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Thursday, June 18 • 5:00pm - 6:00pm
#551 OD: ON DEMAND - Advancing Clinical Trial Innovation Through Model-Informed Drug Development

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Component Type: Forum
Level: Advanced

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 Objectives

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.

Chair

Samantha Roberts, PhD

Speaker

Moderator
Matthew Raymond, PhD

Model-Informed Drug Development: FDA Perspective
Rajanikanth Madabushi, PhD

Industry Perspective on MIDD
Daniele Ouellet, PhD

MIDD Pilot Program: Lessons Learned
Samantha Roberts, PhD



Speakers
SR

Samantha Roberts

Director, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Samantha Roberts is currently a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize and improve the efficiency of drug development and review. Before joining Roche/GNE in 2016, she worked... Read More →
avatar for Matthew Raymond

Matthew Raymond

Director, Science and Regulatory Policy, Astellas
Dr. Raymond currently serves as Director, Science and Regulatory Policy at Astellas. Prior to joining Astellas, Dr. Raymond served as a Director, Science and Regulatory Advocacy at PhRMA. In this role he focused on regulatory policy and advocacy issues including combination products... Read More →
DO

Daniele Ouellet

Global Head Pharmacometrics, Pfizer Inc
Daniele Ouellet, PhD, is Vice-President and Global Head of Pharmacometrics at Pfizer, where her focus is to apply model informed drug development (MIDD) principles to the portfolio. In her current role, Daniele is responsible for a group of Pharmacometricians who provide MIDD input... Read More →
avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER, FDA, United States
Dr. Madabushi has 10 years of regulatory review experience as Pharmacometrics Review and as Team Leader in the Office of Clinical Pharmacology. He was predominantly involved in the application of quantitative clinical pharmacology approaches for regulatory decision making and addressing... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum