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

  1. Author:
    Butterfield, L. H.
    Disis, M. L.
    Fox, B. A.
    Lee, P. P.
    Khleif, S. N.
    Thurin, M.
    Trinchieri, G.
    Wang, E.
    Wigginton, J.
    Chaussabel, D.
    Coukos, G.
    Dhodapkar, M.
    Hakansson, L.
    Janetzki, S.
    Kleen, T. O.
    Kirkwood, J. M.
    Maccalli, C.
  2. Author Address

    Butterfield, Lisa H.; Kirkwood, John M.] Univ Pittsburgh, Dept Med, Div Hematol Oncol, Inst Canc, Pittsburgh, PA 15213 USA. [Disis, Mary L.] Univ Washington, Tumor Vaccine Grp, Ctr Translat Med Womens Hlth, Seattle, WA 98195 USA. [Fox, Bernard A.] Providence Portland Med Ctr, Earle A Chiles Res Inst, Portland, OR 97213 USA. [Fox, Bernard A.] Oregon Hlth & Sci Univ, Dept Mol Biol, Inst Canc, Portland, OR 97213 USA. [Lee, Peter P.] Stanford Univ, Dept Med, Div Hematol, Stanford, CA 94305 USA. [Khleif, Samir N.] NCI, Canc Vaccine Sect, NIH, Bethesda, MD 20892 USA. [Thurin, Magdalena] NCI, Canc Diag Program, Rockville, MD 20852 USA. [Trinchieri, Giorgio] NCI, Canc & Inflammat Program, NIH, Frederick, MD 21702 USA. [Wang, Ena, Marincola, Francesco M.] NIH, IDIS, Dept Transfus Med, Ctr Clin, Bethesda, MD 20892 USA. [Wang, Ena, Marincola, Francesco M.] NIH, Ctr Human Immunol, Bethesda, MD 20892 USA. [Wigginton, Jon] Bristol Myers Squibb Co, Princeton, NJ 08540 USA. [Chaussabel, Damien, Palucka, A. Karolina] Baylor Inst Immunol Res, Dallas, TX 75204 USA. [Chaussabel, Damien, Palucka, A. Karolina] Baylor Res Inst, Dallas, TX 75204 USA. [Coukos, George] Univ Penn, Ctr Res Early Detect & Cure Ovarian Canc, Philadelphia, PA 19104 USA. [Dhodapkar, Madhav] Yale Univ, Dept Hematol, New Haven, CT 06510 USA. [Hakansson, Leif] Lund Univ, Div Clin Tumor Immunol, S-58185 Linkoping, Sweden. [Janetzki, Sylvia] ZellNet Consulting Inc, Ft Lee, NJ 07024 USA. [Kleen, Thomas O.] Cellular Technol Ltd, Shaker Hts, OH 44122 USA. [Maccalli, Cristina] Ist Sci San Raffaele, DIBIT, Unit Immunobiotherapy Solid Tumors, Dept Mol Oncol, I-20132 Milan, Italy. [Maecker, Holden] Baylor Inst Immunol Res, Dallas, TX 75204 USA. [Maio, Michele] Univ Hosp Siena, Ist Toscano Tumori, Dept Oncol, Siena, Italy. [Maio, Michele] IRCCS, Ctr Riferimento Oncol, Dept Med Oncol, Canc Bioimmunotherapy Unit, I-53100 Aviano, Italy. [Malyguine, Anatoli] NCI, SAIC Frederick Inc, Lab Cell Mediated Immun, Frederick, MD 21702 USA. [Masucci, Giuseppe] Karolinska Inst, Dept Oncol Pathol, S-17176 Stockholm, Sweden. [Potter, Douglas M.] Univ Pittsburgh, Grad Sch Publ Hlth, Dept Biostat, Pittsburgh, PA 15213 USA. [Ribas, Antoni] Univ Calif Los Angeles, Dept Med, Jonsson Comprehens Canc Ctr, Los Angeles, CA 90095 USA. [Rivoltini, Licia] Ist Nazl Tumori, IRCCS Fdn, Unit Immunotherapy Human Tumors, I-20100 Milan, Italy. [Schendel, Dolores] German Res Ctr Environm Hlth, Inst Mol Immunol, D-81377 Munich, Germany. [Schendel, Dolores] German Res Ctr Environm Hlth, Clin Cooperat Grp Immune Monitoring, Helmholtz Zentrum Munchen, D-81377 Munich, Germany. [Seliger, Barbara] Univ Halle Wittenberg, Inst Med Immunol, D-06112 Halle, Saale, Germany. [Selvan, Senthamil] Hoag Canc Ctr, Newport Beach, CA 92663 USA. [Slingluff, Craig L., Jr.] Univ Virginia, Sch Med, Div Surg Oncol, Dept Surg, Charlottesville, VA 22908 USA. [Stroncek, David F.] NIH, Cell Therapy Sect, Dept Transfus Med, Ctr Clin, Bethesda, MD 20892 USA. [Streicher, Howard] NCI, Canc Therapy Evaluat Program, Bethesda, MD 20852 USA. [Wu, Xifeng] Univ Texas Houston, MD Anderson Canc Ctr, Dept Epidemiol, Houston, TX 77030 USA. [Zeskind, Benjamin] Immuneering Corp, Boston, MA 02215 USA. [Zhao, Yingdong] NCI, Biometr Res Branch, Bethesda, MD 20852 USA. [Zocca, Mai-Britt] DanDritt Biotech AS, DK-2100 Copenhagen, Denmark. [Zwierzina, Heinz] Innsbruck Med Univ, Dept Internal Med, A-6020 Innsbruck, Austria.
    1. Year: 2008
  1. Journal: Journal of Translational Medicine
    1. 6 AR 81
  2. Type of Article: Editorial Material
  1. 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.

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External Sources

  1. PMID: 19105846

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