Session-8-Senior-Leaders-Town-Hall

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Session 8: Senior Leaders Town Hall: Bridging Statistical Science with Data Science in Drug Development

Session Chair(s)

Jingyu (Julia) Luan, PhD

Executive Regulatory Science Director, BioPharmaceuticals R&D

AstraZeneca, United States

Cristiana Mayer, DrSc, PhD

Head of Biostatistics

Johnson & Johnson Vision, United States

A lot of attention is given in the media to advanced technology and analytics: from big data, electronic health records, and sophisticated data modeling paired with innovative analysis approaches, to cutting-edge tools such as biosensors and health-measurement devices. Statistical science, data science, and computer science seem to converge. New opportunities in drug development are here to leverage data knowledge and improve decision-making. Senior leaders from industry and FDA will discuss the current role of statistics. They will highlight the opportunity as well as the challenges from their different perspectives and experience.

Learning Objective : At the conclusion of this session, participants should be able to:
Understand the collaboration of statistical science with data science in drug development
Understand what has changed in the role of the statistician
Describe opportunities for drug development based on advancements in new technologies and data analytics

Speaker(s)

Speaker

Aloka Chakravarty, PhD

Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States

Director, Data Analytics

Speaker

Eric Gibson, PhD

Novartis Pharmaceuticals Corporation, United States

VP, Global Head Biostatistical Sciences and Pharmacometrics

Speaker

Cyrus Hoseyni, PhD

Janssen R&D, United States

VP & Global Head of Statistics and Decision Sciences

Speaker

Lisa Lupinacci, PhD, MS

Merck and Co., Inc., United States

Senior Vice President, Biostatistics and Research Decision Sciences

Speaker

John Scott, PhD, MA

FDA, United States

Division Director, Office of Biostatistics, CBER

Speaker

Ram Tiwari, PhD, MS

Bristol Myres Squibb , United States

Head of Statistical Methodology

DIA/FDA Biostatistics Industry and Regulator Forum