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Session 7: A Community of Networks, Creating, and Leveraging a Network of Distributed Data Supporting Medical Product Development
Session Chair(s)
Rima Izem, PhD
Associate Director Statistical Methodology
Novartis, Switzerland
Pallavi Mishra-Kalyani, PhD, MS
Deputy Division Director, DBV, OB, CDER
FDA, United States
The size, number and diversity of healthcare data sources increases at a faster pace than the speed of this information’s use in regulatory and business decisions necessary in the drug development lifecycle. The innovation leverages common goals to share resources and advance public health more efficiently than any member of the network could feasibly accomplish alone. The innovation is also in creating standards, processes, designs and analyses which account for the distributed nature of the information and is fair to stakeholders in the network. This latter set of innovation can be borrowed and adapted by future networks and partnerships. This panel will discuss the promise and accomplishments of networks in designing clinical trials or observational studies to assess drug safety, and efficacy in rare diseases and oncology. Panelists will discuss lessons learned in creating these networks, their accomplishments and promising current/future work.
Speaker(s)
Speaker
Jeremy A Rassen, DrSc, MS
Aetion, United States
Co-Founder and President
Speaker
Aracelis Torres, PhD
Flatiron Health, United States
Director, Quantitative Sciences
PPP Networks and Quantitative Drug Development Tools
Klaus Romero, MD, MS
Critical Path Institute, United States
Chief Executive Officer
Speaker
Telba Irony, PhD, MS, MSc
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences
Speaker
Yong Ma, PhD
FDA, United States
Lead Mathematical Statistician, OB, OTS, CDER
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