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| Sponsors of biosimilar products made significant gains in 2017, though Research & Development and commercial challenges remain. Noteworthy news items included more and novel biosimilar approvals in ICH countries, including the first oncology biosimilar approval. There were also significant U.S. court decisions, such as the elimination of the patent dance, evolving and new innovator protection strategies, and promulgation of additional draft regulatory guidance, including those related to interchangeability and biostatistics. |
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This webinar will provide attendees an extended period of time to engage biosimilar experts from IQVIA's Biosimilars Center of Excellence (BCOE) to identify the key issues of 2017 — in a "Year in Review" format.
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Attendees will hear three key case studies in order to discuss strategies to improve cost-effectiveness and patient access to originator biologics. The three case studies will examine:
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How biosimilar sponsors can extend their global development and marketing aspirations outside the EU and US markets |
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How to expedite biosimilar clinical trial recruitment using secondary sources of data |
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How sophisticated modeling tools can optimize your biosimilar protocol design |
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The webinar will then engage the audience to solicit insights from the BCOE experts in a "Meet the Panel" type format.
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| Presenters: |
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Dr. Nigel Rulewski, MD, DRCOG, DCH
Vice President, Strategic Drug Development Head, Biosimilar Center of Excellence, IQVIA |
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Raymond A. Huml, MS, DVM, RAC
Vice President, Head, Global Biosimilars
Strategic Planning,
Biosimilar Center of Excellence, IQVIA |
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| Moderator: |
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Lisa Henderson
Editorial Director, Applied Clinical Trials |
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For technical questions about this webinar,
please contact Kristen Moore at kristen.moore@ubm.com |
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| If you can't make the live webcast, please feel free to register and view it on-demand after the air date. |
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Contact IQVIA at
www.iqvia.com
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