinical development

support for promising biopharmaceutical products when such products emerge from investigator initiated research studies or other sources identified by DMID Program staff. These capabilities will allow DMID to more rapidly and efficiently close development and production gaps. The Contractor shall assist DMID staff in providing all support and appropriate documentation needed for preclinical activities to support IND submissions for Phase I and II clinical testing, or Biologic License Applications (BLAs) for advanced products. Specific Task Orders will depend on the status of the candidate(s) as part of an overall product development plan and/or regulatory submission plan to the FDA. 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 Manufacturing Practices (cGMP) [21 CFR Parts - 11, -210, -211, -600].

The following definitions will apply:  Biopharmaceutical Products - Materials that are derived from biotechnology processes including, but not limited to, monoclonal antibodies and derivatives of monoclonal antibodies; recombinant proteins; peptides; nucleic acid based vectors (siRNA, plasmids); and live, modified-live and/or attenuated entities; Therapeutic - A product intended for use in the cure, mitigation or treatment of disease caused by a pathogen or certain toxins, e.g., botulinum toxin.

The services shall be directed at the following: 1) diseases caused by pathogens and toxins on the National Institute of Allergy and Infectious Diseases (NIAID) Category A, B, and C Priority Pathogens list; 2) emerging and re emerging infectious diseases; 3) antimicrobial resistant and multi drug resistant infections; 4) other bacterial infections; 5) fungal infections; 6) viral infections; and 7) parasitic diseases.

The Contractor shall be required to carry out the Scope and Activities defined in the following six Task Areas:

(1) Administrative, Management and Technical Support: 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 1824 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) Feasibility Assessments and Audits: The scope of Task Area 2 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; and conducting, reviewing and evaluating audits of potential vendors. Audit types include technical and/or facilities audits. The estimate of effort for this task area is 442 hours per feasibility assessment and 154 hours per audit.

(3) Assay Development and Product Characterization: The scope of Task Area 3 includes performing activities required for the design, development, qualification and validation of assays as needed for the characterization of a biopharmaceutical product to demonstrate safety, identity, potency, purity, and quality; performance of product characterization tests required for in-process testing and subsequent lot release of produced materials. Other activities under this service include method comparability studies, redevelopment or improvement of existing assays and technology transfer of assays 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, as well as all PHS Safety and Health provisions. The estimate of effort for this task area is 1,306 hours per task.

(4) Process Development and Related Activities: The scope of Task Area 4 includes development and performance of production and purification processes amendable to scale-up for the manufacture of biopharmaceutical 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. 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, as well as all PHS Safety and Health provisions. The estimate of effort for this task area is 5,232 hours per task.

(5) cGMP Manufacture and Related Activities: The scope of Task Area 5 includes producing cGMP biopharmaceutical 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, as well as all PHS Safety and Health provisions. The estimate of effort for this task area is 4,666 hours per task.

(6) Regulatory Activities and Documentation: The scope of Task Area 6, 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. The estimate of effort for this task area is 1,133 hours per task.

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.

NIAID anticipates award 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 September 30, 2011.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about December 14, 2010, 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.

Inquiries

Please direct all inquiries to:

CONTRACTING OFFICE ADDRESS

Department of Health and Human Services
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Office of Acquisitions
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD  20892-7612

POINT OF CONTACT
Andrew Q. Cherry
Contract Specialist
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-402-2443
Fax 301-402-0972
Email cherryan@niaid.nih.gov

Deborah Anderson
Lead Contract Specialist
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-402-2234
Fax 301402-0972
Email andersondj@niaid.nih.gov


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