SYNTHESIS OF BULK CHEMICALS AND DRUGS FOR PRECLINICAL AND CLINICALSTUDIES



NIH GUIDE, Volume 24, Number 15, April 28, 1995



RFP AVAILABLE:  NCI-CM-57238-30



P.T. 34



Keywords:

  Chemical Synthesis 

  Chemistry, Organic 

  Chemotherapeutic Agents 



National Cancer Institute



The Pharmaceutical Resources Branch (PRB), Developmental Therapeutics

Program (DTP), Division of Cancer Treatment (DCT), National Cancer

Institute (NCI) at the National Institutes of Health (NIH)

anticipates making award(s) of cost-reimbursement, incrementally

funded contracts, for a base period of three years, with two one year

option years, beginning on or about April 1, 1996.  The objective of

this project is the preparation of chemicals and bulk drugs needed by

the program for preclinical and clinical studies.  This contract will

provide and operate a materials preparation laboratory for the

synthesis of varying amounts of materials, not readily available from

other sources in the quantity and/or quality needed by the NCI.  The

scale of the work to be performed under this solicitation requires a

functional large-scale facility with at least one (20-100 gallons)

glass-lined reactor, and several glass reaction vessels (50 and 100

litres), with the necessary supporting equipment and laboratories.

The project may be proposed on two levels.  Level I offerors shall

provide 2.75 to 3 technical staff years, per year, with completion

and deliveries of the targets of 8 to 12 assignments, excluding

reports.  Level ii offerors shall provide 5.5 to 6 technical staff

years, per year, with completion and deliveries of the targets of 15

to 25 assignments, excluding reports.  The proposed principal

investigator should be trained in organic or medicinal chemistry,

preferably at the Ph.D. level, from an accredited university or

possess equivalent experience, and have extensive experience in the

conception and execution of chemical syntheses, scaleups and

synthetic process development.  The offeror must be registered with

the Food and Drug Administration (FDA) as a manufacturer of bulk

drugs.  Facilities shall meet FDA standards in accordance with the

current good manufacturing practices (GMP), as well as be in

compliance with all OSHA, DOT, and EPA regulations, and those of

similar state and local agencies.  Non-compliance of the above

requirements shall render the proposal technically unacceptable,

without the consideration of award.  The standard industrial

classification (sic) code is 8731.  Offerors who qualify as a small

business are encouraged to submit proposals.  The facilities of

foreign offerors must conform to all the standards of their

equivalent national, state and local regulatory agencies.  This is a

recompetition of a group of contracts and clinical studies.  The

Request for Proposal (RFP) will be available on or about May 29,

1995.



INQUIRIES



A copy of the RFP may be obtained by written request to:



Elsa B. Carlton

Research Contracts Branch

National Cancer Institute

Executive Plaza South, Room 603

6120 Executive Boulevard MSC 7220

Bethesda MD  20892-7220



.

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