Focus Workshop Slides 2017 June
Program of EBF Workshop “Bioanalytical Strategies for Large Molecules in Modern Drug Development: LBA and LC-MS united” June 21-22, 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.
Program
| 21-Jun-2017 | ||
| 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 (NOT PUBLISHED) | ||
| 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 bioanalytics? |
| 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 | |
| 22-Jun-2017 | ||
| 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 |
