EBF
EBF Focus
Focus

EBF - Trainingday:

Critical Reagents for LBA

EBF - Focus Workshop:

New Modalities and Novel Concepts in Bioanalysis
The Altis Grand Hotel
Lisbon, Portugal
14 May 2018
- Training day
15-16 May 2018
- Focus Workshop

 

Program Focus Workshop

15-16 May 2018, Lisbon

New Modalities and Novel Concepts in Bioanalysis

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
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
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
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?
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
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12:30 – 13:45 Lunch
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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
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15:00 – 15:30 Summary, conclusion and next steps
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15:30 – 16:00 Closing Tea break and adjourn