1 / 7

Session I – Strengths and Weaknesses of the EDSP Screening Assays

Session I – Strengths and Weaknesses of the EDSP Screening Assays Moderator: Angelina J. Duggan Exponent Health Group September 9, 2009. Session I Objectives. EPA EDSP update Provide forum to discuss stakeholder’s EDSP perspectives, interpretations and recommendations.

oren-fitzgerald
Download Presentation

Session I – Strengths and Weaknesses of the EDSP Screening Assays

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Session I – Strengths and Weaknesses of the EDSP Screening Assays Moderator: Angelina J. Duggan Exponent Health Group September 9, 2009

  2. Session I Objectives EPA EDSP update Provide forum to discuss stakeholder’s EDSP perspectives, interpretations and recommendations

  3. EDSP Tier 1 Development • More than 10 years since August 2008 EDSTAC Final Report • Validation was a global effort • EPA and international regulators • Academic, industry, government and CRO scientists • Stakeholders recommendations • Implementation and interpretation of Phase 1 EDSP screening will present new challenges and expectations for EPA, stakeholders, industry and NGOs

  4. Challenges and Expectations • Individual and collective interpretation of Tier 1 Phase 1 screening results • Provide guidance to implement mid-course corrections • Provide guidance on weight-of-evidence to proceed to Tier 2 testing (EDTP) • Tier 1 lessons learned and expert recommendations (ILSI, NAS) should be applied in Tier 2 testing validation • Can the EDSP accommodate and compliment new technologies • Genomic technologies • Alternative screening programs (e.g., ToxCast) • Nanotechnology

  5. EPA EDSP Update • Gary Timm, EPA OCSP: “An Update on the Implementation of the EPA’s Endocrine Disruption Screening Program” • EDSP background and path forward • ESTAC’s recommendation • Validation criteria • Timelines to implement test orders and Tier 2 testing validation

  6. EDSP Stakeholder Expert Panel • CRO perspective • Shelley Tyl, RTI, “Challenges in Conducting and Interpreting Tier 1 EDSP Screening Assays: CRO Perspective ” • Registrant /industry assessments • Sue Marty, Dow Chemical Corp., “Mammalian Tier 1 EDSP Screening Assays: What do they tell us?” • Pat Guiney, SC Johnson, “Wildlife Tier 1 EDSP screening assays:  What do they tell us?” • Christopher Borgert, Applied Pharmacology and Toxicology Inc., “Staging Screening and Testing”

  7. Thank You

More Related