Pre-Congress Workshop Presented by the OARSI Young Investigators Committee

Harnessing the OA White Paper to Accelerate Development and Translation of New OA Therapies

Date/Time: Thursday, May 2, 2019 - 8:00 AM to 11:30 AM
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Description:

8:10 AM

Introduction

8:15 AM

Overview of FDA/EMA Regulatory Requirements
Lee S. Simon, MD – FDA/SDG, LLC

8:30 AM

Understanding the Accelerated Approval Pathway
Virginia Byers Kraus, MD, PhD – Duke University
Morten A. Karsdal, MSc, PhD – Nordic Bioscience

9:15 AM

Discussion (Q & A)

9:30 AM

Break

9:45 AM

Building a Translational Team
Timothy E. McAlindon, MD, MPH – Tufts Medical Center
Christoph Ladel, PhD – Merck
David J. Hunter, MBBS, PhD, Msc – University of Sydney

10:30 AM

Partnering with Other Disease Communities to Accelerate Translation
Gillian A. Hawker, MD, MSc – University of Toronto

10:45 AM

Discussion (Q & A)

11:00 AM

Wrap-up, Full Panel Discussion (Q & A)

Objective(s):

  • To identify current regulatory barriers to development and testing of new disease-modifying pharmacologic treatments and non-pharmacologic interventions for OA

  • To understand the current state of development for new clinical trial endpoints and guidelines for DMOADs and non-pharmacologic treatments

  • To understand the process for moving promising targets and/or interventions to clinical trials, strategies for accelerating the approval process, and broader implications for advocacy and health policy