アジェンダ
8:30 AM — 8:45 AM
Welcome and Opening Remarks: How Study Endpoints are Used and Why8:45 AM — 9:30 AM
Commercial Interest in Study Endpoints9:30 AM — 10:15 AM
Translational Medicine: The Bridge Between the Beginning and the End10:15 AM — 10:30 AM
10:30 AM — 11:15 AM
Addressing Study Endpoints for Clinical Relevance11:15 AM — 12:00 PM
Study Endpoints: A Market Access Perspective12:00 PM — 1:00 PM
1:00 PM — 1:45 PM
What Does Differentiation Mean to You and How You Select Endpoints?1:45 PM — 2:30 PM
Tools to Help Gain Alignment in the Project Team2:30 PM — 2:45 PM
2:45 PM — 3:30 PM
Beginning with Differentiation in Mind – Easier Said than Done3:30 PM — 4:00 PM
8:45 AM — 9:30 AM
Adaptive Designs and Endpoint Selection (Via Telecommunications)10:15 AM — 10:30 AM
10:30 AM — 11:15 AM
Patient-Centered Outcomes Targeting Payers and Regulators11:15 AM — 12:00 PM
Study Endpoints and Patient-Centered Outcomes: Payer Needs vs. Regulatory Limits12:00 PM — 12:15 PM
12:15 PM — 1:15 PM
1:30 PM — 3:00 PM
Navigating Instrument Development Using the Wheel and Spokes3:00 PM — 3:15 PM
3:15 PM — 4:30 PM
Spoke 1: Defining the Clinical Trial Context of Use4:30 PM — 4:45 PM
4:45 PM — 5:45 PM
8:45 AM — 10:15 AM
Conceptualization and Generation of a Draft Measure10:15 AM — 10:30 AM
11:45 AM — 12:45 PM
2:15 PM — 2:30 PM
3:45 PM — 4:00 PM
Wrap Up and Adjournment