Preclinical Development Support

Added: Aug 13, 2010 9:15 am PRESOLICITATION NOTICE

NIAD Preclinical Product Development Support
RFP: NIAD-DAIDS-NIHAI2010098

Type of Requirement
0 New Requirement
1 Re-competition (Contract No.: N01-AI-40045)
0 Expansion of (Contract/RFP No.:______________)

Place of Performance
1 Place of performance is unknown at this time
0 Place of performance is known

Recompetition (if applicable)
Advanced BioScience Laboratories, Inc.
5510 Nicholson Lane
Kensington, MD 20895

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

Primary Point of Contact
Kishan Patel
Contract Specialist
patelki@niaid.nih.gov
Phone: (301) 594-0983

Secondary Point of Contact
Michelle L. Scala
Contracting Officer
mscala@niaid.nih.gov
Phone: (301) 451-3693

Anticipated Period of Performance
The anticipated period of performance is August 29, 2011 through August 28, 2018.

Anticipated award date: August 29, 2011

The NAICS Code is 541712-Research and Development in the Physical, Engineering and Life Sciences.

Presolicitation Notice Information

The NIAID is seeking a contractor to provide preclinical development support for promising candidates when such candidates emerge from investigator-initiated research studies.

The development of prophylactic vaccines in addition to other mucosally delivered inhibitory agents of HIV and/or preventative technologies 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.

The NIAID anticipates 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 will be issued after the award of the base contract.

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.

Specifically, the Contractor will manage a preclinical research program that identifies and develops potential HIV vaccines and microbicides by providing scientific, technical, and management expertise. The Contractor will assist in identification, testing, and development of vaccine and microbicide candidates; 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 vaccine and microbicide candidates. Furthermore, the Contractor will also maintain inventories of candidate vaccine and microbicide lots, provides quality assurance and quality control, provide the appropriate regulatory documentation, and develops and manages a database that will track the preclinical development of the vaccine and microbicide candidates. The Contractor will carry out, either directly or through subcontractors and/or consultants, tasks in the following areas: 1) Essential Core Activities, which include essential activities that will be performed by the Contractor on a regular basis and consists of the following: (a) Project Management; (b) Quality Assurance/Quality Control; (c) Information Technology and Data Management; (d) Storage and Shipping; (e) Reporting Requirements/Deliverables; and (f) Transition; 2) Feasibility Assessments, which include the assessment of products for feasibility of design, development, manufacture, potency assay development and stability for the development of phase I-III clinical trial materials; 3) Audits, which include the conduct, review and evaluation of audits. Types of audits to be conducted include, but are not limited to, technical and/or facilities audits; 4) Regulatory Documentation which include the development of a Master File, Investigator's Brochure, and compilation of 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).] Regulatory documentation is required for products produced and/or tested for use in NIAID-sponsored research, in collaboration with the product supplier; 5) Process Development and cGMP Manufacture, which includes the production of vaccines and research-grade products as requested by the COTR, including process development and production of cGMP pilot lots suitable for early phase human clinical trials, and performance of the necessary characterization tests required for release for clinical use; 6) Safety and Immunogenicity Testing, which includes the performance of pre-clinical testing of products as required for regulatory compliance prior to initial human clinical trial evaluation.

This is a recompetition of an existing contract entitled "Master Contract for Preclinical Development" with Advanced BioScience Laboratory, Inc., under contract number N01-AI-40045.

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 August 29, 2011.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about August 20, 2010, and may be accessed through FedBizOpps http://www.fedbizopps.gov/ and the NIAID Office of Acquisition (OA) Home Page at http://www.niaid.nih.gov/contract. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.