Commentary
A systematic approach to biomarker discovery; Preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"
1 Department of Medicine, Division of Hematology Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15213, USA
2 Tumor Vaccine Group, Center for Translational Medicine in Women's Health, University of Washington, Seattle, Washington, 98195, USA
3 Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, 97213, USA
4 Department of Molecular Biology, OHSU Cancer Institute, Oregon Health and Science University, Portland, Oregon, 97213, USA
5 Department of Medicine, Division of Hematology, Stanford University, Stanford, California, 94305, USA
6 Cancer Vaccine Section, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, Maryland, 20892, USA
7 Cancer Diagnosis Program, NCI, NIH, Rockville, Maryland, 20852, USA
8 Cancer and Inflammation Program, NCI, NIH, Frederick, Maryland, 21702, USA
9 Infectious Disease and Immunogenetics Section (IDIS), Department of Transfusion Medicine, Clinical Center and Center for Human Immunology, National Institutes of Health, Bethesda, MD, USA
10 Bristol Myers-Squibb, Princeton, New Jersey, 08540, USA
11 Baylor Institute for Immunology Research and Baylor Research Institute, Dallas, Texas, 75204, USA
12 Center for Research on the Early Detection and Cure of Ovarian Cancer, University of Pennsylvania, Philadelphia 19104, USA
13 Department of Hematology, Yale University, New Haven, Connecticut 06510, USA
14 Division of Clinical Tumor Immunology, University of Lund, 581 85, Sweden
15 ZellNet Consulting Inc. Fort Lee, New Jersey, 07024, USA
16 Cellular Technology Limited, Shaker Heights, Ohio, 44122, USA
17 Unit of Immuno-Biotherapy of Solid Tumors, Department of Molecular Oncology, San Raffaele Scientific Institute DIBIT, Milan, 20132, Italy
18 Baylor Institute for Immunology Research, Dallas, 75204, Texas, USA
19 Medical Oncology and Immunotherapy, Department. of Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy
20 Cancer Bioimmunotherapy Unit, Department of Medical Oncology, Centro di Riferimento Oncologico, IRCCS, Aviano, 53100, Italy
21 Laboratory of Cell Mediated Immunity, SAIC-Frederick, Inc., NCI-Frederick, Frederick, MD, 21702, USA
22 Department of Oncology-Pathology, Karolinska Institute, Stockholm, 171 76, Sweden
23 Biostatistics Department, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, USA
24 Department of Medicine, Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095, USA
25 Unit of Immunotherapy of Human Tumors, IRCCS Foundation, Istituto Nazionale Tumori, Milan, 20100, Italy
26 Institute of Molecular Immunology, and Clinical Cooperation Group "Immune Monitoring" Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, 81377, Germany
27 Institute of Medical Immunology, Martin-Luther University, Halle Wittenberg, Halle (Saale), 06112, Germany
28 Hoag Cancer Center, Newport Beach, California, 92663, USA
29 Department of Surgery, Division of Surgical Oncology, University of Virginia School of Medicine, Charlottesville, Virginia, 22908, USA
30 Cell Therapy Section, Department of Transfusion Medicine, Clinical Center, NIH, Bethesda, Maryland, 20892, USA
31 Cancer Therapy Evaluation Program, NCI, Bethesda, Maryland, 20852 USA
32 Department of Epidemiology, University of Texas, MD Anderson Cancer Center, Houston, Texas, 77030, USA
33 Immuneering Corporation, Boston, Massachusetts, 02215, USA
34 Biometrics Research Branch, NCI, NIH, Bethesda, Maryland, 20852, USA
35 DanDritt Biotech A/S, Copenhagen, 2100, Denmark
36 Department of Internal Medicine, Innsbruck Medical University, Innsbruck, 6020, Austria
Journal of Translational Medicine 2008, 6:81 doi:10.1186/1479-5876-6-81
Published: 23 December 2008Abstract
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.
