EBF
EBF
EBF
European
Bioanalysis
Forum


EBF vzw is the registered non-profit organisation of the European Bioanalysis Forum

 

Science – Our Universal Language

01-03 December 2021

OS Agenda (Dec.) 2021

PDF renditions of the PowerPoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here.

01 DECEMBER – DAY 1 – CET Morning Sessions
09:30 09:40 Introduction to the Cybermeeting Europe/APAC
09:40 11:50 ADA Strategies
09:40 09:50 Welcome – Introduction to the session – Michaela Golob, Nuvisan
09:50 10:10 Michaela Golob, on behalf of the EBF
Immunogenicity Strategies: cross-industry, cross-functional approaches to understand immunogenicity potential from discovery through launch – incl. FB from 14th OS panel discussion
10:10 10:30 Kyra Cowan, Merck KGaA
Immunogenicity Strategies – Cross-functional collaborations
10:30 10:50 Yvonne Katterle, Bayer
How immunogenicity risk assessment can translate into an immunogenicity testing strategy
10:50 11:20 Daniel Kramer (Sanofi) (Not released for publication)
Michael Partridge (Regeneron)
Risk Based Approaches to Immunogenicity – Progress since the March EBF Training Day
11:20 11:50 Panel discussion
Panelist: Session presenters
12:30 14:30 Regulatory updates and emerging challenges
12:30 12:40 Welcome – Introduction to the session – Philip Timmerman, EBF
12:40 13:00 Anna Laurén, on behalf of the EBF qPCR team
EBF recommendation on applying CoU principles for qPCR
13:00 13:20 Eric Woolf, representing the AAPS China BA Support Discussion Group
Bioanalytical Support for Studies in China
13:20 13:45 Tom Verhaeghe, on behalf of the EBF team
EBF feedback to industry and FDA on FDA Bioanalytical Method Template
13:45 14:10 Faye Vazvaei,  representing the AAPS Discussion Group
AAPS feedback to industry and FDA on FDA Bioanalytical Method Template
14:10 14:30 Q&A – discussion
02 DECEMBER – DAY 2 – CET Morning Sessions
09:15 Coming Online
09:30 11:30 Data integrity & E-Data
09:30 09:40 Welcome – Introduction to the session – Cecilia Arfvidsson, AstraZeneca
09:40 10:00 Tsvetelina Ivanova, on behalf of the EBF
Updates on Data integrity requirements in (emerging/draft/new) regulatory Guidelines
10:00 10:20 Cecilia Arfvidsson, on behalf of the EBF
Status update on EBF e-team progress (Chromatography & LBA tools)
10:20 10:35 Ranbir Mannu, Labcorp (Not released for publication)
Case study 1 – day to day data integrity challenges in the LBA workflow
10:35 10:50 Harm Buddiger, Genmab (Not released for publication)
Case study 2 – day to day data integrity challenges in the LBA workflow
10:50 11:30 Panel discussion  – dialogue (based on pre-meeting survey and in-meeting polls)
From Challenges in data integrity challenges in the LBA workflow to  solutions for end users and instrument vendors
11:30 Wrap up – Adjourn
12:00 14:20 Strategies on nAb – parallel
12:00 12:10 Welcome – Introduction to the session – Robert Nelson, Labcorp
12:10 12:30 Robert Nelson, on behalf of the EBF NAb team
Feedback from EBF discussion on NAb strategies
12:30 12:50 Nicoline Videbæk, NovoNordisk
Recent Developments in the PK, PD, ADA Integrated Approach versus in vitro NAb Assay, New Case Studies and Evolving Trends
12:50 13:10 Weifeng Xu, MSD (Not released for publication)
Novel idea to overcome Drug Interference in Immunogenicity Testing with Much Reduced Acid Treatment and Biotin-conjugated Drug Usage
13:10 13:30 Todd Lester/Heather Myler (presenting) – AAPS
FB from AAPS nAb team
13:30 13:50 Joao Pedras-Vasconcelos, CDER
A regulatory perspective
13:50 14:20 Panel discussion
Panelist: Session presenters
12:30 14:30 The future of BA – our responsibility to the community – parallel
12:30 12:40 Welcome – Introduction to the session – Jo Goodman, AstraZeneca
12:40 13:00 Connor Walker, on behalf of the EBF-YSS community
Sustainable Bioanalysis: Where are we now, where are we going?
13:00 13:20 Coral Munday, on behalf of the EBF-YSS community
How Covid-19 impacted our day to day work – learnings for the future
13:20 14:20 Brain storm and panel discussion on future challenges for the Bioanalytical community
Moderator: Philip Timmerman, EBF
Panel: SMEs from 14th OS organising committee
Themes include, New modalities, old modalities, 3R, Is every patient/volunteer sample needed? Learnings from Covid-19
14:20 14:30 Wrap up
03 DECEMBER – DAY 3 – CET Morning Sessions
10:00 12:00 Remote HA audits: Opportunity or threat?
10:00 10:10 Welcome – Introduction to the session – Philip Timmerman, EBF
10:10 10:30 Tsvetelina Ivanova, on behalf of the EBF
Regulatory framework for and challenges for industry with remote HA audits
10:30 10:50 Robert Nelson, on behalf of the EBF (Not released for publication)
Feedback from the EBF on experiences with remote HA inspections
10:50 11:00 Martijn Baeten, Sciensano (Belgian Institute for Health)
On: Experience and learnings from remote inspections.
11:00 11:10 Lee Monk, UCB Biopharma
1-2-6: A Tale of 1 Analytical Method, 2 FDA Inspections, 6 years apart
11:10 11:50 Round table discussion discussing outcome of pre-meeting survey to delegates and EBF members
Panellist: Session presenters
11:50 12:00 Wrap up
12:30 14:30 The global challenge of Biomarker assay validations
12:30 12:40 Welcome – Introduction to the session – Kyra Cowan, Merck KGaA
12:40 13:00 Peter Groenen, Idorsia
A stakeholder perspective
13:00 13:20 Arvind Kinhikar, AAPS Biomarker and Precision Medicine Community (Not released for publication)
Clinical Biomarker Assay Validation: The Power of Western Blotting……Thinking Outside the Box!
13:20 13:40 Kyra Cowan, on behalf of the EBF
Feedback from 14th EBF Open Symposium & Recent EBF discussions
13:40 14:00 Lauren Stevenson, Immunologix/AAPS-OSD
Biomarkers Require Reason, not Rules.  #BeAScientist
14:00 14:10 Philip Timmerman, EBF
CoU: a new Tower of Babel? – introduction to the panel discsuon
14:10 14:30 Panel discussion
Panellist: Session presenters