Video

Statistical expert Julia O'Neill shares lessons learned over the course of a career in the life sciences

Design of experiments accelerates innovation and progress

O'Neill shares an example of a case in which R&D scientists cut their experimentation time from 2 years to 1 year with a design of experiments approach. "Just think of the impact," she says.

Lessons in yield and comparability in the life sciences

A statistical approach, O'Neill explains, is a strategic investment that scientists and statisticians can make up front so that comparability can easily be demonstrated in the process of scaling up production.

Securing leadership support for analytics initiatives

"The characteristic that stands out for organizations that really want to lead in analytics is typically there are key leaders in the leadership team who have experienced the benefit of powerful analytics in solving real problems," O'Neill says.

Julia O'Neill

Founder & Principal Consultant, Direxa Consulting

Julia O’Neill is Founder and Principal Consultant of Direxa Consulting. She previously led CMC Modeling & Statistics as a Distinguished Fellow at Moderna, where she served as a member of the Technical Development Leadership Team.

Prior to joining Moderna, 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.

O'Neill is currently a Fellow of the American Society for Quality and recipient of the 2023 Gerald J. Hahn Q&P Achievement Award. Since 2005 she has consulted to support the approval of multiple accelerated products, including gene therapy, microbiome and regenerative medicine.

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