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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)
Hillel P Cohen, PHD
Biosimilars Expert, Retired, United States
Table #1: Biosimilar Substitution and Switching
Martin Schiestl, PHD
Global Head Regulatory Affairs Policy, Sandoz GmbH, Austria
Table #2: Statistical Tools for CQA Comparisons
Emily Shacter, PHD
Independent Consultant, ThinkFDA, LLC, United States
Table #3: Evaluating Analytical Similarity
Jian Wang, MD, PHD
Division Manager, Clinical Review Division – Heamatology/Oncology, Health Canada, Canada
Table #4: Navigating Regulatory Requirements: Clinical Trial Design, Population, and Endpoints
Cornelia Ulm
Head of Regulatory Affairs, Biosimilars, Fresenius Kabi, Switzerland
Table #5: Regulatory Considerations for Global Development
Thomas Felix, MD
Medical Director, R&D Policy, Global Regulatory Affairs and Safety, Amgen Inc., United States
Table #6: Real World Evidence
Michael Muenzberg
Vice President, Director Medical Affairs Biosimilars, Ares Trading S.A, Switzerland
Table #7: Patient Access
Jurgen Venitz, MD, PHD
Professor, Dept of Pharmaceutics, Pharmacotherapy & Outcomes Sci, Dir PK/PD Lab, Virginia Commonwealth University, United States
Table #8: PK/PD Issues in Biosimilar Development
Mary Jo Carden, JD
, Carden Associates, United States
Table #9: Need for Education of Health Care Providers
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