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Session 2: Opportunities for CMC in Accelerated Development Programmes Part 1
Session Chair(s)
Ursula Busse, PhD, MBA
Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
Frank Montgomery, PhD
Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom
This session will explore current trends and novel approaches for CMC in accelerated development programmes. Case studies will illustrate CMC strategies, opportunities and challenges faced for different treatment modalities (small molecules, biotherapeutics, cell and gene therapies) both pre- and post-approval. Different means to accelerate development, such as the use of prior knowledge or predictive stability studies, will be discussed between industry and regulatory representatives. Presentations will be followed by an interactive panel discussion.
Speaker(s)
Case Study: Small Molecules
Fabian Schwarb, PhD
Siegfried AG, Switzerland
Global Head Regulatory Affairs
Case Study: Biologics
T. Venkateshwaran, PhD
Merck & Co., Inc., United States
Vice President and Global Head CMC Biologics, Medical Devices and Comb
Case Study: Cell and Gene Therapy
Florence Salmon
Novartis, Switzerland
Director Regulatory Affairs CMC
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