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