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

Final Agenda                          EBF – Focus Workshop                     21-22 June 2017, Lisbon

Bioanalytical Strategies for Large Molecules in Modern Drug Development:
LBA and LC-MS United

The agenda can also be downloaded as a PDF here  


07:30 Registration desk opens
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
using LC-MRM3
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
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