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Session 7: Complex Innovative Design Pilot Program
Session Chair(s)
Li Wang, PhD
Senior Director, Head of Statistical Innovation
AbbVie , United States
Fairouz Makhlouf, PhD
Deputy Director, Office of Biostatistics, Office of Translational Science, CDER
FDA, United States
To promote innovation and efficiency, FDA started Complex Innovative Design (CID) Pilot Program in 2018. Over the years, five use cases proposed by different sponsors were accepted by FDA and significant progress had since been made. In this session, FDA speakers and sponsors will give the audience an update on the progress and share the challenges and lessons learned from CID pilot program.
Learning Objective : - Understand the progress of certain CID pilot use cases
- Discuss the challenges of certain CID pilot use cases
- Be prepared to submit their own proposals
Speaker(s)
Moving Forward: The CID Pilot Program
Dionne Price, PhD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER
CID Case Study in SLE: Experiences and Considerations
May F Mo, MBA, MS
Amgen, United States
Executive Director, Biostatistics
FDA Commentary on CID Case Study in SLE
Cesar Daniel Torres, PhD, MS
FDA, United States
Senior Mathematical Statistician, OB, OTS, CDER
FDA Commentary on DLBCL External Control Design in CID Program
Jonathon J. Vallejo, PhD
FDA, United States
Mathematical Statistician, OB, OTS, CDER
Label-enabling Dynamic Borrowing with External Control for OS - FDA Complex Innovative Designs Pilot Program
Jiawen Zhu, PhD
Genentech, a Member of the Roche Group, United States
Senior Principal Statistical Scientist