European Bioanalysis Forum

 

Training Day Slides 2017 June

Program of EBF Training Day  “Bringing ADC into Practice” June 20, 2017

PDF renditions of the powerpoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here.

 

Agenda

 
08:45 09:00 Welcome and Introduction
 
09:00 10:30 Defining a bioanalytical strategy for ADCs or ‘what do I measure
for ADCs and why?’
09:00 09:30 Complexity and inter-modality nature of Antibody drug conjugates
Speaker: Surinder Kaur (Genentech)
09:30 10:00 Development phase bioanalytical strategy approach to Bioanalysis of ADCs from Discovery to Late Non-clinical to Clinical support
Speaker: Boris Gorovits (Pfizer)  
10:00 10:30 Analyte diversity required for appropriate description of ADC PK
Speaker: Surinder Kaur (Genentech) 
 
10:30 11:00 Coffee break & networking
 
11:00 12:30 Technology or ‘how do I measure ADCs?
11:00 11:45 ADC BA: Challenges and opportunities when using Ligand Binding Assay platform, including assay development and validation
Speaker: Sarah Childs (GlaxoSmithKline)
11:45 12:30 ADC BA: Challenges and opportunities when using LCMS platform, including assay development and validation
Speaker: Rand Jenkins (PPDi) 
 
12:30 13:30 Lunch
 
13:30 14:45 Does theory match practice?
13:30 14:15 ADCs, what is industry doing today? An overview.
Speaker: Joe Stanta (Covance)
14:15 14:45 Correlation between LBA and hybrid assay: BMS’s perspective on analyte and assay selection for ADC PK in Discovery and Development
Speaker: Jian Wang (BMS)
 
14:45 15:30 Coffee break & networking
 
15:30 17:00 Feedback from submissions and regulatory aspects
15:30 16:00 The regulatory space
Speaker: Matthew Barfield (on behalf of the EBF)
16:00 16:30 Case studies 1
Speaker: Surinder Kaur (Genentech) 
16:30 17:00 Case studies 2
Speaker: Boris Gorovits (Pfizer)
 
17:00 18:00 Questions & Answers
Panel of presenters answering delegate’s pre-submitted questions
 
18:00  18:00 Adjourn

 

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