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Virtual Event

27 may 2020 10:45 a.m. - 29 may 2020 3:30 p.m.

(US Eastern Standard Time)

Fort Washington, PA 19034

DIA/FDA Biostatistics Industry and Regulator Forum

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

Session Chair(s)

Karen Lynn Price, PhD

Karen Lynn Price, PhD

Senior Research Fellow, Statistical Innovation Center/Design Hub

Eli Lilly and Company, United States

Dionne  Price, PhD

Dionne Price, PhD

Deputy Director, 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

Speaker(s)

Paul  Schuette, PhD, MA

Speaker

Paul Schuette, PhD, MA

FDA, United States

Mathematical Statistician, Scientific Computing Coordinator

Matilde  Kam, PhD

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

Matilde Kam, PhD

FDA, United States

Associate Director Analytrics and Informatics, OB, OTS, CDER

Roger  Lewis, MD, PhD

Speaker

Roger Lewis, MD, PhD

Berry Consultants, LLC, United States

Senior Medical Scientist

Eric  Nantz, DrSc, MSc

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

Eric Nantz, DrSc, MSc

Eli Lilly and Company, United States

Principal Research Scientist

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