iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer

October 28, 2009
Gaylord National Hotel and Convention Center
Washington, D.C.

The iSBTc-FDA-NCI Workshop was an exceptional program.  With over 300 participants, this was the most well attended Workshop in iSBTc history!  The program focused on the unique issues related to immunologic monitoring assays as well as novel methodologies for assessing the immune landscape in cancer. Standardization of assays, assay validation, and appropriate potency assays were the subject of one subcommittee while the other assessed the clinical utility of promising novel technologies and discussed recommendations on how to incorporate them into the clinical arena.  A results document is planned for publication in 2010.

Audience
The audience for this program included scientists and clinicians from regulatory agencies, industry, and academics 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 Goals

1. Establish a "best practices" protocol for the collection and storage of clinical samples for the assessment of immunologic outcomes in clinical trials of immune based therapies.
2. Define minimum quality standards for laboratories developing immunologic biomarkers to be used for clinical trial analyses.
3. Establish a consensus for performance characteristics of the most common immunologic assays to be used for the evaluation of immune based therapies and discuss standards for the reporting of immunologic results.
4. Evaluate and determine key measures of potential potency of cell based immunotherapeutic products.

Participating Organizations

• Association for Immunotherapy of Cancer (CIMT)
• Biotherapy Development Association (BDA)
• Cancer Vaccine Consortium (CVC) of the Cancer Research Institute (CRI)
• Food and Drug Administration (FDA)
• Italian Network for Tumor Biotherapy (NIBIT)
• Japanese Society of Cancer Immunology (JSCI)
• National Cancer Institute (NCI)
• National Institutes of Health (NIH)
• Nordic Center for Development of Antitumour Vaccines (NCV-network)