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 | |||
