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Oct 09
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09:00 - 09:10 10 mins
Chairperson's Opening Remarks
09:10 - 09:40 30 mins
Method validation based on total error
  • Harry Yang - Senior Director, Medimmune, USA
09:40 - 10:10 30 mins
Global regulations for bioanalytical method development and validation
  • Declan Lowney - Associate Director, Janssen
  • What are the expectations of the FDA vs. EMA vs. Asian regulators for method development, validation and transfer?
  • Experiences with meeting global regional regulatory requirements
  • ICH harmonising requirements
  • Sharing strategies used to meet expectations
10:10 - 10:40 30 mins
Spotlight session
10:40 - 11:20 40 mins
Morning Coffee
11:20 - 11:50 30 mins
Demystifying the USP Chapters on Bioassay Development and Analysis
  • Steven L. Walfish - Principal Scientist and Standards Liaison, USP

USP Chapter <1032>, Design and Development of Bioassay provides a framework for bioassay development, though many of the statistical concepts are not implemented from lack of understanding. This talk will cover the use of different statistical designs and analysis for developing a bioassay that is robust.

11:50 - 12:20 30 mins
The use of sensitivity analysis to set acceptance criteria in the validation of biomarker assays.
  • Graham Healey - Senior Biostatistician, Oncimmune

In biomarker diagnostic work, an analyte assay may lead to a binary or qualitative outcome such as disease or not-disease, or to-treat or not-to-treat. It is important to know what level of random change in the analytes can be tolerated to guarantee the claimed diagnostic performance. We can define the maximum allowable deviation (MAD) such that the binary endpoint claim is maintained. It can be determined from previously run validation datasets by varying analyte signals in small increments and then creating ruggedness plots. These can then be used to set acceptance limits for validation studies of operational factors. For multi-analyte assays this is not entirely straightforward, but summary measures including logistic regression scores make it possible. It still remains to confirm if such limits are achievable given the underlying variability of the analytes. An accelerated stability example is presented.

12:20 - 12:50 30 mins
Interlaboratory Performance Metrics from the MAM Consortium New Peak Detection Round Robin Study
  • Richard Rogers - Principal Scientist, Just Biotherapeutics, USA
12:50 - 14:10 80 mins
Lunch & Live Labs
14:10 - 14:40 30 mins
α, β, λ easy as 1,2,3: Total error in analytical transfer
  • Cyrille C. Chéry - Principal Scientist, UCB
14:40 - 15:10 30 mins
Implementing bioassays for a kλ-Body
  • Anaëlle Dos Santos - Head of Bioanalytics Unit, Novimmune
15:10 - 15:40 30 mins
High-throughput Release N-glycan Method for Product Quality Assessment
  • Vithiya Vimalraj - Senior Scientist, GlaxoSmithKline

N-Glycosylation of biotherapeutics is an important critical quality attribute. Glycans can influence protein stability, serum clearance, immunogenicity and pharmacokinetics. Therefore it is crucial to monitor the full glycan profile of a glycoprotein throughout discovery, clinical and manufacturing phases. A High-throughput RapifluorMS N-glycan method has been employed in our lab to address the challenges that are encountered with product quality support and meet aggressive timelines. This presentation will provide an overview of the development workflow to automate all the steps from sample preparation to data analysis of the RapifluorMS released N-glycan analysis.

15:40 - 16:10 30 mins
Afternoon Coffee
16:10 - 16:40 30 mins
Biotherapeutics Formulation Design in the Age of Lab Automation and Biological Performance Screening
  • Kathrin Schäker-Theobald - Senior Scientist I, NBE HTS Operation & Analytics, AbbVie Deutschland

An overlook of the evolution of our automation line addressing scientific as well as data handling matters.

16:40 - 17:10 30 mins
Round-Table Discussion: Automating analytical workflows
  • Mario Richter - Principal Scientist DMPK-BA, AbbVie Deutschland GmbH & Co. KG, Germany
  • Future focuses
  • Data analysis and evaluation strategies
  • Moving away or moving on to alternatives
  • Strategies to implement automation into existing workflows
17:40 - 18:25 45 mins
Rosetta - Philae and Hayabusa 2 - MASCOT: Long Term Space Projects with Landers
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
18:25 - 20:25 120 mins
End of Day Two and Evening Entertainment