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Statistical Strategies to Accelerate Development (Not Slow It Down)

Watch the Keynote and Q&A

Development pathways for pioneering biopharmaceuticals have moved far beyond traditional approaches for biologics. The old mantra “the product is the process” has (fortunately) been replaced by terms like “precision medicine” and even “precision vaccinology.” Characterization techniques have advanced rapidly as an essential component of the modern development era.

Accelerated timelines have become the norm, driven by breakthrough designation products for unmet medical needs and pandemic emergency scenarios. However, conventional standards for regulatory submissions were established in the context of older development paradigms. Strategies for reconciling health authority expectations and modern development and characterization are hot topics.

In this Statistically Speaking, Julia O'Neill uses the Quality by Design (QbD) framework for maintaining an accelerated timeline while satisfying reviewer expectations. Examples are drawn from Julia's previous experiences supporting approval of multiple accelerated products since 2015, and her earlier work modernizing control strategies for legacy vaccines. Statistical thinking and techniques form the backbone for QbD. JMP capabilities for executing these are showcased.

Q&A with the speaker is available at the conclusion of the keynote.

What you’ll learn:

 
  • Methods in which Quality by Design framework can streamline your processes and maintain an accelerated timeline.
  • How various capabilities in JMP can assist in executing QbD framework. 
  • The significance of emerging fields — such as precision medicine and precision vaccinology — in biologics.