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A systematic approach to biomarker discovery; preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"
Lisa H Butterfield1, Mary L Disis, Bernard A Fox
1Department of Medicine, Division of Hematology Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15213, USA. butterfieldl@upmc.edu
Abstract:
The International Society for the Biological Therapy of Cancer (iSBTc) has initiated in collaboration with the United States Food and Drug Administration (FDA) a programmatic look at innovative avenues for the identification of relevant parameters to assist clinical and basic scientists who study the natural course of host/tumor interactions or their response to immune manipulation. The task force has two primary goals: 1) identify best practices of standardized and validated immune monitoring procedures and assays to promote inter-trial comparisons and 2) develop strategies for the identification of novel biomarkers that may enhance our understating of principles governing human cancer immune biology and, consequently, implement their clinical application. Two working groups were created that will report the developed best practices at an NCI/FDA/iSBTc sponsored workshop tied to the annual meeting of the iSBTc to be held in Washington DC in the Fall of 2009. This foreword provides an overview of the task force and invites feedback from readers that might be incorporated in the discussions and in the final document.
Insights
The International Society for the Biological Therapy of Cancer (iSBTc) and FDA are developing standardized immune monitoring and novel biomarkers for cancer research. This initiative aims to improve understanding and application of cancer immune biology in clinical settings.
Area of Science:
- Oncology
- Immunology
- Biomarker Discovery
Background:
- The International Society for the Biological Therapy of Cancer (iSBTc), in collaboration with the United States Food and Drug Administration (FDA), has launched a program to explore innovative methods for identifying key parameters in cancer research.
- This initiative focuses on understanding host/tumor interactions and responses to immune manipulation, crucial for advancing cancer therapies.
Discussion:
- The task force has two main objectives: establishing best practices for standardized immune monitoring assays to enable consistent comparisons across studies.
- Developing strategies for identifying novel biomarkers to deepen the understanding of human cancer immune biology and facilitate clinical applications.
Key Insights:
- Standardized immune monitoring is essential for reliable comparison of results in cancer immunotherapy trials.
- Identification of novel biomarkers will enhance the understanding of cancer immune biology and its clinical translation.
- Collaboration between iSBTc and FDA is driving advancements in cancer research methodologies.
Outlook:
- Two working groups will present their findings on best practices at an NCI/FDA/iSBTc sponsored workshop in Fall 2009.
- The initiative seeks reader feedback to refine discussions and the final documentation on cancer immune biology and monitoring.
- This program aims to bridge basic research findings with clinical applications in cancer treatment and immune manipulation.
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