Key Dates

Related Announcements

Issued by

National Cancer Institute (NCI)

Purpose

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.

Background

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.

Information Requested

Respondents are requested to address the following topics as appropriate for their organizations:

1. A statement of your organization’s interest in the program and in participating in any future RFPs in support of the CBC mission, which is described at https://next.cancer.gov/discoveryResources/cbc.htm.

2. A summary of your organization’s comments on the CBC, any suggestions to improve its operational or technical aspects, and other comments or observations that you feel will enhance the impact of the CBC on cancer drug discovery and development. In addition, please comment on the following:

• • Participation in the CBC requires that each CBC member agree in writing that all members share resources and data in a way that not only facilitates the rapid advancement of research and development (R&D) goals but also promotes the future commercialization of innovative therapeutics (for further information, go to https://next.cancer.gov/pipelineManagement/ipAccess.htm). Please recommend and describe alternate governance models in which mechanisms are provided to manage intellectual property (IP) rights and data confidentiality.

• • CBC operates using industry’s best practices model, via a project team with scientific decision-making power facilitated by project team leadership and a stage gate process with clear Go/No-Go criteria. Please recommend any other model(s) suitable for the program.
  • CBC is one model through which the NCI collaborates with the extramural community (academia, non-profit, and private sector organizations) to address unmet needs in cancer therapeutics (e.g., therapeutics for understudied malignancies or drugs targeting novel mechanisms or targets).

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.

General Information:

1. Please identify whether you are a scientist or clinician-scientist or other interested person at an academic institution, a non-profit institution/organization, for-profit company (e.g., a biotech or pharmaceutical company), government agency, or other.
2. Please indicate your main area of interest and expertise related to oncology drug discovery and development.
3. Describe your interest in the NExT Program and the CBC.

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).

Inquiries

Please direct all inquiries to:

Specific questions about this RFI should be directed to the following e-mail address: NCINExTinfo@mail.nih.gov