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Investment in Biomarker Research for Cancer Detection, Diagnosis and Prognosis Research Priorities for the Future: Stakeholder's Views

Presented by

Richard Schilsky, MD
Sam Hanash, MD
Sudhir Srivastava, PhD, MPH

Date

May 20-21, 2010

Time

8:00am - 5:00pm

Location

Hilton Hotel Exit Disclaimer
Twinbrook Location
Rockville, MD 20852

Meeting Objectives

The biomarker research enterprise has many stakeholders who invest substantial resources and advance policies that can influence the outcome and utility of biomarker-based clinical applications. These include basic science researchers, clinicians, health care professionals, policy makers, regulators, and the groups and agencies that fund research and reimburse clinical care. This diverse assemblage can have competing priorities and agendas; any successful business model must identify a common theme around which all can work effectively.

Due to the long time needed to discover, develop and integrate biomarkers in clinical application, investors in biotechnologies and pharmaceutical companies are less inclined to support biomarker diagnostics research. It is important that sponsors, funding agencies and investors take a long-term view of the development cycle of biomarkers. The objective of this meeting is to set a realistic research agenda for the next five to ten years in the clinical development of biomarkers for cancer detection and treatment. Some of the issues that will be addressed are as follows:

Define high priority clinical applications of biomarkers for early detection and for assessment of therapeutic response, including chemoprevention and monitoring disease recurrence, that are achievable near term. Criteria to be considered in prioritizing marker development include:

  • Known risk factors that define the population to be screened for early detection
  • Potential for integration with imaging modalities to improve diagnostic accuracy
  • Potential to reduce the need for invasive procedures
  • Potential to affect patient management through early assessment of response or lack of response to treatment
  • Potential to affect patient management by providing an early indication of disease recurrence
  • Potential to guide patient selection and/or endpoint assessment in clinical trials

Define strategies for fast tracking the validation of promising cancer biomarkers that overcome limitations stemming from:

  • modest performance of individual markers
  • diverse "ownership" of individual markers
  • lack of standardized reagents/assays to test markers     
  • Need for specialized platforms to test individual markers in a panel
  • limited availability of quality specimens that minimize potential bias
  • Perceived obstacles to the inclusion of biomarkers in clinical trials

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