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 Workshop

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.

13 MAY 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
    Presenter identified, Ferring Pharmaceuticals
09:20 – 09:50   Be Specific – Putting Biomarker Assay Validation in context
    Lauren Stevenson – Immunologix
09:50 – 10:10   LC-MS/MS Biomarker Assay Validation Considerations from the New Guidance: Discussion of the Upcoming AAPS Whitepaper Recommendations
    Carmen Fernandez-Metzler – PharmaCadence
10:10 – 10:30   Towards an updated EBF recommendation refining CoU requirements for the Biomarker assay community
    Philip Timmerman, on behalf of the EBF
     
10:30 – 11:00   Coffee break & networking 
     
11:00 – 12:40   Session 2 – Learnings and actions from the 2019 EBF FW
11:00 – 11:10   Introduction to the session
    Michaela Golob, on behalf of the EBF
11:10 – 12:40   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   AAPS contribution – awaiting title
    Presenter: – awaiting confirmation
17:50 – 18:10   Industry contribution – refining contribution
    Presenter: – awaiting confirmation
     
18:10 – 18:30   Day 1 closing panel discussion
     
18:30   End of day 1 –  Free Evening in Malaga
     
14 MAY 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