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

Lisa H Butterfield¹ , Mary L Disis² , Bernard A Fox^3,4 , 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 Maio^19,20 , Anatoli Malyguine²¹ , Giuseppe Masucci²² , A Karolina Palucka¹¹ , Douglas M Potter²³ , Antoni Ribas²⁴ , Licia Rivoltini²⁵ , Dolores Schendel²⁶ , Barbara Seliger²⁷ , Senthamil Selvan²⁸ , Craig L Slingluff Jr²⁹ , David F Stroncek³⁰ , Howard Streicher³¹ , Xifeng Wu³² , Benjamin Zeskind³³ , Yingdong Zhao³⁴ , Mai-Britt Zocca³⁵ , Heinz Zwierzina³⁶ and Francesco M Marincola⁹

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