Agenda

Day 1 Oct 26, 2016

1:30 PM — 5:00 PM

Course: Navigating the Complexities of Biosimilar Clinical Trial Development

Day 2 Oct 27, 2016

7:15 AM — 8:15 AM

Registration and Continental Breakfast

8:15 AM — 8:25 AM

Welcome and Opening Remarks

8:25 AM — 8:45 AM

Keynote Address: The Current State of Biosimilars and Prospects for the Future

8:45 AM — 9:45 AM

Session 1: Determining Biosimilarity: By Use of Totality of the Evidence

9:45 AM — 10:15 AM

Refreshment and Networking Break

10:15 AM — 11:45 AM

Session 2: Critical Quality Attributes (CQA)

11:45 AM — 1:00 PM

Luncheon

1:00 PM — 3:00 PM

Session 3: Value/Relevance of Clinical Data: Challenges of Designing Clinical Studies and Generating Clinical Data

3:00 PM — 3:30 PM

Refreshment and Networking Break

3:30 PM — 4:30 PM

Session 4: The Role of Real-World Evidence (RWE) in the Post-Approval Setting

4:30 PM — 5:30 PM

Session 5: Education

5:30 PM — 6:30 PM

Networking Reception

Day 3 Oct 28, 2016

7:15 AM — 8:15 AM

Registration and Continental Breakfast

8:15 AM — 8:30 AM

Welcome to Day Two

8:30 AM — 10:15 AM

Session 6: Global Harmonization and Regulator Update

10:15 AM — 10:45 AM

Refreshment and Networking Break

10:45 AM — 11:45 AM

Session 7: Ask the Regulators

11:45 AM — 1:00 PM

Luncheon and Round Table Discussions

1:00 PM — 2:30 PM

Session 8: Patient Access

2:30 PM — 2:45 PM

Refreshment and Networking Break

2:45 PM — 4:45 PM

Session 9: Transitions and Interchangeability

4:45 PM — 5:00 PM

Closing Session: Summary of Take-a-Ways and Calls to Action

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Biosimilars 2016

Agenda

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