• 5th FDA / IABS Sponsored workshop:
    Statistical Approaches for CMC
    Development and Lifecycle Mgmt.
    of Biotherapeutics and Vaccines

    November 26-28, 2018
    USP - Rockville, Maryland
    CIRM IABS
  • Meeting co-organized by
    » IABS
    » FDA

Meeting documents & Info

Presentations

About the Meeting

Objectives of the meeting

Conventional approaches for addressing CMC development and commercial inquiries are hampered by the time and resources necessary to carry out powerful and fully representative studies. These restrictions sometimes result in a failure to appropriately address the study goal, while failing to explore alternative approaches which could lead to better success. In the end, a consequence is a lack in robustness of our manufacturing and control processes, and potential risks to the quality of biotech and vaccines products.

These issues are not unique to CMC, while other pharmaceutical development disciplines have moved forward and embraced alternative approaches for information and decision management. Modeling and simulation as well as Bayesian methods are being employed in bioinformatics and early clinical trials, while “big data” has drawn the attention of the industry. These approaches have been considered and utilized in CMC, but not without cost and effort.

The 5th FDA/IABS sponsored workshop on Statistical Approaches for CMC Development and Lifecycle Management of Biotherapeutics and Vaccines will examine the current and future state of decision making in CMC development and commercial control. Sessions on applications in bioinformatics and early clinical trials as well as training in Bayesian statistics will lay the groundwork for opportunities in CMC. Other sessions will illustrate applications of advanced methods in CMC, including multivariate analysis and advanced DOE. CMC statisticians, process and analytical engineers, and regulators will discuss the hurdles and pathways to adoption of advanced statistical methods to improve CMC development and address commercial challenges.

Scientific committee

Tim Schofield, Chair
GlaxoSmithKline
Stan Altan
J&J
Richard Burdick
Elion Labs
Robert Capen
Merck & Co., Inc.
Katherine Giacoletti
SynoloStats LLC
Kristi Griffeths
Eli Lilly and Company
David LeBlond
CMC Statistics
Ruojia Li
Bristol-Myers Squibb
Tsai-lien Lin
FDA
Chuck Miller
Merck & Co., Inc.
Daniel Obeng
Sanofi
Laura Pack
Seattle Genetics
Jose Ramirez
Amgen
Andrew Rugaiganisa
Pfizer
Meiyu Shen
FDA
Perceval Sondag
Arlenda
Yi Tsong
FDA