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Session 5: Statistical Innovation in Antimicrobial Drug Development
Session Chair(s)
Amy Xia, PhD
Vice President, Center for Design and Analysis, Amgen Inc., United States
Antimicrobial drug development encompasses treatments for viruses and bacterial infections. Viruses, such as Ebola and Zika, often pose an immediate public health threat and unique clinical trial challenges. An equally concerning risk to public health is the simulataneous increase in the number of bacteria that are highly resistant to available antibiotics and lack of new antibiotics in drug development. The 21st Century Cures Act includes legislation pertaining to novel clinical trial designs as well as antimicrobial innovation and stewardship. In this session, the landscape of antimicrobial drug development will be reviewed and two innovative Bayesian adaptive designs will be presented.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe unique challenges associated with antimicrobial drug development
- Identify opportunities for statistical innovation in antimicrobial drug development
- Discuss Bayesian adaptive design case studies
Speaker(s)
Session Co-Chair
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Landscape of Antimicrobial Drug Development
John Farley, MD, MPH
Director, Office of Infectious Diseases, OND, CDER, FDA, United States
An Innovative Trial Design and Analysis Undertaken During the Ebola Crisis
Michael Proschan, PhD
Mathematical Statistician, NIAID/NIH, United States
The ADAPT Platform Trial Design for Innovative Antibiotic Development
Kert Viele, PhD
Director of Research. Senior Statistical Scientist, Berry Consultants, United States
Panelist (Joining Session Speakers)
Telba Irony, PhD, MS, MSc
Senior Scientific Director, Quantitative Sciences, Janssen R&D, United States
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