SPECIAL NOTICE
A -- Pediatric Preclinical Testing
- Notice Date
- 2/7/2014
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- RFI-NCI-DCTD-2014-0001
- Point of Contact
- Catherine Kennedy,
- E-Mail Address
-
catherine.kennedy3@nih.gov
(catherine.kennedy3@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PURPOSE The objective of this Request for Information (RFI) is to ascertain the level of interest and the capabilities within the academic and private sector cancer research communities for participating in the preclinical testing of novel anticancer agents using pediatric models through a testing program supported by the Division of Cancer Treatment and Diagnosis (DCTD). DCTD is particularly interested in ascertaining the range of available pediatric preclinical models and their suitability for anticancer drug testing as part of a cost-effective, scientifically sound testing program. Respondents are further asked to indicate whether they would be likely to submit a proposal for participation in a DCTD-supported research contract to systematically test anticancer agents using their preclinical models. Based on the response to this RFI, the National Cancer Institute is considering issuing a Request for Proposals (RFP) in calendar year 2014. BACKGROUND The Pediatric Preclinical Testing Program (PPTP) initiated testing in 2005 to address some of the challenges associated with developing new therapies for childhood cancers that are distinctive compared to those encountered in developing therapies for adult cancers. Since 2005 the PPTP has completed in vivo evaluations of more than 70 agents. Approximately 80 single agents and three sets of combinations have been tested against the in vitro cell line panel. To date more than 60 peer-reviewed papers have been published by the PPTP reporting the activity of single agents or drug combinations. Looking to the future, NCI wants to ensure that the models that it employs for pediatric preclinical testing represent those most suitable to provide predictive testing data for the range of novel anticancer agents that will be available for testing. Two types of contracts are under consideration for a new funding period to support pediatric preclinical testing. One is for individual testing sites that will be responsible for conducting testing for one or more tumor panels, and the second is for a Coordinating Center. Individual testing sites for in vivo testing will be expected to offer panels of models for testing for one or more childhood cancers. The following are expectations for preclinical models proposed for testing: - Molecular characterization to include gene expression, copy number alteration, and gene sequencing for mutations (e.g., exome sequencing). - For xenograft models, establishment by direct transplantation into immunocompromised mice without in vitro passage. - For all model types, the ability to reproducibly and expeditiously test 6 to 10 agents per year. The following are examples of the tasks expected of the in vivo testing sites in the anticipated solicitation: 1) Propagating and maintaining human tumor lines or genetically engineered mouse models (GEMMs) in vivo as required to support PPTP testing at their site. 2) Receiving, storing, and preparing experimental agents for testing, and then administering test materials to tumor-bearing or non-tumor bearing animals. 3) Performing dose-finding toxicity testing as needed prior to initiating efficacy testing. 4) Entering parameters of in vivo experiments (e.g., information on test agents, treatment regimens, days of death or sacrifice, body weights and tumor dimensions) in a data format specified by NCI. 5) Noting toxic side-effects of the administered material(s) in the rodents and distinguish between tumor-and drug-related deaths. 6) Participating in the interpretation of testing results and in writing manuscripts describing PPTP testing results. 7) Contributing to the identification of agents for testing based on disease expertise for the histology of the testing panel. 8) Participating in regular teleconferences with other testing sites, the Coordinating Center, and NCI. 9) Monitoring the genetic stability of the tumor lines and reinitiating xenografts at regular intervals from early passages. 10) Collecting blood and tissue samples from treated animals and sending these to the sites designated by NCI. The following are examples of the tasks expected of the Coordinating Center: 1) Receiving, storing, and distributing to testing sites anticancer agents for testing as specified by NCI. 2) Coordinating communication with testing sites and with NCI, including via regular teleconferences and through procedures for confidential sharing of documents (e.g., SharePoint site), so that coordinated testing of agents and preparation of reports and manuscripts based on testing results can occur. 3) Coordinating the testing schedule across PPTP testing sites for agents specified by the NCI for testing. 4) Managing data generated at testing sites, including the central collection of data from testing sites, preparation of data for statistical analysis, and establishment of a database for PPTP data and analyses. 