10th IABS Statistics Workshop
INTERNATIONAL ALLIANCE FOR BIOLOGICAL STANDARDIZATION
INTERNATIONAL ALLIANCE FOR BIOLOGICAL STANDARDIZATION
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    • DAY 1 - Tuesday 12 November, 2024
    • DAY 2 - Wednesday 13 November, 2024
    • DAY 3 - Thursday 14 November, 2024
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10th IABS Statistics Workshop 
Science & Statistics – Elevating CMC through Partnership

Rockville - U.S.A

November 12-14, 2024

Hybrid Meeting

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Agenda

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Objectives of the meeting

This year the IABS Statistics workshop is celebrating its 10th anniversary. This conference is aiming at bringing statisticians, subject matter experts and regulators together to exchange on the intersection of statistics and science, and to pave the way to improve the usage of CMC Statistics, data analytics, and modeling for Biologics. The beautiful venue at the Institute for Bioscience & Biotechnology Research at the University of Maryland will again be the place to host this conference.

To start the workshop, the conference provides interesting short courses about tolerance intervals as well as automating statistical analysis and GxP reporting. Four sessions will guide discussions through the remainder of
the conference.

These sessions focus on CMC Statistics and the intersection to Science, to Stability, to advanced analytical approaches and to comparability topics. The agenda is full
of presentations covering current industry topics, application of statistical and data analytics tools to practical scientific challenges in CMC, impact of regulatory changes to data analysis applications and many more. We are pleased to have a variety of presenters on board, covering statistical experts, subject matter experts and regulators.

Scientific Committee

  • Laura Pack - Moderna (Co-Chair)
  • Timo Bailer - Boehringer Ingelheim (Co-Chair)
  • Ruojia Li - BMS (Co-Chair)
  • Irina Gershgorin - Novartis C&GT
  • Ashley Giambrone - Regeneron
  • Kristi Griffiths - Eli Lilly & Co.
  • Franz Innerbichler - Novartis
  • Jennifer Kirk - FDA
  • Jia Liu - Pfizer
  • Chuck Miller - Merck
  • John Oleynick - Johnson & Johnson
  • Jennifer Kirk - FDA
  • Cristian M. Oliva-Aviles - Genentech
  • José Ramírez - Kite Pharma, a Gilead Company
  • Tim Schofield - CMC Sciences, LLC
  • Travis Wolter - Amgen

Organising Committee

  • Laura Pack - Moderna (Co-Chair)
  • Timo Bailer - Boehringer Ingelheim (Co-Chair)
  • Ruojia Li - BMS (Co-Chair)
  • Madinina Cox - IABS, France
  • Marlène Louis - IABS, France

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