FDA News

AACR, FDA And NCI Announce Cancer Biomarkers Collaborative

(April 21, 2007)--The American Association for Cancer Research, together with the Food and Drug Administration and National Cancer Institute, have announced the formation of the AACR-FDA-NCI Cancer Biomarkers Collaborative (CBC) to facilitate the use of validated biomarkers in clinical trials and ultimately in evidence-based oncology and cancer medicine.

The Collaborative brings together leaders from academia, government, industry, and patient advocacy groups to develop a set of guidelines for effectively integrating predictive biomarkers into clinical trials.

"The FDA's Critical Path is an important initiative that aims to modernize the processes and methods used to evaluate the safety, efficacy and quality of medical products as they move from product selection and design to mass manufacture," said Samir Khleif, M.D., of the NCI and Special Assistant to the FDA Commissioner.

The Collaborative evolved from a special "Think Tank" session of academic, industry and government researchers and patient advocacy groups held at AACR's headquarters in Philadelphia in November, 2006. Think Tank participants laid the groundwork for the new collaborative and identified four priority areas of research to focus on: biospecimens, bioinformatics, assay validation, and information sharing.

This summer, the Collaborative will meet again in Philadelphia to discuss various aspects of these four areas as they relate to biomarker validation and to begin to develop guidelines for integrating predictive biomarkers into clinical trials.

These guidelines will inform policies that are a part of the Critical Path Initiative, the FDA's effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product.

"We believe that the CBC will address the mission of the AACR, the goals of the NCI, and the FDA's Critical Path Initiative and will make a major contribution to the success of a new generation of clinical trials and to progress in cancer drug development, " said James H. Doroshow, M.D., Director of NCI's Division of Cancer Treatment and Diagnosis.

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