EBF
EBF Open Symposium
EBF Barcelona

14th EBF Open Symposium

Science – Our Universal Language
24-26 November 2021 (Live at Hyatt Regency Barcelona Tower – Barcelona – Spain)
01-03 December 2021 (limited Cyberconnect event)

OS Agenda (Dec.)

Although ‘Covid-safe’ travel is a reality with vaccination and EU Digital Covid Certification (or equivalent), we are aware that some of you may not be permitted/willing to travel for company or personal limitations. 

To allow you to stay connected to the EBF and our yearly Open Symposium, we have included an additional online event on 1-3 December 2021 favouring NA, Europe and Asia time zones (e.g., sessions from approx. 10 am – 1:30 pm CET for Asia/EU mornings and duplicated from 3 pm – 6:30 pm CET for NA/LA and EU afternoon).

This online event/cybermeeting will consist of 7 sessions spread over 3 days. The program is being finalised. Although there may be partial overlap with the themes of face-to-face meeting of 24-26 November, it is not our intention this cybermeeting becomes a ‘the best of’ or ‘the highlights from’ the November meeting. Instead, we are planning for a cybermeeting in which we discuss strategic themes for the regulated BA community “fitting a cyberspace environment”.

This online event/cybermeeting is a stand-alone meeting. Registered delegates for the live meeting will get a waiver for the online event/cybermeeting. New delegates need to register separately using the registration link in this website 

09:30 - 15:00 CET
Morning sessions:
Favouring time zones of:
Europe and APAC

01 DECEMBER – DAY 1 – CET Morning Sessions
09:15 Coming Online
09:30 09:40 Introduction to the Cybermeeting Europe/APAC
09:40 11:50 Session 1: ADA Strategies
09:40 09:45 Welcome – Introduction to the session – Michaela Golob, Nuvisan
09:45 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 A company ADA strategy presentation, tbc
title
10:30 10:50 Yvonne Katterle, Bayer
How immunogenicity risk assessment can translate into an immunogenicity testing strategy
10:50 11:20 presenters tbc
Risk Based Approaches to Immunogenicity – Are we over reporting ADA? Progress since the March EBF Training g Day
11:20 11:50 Panel discussion
Panelist: Session presenters
12:30 14:30 Session 2: 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 Tsvetelina Ivanova, on behalf of the EBF
Updates on Data integrity requirements in (emerging/draft/new) regulatory Guidelines
13:20 13:40 Eric Woolf, representing the AAPS China BA Support Discussion Group
Bioanalytical Support for Studies in China
13:40 14:00 Tom Verhaeghe, on behalf of the EBF team
EBF feedback to industry and FDA on FDA Bioanalytical Method Template
14:00 14:20 Stephany Cape (tbc),  representing the AAPS Discussion Group
AAPS feedback to industry and FDA on FDA Bioanalytical Method Template
14:20 14:30 Q&A – discussion
14:30 Adjourn
14:30 adjourn of day 1 Europe/APAC day
02 DECEMBER – DAY 2 – CET Morning Sessions
09:15 Coming Online
09:30 11:30 Session 3: The future of BA – our responsibility to the community
09:30 09:40 Welcome – Introduction to the session – Jo Goodman, AstraZeneca
09:40 10:00 Connor Walker, on behalf of the EBF-YSS community
Sustainable Bioanalysis: Where are we now, where are we going?
10:00 10:20 Coral Munday, on behalf of the EBF-YSS community
How Covid-19 impacted our day to day work – learnings for the future
10:20 11:20 All-delegates interactive brain storm and panel discussion on future challenges for the Bioanalytical community
Moderator: Philip Timmerman, EBF
Panel: SMEs from 14th OS organising committee
Themes at least include
 – New modalities, old modalities
 – Avoiding unnecessary experimental animal usage
 – Is every patient/volunteer sample needed? Learnings from Covid-19
Additional themes may be identified with input from a pre-meeting survey to EBF members and meeting delegates
11:20 11:30 Wrap up
12:30 14:30 Session 4: Data integrity & E-Data (semi-parallel to session 5)
12:30 12:40 Welcome – Introduction to the session – Cecilia Arfvidsson, AstraZeneca
12:40 13:00 Cecilia Arfvidsson, on behalf of the EBF
Status update on EBF e-team progress (Chromatography & LBA tools)
13:00 13:15 Ranbir Mannu, Labcorp
Case study 1 – day to day data integrity challenges in the LBA workflow
13:15 13:30 Harm Buddiger, Genmab
Case study 2 – day to day data integrity challenges in the LBA workflow
13:30 14:20 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
14:20 14:30 Wrap up – Adjourn
12:00 14:20 Session 5: Strategies on NAb (semi-parallel to session 4)
12:00 12:10 Welcome – Introduction to the session – Robert Nelson, Labcorp
12:10 12:30 Weifeng Xu, MSD
Novel idea to overcome Drug Interference in Immunogenicity Testing with Much Reduced Acid Treatment and Biotin-conjugated Drug Usage
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 Robert Nelson, on behalf of the EBF NAb team
Feedback from EBF discussion on NAb strategies
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
14:30 adjourn of day 2 Europe/APAC day
03 DECEMBER – DAY 3 – CET Morning Sessions
09:30 Coming Online
10:00 12:00 Session 6: Challenges and experience with remote HA audits
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 Contribution from HA, tbc
title tbc
10:50 11:00 Case study from pre-meeting survey to delegates and EBF members – in progress
title tbc
11:00 11:10 Case study from pre-meeting survey to delegates and EBF members – in progress
title tbc
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 Session 7: The global challenge of Biomarker assay validations
12:30 12:40 Welcome – Introduction to the session – Kyra Cowan, Merck KGaA
12:40 13:00 Kyra Cowan, on behalf of the EBF
Feedback from 14th EBF Open Symposium & Recent EBF discussions
13:00 13:20 Laetitia Sordé – Sobi
a cases study.
13:20 13:40 Peter Groenen, Idorsia
a stakeholder perspective
13:40 14:00 Philip Timmerman, EBF
CoU: a new Tower of Babel?
14:00 14:30 Panel discussion
Panellist: Session presenters
14:30 adjourn of day 3 Europe/APAC day and end of the Europe/APAC conference

