The EDMVS’ Draft Work Plan - PowerPoint PPT Presentation

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The EDMVS’ Draft Work Plan

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  1. The EDMVS’Draft Work Plan Presentation to the EDMVS, December 10, 2001

  2. Today’s talk will identify • the assays • the major milestones for each assay • when the assay milestones will be reviewed by EDMVS • the OECD interactions

  3. Tier I Screening Battery recommended for consideration by EDSTAC • Steroidogenesis (EPA) • Pubertal - female (EPA) • Fish reproduction (EPA lead for OECD) • Frog Thyroid (EPA lead for OECD) • Estrogen/Androgen receptor/ binding & reporter gene (ICCVAM for EPA) • Hershberger (OECD) • Uterotrophic (OECD)

  4. Alternative Assaysrecommended for consideration by EDSTAC Tier I • Aromatase (EPA) • Pubertal male (EPA) • Adult 14 –day intact male (Industry) Tier ? • In Utero through Lactation (EPA)

  5. Tier II Assays recommended for consideration by EDSTAC • Mammalian 2-generation (EPA / OECD) • Avian 2-generation (EPA lead for OECD) • Amphibian chronic (EPA lead for OECD) • Invertebrate Chronic (EPA lead for OECD) • Fish Chronic (EPA lead for OECD)

  6. Steroidogenesis (Tier I) Milestone Meeting Date • DRP March 2002 • Prevalidation Report Oct 2002 • Validation Report May 2003 • Integrated Summary May 2003

  7. Pubertal – female (Tier I) Milestone Meeting Date • DRP equivalent Dec 2001 • Prevalidation Report Oct 2002 • Validation Report July 2003 • Integrated Summary July 2003

  8. Fish Reproduction (Tier I) Milestone Meeting Date • DRP March 2002 • Prevalidation Report Dec 2002 • Validation Report July 2003 • Integrated Summary July 2003 • OECD interaction: US lead within OECD. Timelines Pending.

  9. Frog Thyroid(Tier I) MilestoneMeeting Date • DRP June 2002 • evaluate utility & future of assay before setting milestone dates

  10. ER/AR binding/reporter gene(Tier I) ICCVAM • DRP, Prevalidation, Validation & Integrated Summary Reports • Expert Consultation May 2002 • Peer Review Fall 2002 EDMVS • reviews ICCVAM Peer Review Report Spring 2003 • provides recommendation on Tier I battery Oct 2003

  11. Hershberger(Tier I) OECD • Completed prevalidation • Validation Fall 2002 EDMVS • reviews Integrated Summary Report Feb 2003 • provides recommendation on Tier I battery Oct 2003

  12. Uterotrophic(Tier I) OECD • Validation process completed EDMVS • reviews Integrated Summary Feb 2003 • provides recommendation on Tier I battery Oct 2003

  13. Aromatase(Tier I) Milestone Meeting Date • DRP March 2002 • Prevalidation Report Oct 2002 • Validation Report May 2003 • Integrated Summary May 2003

  14. Pubertal – male(Tier I) Milestone Meeting Date • DRP equivalent Dec 2001 • Prevalidation Report Oct 2002 • Validation Report July 2003 • Integrated Summary July 2003

  15. Adult 14-day intact male(Tier I) • Development supported by Industry • EDMVS reviews EPA paper comparing results of adult 14-day intact male, pubertal male, and OECD 407 July 2003

  16. In Utero through Lactation(Tier ?) Milestone Meeting Date • DRP Today • Prevalidation Report Dec 2002 • Validation Report Oct 2003 • Integrated Summary Oct 2003

  17. Tier II Assays

  18. Mammalian 2-generation(Tier II) Milestone Meeting Date • DRP none planned • Prevalidation Report Feb 2003 • Validation Report 2004 • Integrated Summary 2004 OECD interaction: Likely to be US lead within OECD. Timelines pending: OECD acknowledges need to revise guideline, but will finish revisions currently in process first.

  19. Avian 2-generation(Tier II) Milestone Meeting Date • DRP March 2002 • Prevalidation Report 2004 • Validation Report 2004 • Integrated Summary 2004 • OECD interaction: US lead within OECD. Timelines pending.

  20. Amphibian Chronic(Tier II) Milestone Meeting Date • DRP Oct 2002 • Prevalidation Report May 2003 • Validation Report 2004 • Integrated Summary 2004 • OECD interaction: US lead within OECD. Timelines pending.

  21. Invertebrate Chronic(Tier II) Milestone Meeting Date • DRP June 2002 • Prevalidation Report May 2003 • Validation Report 2004 • Integrated Summary 2004 • OECD interaction:US lead within OECD. Timelines pending.

  22. Fish Chronic(Tier II) Milestone Meeting Date • DRP March 2002 • Prevalidation May 2003 • Validation 2004 • Integrated Summary 2004 • OECD interaction: US lead within OECD. Timelines pending.

  23. Assays and Milestones for Future EDMVS Meetings March 2002 • Steroidogenesis DRP • Fish Reproduction DRP • Aromatase DRP • Avian 2-gen DRP • Fish Chronic DRP

  24. June 2002 • Frog Thyroid DRP • Invertebrate DRP 

  25. October 2002 • Steroidogenesis Preval. Report • Pubertal - female Preval. Report • Pubertal - male Preval. Report • Aromatase Preval. Report • Amphibian DRP

  26. December 2002 • Fish repro. Preval. Report • In utero  Lactation Preval. Report February 2003 • Hershberger Integrated Summary • Uterotrophic Integrated Summary • Mammalian 2-gen Preval. Report

  27. May 2003 Validation & Integrated Summary Reports: • Steroidogenesis • Aromatase Prevalidation Reports: • Amphibian Chronic • Invertebrate Chronic • Fish Chronic

  28. July 2003 Validation & Integrated Summary Reports: • Pubertal - male • Pubertal - female • Fish Reproduction Comparison Paper – adult 14-day intact male, pubertal male, and OECD 407

  29. October 2003 • In Utero through Lactation Validation & Integrated Summary Report • Tier I Screening Battery Composition Review

  30. - 2004 - Validation & Integrated Summary Reports: • Mammalian 2-gen • Amphibian Chronic • Invertebrate Chronic • Fish Chronic Avian 2-gen Preval., Validation & Integrated Summary Reports

  31. March Agenda • Steroidogenesis DRP • Fish Reproduction DRP • Aromatase DRP • Avian 2-gen DRP • Fish Chronic DRP • Other Issues: Low dose