EBF
EBF
EBF
European
Bioanalysis
Forum


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

 

Training Day Slides 2018 May

Program of the EBF Training Day  “Critical reagents for LBA”  May 14, 2018

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

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  (not released for publication)
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