9th Annual IABS Statistics Meeting - Statistical Innovation Advancing CMC
INTERNATIONAL ALLIANCE FOR BIOLOGICAL STANDARDIZATION
INTERNATIONAL ALLIANCE FOR BIOLOGICAL STANDARDIZATION
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9th Annual Statistics Workshop 
 Applying Statistics and Data Science to Evolving Technical and Regulatory Paradigms
- A HYBRID MEETING -

University of Maryland - Institute for Bioscience and Biotechnology Research (IBBR) - Rockville - U.S.A

November 7- 9, 2023

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Objectives of the meeting

The impact of statistics and data science in Chemistry, Manufacturing & Controls (CMC) is constantly expanding, with the introduction of advanced statistical methods and the ability to mine “big data” in the development and
lifecycle management of biological products.

Multiple aspects within the ever-evolving CMC landscape include: improving and developing innovative statistical methodologies to address key development decisions; addressing questions arising from yet unexplored modalities or technologies; advancing the regulatory framework through revised guidance;
and implementation of harmonized statistical
solutions.

This workshop will provide a forum for statisticians, data scientists, development engineers, and regulators to explore approaches that serve future generations of technical and regulatory innovation in biologicals development and lifecycle management.

Scientific Committee

  •     Laura Pack, Co-Chair, Rezolute
  •     Tim Schofield, IABS Advisor, CMC Sciences, LLC
  •     Catherina Cheng, Novartis Gene Therapy
  •     Franz Innerbichler, Novartis
  •     Jun Gao, Health Canada
  •     Ashley Giambrone, Regeneron
  •     Kristi Griffiths, Eli Lilly & Co.
  •     Theo Koulis, Genentech
  •     Jennifer Kirk, FDA/CBER
  •     Timo Bailer, Co-Chair, Boeringher Ingelheim
  •     Madinina Cox, Meeting Coordination, MC’Com
  •     Ruojia Li, Bristol-Myers Squibb
  •     Jia Liu, Pfizer
  •     Chuck Miller, Merck
  •     John Oleynick, Johnson & Johnson
  •     José Ramírez, Kite Pharma, a Gilead Company
  •     Travis Wolter, Amgen
     

Organising Committee

  •     Laura Pack, Co-Chair, Rezolute
  •     Tim Schofield, IABS Advisor, CMC Sciences, LLC
  •     Timo Bailer, Co-Chair, Boeringher Ingelheim
  •     Madinina Cox, IABS, France

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