NCI Frederick Cancer Research and Development Center (NCI-FCRDC), P.O. Box B, Frederick, Maryland 21702-1201

A -- PHARMACEUTICAL CAPABILITIES AND SERVICES SOL S99-RAID DUE 052899 POC Dennis J. Dougherty, Contracting Officer, 301-846-1087; Terry W. Hebb, Sr. Contract Advisor, 301-846-5416 E-MAIL: Click here to submit inquiries or information via, jclarence@mail.ncifcrf.gov. DESCRIPTION: SAIC Frederick, as Operations and Technical Support contractor to the National Cancer Institute (NCI) for the Frederick Cancer Research and Development Center seeks qualified sources for services described below. THIS IS NOT A SOLICITATION OR A REQUEST FOR PROPOSAL. The Biological Resources Branch (BRB) of the Developmental Therapeutics Program (DTP), NCI, currently supports preclinical and early (e.g. Phase I) clinical studies to assess the effects of biological agents and correlate changes in the biological responses with antitumor activity. An NCI Preclinical Repository distributes selected agents for peer-reviewed preclinical studies performed by both extramural and intramural investigators. Other contracts support the production and in vivo evaluation of monoclonal antibodies, immunoconjugates and other biologicals. The NCI BRB Program Staff provides oversight of the Biopharmaceutical Development Program (BDP) at the Frederick Cancer Research and Development Center (FCRDC). The BDP produces a variety of biopharmaceuticals under currect Good Manufacturing Practices (cGMP) for Phase I/II human clinical trials or advanced preclinical animal testing. A new NCI program, RAPID ACCESS to INTERVENTION DEVELOPMENT (RAID), was recently implemented as part of the NCI development programs. It is specifically designed to facilitate translation of novel, scientifically meritorious therapeutic interventions originating in the academic community to the clinic. The program will do so by making available to the academic research community, on a competitive basis, NCI resources for the development of drugs and biologics. The program is intended to remove the most common barriers between discovery and clinical evaluation, including process development, production, testing, and regulatory affairs. The goal of the RAID program is to rapidly demonstrate clinical "proof of principle" for novel therapeutics and rapidly expand to Phase I/II clinical evaluation for promising agents. RAID is designed to accomplish the tasks that are rate-limiting in bringing discoveries from the laboratory to the clinic. Which tasks will be necessary to accomplish in any particular case will vary from project to project. In some cases RAID will support only the one or two key missing steps necessary to bring a compound to the clinic; in other cases it may be necessary to supply the entire portfolio of development tasks needed to file an IND. The NCI and SAIC recognize that alliance with numerous partners will be required to adequately and expeditiously achieve the goal of the RAID program. That efficient translation of novel therapeutics as part of the RAID program will require significant pharmaceutical development capacity or clinical development expertise. NCI and SAIC currently seek applicants interested in participating in a contracting program involving applicant involvement in a team-oriented process, from solicitation development, through proposal preparation, to evaluation, negotiation and award. The contracting program will rely on a team approach to concurrently develop a scope of work, price that scope, and prepare the contract to execute the scope. NCI and SAIC seek to achieve, in collaboration with interested participants several benefits of this contracting process: 1) Reduction in time to complete the proposal, the evaluation and the negotiation and award process; 2) Significant cost savings related to administrative lead time and proposal preparation; 3) Significant improvement in the understanding of project requirements by participating parties; and, 4) Increased accuracy in definition of the scope of work and pricing for RAID projects. SAIC currently seeks interested parties offering commercial services in the areas listed below. Interested parties are encouraged to forward corporate capability statements in response to this announcement. Comments, suggestions and recommendations are also appreciated. Written responses regarding capabilities in accordance with numbered Note 25 are preferred. Chemical Synthesis -- — -- Peptide, Oligonucleotide Synthesis, and Conjugation (Chemical, Radiochemical, Biological) Biologics Process Development and Production Services -- -- -- Expression System Development Cell Banking Fermentation/Mammalian Bioreactor Production Protein Reconstitution/Refolding Processes Downstream Processing and Purification Process Evaluation for Viral Clearance Aseptic Processing and Sterile Operations Gene Therapy Production Services -- -- -- Adenoviral Vector Production Retroviral Vector Production Natural Products Isolation -- -- -- Fermentation Recovery Liquid-Liquid Extraction Purification Formulations Development -- -- -- Lyophilized Dosage Forms Liquid/Semi-Solid Dosage Forms Liposomal Dosage Forms Controlled Release Dosage Forms Stability Evaluation Method Development and Quality Control Testing -- -- -- Biosafety Evaluation (Viral) of Mammalian Cell Lines Mammalian and Microbial Cell Line Characterization Bioanalytical Testing Chemical and Physical Testing Microbiological Testing Molecular Biology Testing Quality Assurance Services -- -- -- GMP Documentation Quality Auditing and Compliance Calibration/Validation Services GMP Training Services Posted 04/28/99 (W-SN325495). 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