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Translating Biomarker Discovery to Clinical Application. Sudhir Srivastava, Ph.D., M.P.H. Cancer Biomarkers Research Group. GOALS. Discover, develop and validate biomarkers for cancer detection, diagnosis and risk assessment

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translating biomarker discovery to clinical application

Translating Biomarker Discovery to Clinical Application

Sudhir Srivastava, Ph.D., M.P.H.

Cancer Biomarkers Research Group

goals
GOALS
  • Discover, develop and validate biomarkers for cancer detection, diagnosis and risk assessment
  • Conduct correlative studies/trials to validate biomarkers as indicators of early cancer, pre-invasive cancer, risk, or as surrogate endpoints
  • Develop quality assurance programs for biomarker testing and evaluation
  • Forge public-private partnerships
slide3

INVESTIGATOR-DRIVEN

CONSORTIUM

An “infrastructure” for supporting collaborative research on molecular, genetic and other biomarkers in human cancer detection and risk assessment.

slide4

MANAGEMENT STRUCTURE

Prostate &

Other Urologic

Cancers

Breast & Ob/Gyn

Cancers

Prioritization

Technology Sharing

Collaboration

Communication and Workshop

Data sharing and Informatics

Steering Committee

Executive

Committee

Colon and Other

GI Cancers

Policy Making

Subcommittees

Lung and Upper

Respiratory

Cancers

organizational success a catalyst for innovations and partnership
ORGANIZATIONAL SUCCESS:A Catalyst for Innovations and Partnership
  • EDRN Business Model and Project Management Reviewed and Cited by Many Scientific Journals and Working Groups for Best Practices:
    • Informatics to Manage and Support Biomarker Research (NCI-FDA-AACR Biomarker Collaborative Working Group Reports, Institute of Medicine on Biomarker)
    • Conducting Discovery and Validation Research (JNCI, J. Proteome Research)
    • Collaborative Model for Biomarker Research (Nature)
    • Milestones-driven Project Management that Ensure Timely Completion
    • NCI Translational Research Working Group

The EDRN structure has been cited by the National Academy of Sciences Institute of Medicine as an effective team-based organization (Large Scale Biomedical Science, Institute of Medicine 2001); and

for following best practices in Biospecimen Resources for the Genomic and Proteomic Era (Rand Science and Technology Publication, 2003), and Cancer Informatics (Eds. Silva, Ball, Chute, et. al., 2002 and in Cancer Biomarkers, Institute of Medicine 2007).

Continues…

organizational success a catalyst for innovations and partnership1
ORGANIZATIONAL SUCCESS:A Catalyst for Innovations and Partnership

Continued.

  • Rewards Collaboration and Promotes Team Science (EDRN Investigator received the first-ever AACR Team Science Award: Arul Chinnaiyan).
  • EDRN is as an Unexpected Catalyst for Innovation, Partnerships, and Biomarker Research Know-How (An EDRN investigator received a DOD Innovator Award on research ideas supported by EDRN).
  • Diagnostic firms, large or small, are seeking partnerships with EDRN.
organizational success a model system for translational research
ORGANIZATIONAL SUCCESS:A Model System for Translational Research
  • An integrated, collaborative model that:
  • Uses a novel mechanism to reward collaboration and promotes inclusiveness through its Associate Membership Program.
  • Has developed a roadmap for biomarkers discovery and validation .
  • Has helped developed biomarker metrology to develop, design and deliver biomarker research free of chance, bias and over-fitting (Pepe et.al., Ransohoff).
  • Has championed protocol-driven, phase-approach to proteomics evaluation for cancer diagnostic.
  • Disseminates resources for extramural communities on protocols, reagents, reference sets, study designs and statistical methodologies.
slide8

PHASES OF BIOMARKER

VALIDATION

Source: J. Natl. Cancer Inst. 93, 1054-1061, 2001

edrn program for rapid independent diagnostic evaluation pride
EDRN PROGRAM FOR RAPID INDEPENDENTDIAGNOSTIC EVALUATION (PRIDE)
  • A RAID-like mechanism that:
  • Encourages extramural investigators to seek assistance from EDRN in cross-laboratory validation of their biomarker assays.
  • Helps develop and institutes quality assurance programs for biomarker testing and evaluation.
  • PRIDE announcement is published in NIH Guide yearly.
present and future
PRESENT AND FUTURE
  • EDRN already practices management philosophy
  • promoted by TRWG.
  • TRWG- supported Risk Device Pathways are already
  • being supported by EDRN.
  • The Network’s productivity, funding opportunities and
  • infrastructure have fashioned a new environment for
  • biomarker research.
  • A number of biomarker tests will be ready for submission
  • to FDA, a remarkable achievement considering the history
  • of approval of diagnostic markers by FDA.
slide11

FDA APPROVAL OF

CANCER BIOMARKERS

Joseph A. Ludwig*‡ and John N. Weinstein* Nature Rev. Cancer 2005

significant notes
SIGNIFICANT NOTES
  • EDRN 4th Report Released

January 2008

  • EDRN 5th Annual Workshop

March 16-19, Bethesda, MD

  • AACR Sunrise Session on EDRN

April 15, 2008

slide13

UPDATES

  • BIOMARKER DISCOVERY: Dr. Sam Hanash
  • BIOMARKER VALIDATION: Dr. Ian Thompson
  • BIOMARKER REFERENCE LABORATORIES:

Dr. Dan Chan

  • STATISTICAL AND INFORMATICS:

Drs. Ziding Feng, Mark Thornquist, and

Dan Crichton