Statistical Strategies to Accelerate Development

June

June 5, 1:00-2:00 p.m. ET

Statistical Strategies to Accelerate Development (Not Slow It Down)

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 The old mantra “the product is the process” has (fortunately) been replaced by terms like “precision medicine” and even “precision vaccinology”.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 will use the Quality by Design (QbD) framework for maintaining an accelerated timeline while satisfying reviewer expectations. Examples are drawn from my experience supporting approval of multiple accelerated products since 2015, and earlier work modernizing control strategies for legacy vaccines. Statistical thinking and techniques form the backbone for QbD. JMP capabilities for executing these will be showcased.

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

What you’ll learn

The difference between process monitoring methods when first introduced in the Industry 2.0 era and the challenges faced in Industry 4.0.
Why it is important for monitoring methods to be desensitized.
How monitoring methods have been adapted to account for larger amounts of data, changes in data structure, and increased computing power.

Meet the speaker

Julia O'Neill

Distinguished Fellow, CMC Modeling & Statistics Lead, Direxa Consulting

Julia O’Neill leads CMC Modeling and Statistics for Moderna as a member of the Technical Development Leadership Team. She is a Fellow of the American Society for Quality. Since 2005 she has consulted to support the approval of multiple accelerated products, including gene therapy, microbiome and regenerative medicine.

O’Neill worked at Merck (MSD) as Senior Scientific Fellow of Statistics in Regulatory & Analytical Sciences and Director of Global Technical Operations, with a primary focus on vaccines and biologics. Her experience includes development of specifications; stability analysis; development, qualification and validation of analytical methods; process development and qualification; control strategy authoring; design and implementation of Continued Process Verification programs; and expert design of experiments support for a wide range of development programs in vaccines, biologics, gene therapies, small molecules, and other products derived from biological materials. She is a Six Sigma Master Black Belt who built and directed multiple teams which have successfully resolved complex investigations, driven sustained improvements, and represented solutions to regulators. Her mentoring has provided encouragement for five colleagues to complete graduate degrees in statistics.

She has over 30 years of experience bridging statistics and chemical engineering in the pharmaceutical and chemical industries. Her education synthesizes statistics and engineering, with an MS in statistics from the University of Wisconsin and a BS in chemical engineering from the University of Maine.

Discussion

After her talk, Julia will join Anne Milley for an extended discussion and Q&A.