5) Providing statistical input in the planning of PPTP studies and performing statistical analysis of in vivo experiments. 6) Performing bioinformatic analyses of testing results (e.g., relating testing findings to molecular characteristics of tested cell lines and xenografts). 7) Maintaining a public PPTP website that provides information about the PPTP, including documents describing the PPTP models and testing procedures and documents describing PPTP testing results (e.g., posters and presentations). 8) Coordinating the monitoring of the quality of all tumor lines and mice, including annual monitoring of the genetic stability of the tumor lines and re-initiation of xenografts and cell lines at regular intervals from early passages. 9) Coordinating the collection of blood and tissue samples from treated animals and distributing these to sites designated by the Project Officer. 10) Preparing a first draft of study reports using a template provided by NCI. 11) Coordinating manuscript preparation and submission of manuscripts describing PPTP testing results. An in vitro testing component will also be solicited. The cell line panel for in vitro testing should be molecularly characterized in a manner similar to models proposed for in vivo testing. In vitro testing should incorporate data analysis by curve-fitting to the Hill Equation to determine IC50 and Ymin% values, and should also include measures of the relative starting and final cell line numbers. INFORMATION REQUESTED In responding to the RFI, research teams with preclinical models that they believe would be suitable for one or more in vivo tumor panels of the PPTP are asked to address the following: - The number of models available and the extent of their molecular characterization, including (but not limited to) gene expression, copy number alteration, and gene sequencing for mutations. - For xenograft models, a description of how the models were established and how they have been passaged. (Note: models established by direct transplantation into immunocompromised mice without in vitro passage are sought). - For GEMMs, a description of the models and of the evidence that they recapitulate the biology and therapeutic responses of the childhood cancer for which they are relevant. - The ability of the models to be used to reproducibly and expeditiously test 6 to 10 agents per year. Experience in using the proposed models for preclinical testing should be briefly described to support the ability to meet this criterion. - Any additional capabilities of the research team that it believes would contribute to meeting the PPTP's testing objectives. Research teams with preclinical models and testing capabilities that they believe would be suitable for the in vitro testing component of the PPTP are asked to address the following: - The number of childhood cancer cell lines available for in vitro testing and the extent of their molecular characterization, including (but not limited to) gene expression, copy number alteration, and gene sequencing for mutations. - The ability of the cell lines to be used to reproducibly and expeditiously test 10 or more agents per year. Experience in using the proposed models for preclinical testing should be briefly described to support the ability to meet this criterion, including an estimate of the throughput of the team (i.e., number of agents that can be evaluated against the entire cell line panel per unit of time). - The methods to be employed to estimate IC50, Ymin% (minimum T/C%), and the relative starting and final cell numbers. - Any additional capabilities of the research team that it believes would contribute to meeting the PPTP's testing objectives. For research teams with capabilities suitable for serving as the Coordinating Center of the PPTP, a response indicating potential interest is requested. HOW TO SUBMIT A RESPONSE Please submit your response to the information requested above via electronic transmission (e.g., a Word document or PDF file) and limit documents to five pages or less. Publications describing your research teams capabilities or preclinical models may be attached (no more than three). Responses are to be e-mailed to catherine.kennedy3@nih.gov. Responses to this RFI are due on or before February 28, 2014. You will receive electronic confirmation acknowledging receipt of your response but will not be notified of the results of this RFI. No proprietary, classified, confidential, or sensitive information should be included in your response. The DCTD will use this information at its discretion. This RFI notice should not be interpreted as a solicitation or as an obligation on the part of the Federal Government or the NCI. No monetary awards will be made to pay for preparation of any information submitted or for use by the Government of such information. INQUIRIES Specific questions about this RFI should be directed to the following e-mail address: catherine.kennedy3@nih.gov
- Web Link
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FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/RFI-NCI-DCTD-2014-0001/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN03284347-W 20140209/140208000220-5b446737c2677d76e0c4830445717537 (fbodaily.com)
- Source
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