15:00 - 19:30 CET
Afternoon sessions:
Favouring time zones of:
Europe and the Americas

01 DECEMBER – DAY 1 – CET Afternoon Sessions
14:30 Coming online
14:45 15:00 Introduction to the Cybermeeting Europe/NA
15:00 17:15 Session 2 – repeat: Regulatory updates and emerging challenges
15:00 15:10 Welcome – Introduction to the session – Philip Timmerman, EBF
15:10 15:30 Anna Laurén, on behalf of the EBF qPCR team
EBF recommendation on applying CoU principles for qPCR
15:30 15:50 Tsvetelina Ivanova, on behalf of the EBF
Updates on Data integrity requirements in (emerging/draft/new) regulatory Guidelines
15:50 16:10 Eric Woolf, representing the AAPS China BA Support Discussion Group
Bioanalytical Support for Studies in China
16:10 16:30 Tom Verhaeghe, on behalf of the EBF team
EBF feedback to industry and FDA on FDA Bioanalytical Method Template
16:30 16:50 Stephany Cape (tbc),  representing the AAPS Discussion Group
AAPS feedback to industry and FDA on FDA Bioanalytical Method Template
16:50 17:15 Q&A – discussion
17:30 19:40 Session 1 – repeat: ADA Strategies
17:30 17:35 Welcome – Introduction to the session – Michaela Golob, Nuvisan
17:35 18:00 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
18:00 18:20 A company ADA strategy presentation, tbc
title
18:20 18:40 Yvonne Katterle, Bayer
How immunogenicity risk assessment can translate into an immunogenicity testing strategy
18:40 19:10 presenters tbc
Risk Based Approaches to Immunogenicity – Are we over reporting ADA? Progress since the March EBF Training g Day
19:10 19:40 Panel discussion
Panelist: Session presenters
19:40 adjourn of day 1 Europe/NA day
02 DECEMBER – DAY 2 – CET Afternoon Sessions
14:30 Coming online
15:00 17:20 Session 5: Strategies on NAb
15:00 15:10 Welcome – Introduction to the session – Robert Nelson, Labcorp
15:10 15:30 Weifeng Xu, MSD
Novel idea to overcome Drug Interference in Immunogenicity Testing with Much Reduced Acid Treatment and Biotin-conjugated Drug Usage
15:30 15:50 Nicoline Videbæk, NovoNordisk
Recent Developments in the PK, PD, ADA Integrated Approach versus in vitro NAb Assay, New Case Studies and Evolving Trends
15:50 16:10 Robert Nelson, on behalf of the EBF NAb team
Feedback from EBF discussion on NAb strategies
16:10 16:30 Todd Lester (presenting)/Heather Myler – AAPS
FB from AAPS NAb team
16:30 16:50 Joao Pedras-Vasconcelos, CDER
A regulatory perspective
16:50 17:20 Panel discussion
Panelist: Session presenters
15:00 17:00 Session 4 – repeat: Data integrity & E-Data (semi-parallel to session 3 – repeat)
15:00 15:10 Welcome – Introduction to the session – Cecilia Arfvidsson, AstraZeneca
15:10 15:30 Cecilia Arfvidsson, on behalf of the EBF
Status update on EBF e-team progress (Chromatography & LBA tools)
15:30 15:45 Ranbir Mannu, Labcorp
Case study 1 – day to day data integrity challenges in the LBA workflow
