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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Advancing Clinical Trial Innovation Through Model-Informed Drug Development

Session Chair(s)

Samantha  Roberts, PhD

Samantha Roberts, PhD

Group Director, US Regulatory Science

Genentech, A Member of the Roche Group, United States

This forum will present case studies from FDA’s Model-Informed Drug Development pilot program. A panel of experts will provide their perspectives on how key learnings from the pilot can be used to advance the acceptability and use of modeling.

Learning Objective : Describe potential applications of modeling to inform and accelerate drug development; Discuss lessons from FDA's Model-Informed Drug Development (MIDD) pilot program; Identify opportunities to use learnings from pilot program to facilitate more routine adoption of MIDD in the future.

Speaker(s)

Matthew  Raymond, PhD

Moderator

Matthew Raymond, PhD

Astellas, United States

Director, Science and Regulatory Policy

Rajanikanth  Madabushi, PhD

Model-Informed Drug Development Pilot Program: FDA Perspective

Rajanikanth Madabushi, PhD

FDA, United States

Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER

Daniele  Ouellet, PhD

Industry Perspective on MIDD

Daniele Ouellet, PhD

Pfizer Inc, United States

Global Head Pharmacometrics

Samantha  Roberts, PhD

MIDD Pilot Program: Lessons Learned

Samantha Roberts, PhD

Genentech, A Member of the Roche Group, United States

Group Director, US Regulatory Science

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