title: A systematic approach to biomarker discovery; preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers".
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.
authors.affiliation: Department of Medicine, Division of Hematology Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15213, USA. butterfieldl@upmc.edu
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Butterfield
authors.forename: Mary L
authors.initials: ML
authors.lastname: Disis
authors.forename: Bernard A
authors.initials: BA
authors.lastname: Fox
authors.forename: Peter P
authors.initials: PP
authors.lastname: Lee
authors.forename: Samir N
authors.initials: SN
authors.lastname: Khleif
authors.forename: Magdalena
authors.initials: M
authors.lastname: Thurin
authors.forename: Giorgio
authors.initials: G
authors.lastname: Trinchieri
authors.forename: Ena
authors.initials: E
authors.lastname: Wang
authors.forename: Jon
authors.initials: J
authors.lastname: Wigginton
authors.forename: Damien
authors.initials: D
authors.lastname: Chaussabel
authors.forename: George
authors.initials: G
authors.lastname: Coukos
authors.forename: Madhav
authors.initials: M
authors.lastname: Dhodapkar
authors.forename: Leif
authors.initials: L
authors.lastname: Håkansson
authors.forename: Sylvia
authors.initials: S
authors.lastname: Janetzki
authors.forename: Thomas O
authors.initials: TO
authors.lastname: Kleen
authors.forename: John M
authors.initials: JM
authors.lastname: Kirkwood
authors.forename: Cristina
authors.initials: C
authors.lastname: Maccalli
authors.forename: Holden
authors.initials: H
authors.lastname: Maecker
authors.forename: Michele
authors.initials: M
authors.lastname: Maio
authors.forename: Anatoli
authors.initials: A
authors.lastname: Malyguine
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Masucci
authors.forename: A Karolina
authors.initials: AK
authors.lastname: Palucka
authors.forename: Douglas M
authors.initials: DM
authors.lastname: Potter
authors.forename: Antoni
authors.initials: A
authors.lastname: Ribas
authors.forename: Licia
authors.initials: L
authors.lastname: Rivoltini
authors.forename: Dolores
authors.initials: D
authors.lastname: Schendel
authors.forename: Barbara
authors.initials: B
authors.lastname: Seliger
authors.forename: Senthamil
authors.initials: S
authors.lastname: Selvan
authors.forename: Craig L
authors.initials: CL
authors.lastname: Slingluff
authors.forename: David F
authors.initials: DF
authors.lastname: Stroncek
authors.forename: Howard
authors.initials: H
authors.lastname: Streicher
authors.forename: Xifeng
authors.initials: X
authors.lastname: Wu
authors.forename: Benjamin
authors.initials: B
authors.lastname: Zeskind
authors.forename: Yingdong
authors.initials: Y
authors.lastname: Zhao
authors.forename: Mai-Britt
authors.initials: MB
authors.lastname: Zocca
authors.forename: Heinz
authors.initials: H
authors.lastname: Zwierzina
authors.forename: Francesco M
authors.initials: FM
authors.lastname: Marincola
mesh_terms: D015415:Biomarkers; D002986:Clinical Trials as Topic; D004493:Education; D006801:Humans; D007167:Immunotherapy; D009369:Neoplasms / Q000175:diagnosis / Q000276:immunology / Q000473:pathology / Q000503:physiopathology; D015203:Reproducibility of Results; D012106:Research / Q000191:economics; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers