14th EBF Open Symposium

IMPORTANT UPDATE on COVID-19 (Delta)

Continuously evaluating the possibilities for travel in November, we are on track for an in-person meeting in Barcelona – we continue our preparation to return to Barcelona, but we add a Cyberspace option after the live symposium.

With SARS-CoV-2 still traveling around the world, the EBF continues to monitor the situation. We have decided to make a few changes to our original planning:

ON TRACK for the live meeting of 24–26 November 2021

• The hotel has informed us on the current social distancing rules which inevitably limit the capacity of each meeting room. These rules may or may not be in place in November. However, for our planning, we will take them into account to calculate the maximum capacity for the meeting. Hence, we reduce the maximum meeting capacity from 600–400 delegates. To allow a maximum number of companies to participate, we also limit the number of delegates to 10 per organisation (delegates with a voucher and presenters excluded).

We are ADDING a Cyberevent on 1–3 December 2021

• Although ‘COVID-safe’ travel is becoming a reality with vaccination and Digital COVID Certification, we are aware that some of you may not be permitted/willing to travel for country, company or personal limitations. To allow you to stay connected to the EBF and our yearly open symposium, we will include an additional online event the week after the symposium (1–3 December 2021) favouring NA, Europe and Asia time zones. This online event/cybermeeting will consist of five or six sessions. The program is being discussed within the EBF. For sure there will be partial overlap with the themes of face to face meeting of 24–26 November. However, it is not our intention this cybermeeting becomes a ‘the best of’ or ‘the highlights from’ that face to face. Instead, we will plan for a meeting in which we discuss strategic themes for the regulated BA community “fitting a cyberspace environment”. In view of the complementarity of this 2nd meeting, invoiced delegates from the live meeting and presenters at the cybermeeting will get a waiver for the cybermeeting but will need to register separately. The registration fee for new delegates (i.e. those not able to come to Barcelona or delegates with a voucher and presenters from the face to face meeting) will be 345 Euro. A separate registration link will be provided early September. There will be no separate call for speakers nor a separate call for sponsors.

Themes for the 14^th Open Symposium

Our agenda is very ambitious and sets the stage for the new era. You can submit an abstract for podium presentations/workshop with focus on below categories (including suggested sub-themes):

• NCEs (chromatography focus): focus on scientific and regulatory challenges and best state of the art practices for
  • metabolite quantification
  • non-liquid matrix analysis
  • new tools surrounding Chromatography: Blue Sky – new technologies at our doorstep

• NBE (LBA/CBA based): focus on scientific and regulatory challenges and best state of the art practices for
  • critical reagents,
  • immunocapture-LC/MS (hybrid) assays
  • PK interpretation of NBEs (total/Free..)
  • Bio-metabolism of Biotherapeutics

• C&GT and new modalities: are we ready to support the next generation Pharma R&D challenges?
• Immunogenicity: focus on what’s new/different and making sense for biologics, C&GT, new modalities and peptides
• Biomarker Science: includes a spotlight on non-liquid matrices analysis for Biomarkers
• Biosimilars: scientific and regulatory challenges for the BioA community
• Regulations: risk based approach, GCP, data integrity, post Covid-19 inspection readiness (remote inspections), ICH M10 and new emerging guidelines as required
• The Future of Bioanalysis: focus on the role of BioA
  • in speeding up drug development (process, tools, Risk based Approach),
  • for standard of care drugs
  • sustainability – see also:  https://www.tandfonline.com/doi/10.4155/bio-2021-0017
  • technologies on the fringe – SMART lab and AI

• The Patient: focus on role of BA in patient centric technologies, diagnostics and TDM
• Technology (Chromatography & LBA/CBA):
  • focus on automation/robotics after Covid-19,
  • new tools for increasing throughput, sensitivity and DI compliance (e-environment) for (LC-)MS and LBA/CBA