15:45 16:00 Harm Buddiger, Genmab
Case study 2 – day to day data integrity challenges in the LBA workflow
16:00 16:40 Panel discussion  – dialogue (based on pre-meeting survey and in-meeting polls)
From Challenges in data integrity challenges in the LBA workflowto to solutions for end users and instrument vendors
16:40 17:00 Wrap up – Adjourn
17:30 19:30 Session 3 – repeat: The future of BA – our responsibility to the community (semi-parallel to session 4 – repeat)
17:30 17:40 Welcome – Introduction to the session – Jo Goodman, AstraZeneca
17:40 18:00 Connor Walker, on behalf of the EBF-YSS community
Sustainable Bioanalysis: Where are we now, where are we going?
18:00 18:20 Coral Munday, on behalf of the EBF-YSS community
How Covid-19 impacted our day to day work – learnings for the future
18:20 19:20 All-delegates interactive brain storm and panel discussion on future challenges for the Bioanalytical community
Moderator: Philip Timmerman, EBF
Panel: SMEs from 14th OS organising committee
Themes at least include
 – New modalities, old modalities
 – Avoiding unnecessary experimental animal usage
 – Is every patient/volunteer sample needed? Learnings from Covid-19
Additional themes may be identified with input from a pre-meeting survey to EBF members and meeting delegates
19:20 19:30 Wrap up
19:30 adjourn of day 2 Europe/APAC day
03 DECEMBER – DAY 3 – CET Afternoon Sessions
14:30 Coming online
15:00 17:00 Session 7: – repeat: The global challenge of Biomarker assay validations
15:00 15:10 Welcome – Introduction to the session – Kyra Cowan, Merck KGaA
15:10 15:30 Kyra Cowan, on behalf of the EBF
Feedback from 14th EBF Open Symposium & Recent EBF discussions
15:30 15:50 Laetitia Sordé – Sobi
A case study on recent regulatory interactions for biomarker assays
15:50 16:10 Peter Groenen, Idorsia
Organisational design driving/preventing CoU – a challenge or an opportunity – a stakeholder perspective
16:10 16:30 Philip Timmerman, EBF
CoU: a new Tower of Babel?
16:30 17:00 Panel discussion
Panellist: Session presenters
17:30 19:30 Session 6 – repeat: Challenges and experience with remote HA audits
17:30 17:40 Welcome – Introduction to the session – Philip Timmerman, EBF
17:40 18:00 Tsvetelina Ivanova, on behalf of the EBF
Regulatory framework for and challenges for industry with remote HA audits
18:00 18:20 Contribution from HA, tbc
title tbc
18:20 18:30 Case study from pre-meeting survey to delegates and EBF members – in progress
title tbc
18:30 18:40 Case study from pre-meeting survey to delegates and EBF members – in progress
title tbc
18:40 19:20 Round table discussion discussing outcome of pre-meeting survey to delegates and EBF members
Panellist: Session presenters
19:20 19:30 Wrap up and adjourn
19:30 19:40 adjourn of day 3 Europe/NA day and end of the Europe/NA conference