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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

Session 7: A Community of Networks, Creating, and Leveraging a Network of Distributed Data Supporting Medical Product Development

Session Chair(s)

Rima  Izem, PhD

Rima Izem, PhD

  • Biostatistician, Division of Biostatistics and Study Methodology
  • Children’s Research Institute at Children’s National Medical Center , United States
Pallavi  Mishra-Kalyani, PhD, MS

Pallavi Mishra-Kalyani, PhD, MS

  • Lead Mathematical Statistician
  • 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.


Jeremy A Rassen, DrSc, MS


Jeremy A Rassen, DrSc, MS

  • President and Chief Science Officer
  • Aetion, United States
Aracelis  Torres, PhD


Aracelis Torres, PhD

  • Director, Quantitative Sciences
  • Flatiron Health, United States
Klaus  Romero, MD, MS

PPP Networks and Quantitative Drug Development Tools

Klaus Romero, MD, MS

  • Clinical Pharmacologist
  • Critical Path Institute, United States
Telba  Irony, PhD


Telba Irony, PhD

  • Deputy Director, Office of Biostatistics and Epidemiology, CBER
  • FDA, United States
Yong  Ma, PhD


Yong Ma, PhD

  • Lead Mathematical Statistician, OB, OTS, CDER
  • FDA, United States

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Biostatistics Industry Resource Kit