Breakout Session 1 - Prior Knowledge as a Means to Further QbD Implementation
Facilitated by Ruojia Li, Bristol-Myers Squibb
Breakout Session 2 – Opportunities for Working with Big Data in Biologicals
Facilitated by JoAnn Coleman, Spark Therapeutics
Breakout Session 1 – CMC Statistics Advancement in a Regulated Industry
Facilitated by Laura Pack, Rezolute
Breakout Session 2 – Patient-Centric Specifications
Facilitated by Tim Schofield, IABS; CMC Science LLC
Breakout Session 1- Current Trends and Issues in Continuous Manufacture Driving Drug Development
Facilitated by Areti Manola, Janssen
Breakout Session 2 – Updating Limits Using Bayesian Methods
Link to Abstract
Facilitated by Tara Scherder, Synolostats, LLC
Breakout Session 1- Case Studies of Acceleration with a Lifecycle Approach
Facilitated by Katherine Giacoletti, Merck & Co., Inc.
Breakout Session 2 – Bayesian Success Stories in CMC
Facilitated by Chuck Miller, Merck & Co., Inc.
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The International Alliance for Biological Standardization (IABS) is an independent, non-profit scientific Alliance, governed by Articles 60-79 of the Swiss Civil code and by its Constitution. Its office is located in Geneva (Switzerland). IABS has members in over 50 countries.
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