National Cancer Institute (NCI)
The goal of this Request for Information (RFI) Notice is to collect feedback about the Chemical Biology Consortium (CBC), the discovery engine of the NCI Experimental Therapeutics (NExT) Program. This information is being sought from the academic biomedical research community, research institutions, pharmaceutical and biotech companies, and for-profit providers of pharmaceutical and discovery services, as well as current participants in the CBC. The NExT Program is specifically interested in comments on the overall programmatic concept and operational aspects of the CBC. Any suggestions and/or recommendations for changes to improve the program are welcomed. Respondents are also asked to indicate their level of interest in responding to, and participating in, any future subcontracting opportunities in support of this initiative. Based on the response to this RFI, the NCI may issue subsequent RFI(s) and a Request for Proposals (RFP) before the end of the calendar year 2020.
The CBC was launched in 2009 as a component of the NExT Program by NCI’s Division of Cancer Treatment and Diagnosis (DCTD) in conjunction with NCI’s Center for Cancer Research (CCR). It was renewed in 2016 and incorporated suggestions received in response to a similar RFI issued in 2013. The program brings together chemists, biologists, pharmacologists, and molecular oncologists from government, industry, and academia to address unmet needs in therapies for cancer. Members of the consortium contribute their expertise in high-throughput screening, structural biology, medicinal chemistry, compound profiling, cancer cell biology, and animal models for oncology to advance early-stage drug discovery projects through to selection of a clinical candidate.
Some CBC efforts begin as early as seeking validation of novel cancer targets, but projects can be initiated at any stage along the discovery continuum. NExT project teams assemble the expertise needed to advance the project from one milestone to the next and include the applicant/principal investigator (PI), scientists from CBC Centers, and scientists from the Frederick National Lab and NCI. Participation in CBC discovery projects is orchestrated through a contract mechanism wherein data and materials generated by members of the project team are deliverables to NCI that are housed in a secure, centralized repository to facilitate sharing of confidential information among project team members.
The scientific expertise and novel technologies assembled within the CBC are designed to expedite the movement of promising new molecules through the NExT drug discovery pipeline and into first-in-human clinical trials. Oversight of the program is provided through regular meetings with the NCI Senior Advisory Committee and an annual portfolio review by external experts in oncology and cancer drug discovery.
The patent rights for inventions made while participating under subcontracts on CBC projects will be governed by the Bayh-Dole Act as implemented by the Federal Acquisition Regulations (FAR) clause 52.227-11 Patent Rights (Dec 2007). Rights in data first produced in the performance of potential subcontracts will be governed by FAR 52.227-14 Rights in Data (Dec 2007).
Although the management of patent rights for inventions produced under the CBC will be governed by the Bayh-Dole Act, effective sharing of resources and data is imperative to the success of this program. To facilitate confidential sharing of information, all members of the CBC are required to sign a Participant’s Agreement that describes in principle how all members will share data and materials for furtherance of the project. In addition, CBC Participants will provide representation to a joint Technology Transfer committee that will oversee issues related to licensing any CBC-related technology.
Respondents are requested to address the following topics as appropriate for their organizations:
How to Submit a Response
Please limit your response (i.e., Word document or Word with a sortable spreadsheet in Excel if a bullet list or table is to be attached) to 10 pages or less. Submit via electronic transmission to: NCINExTinfo@mail.nih.gov. Responses to this RFI will be accepted through June 22, 2020.
You will receive electronic confirmation acknowledging receipt of your response but will not be notified of the results of this RFI. All information will be processed and analyzed to ensure anonymity and confidentiality. No self-identifying, proprietary, classified, confidential, or sensitive information should be included in your response.
The NExT Program will use the submitted 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, NCI, or the NExT Program. No monetary awards will be made to pay for preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this RFI and/or from the Government’s use of such information.
Response to this RFI is voluntary. Responders are free to address any or all the categories listed above. The submitted information will be reviewed by NIH staff.
This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may be aggregated in presentations and reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Specific questions about this RFI should be directed to the following e-mail address: NCINExTinfo@mail.nih.gov