title: Summary of roundtable discussion meeting: non-human primates to assess risk for EBV-related lymphomas in humans.
abstract: Epstein-Barr virus (EBV)-associated lymphomas are a known risk for immunosuppressed individuals. Non-clinical methods to determine the potential of new immunomodulatory compounds to produce EBV-associated lymphomas (hazard identification) have not been developed. Since lymphocryptovirus (LCV) in non-human primates (NHP) has similar characteristics to EBV in humans, a Roundtable meeting was held in October 2010 to explore how the potential for EBV-related lymphomas in humans can be assessed by using surrogate biomarkers for lymphoma risk in NHP toxicity studies. Stakeholders from regulatory agencies, academia, and industry came together to determine the research gaps and potential benefits and considerations of such an approach given the current state-of-the-science. Key conclusions from the discussion included considerations raised about the potential usefulness of LCV-related biomarkers from NHP studies since there is significant controversy over the reliability of using EBV viral load or EBV-specific T-lymphocytes to predict for lymphoproliferative disorders in transplant patients. In addition, there are technical challenges that need to be further addressed in order to develop methods to measure LCV viral load and LCV-specific T-lymphocytes from cynomolgus monkeys.
authors.affiliation: Drug Safety R&D, Pfizer Inc., Groton, CT 06340, USA. thomas.t.kawabata@pfizer.com
authors.forename: Thomas
authors.initials: T
authors.lastname: Kawabata
authors.forename: James
authors.initials: J
authors.lastname: Weaver
authors.forename: Dolca
authors.initials: D
authors.lastname: Thomas
authors.forename: Martin
authors.initials: M
authors.lastname: Rowe
authors.forename: Fred
authors.initials: F
authors.lastname: Wang
authors.forename: Cris
authors.initials: C
authors.lastname: Kamperschroer
authors.forename: Helen
authors.initials: H
authors.lastname: Haggerty
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis; D020031:Epstein-Barr Virus Infections / Q000175:diagnosis / Q000276:immunology / Q000821:virology*; D006566:Herpesviridae Infections / Q000175:diagnosis / Q000276:immunology / Q000821:virology*; D006801:Humans; D007155:Immunologic Factors / Q000633:toxicity*; D018143:Lymphocryptovirus / Q000472:pathogenicity*; D008214:Lymphocytes / Q000187:drug effects / Q000276:immunology / Q000821:virology; D008223:Lymphoma / Q000175:diagnosis / Q000209:etiology* / Q000276:immunology / Q000821:virology; D023421:Models, Animal; D011323:Primates; D018570:Risk Assessment; D012307:Risk Factors; D018675:Toxicity Tests; D014412:Tumor Virus Infections / Q000175:diagnosis / Q000276:immunology / Q000821:virology*; D019562:Viral Load
chemical_list: D015415:Biomarkers; D007155:Immunologic Factors