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 Workshop

Status 14 May 2020 :

Covid-19 travel restrictions has forced the EBF Focus Workshop to change the format of its original planned event (16-17 September 2020, Lisbon) into a live-streaming event (sessions from 15-17 September in the afternoon + early evening (EU time zone) 3 web-sessions from 15-17 September/morning + early afternoon (NA-time zones)/ (late) 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 in the beginning of June.

Status 08 March 2020:

It is our intention to bring the program of the  Biomarker Focus Workshop 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 Spring Focus Workshop version 09FEB2020

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

16 SEP 2020    
     
08:30 – 08:40   Welcome and introduction
     
08:40 – 10:30   Session 1 – Context of Use – the problem statement
08:40 – 09:00   Wrong Data – Wrong Decisions: the CoU Problem Statement
    Jo Goodman, AstraZeneca
09:00 – 09:20   Are we informed – have we informed ? The end user’s voice
    Tova Landström, Ferring Pharmaceuticals
09:20 – 09:50   Be Specific – Putting Biomarker Assay Validation in context
    Lauren Stevenson – Immunologix
09:50 – 10:10   Current understanding of COU and its impact – Results from the 2020 AAPS Survey
    Yan Ni, Regeneron-US
10:10 – 10:30   LC-MS/MS Biomarker Assay Validation Considerations from the New Guidance: Discussion of the Upcoming AAPS Whitepaper Recommendations
    Carmen Fernandez-Metzler – PharmaCadence
10:30 – 10:50   Towards an updated EBF recommendation refining CoU requirements for the Biomarker assay community
    Philip Timmerman, on behalf of the EBF
     
10:50 – 11:30   Coffee break & networking
     
11:30 – 13:40   Session 2 – Learnings and actions from the 2019 EBF FW
11:30 – 11:40   Introduction to the session
    Michaela Golob, on behalf of the EBF
11:40 – 12:50   Interactive round table, moderated by Ulrich Kunz (Boeringer Ingelheim), Linda Terry (GlaxoSmithKline), Michaela Golob (Nuvisan) and Kyra Cowan (Merck KGaA).
Contribution from the Health Authorities is being defined.
    During the session, we will engage with the delegates around the key challenges related to understand CoU.
    * hurdles in connecting outside of BA / inside BA
    * asking the rigth questions
    * understanding the questions asked
    * sense and nonsense of aligning CoU with development stage
     
    Registered delegates will get the opportunity to pre-submit questions, experiences and challenges via a pre-meeting survey around mid-April
     
12:40 – 14:00   Lunch & networking
     
14:00 – 15:30   Session 3 – Applications, incl. Panel discussion: Is there convergence or divergence with CoU principles?
14:00 – 14:20   Biomarker assay development: Translation from research into clinical trials
    Tobias Marquardt, Bayer
14:20 – 14:40   Biomarker Assay Validation and Context of Use: A CRO’s Perspective From Discovery through Clinical Drug Development
    Jessica Coash, Charles River Laboratories
14:40 – 15:00   The Influence of Context of Use (CoU) on Biomarker Method Development and Validation
    Krystal Alligood – Bioagylitix
15:00 – 15:20   Biomarker assays in a bioanalytical environment – a case study
    Dorte Kornerup Ditlevsen – Lundbeck
15:20 – 15:40   Panel discussion
    How do current practices already align with CoU principles?
     
15:40 – 16:10   Coffee break & networking
     
16:10 – 18:30   Session 4 – The Building Blocks of a Good BM Assay
16:10 – 16:30   Introdcution to the session
    John Allinson/Lauren Stevenson – Immunologix
16:30 – 16:50   The importance of selecting appropriate matrix sources for biomarker assays
    Radboud van Trigt, PRAHS
16:50 – 17:10   EBF feedback for critical reagents in LBA biomarker assays
    Susanne Pihl, on behalf of the EBF
17:10 – 17:30   Parallelism Acceptance Criteria: Driven by Context of Use
    Marc-Olivier Pepin, Charles River Laboratories
17:30 – 17:50   Key messages from the recent paper: “Considerations for Soluble Protein Biomarker Blood Sample Matrix Selection”
    Yan Ni, Regeneron-US
17:50 – 18:10   Awaiting title of presentation
    Presenter: – awaiting confirmation
     
18:10 – 18:30   Day 1 closing panel discussion
     
18:30   End of day 1 – Free Evening in Lisbon
     
17 SEP 2020    
     
09:00 – 10:30   Session 5 – Regulatory session: Is Industry Creating their own Regulatory Hurdles? ?
09:00 – 09:10   Good morning – a quick recap of day 1
    Kyra Cowan, on behalf of the EBF
09:10 – 09:30   The Regulatory environment on BMV for Biomarkers: a Labyrinth
    Robert Nelson, on behalf of the EBF
09:30 – 09:50   Feedback from industry:
    We are compiling the current EBF experience
09:50 – 10:10   Feedback from the regulators:
    We are continuing to engage with Health Authorities to contribute to the meeting
10:10 – 10:40   Q&A – Panel Discussion
     
10:40 – 11:20   Coffee break & networking
     
11:20 – 13:00   Session 6 – Translation of CoU into bioanalytical strategies
11:20 – 11:40   Staging Biomarker Development
    Devangi Mehta – Immunologix
11:40 – 12:00   Cytokines as Biomarkers of Immunotoxicity in Preclinical Safety Assessment: Navigating “Context of Use”
    Amy Reeves – Covance
12:00 – 12:20   Understanding the Biomarker Strategy of Antisense Oligonucleotide (ASO) Drugs from Non-Clinical and Clinical Studies
    Nick White – AstraZeneca
12:20 – 12:40   The chemokine MCP-1/CCL2 is a key biomarker for respiratory diseases and lung tissue harm
    Marita Zoma – Celerion
12:40 – 13:00   Facilitate fast trial/project decisions and confirmation of context of use based on early PK and biomarker data – The VISTA Approach
    Thomas Arnhold – Boehringer-Ingelheim
     
13:00 – 14:10   Lunch
     
14:10 – 16:30   Session 7 – Closing Panel Discussion: – Towards an Recommendation on CoU from the EBF
14:10 – 14:20   Introduction to the Closing Panel Discussion
    Closing Panel Discussion is being built and will include key elements to contrinute to an updated recommendation from the EBF on BM BMV
14:20 – 15:45   Closing Panel Discussion – small tables 12p max (15:45 – 16:00 logistic break)
16:00 – 16:30   Plenary feedback closing panel discussion and way forward
     
16:30   Closing Remarks and Adjourn