EBF
EBF
EBF
European
Bioanalysis
Forum


EBF vzw is the registered non-profit organisation of the European Bioanalysis Forum

 

Focus Workshop Slides 2018 May

Program of EBF Focus Workshop  “New Modalities and Novel Concepts in Bioanalysis”
May 15-16, 2018

PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page. The program itself can be viewed and downloaded by clicking here 

 

15 May 2018
08:45 – 09.00 Welcome and aim of the meeting
09:00 – 10.00 Challenges of and advancements in Bioanalysis of (oligo)nucleotides and related molecules
09:00 – 09:20 Introduction to the session
Cecilia Arfvidsson, on behalf of the EBF
09:20 – 09:40 LC-MS/MS Quantification of Oligonucleotides using SPE and hybridization extraction
Lieve Dillen, Janssen R&D
09:40 – 10:00 Validation of qPCR assay for the quantification of gene therapy therapeutics in preclinical and clinical studies
Lydia Michaut, Novartis PK Sciences
   
10:00 – 10:50 Coffee break & networking
   
10:50 – 11:10 Utility of Branched DNA Methodology for the Quantitation of Oligonucleotides
Amy Smith, MPI Research
11:10 – 11:30 Novel Analytical Approaches for the Quantitation of Oligonucleotides – Combining LC-HRMS and LC-FL, ELISA, and RT-PCR based techniques   (not released for publication)
Alex Behling, PPDi
11:30 – 12:00 Panel discussion: how to optimally use bioanalytical data from new modalities? A new role for the bioanalytical lab?
   
12:00 – 13:40 Lunch
   
13:40 –17:30 New analytical challenges for Immunogenicity testing
13:40 – 14:00 Considerations for the Development of ADA Assays for the Analysis of Novel Modalities
Amy Lavelle, PPDi
14:00 – 14:20 When 2-become- 1; Don’t be a Stranger to the Challenges of Immunogenicity Testing in Dual Peptide Therapies
Nick White, MedImmune Ltd
14:20 – 14:40 A company strategy for immunogenicity testing of peptide drugs
Birgitte Buur Rasmussen, Ferring
14:40 – 15:00 Immunogenicity Testing Strategies for a Novel Modality: Lipid Nanoparticles Containing Small Interfering RNA Payloads
Renuka C. Pillutla, BMS
   
15:00 – 15:40 Tea break & Networking
   
15:40 – 16:00 It’s alive! Current and future challenges for bioanalysis of CAR-T cell therapies  (not released for publication)
Grzegorz Terszowski, Novartis Pharma AG
16:00 – 16:20 Challenges in ADA/NAb Assay Design to Support Gene Therapy Programs
Amy Smith, MPI Research
16:20 – 16:40 Immunogenicity assessment of COVA322: beyond classical screening and titer analysis  (not released for publication)
Wibke Lembke, Covagen
16:40 – 17:30 Panel discussion: challenges for immunogenicity testing for new modalities
   
17:30 End of Day 1
   
16 May 2018
08:45 – 09:00 Introduction to day 2
09:00 – 12:30 Session theme: Impact of novel formulations for bioanalysis
09:00 – 09:20 types of complex formulations.
Joe Stanta, on behalf of the EBF
09:20 – 09:40 PK/PD modelling perspective – why we need multicomponent assays
Mingguang Li, Covance
09:40 – 10:00 Characterisation of formulations. Continuation of the introduction. Issues that you can get.
Fred van Heuveln, QPS the Netherlands
10:00 – 10:20 Pro-drugs: what are the challenges?  (not released for publication)
Susanne Pihl, Ascendis Pharma
   
10:20 – 11:00 Coffee Break & networking
 
11:00 – 11:20 Challenges and strategies for bioanalysis following nanoparticle drug delivery
Amanda Wilson, AstraZeneca
11:20 – 11:40 Quantification of an excipient in microsamples: the challenges of hydroxypropyl-ß-cyclodextrin determination in a 15-µL drop of blood
Tom Verhaeghe, Janssen R&D
11:40 – 12:30 Panel discussion on the theme of the session
   
12:30 – 13:45 Lunch
   
13:45 – 15:00 Panel discussion – How do we integrate New Modalities and Novel Concepts in Bioanalysis in regulations.
13:45 – 14:00 Introduction to the closing panel discussion
Philip Timmerman, EBF
14:00 – 15:00 Closing panel discussion
   
15:00 – 15:30 Summary, conclusion and next steps
   
15:30 – 16:00 Closing Tea break and adjourn