EBF 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 program itself can be viewed and downloaded by clicking here 


08:45 09:00 Welcome and aim of the meeting
09:00 10:00 What is the question asked? What do we need to measure?
Session chair: Joe Stanta, Covance
09:00 09:20 Bioanalysis of large molecules in a regulated bioanalytical environment –
which is industry’s challenge today
Presenter:  Philip Timmerman, on behalf of the EBF
09:20 09:40 Setting up a Bioanalytical Strategy – the Role of the Bioanalyst in
Interdisciplinary Drug Development Teams
Presenter:  Michaela Golob, on behalf of the EBF
09:40 10:00 The importance of clearly defined bioanalytical data
Presenter:  Roland Staack, Roche 
10:00 10:40 Coffee break & networking
10:40 12:00 The toolbox: What are we measuring? 
How does the technology impact the results?
Session chair: Roland Staack, Roche
10:40 11:00 An industry perspective on the tools used today
Presenter:  Pascal Delrat, on behalf of the EBF   
11:00 11:20 Why do results for proteins differ? A literature evaluation of different
bioanalytical platforms
Presenter:  Nico van de Merbel, PRA HS
11:20 11:40 LBA and LC-MS: Why incorporate both for large molecule drug bioanalysis?
Presenter:  Surinder Kaur, Genentech, on behalf of the IQ Consortium
11:40 12:00 Panel discussion
12:00 13:30 Lunch
13:30 15:00 The toolbox: What are we measuring? 
How does the technology impact the results?
Session Chair: Nico van de Merbel, PRA HS
13:30 13:40 Introduction into the toolbox discussion
Presenter: Magnus Knutsson, on behalf of the EBF 
13:40 14:00 Improvement of specificity for multiplex mAbs DMPK triage studies
Presenter:  Quentin Enjalbert, ANAQUANT
14:00 14:20 Cell-based PK assays a useful additional “tool” for large molecule bioanalysis
Presenter:  Martin Schäfer, Roche
14:20 14:40 What can LC-MS offer beyond LBA approaches in the field of large molecules
Presenter:  Benno Ingelse, Q2Solutions
14:40 15:00 A multidisciplinary approach for regulated bioanalysis of ADCs
Presenter: Fabrizia Fusetti, QPS  
(only available on demand)
15:00 15:40 Tea break & Networking
15:40 17:30 The regulatory space
Session Chair: Michaela Golob, Nuvisan
15:40 15:50 Introduction to the session
Presenter:  Magnus Knutsson, on behalf of the EBF
15:50 16:10 Limitations of current PK assay guidelines for the validation of active
drug assays
Presenter:  Eginhard Schick, Roche
16:10 16:30 Comparison of LBA and LC-MS Using a Well-Defined Set of GLP
Study Samples
Presenter:  Kevin Bateman, MSD 
16:30 17:30 Workshop discussion – what is missing in the regulatory space?
Recommendations to the regulators
17:30 End of Day 1
08:30 08:40 Introduction to day 2
08:40 10:00 Strategizing the bioanalysis for large molecules in early development –
learning your molecule
Session Chair: Matthew Barfield, Glaxo Smith Kline
08:40 09:00 LBA versus LC-MS/MS for quantitative analysis of large molecules.
Are results comparable?
Presenter:  Lieve Dillen, Janssen R&D
09:00 09:20 LBA strategies to support Early Drug Development
Presenter:  Sarah Childs, GlaxoSmithKline  
09:20 09:40 Biotherapeutics Quantification in Discovery and Early Development:
Comparison of LC-MS Techniques for both Digested and Intact Quantification
John C Gebler, Waters  
09:40 10:00 Quantification of free and total desmosine and isodesmosine in human
plasma & urine by a high-throughput assay
Presenter: Sina Pleiner, Boehringer-Ingelheim
10:00 10:40 Coffee Break & networking
10:40 11:40 Strategizing the bioanalysis for large molecules in late development – 
developing your molecule
Session Chair: Pascal Delrat, Servier
10:40 11:00 LC–MS/MS strategies for therapeutic antibodies
Presenter:  Joe Stanta, Covance  
11:00 11:20 Hybrid LC-MS becomes routine: A fully validated assay for measuring
clinically relevant concentrations of therapeutic peptides
Presenter:  Michael Blackburn, ARCinova
11:20 11:40 Elucidation of atypical PK in a clinical trial using a CDR specific anti-peptide
antibody and 2D-LC-MS/MS
Presenter:  Carsten Krantz, Novartis
11:40 12:30 Workshop – prepare for closing panel discussion – 
continue over lunch
12:30 13:45 Lunch
13:45 15:00 Closing Focus workshop panel discussion
15:00 15:30 Summary, conclusion and next steps
15:30 16:00 Closing Tea break, networking  and adjourn