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Overview

DIA’s conference on clinical trial endpoints will bring together key stakeholders to address critical questions and generate potential solutions to challenges associated with determining study endpoints and outcomes. The 2016 conference will examine global strategies for selecting study endpoints, and the impact of study endpoints during analysis of clinical evidence in the various types of drug approval processes.

This program has been developed in collaboration with the Study Endpoints Community.


Highlights

  • Two Keynote Addresses! Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA, and Dr. Mark McClellan, Director of the Duke Robert J. Margolis Center for Health Policy at Duke University, will share their perspectives on the development of study endpoints - Where are We Now and Where are We Going?
  • Global speakers from regulatory agencies, industry, academia, and non-profit organizations


The Study Endpoints conference provided a lot of opportunities to speak to key decision makers at the FDA in an informal setting, which was very valuable to me and to many. The talks were also refreshing and provided information from different perspectives (industry, FDA, clinicians, patient advocacy, academics).
- 2015 Attendee


Network early and start engaging on social media using the hashtag #Endpoints16.

Learning objectives

At the conclusion of this conference, participants should be able to:

  • Describe the relationship between endpoint selection and the different types of drug approval pathways
  • Discuss the needs and requirements of critical stakeholders — patients, regulatory agencies, clinicians, payers — when identifying endpoints
  • Identify techniques for establishing the clinical relevance of changes in endpoints in clinical trials 
  • Explain the use of wearables for collecting study endpoint data in clinical trials

Program Committee

  • Chad  Gwaltney, PhD
    Chad Gwaltney, PhD President
    Gwaltney Consulting, United States
  • Annabel  Nixon, PhD
    Annabel Nixon, PhD PRO Consultant
    Chilli Consultancy, United Kingdom
  • Keith  Wenzel
    Keith Wenzel Senior Director, Scientific Data Organization
    Parexel, United States
  • René  Allard, PhD
    René Allard, PhD Contractor
    Self Employed, Germany
  • J. Jason  Lundy, PhD
    J. Jason Lundy, PhD Principal
    Outcometrix, United States
  • David H. Schubert
    David H. Schubert Vice President of Regulatory and Quality
    Stealth BioTherapeutics, United States
  • Ashley F. Slagle, PhD, MS
    Ashley F. Slagle, PhD, MS Principal, Scientific and Regulatory Consulting
    Aspen Consulting, LLC, United States
  • Michael  Lees
    Michael Lees Head of Value, Evidence and Portfolio Strategy – EUCAN
    Takeda Pharmaceuticals International GmbH, Switzerland
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Contact us

Registration Questions?

Send Email
1.888.257.6457
+1.215.442.6100


Agenda Details

Send Email
+1.215.442.6117


Event Logistics

Send Email
+1.215.442.6149


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