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Workshop Session Three: Phase Appropriate Development from a GMP Perspective

Date
October 15, 2020
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In response to the competitive landscape, unmet medical needs and increased patient demand, pharmaceutical companies have taken phase appropriate GMP approaches to accelerate drug development to market. In addition, increased interactions between regulatory agencies and industry also allowed for clarity and acceptability of these expedited approaches. This session focuses on industry and regulatory perspectives of phase appropriate GMP considerations for process and analytical development and validation, including considerations for different modalities (e.g. antibody-drug conjugates, vaccines, cell/gene therapies). Furthermore, the session will also cover innovative approaches such as setting of phase appropriate specifications, use of pools of clones for toxicological studies, clearance of process- and product-related impurities, phase appropriate raw materials testing, and inspection and commercial readiness.

Session Chairs

Speaker Image for Lucy Chang
Merck & Co., Inc.
Speaker Image for Bharat Dixit
ClearB Therapeutics
Speaker Image for Polly Mak
Genentech, a Member of the Roche Group
Speaker Image for Paula Russell
Health Canada

Speakers

Speaker Image for Patricia Hughes
Patricia Hughes, CDER, FDA
CDER, FDA
Speaker Image for Sven Deutschmann
Roche Diagnostics GmbH
Speaker Image for Todd Mabe
Merck & Co., Inc.
Speaker Image for Megan Powdrill
Health Canada

Panelists

Speaker Image for Kathy Lee
Eli Lilly and Company
Speaker Image for Balaji Viswanathan
Pfizer, Inc.

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