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
09:3009:40 Introduction to the Cybermeeting Europe/APAC
    
09:4011:50 ADA Strategies
09:4009:50 Welcome – Introduction to the session – Michaela Golob, Nuvisan
09:5010:10 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
10:1010:30 Two companies requested to present – approval pending
   on: ADA strategy – a company perspective
10:3010:50 Yvonne Katterle, Bayer
   How immunogenicity risk assessment can translate into an immunogenicity testing strategy
10:5011:20 Daniel Kramer (Sanofi)/Michael Partridge (Regeneron) – presenter tbd
   Risk Based Approaches to Immunogenicity – Are we over reporting ADA?
Progress since the March EBF Training Day
11:2011:50 Panel discussion
   Panelist: Session presenters
    
12:3014:30 Regulatory updates and emerging challenges
12:3012:40 Welcome – Introduction to the session – Philip Timmerman, EBF
12:4013:00 Anna Laurén, on behalf of the EBF qPCR team
   EBF recommendation on applying CoU principles for qPCR
13:0013:20 Eric Woolf, representing the AAPS China BA Support Discussion Group
   Bioanalytical Support for Studies in China
13:2013:45 Tom Verhaeghe, on behalf of the EBF team
   EBF feedback to industry and FDA on FDA Bioanalytical Method Template
13:4514:10 Faye Vazvaei,  representing the AAPS Discussion Group
   AAPS feedback to industry and FDA on FDA Bioanalytical Method Template
14:1014:30 Q&A – discussion
    
14:30  adjourn of day 1 Europe/APAC day
    
02 DECEMBER – DAY 2 – CET Morning Sessions
    
09:15  Coming Online
09:3011:30 Data integrity & E-Data
09:3009:40 Welcome – Introduction to the session – Cecilia Arfvidsson, AstraZeneca
09:4010:00 Tsvetelina Ivanova, on behalf of the EBF
   Updates on Data integrity requirements in (emerging/draft/new) regulatory Guidelines
10:0010:20 Cecilia Arfvidsson, on behalf of the EBF
   Status update on EBF e-team progress (Chromatography & LBA tools)
10:2010:35 Ranbir Mannu, Labcorp
   Case study 1 – day to day data integrity challenges in the LBA workflow
10:3510:50 Harm Buddiger, Genmab
   Case study 2 – day to day data integrity challenges in the LBA workflow
10:5011:30 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
    
12:0014:20 Strategies on nAb – parallel
12:0012:10 Welcome – Introduction to the session – Robert Nelson, Labcorp
12:1012:30 Robert Nelson, on behalf of the EBF NAb team
   Feedback from EBF discussion on NAb strategies
12:3012:50 Nicoline Videbæk, NovoNordisk
   Recent Developments in the PK, PD, ADA Integrated Approach versus in vitro NAb Assay, New Case Studies and Evolving Trends
12:5013:10 Weifeng Xu, MSD
   Novel idea to overcome Drug Interference in Immunogenicity Testing with Much Reduced Acid Treatment and Biotin-conjugated Drug Usage
13:1013:30 Todd Lester/Heather Myler (presenting) – AAPS
   FB from AAPS nAb team
13:3013:50 Joao Pedras-Vasconcelos, CDER
   A regulatory perspective
13:5014:20 Panel discussion
   Panelist: Session presenters
    
12:3014:30 The future of BA – our responsibility to the community – parallel
12:3012:40 Welcome – Introduction to the session – Jo Goodman, AstraZeneca
12:4013:00 Connor Walker, on behalf of the EBF-YSS community
   Sustainable Bioanalysis: Where are we now, where are we going?
13:0013:20 Coral Munday, on behalf of the EBF-YSS community
   How Covid-19 impacted our day to day work – learnings for the future
13:2014:20 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
14:2014:30 Wrap up
    
14:30  adjourn of day 2 Europe/APAC day
    
03 DECEMBER – DAY 3 – CET Morning Sessions
    
09:30  Coming Online
    
10:0012:00 Remote HA audits: Opportunity or threat?
10:0010:10 Welcome – Introduction to the session – Philip Timmerman, EBF
10:1010:30 Tsvetelina Ivanova, on behalf of the EBF
   Regulatory framework for and challenges for industry with remote HA audits
10:3010:50 Presenter from EBF
   Feedback from the EBF on experiences with remote HA inspections
10:5011:00 Presenter from labcorp Drug Developent, tbc
   on: remote HA inspections around the globe
11:0011:10 Lee Monk, UCB Biopharma
   1-2-6: A Tale of 1 Analytical Method, 2 FDA Inspections, 6 years apar
11:1011:50 Round table discussion discussing outcome of pre-meeting survey to delegates and EBF members
   Panellist: Session presenters
11:5012:00 Wrap up
    
12:3014:30 The global challenge of Biomarker assay validations
12:3012:40 Welcome – Introduction to the session – Kyra Cowan, Merck KGaA
12:4013:00 Peter Groenen, Idorsia
   A stakeholder perspective
13:0013:20 Carmen Fernandez-Metzler , AAPS Biomarker and Precision Medicine Community
   Clinical Biomarker Assay Validation: The Power of Western Blotting……Thinking Outside the Box!
13:2013:40 Kyra Cowan, on behalf of the EBF
   Feedback from 14th EBF Open Symposium & Recent EBF discussions
13:4014:00 Lauren Stevenson, Immunologix/AAPS-OSD
   #BeAScientist
14:0014:10 Philip Timmerman, EBF
   CoU: a new Tower of Babel? – introduction to the panel discsuon
14:1014:30 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
14:4515:00 Introduction to the Cybermeeting Europe/NA
    
