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Hotel Ilunion Alcora Sevilla

Sep 27, 2022 8:30 AM - Sep 28, 2022 3:00 PM

San Juan de Aznalfarache, 41920 Sevilla, Spain

Accelerating CMC Workshop

This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective.

Session 4: Alternative Approaches to Accelerate Development

Session Chair(s)

Gregory  Rullo, MS

Gregory Rullo, MS

Senior Director, Regulatory Affairs - CMC

AstraZeneca , United States

Products with accelerated clinical development activities often face challenges in expediting CMC development activities to align with the accelerated clinical timelines. Innovative approaches that overcome these CMC challenges and deliver new medicines to patients require the use of advances in modelling tools to support drug development and continued process improvement.

This session will review recent advances in formulation and manufacturing technologies, novel dissolution approaches and the emergence of Physiologically-Based Biopharmaceutics Modelling (PBBM) that present new opportunities to optimize drug product design, manufacture and release, and focus on optimal product performance in the patient.


Talia  Flanagan, PhD

Biopharmaceutics models as tools for Accelerating CMC

Talia Flanagan, PhD

UCB, United Kingdom

Tycho  Heimbach

Physiologically Based Biopharmaceutic Models in Drug Development

Tycho Heimbach

Merck &Co. (MSD), United States

Sterile & Specialty Products Group

Gert  Thurau, DrSc, PhD

Modeling tools for accelerated drug substance or drug product development

Gert Thurau, DrSc, PhD

F. Hoffmann-La Roche Ltd, Switzerland

Head of Manufacturing Technology Innovation in CMC Regulatory Policy

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