EBF
EBF Focus

Training Day: BA strategies for Cell & Gene Therapies

Workshop: Biomarkers in Pharma R&D

NH Málaga Centro
Málaga, Spain
12 May 2020 (Training Day)
13-14 May 2020 (Workshop)

Program Training day

Agenda of the Training Day  version 09FEB2020

The organising committee continues to refine the agenda to include contributions from our industry partners. Additions to the agenda will be communicated as they occur.

11 MAY 2020    
     
15:30 – 19:30   Registration desk opens
     
12 MAY 2020    
     
07:30 – 08:25   Registration desk opens
     
08:25 – 08:30   Welcome and introduction
    Philip Timmerman, on behalf of the EBF
     
08:30 – 10:30   Session 1 – General overview of C&GT and the bioanalytical challenges
08:30 – 09:00   An overview of C&GT and how they differ from traditional biologics
    Presenter identified – Novartis
09:00 – 09:20   Regulatory overview – Manuela Braun
    Manuela Braun, Bayer
09:20 – 09:50   Understand how to measure and demonstrate exposure during the development of cell therapies
    James Munday, Covance
09:50 – 10:10   Am I Biomarker or am I PK?
    Presenter  identified – awaiting confirmation
10:10 – 10:30   Q&A
.    
10:30 – 11:00   Coffee break & networking
     
11:00 – 12:30   Session 2 – Therapy immunity and Immunogenicity
11:00 – 11:20   Bioanalytical approaches to assess the immunogenicity in C&GT
    Arno Kromminga, on behalf of the EBF C&GT team
11:20 – 11:40   Assessing cellular Immunogencitiy for CGT
    James Munday, Covance
11:40 – 12:00   Pre-clinical challenges and translational solutions
    Philippe Ancian, Charles River Laboratories
12:00 – 12:20   Integrated summary of immunogenicity
    Jo Goodman, on behalf of the EBF
12:20 – 12:30   Expert panel discussion – Building bioanalytical strategies in support of C&GT. Based on Question from survey to delegates/open questions from the morning session.
    Panel: mixed expert group EBF/AAPS
     
12:30 – 13:30   Lunch
     
13:30 – 15:20   Session 3 – Addressing the bioanalytical challenges – 1
13:30 – 13:40   Introduction to the afternoon sessions
    Johannes Stanta, on behalf of the EBF
13:40 – 14:00   Succesful Gene therapeutics: BA and regulatory challenges
    Federico Mingozzi, Spark/Roche, tbc
14:00 – 14:20   Presenters identified – agenda refinement ongoing
    Presenters identified – agenda refinement ongoing
14:20 – 14:40   qPCR applications and how to approach the method development and validation
    Milena.Blaga, on behalf of the EBF qPCR Team
14:40 – 15:00   How to approach the development and validation  to measure the expression of the transgene product.
    Chris Cox, PsiOxus
15:00 – 15:20   Challenges and Strategies for Assessing the Activity of Transgene-expressed Enzymes
    Zhuqiu Ye, PPD
     
15:20 – 16:00   Coffee break & networking
     
16:00 – 17:00   Session 4 – Addressing the bioanalytical challenges – 2
16:00 – 16:20   Case Studies: The use of ELISpot in C&GT
    Julia Oberbloebaum, Bioagilytix
16:20 – 16:40   Current industry standards and expectations for reliable Flow Cytometry Assays to support cell therapies
    Daisy Yuill, UCB Biopharma
16:40 – 17:00   Pre-Existing Antibodies: Considerations for Cell & Gene Therapy Products
    Kelli Phillips, PPD
     
17:00 – 18:00   Closing Training Day Expert panel discussion  – Bioanalytical in support of C&GT in practice
    Based on Question from survey to delegates/open questions from the morning session
    Panel: mixed expert group EBF/AAPS
     
18:00 – 18:15   Closing Remarks
     
18:15 – 19:15   Complementary reception (incl. C&GT and BM Workshop delegates)