Open Access Commentary

A systematic approach to biomarker discovery; Preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"

Lisa H Butterfield1*, Mary L Disis2, Bernard A Fox34, Peter P Lee5, Samir N Khleif6, Magdalena Thurin7, Giorgio Trinchieri8, Ena Wang9, Jon Wigginton10, Damien Chaussabel11, George Coukos12, Madhav Dhodapkar13, Leif Håkansson14, Sylvia Janetzki15, Thomas O Kleen16, John M Kirkwood1, Cristina Maccalli17, Holden Maecker18, Michele Maio1920, Anatoli Malyguine21, Giuseppe Masucci22, A Karolina Palucka11, Douglas M Potter23, Antoni Ribas24, Licia Rivoltini25, Dolores Schendel26, Barbara Seliger27, Senthamil Selvan28, Craig L Slingluff29, David F Stroncek30, Howard Streicher31, Xifeng Wu32, Benjamin Zeskind33, Yingdong Zhao34, Mai-Britt Zocca35, Heinz Zwierzina36 and Francesco M Marincola9*

Author Affiliations

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

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Journal of Translational Medicine 2008, 6:81  doi:10.1186/1479-5876-6-81

Published: 23 December 2008

Abstract

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.