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Luncheon and Round Table Discussions
Session Chair(s)
Speaker Invited
United States
NEW this year!
Join a discussion led by a leader within the Biosimilars Community.
Approximately 15 minutes into the luncheon, leaders within the Biosimilars community will facilitate discussions, while also encouraging you to connect with your colleagues and share your experiences and questions.
This is an optional activity and prior to the conference all registered attendees will be asked, via an email from DIA, to pre-select a table if they are interested in participating.
Topic List with Discussion Leaders:
Speaker(s)
Table #1: Biosimilar Substitution and Switching
Hillel P Cohen, PhD
Sandoz Inc., United States
Executive Director, Scientific Affairs
Table #2: Statistical Tools for CQA Comparisons
Martin Schiestl, PhD
Sandoz GmbH, Austria
Global Head Regulatory Affairs Policy
Table #3: Evaluating Analytical Similarity
Emily Shacter, PhD
ThinkFDA, LLC, United States
Independent Consultant
Table #4: Navigating Regulatory Requirements: Clinical Trial Design, Population, and Endpoints
Jian Wang, MD, PhD
Health Canada, Canada
Division Manager, Clinical Review Division – Heamatology/Oncology
Table #5: Regulatory Considerations for Global Development
Cornelia Ulm
Fresenius Kabi, Switzerland
Head of Regulatory Affairs, Biosimilars
Table #6: Real World Evidence
Thomas Felix, MD
Amgen Inc., United States
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Table #7: Patient Access
Michael Muenzberg
Ares Trading S.A, Switzerland
Vice President, Director Medical Affairs Biosimilars
Table #8: PK/PD Issues in Biosimilar Development
Jurgen Venitz, MD, PhD
Virginia Commonwealth University, United States
Professor, Dept of Pharmaceutics, Pharmacotherapy & Outcomes Sci, Dir PK/PD Lab
Table #9: Need for Education of Health Care Providers
Mary Jo Carden, JD, RPh
Sandoz, Inc., United States
Head, Policy
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