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Roundtables – Lunch

Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)

Wed, Aug 5, 12:30 PM - 1:50 PM Room CC-Ballroom Foyer Thomas M. Menino Convention & Exhibition Center

2 Presentations

WL04: Beyond ORR: Go/No-Go Decision-Making of Transitioning to P3 Study in Oncology Clinical Development

12:30 PM - 1:50 PM

Yusuke Yamaguchi (Astellas Pharma Global Development, Inc.)

Co-authors: Cong Han

Clinical trial Pharmaceutical statistics Oncology drug development Go/No-Go decision

WL05: Data Monitoring Committees: Advancing Best Practices and Developing the Next Generation of Experts

12:30 PM - 1:50 PM

Li Chen (Amgen)

Interim monitoring of clinical trials High-quality clinical trial oversight Training and mentorship

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