15:0017:00  Regulatory updates and emerging challenges
15:0015:10 Welcome – Introduction to the session – Philip Timmerman, EBF
15:1015:30 Anna Laurén, on behalf of the EBF qPCR team
   EBF recommendation on applying CoU principles for qPCR
15:3015:50 Eric Woolf, representing the AAPS China BA Support Discussion Group
   Bioanalytical Support for Studies in China
15:5016:15 Tom Verhaeghe, on behalf of the EBF team
   EBF feedback to industry and FDA on FDA Bioanalytical Method Template
16:1516:40 Faye Vazvaei,  representing the AAPS Discussion Group
   AAPS feedback to industry and FDA on FDA Bioanalytical Method Template
16:4017:00 Q&A – discussion
    
17:3019:40  ADA Strategies
17:3017:40 Welcome – Introduction to the session – Michaela Golob, Nuvisan
17:4018:00 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
18:0018:20 Two companies requested to present – approval pending
   on: ADA strategy – a company perspective
18:2018:40 Yvonne Katterle, Bayer
   How immunogenicity risk assessment can translate into an immunogenicity testing strategy
18:4019:10 Daniel Kramer (Sanofi)/Michael Partridge (Regeneron) – presenter tbd
   Risk Based Approaches to Immunogenicity – Are we over reporting ADA?
Progress since the March EBF Training Day
19:1019:40 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
15:0017:00 The future of BA – our responsibility to the community – parallel
15:0015:10 Welcome – Introduction to the session – Jo Goodman, AstraZeneca
15:1015:30 Connor Walker, on behalf of the EBF-YSS community
   Sustainable Bioanalysis: Where are we now, where are we going?
15:3015:50 Coral Munday, on behalf of the EBF-YSS community
   How Covid-19 impacted our day to day work – learnings for the future
15:5016:50 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
16:5017:00 Wrap up
    
15:0017:20 Strategies on nAb – parallel
15:0015:10 Welcome – Introduction to the session – Robert Nelson, Labcorp
15:1015:30 Robert Nelson, on behalf of the EBF NAb team
   Feedback from EBF discussion on NAb strategies
15:3015:50 Nicoline Videbæk, NovoNordisk
   Recent Developments in the PK, PD, ADA Integrated Approach versus in vitro NAb Assay, New Case Studies and Evolving Trends
15:5016:10 Weifeng Xu, MSD
   Novel idea to overcome Drug Interference in Immunogenicity Testing with Much Reduced Acid Treatment and Biotin-conjugated Drug Usage
16:1016:30 Todd Lester (presenting)/Heather Myler – AAPS
   FB from AAPS nAb team
16:3016:50 Joao Pedras-Vasconcelos, CDER
   A regulatory perspective
16:5017:20 Panel discussion
   Panelist: Session presenters
    
17:3019:30 Data integrity & E-Data
17:3017:40 Welcome – Introduction to the session – Cecilia Arfvidsson, AstraZeneca
17:4018:00 Tsvetelina Ivanova, on behalf of the EBF
   Updates on Data integrity requirements in (emerging/draft/new) regulatory Guidelines
18:0018:20 Cecilia Arfvidsson, on behalf of the EBF
   Status update on EBF e-team progress (Chromatography & LBA tools)
18:2018:35 Ranbir Mannu, Labcorp
   Case study 1 – day to day data integrity challenges in the LBA workflow
18:3518:50 Harm Buddiger, Genmab
   Case study 2 – day to day data integrity challenges in the LBA workflow
18:5019:30 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
19:30  Wrap up – Adjourn
    
19:30  adjourn of day 2 Europe/APAC day
    
03 DECEMBER – DAY 3 – CET Afternoon Sessions
    
14:30  Coming online
    
15:0017:00 The global challenge of Biomarker assay validations
15:0015:10 Welcome – Introduction to the session – Kyra Cowan, Merck KGaA
15:1015:30 Peter Groenen, Idorsia
   A stakeholder perspective
15:3015:50 Carmen Fernandez-Metzler, AAPS Biomarker and Precision Medicine Community
   Clinical Biomarker Assay Validation: The Power of Western Blotting……Thinking Outside the Box!
15:5016:10 Kyra Cowan, on behalf of the EBF
   Feedback from 14th EBF Open Symposium & Recent EBF discussions
16:1016:30 Lauren Stevenson, Immunologix/AAPS-OSD
   #BeAScientist
16:3016:40 Philip Timmerman, EBF
   CoU: a new Tower of Babel? – introduction to the panel discsuon
16:4017:00 Panel discussion
   Panellist: Session presenters
    
17:3019:30 Remote HA audits: Opportunity or threat?
17:3017:40 Welcome – Introduction to the session – Philip Timmerman, EBF
17:4018:00 Tsvetelina Ivanova, on behalf of the EBF
   Regulatory framework for and challenges for industry with remote HA audits
18:0018:20 Presenter from EBF
   Feedback from the EBF on experiences with remote HA inspections
18:2018:30 Presenter from labcorp Drug Developent, tbc
   on: remote HA inspections around the globe
18:3018:40 Lee Monk, UCB Biopharma
   1-2-6: A Tale of 1 Analytical Method, 2 FDA Inspections, 6 years apar
18:4019:20 Round table discussion
   Panellist: Session presenters
19:2019:30 Wrap up and adjourn
    
19:3019:40 adjourn of day 3 Europe/NA day and end of the Europe/NA conference