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DIA/FDA Biostatistics Industry and Regulator Forum

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

Session 3: Technology Advances for Design and Analysis of Complex Innovative Designs Issues

Session Chair(s)

Karen Lynn Price, PhD

Karen Lynn Price, PhD

  • Research Fellow, Statistical Innovation Center/Design Hub
  • Eli Lilly and Company, United States
Dionne  Price, PhD

Dionne Price, PhD

  • Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
  • FDA, United States
The Food and Drug Administration launched the Complex Innovative Trial Design (CID) Pilot Program as a deliverable under the sixth iteration of the Prescription Drug User Fee Amendments. The goal of the program is to facilitate the advancement and use of complex adaptive, Bayesian, or other innovative clinical trial designs requiring simulations to estimate operating characteristics. Given the extent of simulations required and computational intensity associated with the number of simulations needed, it is important that we leverage and advance cutting-edge technology to enable efficient conduct and evaluation of simulations for CIDs. In this session, we will discuss the latest technological advances further enabling CIDs and explore gaps still existing and ways to potentially meet those gaps.
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Describe current state of advanced technology being utilized to further enable CIDs
  • Recognize the importance of advancing technology in this space
  • Recognize potential gaps in state of technology and opportunities for improving efficiency of conducting and evaluating simulation results


Paul  Schuette, PhD, MA


Paul Schuette, PhD, MA

  • Mathematical Statistician, OB, OTS, CDER
  • FDA, United States
Matilde  Kam, PhD

Leveraging FDA’s Technology Modernization Action Plan to Meet Computing Needs for Complex Innovative Designs

Matilde Kam, PhD

  • FDA/CDER/OTS/OB/AIS, United States
Roger J. Lewis, MD, PhD


Roger J. Lewis, MD, PhD

  • Professor and Chair, Department of Emergency Medicine
  • Harbor-UCLA Medical Center, United States
Eric  Nantz, DrSc, MSc

Harnessing the Evolving Landscape of R & High-Performance Computing for CID (and Beyond)

Eric Nantz, DrSc, MSc

  • Principal Research Scientist
  • Eli Lilly and Company, United States

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Additional Information

Biostatistics Industry Resource Kit