Biomarkers Purpose

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September 30, 2010
Masur Auditorium, Building 10, Clinical Center, NIH Campus
Bethesda, MD

Program Purpose

Intended Audience
The primary audience for this meeting includes scientist and clinicians from regulatory agencies, industry, and academics who are interested in the development of immune based therapies for the treatment of cancer as well as analysis of the immune impact of other types of clinical interventions.

Program Purpose
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. Results must be reported in a detailed and uniform way. New assays which have been developed, that will allow broad analysis of multiple immune parameters, must now be better utilized. The lessons learned from biomarker studies in fields such as AIDS and other infectious diseases, must be better incorporated into cancer immunotherapy studies.

Program Goals

• Define minimum quality standards and procedures for laboratories developing immunologic biomarkers for clinical trial analyses.
• Discuss development of potency assays and the reporting of immunologic results.
• Review the current data supporting correlations of immunity and clinical outcome, and how knowledge from other fields (other than immunotherapy of cancer) can contribute to cancer immunotherapy.
• Determine which novel and high through-put technologies are now appropriate for use in cancer immunotherapy trials.

Expected Learner Outcomes

Upon completion of this symposium, attendees will be able to:

• Discuss state-of-the-art procedures and standards for laboratories developing and applying immunologic biomarkers for clinical trials.
• Define key considerations in developing and validating potency assays and standardizing the reporting of immunologic results.
• Discuss and assess recent data that correlate potency assays results to immunity and clinical responses.
• Identify and critically evaluate technologies for assessing immune responses in cancer immunotherapy trials.

The Symposium on Immuno-Oncology Biomarkers is a non-accredited continuing medical education event. No credits are offered for physician participation in this educational program.