Synthesis of Non-GMP Small Molecules

The Development Therapeutics Program (DTP) of the National Cancer Insitute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is soliciting organizations with expertise in organic synthesis to perform re-synthesis of compounds needed for NCI Experimental Therapeutics (NExT) Program, other NCI/NIH (National Institutes of Health) programs and molecules arising from biological evaluations as potential anticancer agents.

The Offerors shall synthesize target compounds as prioritized by NCI and deliver the synthesized compounds (15-25 per contract year) in amounts of 100 mg to 100 grams to the NCI repository.

The Offerors shall be responsible for the synthesis of generally known small molecules in the chemical literature and/or their derivatives with minor modifications as requested by NCI, and their shipment to the NCI repository. The synthesis assignments will include synthesis of the potential target anti-cancer agents of high purity and may include parallel synthesis of selected analogs. This solicitation is anticipated to result in multiple awards. The Offerors shall prepare Material Safety Data Sheets for all single compounds and libraries which are delivered, and check the purities of compounds when requested.

The contract type is multiple year, multiple award, work assignment, completion type contract with a one year base and four one year options. Offerors will be invited to submit proposals for an estimated 5,300 direct labor hours (~2.8 FTE's at 1875/hours per year) per contract year. The following mandatory qualification criteria will apply: 1) the Contractor cannot be a commercial pharmaceutical, chemical, or biotechnology firm or their subsidiary since the assignments include agents of a commercially confidential (discreet) nature; 2) as many of the compounds assigned for synthesis may be of a hazardous nature, the Contractor shall have the licenses in place at the time of application, required by Local, State, and Federal Governments to handle, synthesize, store, and ship such compounds and dispose of toxic waste.

The NAICS code for this acquisition is 541990. The solicitation is scheduled for electronic release on or about September 15, 2012. The RFP may be accessed through the NCI Office of Acquisitions, NCI homepage by using the following address: http://rcb.cancer.gov/rcb-internet/index.jsp; or through FedBizOpps.gov https://www.fbo.gov/. It is the offeror's responsibility to monitor the above internet sites for the release of this solicitation and amendments if any. ALL OFFERORS WILL BE RESONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN ADDITIONAL, ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY. NO ELECTRONIC OR FAX SUBMISSIONS WILL BE ACCEPTED. NO COLLECT CALLS WILL BE ACCEPTED.

Point of Contact: Brenda Oberholzer
oberholzerb@mail.nih.gov
Phone: 301-624-8750

Incorrect description posted.

The mission of the Developmental Therapeutics Program (DTP), DCTD, NCI centers on the discovery and preclinical development of agents with clinical anticancer potential. Preclinical pharmacokinetic and metabolism studies are an early and integral part of the overall drug development process and contract resources for preclinical development studies have existed in DTP continuously since the late 1970s. Characterization of the pharmacokinetics of new compounds provides important information for the selection of optimal drug development candidates and for the design and interpretation of preclinical efficacy studies, including the selection of formulations, routes, and schedules of administration. Moreover, one objective of preclinical toxicology evaluations is the correlation of toxic effects of a compound with plasma concentrations and/or area under the curve (AUC). The successful outcome of these studies thus depends heavily on the availability of sensitive methods for quantifying compounds in biological fluids and the careful integration of preclinical pharmacology and toxicology data.


Project Requirements

Activities of any contract awarded from the proposed solicitation will include, but not be limited to, the following tasks:

(1) Development of sensitive analytical methods to quantify compounds in plasma, urine, tissues, and other biological matrices;

(2) Plasma stability and protein binding studies, which are conducted at an early stage of compound development to ensure proper sample handling and to aid in the interpretation of in vivo studies;

(3) Pharmacokinetic evaluation of test compounds following administration to animals by various routes and schedules, including a determination of bioavailability by various routes;

(4) Quantification and identification of drug metabolites generated in vivo and in various in vitro systems (S9 fractions,


Anticipated Period of Performance

The anticipated period of performance will consist of a one year base and four (4), one year options, from March 15, 2012 through March 14, 2017.

Mandatory Qualification/Mandatory Exclusion Criteria

Supporting documentation demonstrating compliance with the Mandatory Qualification and Mandatory
Exclusion Criteria listed below must be included with the initial proposal submission.

1. Mandatory Qualification Criterion

The offeror must possess a valid Nuclear Regulatory Commission (NRC) license, a license issued by a state that has entered into an agreement with the NRC, or an equivalent foreign license at the time of proposal submission permitting the purchase, storage, and use of radioisotopes (e.g., 3H, 14C, 35S) likely to be used in the proposed pharmacological research.

2. Mandatory Exclusion Criterion

The offeror may not be a pharmaceutical, chemical, or biotechnology firm. For purposes of this RFP, a pharmaceutical, chemical or biotechnology company is defined as an organization which sells drugs and/or chemicals to the general public for profit or is engaged in research leading to such products.

NAICS for this acquisition is 541990.

The solicitation is scheduled for release on or about September 15, 2012. The RFP may be accessed through the NCI Office of Acquisitions homepage located as http://rcb.cancer.gov/rcb-internet/index.jsp. It is the offeror's responsibility to monitor the above internet site for the release of this solicitation as well as any amendments. ALL OFFERORS WILL BE RESONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN ADDITIONAL, ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY. NO ELECTRONIC OR FAX SUBMISSIONS WILL BE ACCEPTED. NO COLLECT CALLS WILL BE ACCEPTED.

Point of Contact: Brenda Oberholzer
oberholzerb@mail.nih.gov
Phone: 301-624-8750