RFP Announcement: Pharmaceutical and Chemical Resources for AIDS Drug Development; RFP-NIH-NIAID-DAIDS-07-22

Notice Number: NOT-AI-06-025

Key Dates
Release Date: March 20, 2006
Receipt Date:  June 29, 2006

Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

The National Institute of Allergy and Infectious Disease (NIAID), NIH has requirements to establish formulations and clinical trial materials for AIDS therapeutics and establish analytical chemistry evaluation of AIDS therapeutics. This requirement will consist of Part A and Part B. Offerors may respond to Part A or Part B or both.


Part A shall develop and manufacture clinically relevant formulations or new pharmaceutical dosage forms for new anti-infectives or microbicides, or formulations for new uses of established anti-infectives or microbicides.  Additionally, small scale manufacture of clinical dosage forms shall be done in compliance with current Good Manufacturing Practices (GMP) guidelines to support NIAID-sponsored or other clinical trials.

The Contractor shall perform any necessary preformulation studies to determine physical/chemical properties of drug substances.  These determinations may include: identification of pKa's; partition coefficients; solubility in various solvents; pH-solubility profiles; pH-rate profiles; identification of drug-excipient interactions; and estimates of short term stability.  The Contractor shall develop dosage forms that are designed to: enhance drug solubility, or prolong drug delivery, or enhance drug stability, or provide targeted drug delivery, or improve bioavailability, or permit alternate route of administration or for alternative patient populations (e.g. pediatrics). The Contractor shall utilize appropriate analytical methods and techniques to characterize bulk drug substances, to quantitate and assess the stability of drug substances and drug products, and to investigate drug release properties in vitro.

The Contractor or its subcontractor shall manufacture pilot batches of conventional pharmaceutical dosage forms, and then manufacture, process, package, label and ship production batches in full compliance with current 21 CFR sections 210 and 211, Good Manufacturing Practice (GMP) regulations.  It is expected that the Contractor shall conduct quality control testing on bulk drug substances and on clinical dosage forms.  Tests may include, e.g., determinations of drug identity and purity, content uniformity, weight variation, sterility, pyrogenicity, particulate matter, pH, residual moisture, dissolution/disintegration characteristics, and stability studies.

The Contractor shall provide documentation pertaining to the composition, manufacture, and quality control of the drug substance and the manufactured drug product in sufficient detail such that it can be submitted to the FDA as part of an IND application.   The Contractor shall ship the manufactured, packaged, and labeled dosage forms utilizing shipping procedures and materials that maximize product stability.


Part B shall provide analytical chemistry evaluations of bulk drug substances and dosage formulations intended for use elsewhere in animal efficacy models, pharmacology and toxicology studies, pharmaceutical dosage form manufacture, and clinical trials. The Contractor shall conduct these evaluations in compliance with the U.S. Food and Drug Administration (FDA) current Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations when necessary to help assure that materials of known purity and defined quality are used in these other studies.  The Contractor also shall develop and validate new methods for detecting and quantitating experimental therapies and microbicides in biological matrices, and use these methods to analyze biological samples provided from outside sources.

The chemical entities to be submitted for analysis or assay development likely will include small molecules, peptides, and polymeric substances.  It is not anticipated that antibodies or vaccine products will be submitted for analysis.  Biological samples submitted for analysis will not contain infectious agents, but could be derived from once infectious material inactivated via chemical or thermal means prior to submission.

It is anticipated that one to two cost reimbursement, completion type contracts will be awarded, each with a period of seven (7) years, beginning approximately February 27, 2007. RFP NIH-NIAID-DAIDS-07-22 will be available electronically on or about February 27, 2006 with a closing date tentatively set for June 29, 2006, and may be accessed through the NIAID Office of Acquisition (OA) Home Page at http://www.niaid.nih.gov/contract -- and will also be posted on FedBizOps. Any responsible Offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract.  No collect call will be accepted.

For questions or further information, contact:
Catherine M. Kennedy, Contract Specialist
Office of Acquisitions, DEA, NIH, NIAID
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20817-7612
Phone 1-866-410-5787 (Ext 59981)
Fax 301-402-0972
Email: kennedyca@niaid.nih.gov

Michelle Scala, Contracting Officer
Office of Acquisitions, DEA, NIH, NIAID
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20817-7612
Phone 301-451-3693
Fax 301-480-4675
Email: MScala@niaid.nih.gov

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