EBF
EBF Focus
Focus

EBF - ADC Training day:

Bringing ADC into Practice

EBF - Focus Workshop:

Bioanalytical Strategies for Large Molecules in Modern Drug Development: LBA and LC-MS united
The Altis Grand Hotel
Lisbon, Portugal
June 20, 2017
the ADC Training day
June 21-22, 2017
the Focus Workshop

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

Agenda

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08:45 09:00 Welcome and Introduction
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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) 
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10:30 11:00 Coffee break & networking
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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)  
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12:30 13:30 Lunch
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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)
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14:45 15:30 Coffee break & networking
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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)
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17:00 18:00 Questions & Answers
Panel of presenters answering delegate’s pre-submitted questions
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18:00  18:00 Adjourn