Ana Del Amo, Gerald J. Hahn Q&P Achievement Award Committee Chair
Members of the Gerald J. Hahn Q&P Achievement Award Committee chose Julia O’Neill of Moderna Therapeutics for the 2023 Gerald J. Hahn Q&P Achievement Award.
O’Neill contributed to speeding up global regulatory agencies’ early approval of Moderna’s COVID vaccine, SPIKEVAX, for release to the world, thereby saving thousands of lives. Her modeling and analysis of stability data determined SPIKEVAX’s commercial shelf life, the most critical quality attribute. Additionally, she was the lead author or co-author of reports to regulators that provided stability summaries, justification of specifications, and responses to questions. She was also the key contributor to successful commercial pre-approval inspections, regular audits, and review meetings with regulatory agencies.
O’Neill has published numerous articles in international statistics, quality, and pharmaceutical journals that improved statistical practice. She has presented keynote talks at engineering, statistics, and quality and productivity–related conferences and will give the Q&P plenary address at the Fall Technical Conference October 4–6 in Raleigh, North Carolina.
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