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October 28, 2009
Gaylord National Hotel and Convention Center
Washington, D.C.
Over the last decade, cancer therapies that are based on targeting specific molecular pathways or specific cell types have moved from the bench into clinical practice. Similarly, biomarkers that may indicate patient populations suitable for these therapies or act as surrogates for the potential development of a clinical response are being used increasingly in the clinic. The clinical application of biomarkers to assess the effect of immune based therapies is important for several reasons. First, immune based treatments, such as vaccines, are often designed to elicit a specific response so that the measurement of that response could be a marker of the vaccine or product potency. Secondly, as immune based therapies are being tested earlier in the therapeutic pathway, i.e. in the adjuvant setting, biomarkers of response become increasingly important as potential endpoints of clinical trials. Finally, clinically validated biomarkers are needed so that new immunotherapy approaches can be rapidly tested and translated to clinical practice.
As laboratory-based assays are being transitioned to clinical assays, however, several issues are raised. The assays must be robust. The clinical samples collected for analysis must be processed in a uniform way to ensure reproducibility of results. Performance characteristics of the assays must be defined so that data collected can be interpreted and fully understood. Best practices need to be implemented so that as multiple groups conduct immunotherapeutic trials, data from those studies can be interpreted across multiple sites. New assays must be developed and utilized that will allow broad analysis of multiple immune parameters.
To address these needs within the scientific community, the 2009 iSBTc-FDA-NCI Workshop will seek to:
The iSBTc is ideally suited to conduct this workshop. We have brought together experts from multiple stakeholders who have been focusing significant effort in this area including the United States Food and Drug Administration (FDA); the National Cancer Institute (NCI); the National Institutes of Health (NIH); members from industry; and partnering organizations such as the Biotherapy Development Association (BDA), the Association for Immunotherapy of Cancer (CIMT) of Germany; Cancer Vaccine Consortium (CVC) a program of the Cancer Research Institute, Nordic Center for Development of Antitumour Vaccines (NCV-network), the Italian Network for Tumor Biotherapy (NIBIT), and the Japanese Society of Cancer Immunology (JSCI), as well as academic experts in the field of immunologic biomarker development and standardization. The workshop is unique in that is meant to be an interactive exchange rather than merely a didactic exercise as it is organized around lively discussion and sharing of data on biomarker development. Ultimately, the workshop will define the “state of the art” in assay and cellular product development and standardization.
