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Session 4: Alternative Approaches to Accelerate Development
Session Chair(s)
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.
Speaker(s)
Biopharmaceutics models as tools for Accelerating CMC
Talia Flanagan, PhD
UCB, United Kingdom
Physiologically Based Biopharmaceutic Models in Drug Development
Tycho Heimbach
Merck &Co. (MSD), United States
Sterile & Specialty Products Group
Modeling tools for accelerated drug substance or drug product development
Gert Thurau, DrSc, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Head of CMC Regulatory Policy for Manufacturing Technology Innovation in