EBF
EBF Focus
Training Day: BA strategies for Cell & Gene Therapies 
Focus Workshop: Biomarkers in Pharma R&D
The meeting will be
organised in cyberspace


15-16-17 September 2020: C&GT Training Day (part of the day)
15-16-17 September 2020: Biomarker Focus Workshop (part of the day)

Program Training day

Status 14 May 2020 :

Covid-19 travel restrictions has forced the EBF C&GT Training Day to change the format of its original planned event (15 September 2020, Lisbon) into a live-streaming event (3 web-sessions from 15-17 September in the afternoon (EU time zone)/morning (NA-time zones)/Evening (Asia Time zones).

For the new meeting template, it will be a challenge to bring the current program unaltered. We may need to make some refinements to the program/timing/flow to allow us to cover the meeting goals and at the same time be mindful of time zone differences.

The revised agenda will be uploaded on the website before the end of May.

Status 08 March 2020:

It is our intention to bring the program of the Cell & Gene Therapy Training Day (C&GT TD) unaltered. The EBF has connected with all presenters and close to all have currently confirmed their availability.

Any changes to the agenda will be communicated via e-mail updates as they occur (general  to all & dedicated mailings to the registered delegates from the focus@e-b-f.eu mail account) 

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.

14 SEP 2020    
     
15:30 – 19:30   Registration desk opens
     
15 SEP 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)