Request for Proposals (RFP): NIAID Preclinical Development Support NIAID-DAIDS-NIHAI2015035
Notice Number: NOT-AI-16-036
Release Date: March 3, 2016
This RFP will be available electronically on/about March 11, 2016
National Institute of Allergy and Infectious Diseases (NIAID)
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. NIAID, has a requirement for seeking a contractor to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies.
The primary intent of this RFP solicitation is to provide preclinical development support for promising products 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 provide 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.
Specifically, 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 develop and manage a database 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:
- 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:
- Project Management: Provide overall project management; subcontract solicitation, award and administration; organize and coordinate meetings.
- 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.
- Document Management: Develop, maintain and submit documents (eg. reports, protocols, meeting agendas, meeting minutes, project timelines, etc.)
- Storage and Shipping: Provide secure storage of products, materials, reagents, and specimens under controlled temperatures; retrieve, package and ship materials under CGMP conditions.
- 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.
- Transition: Provide an initial transition plan.
- 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.
- 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.
- 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.
- 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.
- 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.
This is a recompetition of an existing contract entitled “Preclinical Development Support” with Advanced BioScience Laboratories, Inc., under contract number HHSN272201100021I.
It is anticipated that one Indefinite Delivery Indefinite Quantity (IDIQ) type contract will be awarded for a 7-year period of performance beginning on or about March, 2017.
All responsible sources may submit a proposal which shall be considered by the Agency. This RFP will be available electronically on or about 3/11/2016 and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
For this solicitation, the NIAID requires proposals to be submitted via two methods:
- Disc (CD or DVD) and
- Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.
For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."
To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 4 weeks. For more information, please see http://era.nih.gov/applicants/how-to_steps.cfm#register.”
Please direct all inquiries to:
National Institute of Allergy & Infectious Diseases (NIAID)
Michelle L. Scala
National Institute of Allergy & Infectious Diseases (NIAID)