SOLICITATION NOTICE
A -- Early Therapeutics with Phase II Emphasis
- Notice Date
- 7/22/2010
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- N01-CM-01018
- Point of Contact
- Michael P. Marino, Phone: 3014353801
- E-Mail Address
-
marinomic@mail.nih.gov
(marinomic@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- CTEP, NCI holds INDs for new anticancer agents from a variety of sources including those developed through NCI's Developmental Therapeutics Program (DTP), numerous agents developed and supplied by the pharmaceutical and biotechnology industries, and agents developed by academic investigators. NCI has collaborative agreements with 65 industry partners for 160 investigational agents. CTEP has filed approximately 8-10 IND applications annually in recent years and expects to file 10 this year. All but two of NCI's current INDs are for early clinical trials. A number of interrelated initiatives have recently been developed or implemented to create a cohesive and integrated NCI program in drug discovery and clinical development focused on molecularly targeted new agents. The contracts for Early Therapeutics Development with Phase II Emphasis will provide the major resource for rapid, efficient, systematic implementation of drug development plans for evaluation of NCI's portfolio of investigational agents in specific tumors. CTEP requires a total resource that will provide for 1400 to 1700 subjects accrued to 15-25 trials per year. CTEP intends to make multiple contract awards. Each Contractor shall be able to initiate one or more clinical trials per year using NCI-held IND anticancer agents. The size of each trial may vary depending upon whether it will involve the evaluation of an investigational agent administered alone, utilizing a 2-stage design of up to 35 or 40 subjects, or whether the investigational agent will be added to another therapy, which will require randomization to two or more arms, with each arm numbering 50-75 subjects. These contracts will require a consortium of clinicians, pathologists, imagers, statisticians, data managers, research nurses and others with early phase clinical trial expertise with investigational agents in cancer, as well as demonstrate the capability of carrying molecular and functional imaging and of acquiring, in sequential fashion, high quality patient samples. Reflecting the need to incorporate novel imaging endpoints in the development of investigational agents, the re-competed Phase II N01 Program will include the integration of molecular imaging with investigational drug development. Over the next 1-2 years, the DCTD Cancer Imaging program will be qualifying NCI designated Cancer Centers for their ability to carry out advanced molecular and functional imaging. Participation in this Phase II N01 Program will require that each offeror have at least 1-2 sites which have undergone such qualification and have identified committed personnel with appropriate imaging expertise i.e. nuclear medicine physicians and radiologists, who will be an integral part of the drug development team. Rapid translation of promising discoveries in the fields of molecular and functional imaging probes and methodologies requires timely and substantial support. We propose to support, in selective Phase II treatment trials, the evaluation of molecular and functional imaging agents, in a standardized, prospective fashion. This would enable the evaluation of the core issues of preliminary efficacy as well as technical performance issues which is often lacking in current trials (for e.g. reproducibility, quantitative vs. semi-quantitative analysis). The imaging agents and methods which prove successful in these early clinical trials can then be validated in larger studies through clinical trials in Cancer Centers and/or Co-operative Groups. The Government anticipates that eight to ten (8-10) contracts will be awarded for a period of five years. The anticipated date of release of the Request for Proposal (RFP) package is on or about August 6, 2010. The proposals will be due approximately 60 calendar days following the actual date of issuance of the RFP. Award of this project is anticipated by January 1, 2010. The NAICS Code is 541711. The RFP will be accessible through the internet at http://rcb.nci.nih.gov; it is the offeror's responsibility to monitor the internet site for the release of this solicitation and amendments, if applicable. POTENTIAL OFFEROR'S WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. ALL QUESTIONS MUST BE MADE IN WRITING. All responsible sources must submit a proposal that shall be considered by the NCI. No collect calls will be accepted. Original Point of Contact Elizabeth Shanahan, Contract Specialist, Phone (301) 435-3787, Fax (301) 402-6699, E-mail eshanahan@mail.nih.gov - Michael Marino, Contract Specialist, Phone (301) 435-3801, Fax (301) 402-6699, E-mail marinomic@mail.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N01-CM-01018/listing.html)
- Place of Performance
- Address: Various, United States
- Record
- SN02214172-W 20100724/100722234705-f7d52004ce54e2a974fd4cdfd0c44fe2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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