TED Consensus Conference 1

February 2, 2015 to February 3, 2015
NIH Campus Natcher Auditorium

TBI Endpoints Development (TED) Initiative

First Consensus Conference

February 2nd (full day) and 3rd (half day), 2015

Natcher Conference Center on the NIH Campus

We are pleased to announce that the First Consensus Conference for the DoD-funded TBI Endpoints Development (TED) Initiative is in the planning stages. The goal of TED is to identify and validate candidate clinical outcome assessments and biomarkers that could be qualified by FDA as drug development tools for future TBI trials to benefit military and civilian populations.

You are invited to join our consortium of academic, government, private and industry partners to undertake the following:

  • Share our understanding of the FDA validation process
  • Constitute Expert Working Groups that will review the landscape of existing and pipelined:
    • Clinical outcome assessments
    • Genomic, proteomic, and imaging biomarkers
    • Emerging technologies and devices
  • Set our course toward the validation of clinical endpoints

Agenda

I. Opening and Background

Overview of the TED Technical Objectives and Aims.

Describe consensus process to identify existing COAs and biomarkers for further investigation by EWGs, and potential candidacy for validation in Stage II.

II. Tri-Part Plenary Session

Plenary Segment I: FDA guidance regarding DDT qualification process.

Plenary Segment II: Industry perspective on DDTs.

Plenary Segment III: Overview of C-Path and CAMD, and how the TED initiative can proceed within the C-Path framework.

III. COA Case Study

Illustration of how the C-Path framework can facilitate COA development.

IV. Breakout Work Groups

Breakout groups will begin the process of: 1) identification of existing COAs and biomarkers to be analyzed, 2) defining membership of EWGs, and 3) creating work streams to achieve Stage I Aims.

V. EWG Reports

Report-back from the breakout sessions, with panel discussion and input.

VI. Planning

Review revised Landscape Grids; planning for execution of the remaining Aims of TED Stage I.

A block of rooms has been reserved at the NIH Bethesda Marriott at 5151 Pooks Hill Road, Bethesda, MD. Contact information for reservations will be provided shortly.

Questions: Contact the office of Dr. Geoffrey Manley:

Name of Contact: Kimberly Cantero Email: kimberly.cantero@ucsf.edu

Phone: (415) 206-2340