On behalf of the selection committee, it is my pleasure to announce that the 2023 Gerald J. Hahn Q&P Achievement Award recipient is Julia O'Neill, Moderna Therapeutics.
About Julia
Julia O'Neill contributed greatly to speeding global regulatory agencies' early approval of Moderna's covid vaccine SPIKEVAX for release to the world, thereby saving many thousands of lives. Her modeling and analysis of stability data determined SPIKEVX's commercial shelf life, the most critical quality attribute. She was the lead author or co-author of reports to regulators that provided stability summaries, justification of specifications, and response to regulators' questions. She was the key contributor to successful commercial Pre-Approval Inspections, regular Audits, and review meetings with regulatory agencies (EMA, FDA, Health Canada, PMDA, TGA, WHO, et al.). Julia effectively convinced global regulatory agencies to approve SPIKEVAX. Also, she significantly improved production of SPIKEVAX within Moderna and thus increased its supply for saving lives worldwide.
She has published numerous articles in international statistics, quality, and pharmaceutical journals that improved statistical practice. She has presented numerous keynote talks at Engineering, Statistics and Quality and Productivity related Conferences and will give the Q&P plenary address at the Fall Technical Conference
Julia O'Neill has an impressive record of technical leadership and is an exceptional deserving recipient of the prestigious ASA Gerald J. Hahn Q&P Achievement Award.
Congratulations Julia!!
Note: The Gerald Hahn Award recipient will give the Q&P plenary address at the Fall Technical Conference
Nominations for the 2024 award will be open later in the year.
Ana Del Amo, PhD
Gerald J. Hahn Q&P Achievement Award Committee Chair