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Omni Shoreham Hotel

Dec 05, 2016 1:00 PM - Dec 06, 2016 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Advancing the Science of Study Endpoints

Examine global strategies for selecting study endpoints and the impact of endpoints during the analysis of clinical evidence for various types of drug approval processes.

Agenda

12:00 PM — 5:30 PM

Registration

12:00 PM — 1:30 PM

Registration

1:00 PM — 1:25 PM

Welcome and Opening Remarks: Setting the Stage

1:25 PM — 2:40 PM

Session 1: Perspectives on Study Endpoints: Where Are We Now and Where Are We Going?

2:40 PM — 3:00 PM

Refreshment and Networking Break

3:00 PM — 4:30 PM

Session 2: Approval Pathways and Endpoint Selection

4:30 PM — 5:30 PM

Session 3: Research Presentations

5:30 PM — 6:30 PM

Networking Reception

7:15 AM — 8:15 AM

Continental Breakfast

7:30 AM — 8:30 PM

Registration

8:15 AM — 8:30 AM

Welcome to Day Two

8:30 AM — 9:30 AM

Session 4: DIA-ISPOR Session: Prospectively Planning Adaptive Endpoints and Involving All Stakeholders

9:30 AM — 10:00 AM

Refreshment and Networking Break

10:00 AM — 11:30 AM

Session 5: Addressing Multiple Stakeholder Needs with COAs and Endpoints Selection

11:30 AM — 1:00 PM

Luncheon

1:00 PM — 2:30 PM

Session 6: Meaningful Score Changes to Establish Endpoint Definitions

2:30 PM — 3:00 PM

Refreshment and Networking Break

3:00 PM — 4:30 PM

Session 7: Clinical Trial Grade Wearables – The Current State of the Science

4:30 PM — 5:00 PM

Closing Summary

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