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 28 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).

Agenda, version 28 May 2020 – all times are CET (Brussels time zone)


15 September 2020
16:00 – 18:00   Session 1 – General Overview of C&GT and the Bioanalytical Challenges
    Questions we want to ask include:  What types of therapies are currently in development? Or What measurements are needed to fulfil regulatory requirements? 
16:00 – 16:10   Coming online – Welcome and introduction
    Philip Timmerman, on behalf of the EBF
16:10 – 16:30   An overview of Cell and Gene Therapies and how they differ from traditional biologics 
    Fraser McBlane (Novartis)
16:30 – 16:50   Regulatory overview
    Manuela Braun (Bayer)
16:50 – 17:10   Understand how to measure and demonstrate exposure during the development of cell therapies
    James Munday (Covance)
17:10 – 17:30   Am I Biomarker or am I PK?
    Thomas Emrich (Roche)
17:30 – 17:50   How to approach the development and validation  to measure the expression of the transgene product. 
  Chris Cox (PsiOxus)
17:50 – 18:00   Q&A and closing remarks for Session 1
    End of Day 2  – for Biomarker FW delegates, go to session 2 of the FW (18:30 – 20:00)
16 September 2020
16:00 – 18:00   Session 2 – Therapy Immunity and Immunogenicity
    Questions we want to ask include:  How can the current regulatory framework be applied to C&GT?  Or Are pre-dose nAb on the path of becoming companion diagnostics? 
16:00 – 16:10   Introduction to the session
    Chris Cox (on behalf of the EBF)
16:10 – 16:30   Bioanalytical approaches to assess the immunogenicity in C&GT
    Arno Kromminga (on behalf of the EBF C&GT team)
16:30 – 16:50   Assessing cellular Immunogenicity for CGT
    James Munday (Covance)
16:50 – 17:10   Pre-clinical challenges and translational solutions 
    Philippe Ancian (Charles River Laboratories)
17:10 – 17:30   Integrated summary of immunogenicity 
    Jo Goodman (on behalf of the EBF)
17:30 – 17:50   Pre-Existing Antibodies: Considerations for Cell & Gene Therapy Products
  Kelli Phillips (PPD)
17:50 – 18:00   Q&A and closing remarks
    End of Day 2  –  for Biomarker FW delegates, go to session 5 of the FW (18:30 – 20:00)
17 September 2020
16:00 – 18:30   Session 3 – Addressing the bioanalytical Challenges
    Questions we want to ask include:  What analytical platforms are needed to answer bioanalytical questions in C&GT?,  What does it take to bring these platforms under the BioA umbrella? Or  Do you need to measure the transgene product like a PK endpoint?
16:00 – 16:10   Introduction to the afternoon sessions
    Johannes Stanta (on behalf of the EBF)
16:10 – 16:30   Successful Gene therapeutics: BA and regulatory challenges
    Federico Mingozzi, Spark/Roche
16:30 – 16:50   qPCR applications and how to approach the method development and validation 
    Milena Blaga (on behalf of the EBF qPCR Team)
16:50 – 17:10   Case Study: Measuring transgene product activity as a demonstration of therapeutic efficacy
    Paula Miranda (UniCure) 
17:10 – 17:30   Case Studies: The use of ELISpot in CGT
    Julia Oberbloebaum (BioAgilytix)
17:30 – 17:50   Current industry standards and expectations for reliable Flow Cytometry Assays to support cell and gene therapies
  Daisy Yuill (UCB Biopharma)
17:50 – 18:30   Q&A and closing remarks – Bioanalytical in support of C&GT in practice
    Based on Question from survey, live-pols (?) during the sessions and open questions from the experts 
18:30   Adjourn