Request for Information (RFI): Priorities for Biomarkers For Cancer Detection, Diagnosis, and Prognosis

Notice Number: NOT-CA-09-014

Key Dates
Release Date: February 4, 2009

Issued by
National Cancer Institute (NCI), (http://www.cancer.gov)

This Request for Information (RFI) 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 National Institutes of Health (NIH), and the National Cancer Institute (NCI).  The NCI 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. 

Purpose

The purpose of this RFI is to gather information from the scientific community about the opportunity to identify priorities for biomarker discovery and validation research to be conducted under the auspices of the NCI’s Early Detection Research Network (EDRN; www.cancer.gov/edrn). The EDRN is a consortium funded through the NIH cooperative agreement mechanism under programmatic oversight provided by the NCI.  Information submitted in response to this RFI may be used to help NCI Program Officials identity future directions for this Network.

Feedback is sought from the following sources:

Background

The mission of the EDRN is to discover, develop and validate biomarkers for cancer risk assessment, early detection, early diagnosis and prognosis and to coordinate biomarker research with therapeutic strategies.  These goals are achieved through translational research and implementation of strategic and systematic evidence-based biomarker research.  The EDRN was conceived on the premise that a “vertical” approach to biomarker research with an established integrated, multidisciplinary environment will expedite clinical applications of molecular knowledge.  The EDRN provides an infrastructure and environment that fosters translational research by encouraging collaborations among basic scientists, population-based scientists, and physician scientists with expertise in clinical applications. 

The EDRN consists of the following four main components:

The EDRN has focused on cancers where biomarkers have a high potential to reduce cancer morbidity and mortality. In this regard, the EDRN targets mainly the major epithelial cancers and has established collaborative groups for each of the major organ systems (www.cancer.gov/edrn).

Although numerous potential biomarkers are identified every year, few have been validated for clinical use. Most candidate biomarkers fail to meet the rigorous statistical requirements for intended clinical use (Pepe MS et al., JNCI 100:1432-8; 2008). Difficulties in the identification and development of clinically useful biomarkers have been attributed, in part, to the poor quality of samples used for discovery, inappropriate study designs (which failed to account for confounders and bias), and insufficient infrastructure to support the translation of potential biomarker discovery into clinical tests. The currently funded EDRN is taking measures to overcome these obstacles by supporting biomarker research that meets the requirements of sample quality, study design, statistical rigor, and clinical endpoints (see EDRN Fourth; www.cancer.gov/edrn). However, in anticipation of the continuation of the EDRN Program, the NCI is seeking input from the community on all facets of biomarker discovery, development and validation and on development of biomarker-based clinical tests.

Information Requested

This RFI solicits information on biomarkers for cancer risk assessment, early detection, early diagnosis, and prognosis that the EDRN can use to enable and/or expedite the development and validation of biomarkers into clinical tests that can benefit patients. Information provided to the NCI may be used in formulating the re-issuance of the EDRN Request for Applications (RFAs).

Please provide concise responses in the context of biomarkers to any or all of the following topics (do not exceed 3 pages):

  1. Promising Research Directions: Identify promising research areas in cancer biology, epidemiology, prevention, diagnosis, and/or treatment that could stimulate or accelerate the development of biomarkers that are applicable to cancer patients or the general population.  If possible, elaborate on the specific scientific opportunity, clinical and public health importance, technical feasibility of the promising developmental approach and suitability for NCI investment and the time, effort and cost necessary to bring a product to approval by the Food and Drug Administration (FDA). 
  1. Transdisciplinary Research: Collaborations among basic scientists, epidemiologists, and clinicians are essential for successful translation of biomarkers into clinical application.  Provide your ideas on how this process can be optimized. Elaborate specific activities and resources in academia, government and industry that should be coordinated to realize the promising translational opportunities in the most timely and efficient manner.
  1. Strategies for Biomarker Discovery/Validation: Given that the one laboratory-one biomarker approach has not yielded optimum results, identify different strategies to biomarker discovery. Include possible approaches to short-term and long-term clinical validation. Share your opinions on the value of conducting biomarker discovery using multiple platforms (e.g., based on genomic, proteomic, and metabolomic characterizations.) in multiple laboratories on the same clinical samples. Identify the potential challenges if such parallel determinations are employed. Suggest, if possible, approaches to overcome these challenges.
  1. Partnerships. Describe how should the EDRN engage the private sector and foundations to maximize the investment in promising biomarkers, and especially, to increase chances for post-development funding from the pharmaceutical/biotechnology industry or the investment community. Describe if formation of strategic partnerships/alliances would benefit all parties (i.e., NCI, academia, research foundations, and industry). Identify steps to enhance such collaborations and provide reasons for your assessment(s). Please identify actions/conditions needed to facilitate access of the EDRN researchers to financial and/or infrastructure resources of the industry as well as to financial support from non-profit organizations or other philanthropic sources.
  1. Support of Biomarker Research by Traditional NIH Funding Mechanisms: Traditional NIH funding mechanisms for investigator initiated research projects, such as R01and P01, are generally viewed to support mainly mechanistic, hypothesis-driven studies. Describe your experience in seeking funding through such mechanisms for the discovery and development of biomarkers.
  1. Existing Support and Funding Priorities. Please identify cancer-relevant biomarker discovery and validation activities that you believe are presently receiving substantial funding and support from the federal and state governments, industry, foundations, and investment communities (including venture capital). Indicate whether such activities should be considered of lower priority for support through the NCI EDRN Program. Characterize the ability and willingness of the industry to support the full development cycle of biomarker-based diagnostics (from discovery to validation to clinical use) without the NCI involvement.  Assess the likelihood that industry will commercialize validated biomarkers (i.e., those for which NCI-sponsored research demonstrates preliminary efficacy in human studies).
  1. Validation Priorities. Numerous candidate biomarkers are being identified through large-scale NCI programs, such as The Cancer Genome Atlas (TCGA), and genome-wide association studies (GWAS). Some of these candidate markers may be functionally testable and clinically relevant. Nevertheless, EDRN needs to develop a system to evaluate requests to validate these markers.  Suggest approaches to prioritize such requests. Identify the criteria for submitting and evaluating requests for support (funding) on validation of biomarkers derived from TCGA- or GWAS-like activities. Identify specific topics/targets that should be supported by EDRN leading to the development of in vitro tools, methods and reagents to effectively test for these molecular alterations.

Please indicate which type of institution or organization you are primarily affiliated with (using the following categories):

How to Respond?
Responses will be accepted until March 30, 2009.  Responses should be limited to three pages and marked with this RFI identifier NOT-CA-09-014.  Responses are preferred in electronic format and can be e-mailed to dguillory@mail.nih.gov.

Respondents will receive an email confirmation acknowledging receipt of their response, but will not receive individualized feedback.

Responses to this RFI are voluntary and may be anonymous. All individual responses will remain confidential. Any identifiers (e.g., names, institutions, e-mail addresses, etc) will be removed when responses are compiled. Only the processed, anonymized results will be shared internally with scientific working groups convened by the NCI, as appropriate. Nonetheless, no proprietary information should be submitted. 

Inquiries

Inquiries regarding this Notice may be directed to:

Sudhir Srivastava, Ph.D., MPH
Chief, Cancer Biomarkers Research Group
National Cancer Institute
6130 Executive Boulevard, EPN Suite 3142
Bethesda, MD 20892-7362
Telephone: 301-435-1594
Fax: 301-402-8990
E-mail: dguillory@mail.nih.gov

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