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Session 8: Digital Health in Clinical Development
Session Chair(s)
Venkat Sethuraman, PhD, MBA, MS
Senior Vice President, Global Biometrics and Data Sciences
Bristol Myers Squibb, United States
Andrew Potter, PhD
Mathematical Statistician, OB, OTS, CDER
FDA, United States
With the advancement of digital health technologies, cloud computing power, and big data analytics, there is an opportunity to develop an integrated strategy to optimize clinical trial designs and advance the development of innovative medicines. In this session, we will learn from the industry and FDA speakers how digital technologies are leveraged to support clinical development.
Learning Objective : - Describe how digital endpoints captured through digital sensors are used in clinical trials
- Discuss how algorithms are developed to detect, diagnose, and monitor; and how they are deployed into clinical practice
- Recognize the current regulatory landscapes with respect to digital health technologies
- Discuss how pharma is leveraging digital technologies in clinical research
Speaker(s)
Digital Health from Clinical Trials to Clinical Practice
Alex Morozov, MD, PhD
Bristol Myers Squibb , United States
Vice President, Head of Digital Health - Global Drug Development
Application of Digital Medicine in Drug Development
Sandeep Menon, PhD
Pfizer Inc, United States
Chief Scientific Officer of Artificial Intelligence and Digital Science and SVP,
Remote Data Acquisition in Clinical Investigations Using Digital Health Technologies
Christina Webber
FDA, United States
General Engineer
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