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 Training day

Critical reagents for LBA

 

13 MAY 2018  
17:00 Registration desk opens
18:00 – 19:00 Welcome reception – Altis Hotel
 .  
14 MAY 2018  
07:30 Registration desk opens
08:45 – 09:00 Welcome and introduction 
09:00 – 10:30 Session 1 – Critical reagents for PK assays: general & regulatory framework
09:00 – 09:15 Introduction to the session – Susanne Pihl (on behalf of the EBF)
09:15 – 09:45 Update on the guidelines and current practice in industry
Michaela Golob (on behalf of the EBF)
09:45 – 10:15 The EBF decision tree on CR for PK assays, in perspective of current industry practices
Susanne Pihl (on behalf of the EBF)
10:15 – 10:30 Q&A
10:30 – 11:00 Coffee break & networking
11:00 – 12:30 Session 2 – Case studies on alternative approaches to manage critical reagents (PK assays)
11:00 – 11:20 Case study: The importance of quality critical reagents for the entire developmental life cycle of a biopharmaceutical: A PK Case Study
Andrew Mayer (GlaxoSmithKline)
11:20 – 11:40 Characterization of critical reagents – FB from the AAPS ADA community
Jonathan Haulenbeek (BMS, on behalf of the AAPS)
11:40 – 12:00 Critical reagents for PK assessment – How reagent characteristics can impact your result interpretation
Thomas Emrich (Roche Pharma Research and Early Development)
12:00 – 12:30 Expert panel discussion
.  
12:30 – 13:30 Lunch
13:30 – 15:00 Session 3 – Critical reagents for immunogenicity assays –  general & regulatory framework
13:30 – 13:45 Introduction to the session – Birgit Jaitner (on behalf of the EBF)
13:45 – 14:05 Update on the guidelines and current practice in industry
Jo Goodman (on behalf of the EBF)
14:05 – 14:40 Recommendations on CR for immunogenicity assays, in perspective of current industry practices
Barry van der Strate (on behalf of the EBF)
14:40 – 15:00 Q&A
 .  
15:00 – 15:40 Coffee break & networking
15:40 – 17:15 Session 4 – Case studies on alternatives approaches to manage critical reagents (immunogenicity assays)
15:40 – 16:00 Qualification of new lots of critical reagents for IG assays: Some practical examples
Lydia Michaut (Novartis)
16:00 – 16:20 Management of an ADA critical reagent issue during a clinical study support
Laurent Vermet (Sanofi)
16:20 – 16:40 ADA Case study: Generation and characterization of critical reagents supporting immunogenicity assays: Case studies on how to navigate challenging drug modalities
Terri Caiazzo (Pfizer)
16:40 – 17:15 Expert panel discussion
17:15 – 17:30 Closing Questions & Answers session
Panel of presenters answering delegate’s pre-submitted questions
17:30 Adjourn