INTRODUCTION AND AIM OF THE MEETING
We want to dedicate our Autumn Focus Workshop (FW) to the clinical aspects of immunogenicity and correlating what happens in the bioanalytical laboratory with the impact for the patient. Recent regulatory requirements have placed immunogenicity assays under greater scrutiny with more emphasis on assay performance and in-depth characterization of the immune response. Whilst patient safety is always of upmost concern, are we taking the best approach(es)? This FW will discuss current requirements/practices and utilize recent case studies.
At the workshop, we want to engage with all delegates to come to a better understanding of the day-to-day challenges related to 3 novel areas:
- Harmonized approaches for immunogenicity method validation (e.g. cut points – are we just measuring assay noise, challenges when changing disease states, positive control placement, etc.)
- Clinical nAb assays and alternative approaches (e.g. do we always need a clinical nAb assay, what assay format answers the question, can integration of PK-PD-ADA correlations be more informative, etc.)
- Clinical reporting of immunogenicity and the value for the patient and physician (e.g. is sensitivity really the key issue for reporting, what does titer tell us, what is clinically impactful, etc.)
WHO SHOULD ATTEND?
Scientists and managers from Pharma R&D, CRO and Health Authorities involved in research, assay validation & analysis, data interpretation and filing involving all aspects of immunogenicity with new and existing biopharmaceuticals.
CALL FOR REGISTRATION
The meeting will start on September 19th (Wednesday) of at 8.30 am and will end at 4.00 pm approx. on the September 20th (Thursday). On the evening of September 18th, all delegates are invited to a complementary cocktail reception.
Participation to the 2-day meeting is 410 Euro. The fee includes entrance to the workshop, conference material and food and beverages during lunch, coffee breaks and cocktail reception. Dinners and lodging are not included (After September 12th, we only accept on-site registration at an increased registration fee of € 500 (cash only)).
To allow a multi-company multi-angle discussion, only 4 delegates/company can register and the meeting is capped at 100 delegates. To register, follow http://autumnfocus.e-b-f.eu/registration/
The meeting will be held in the ALTIS GRAND HOTEL, Lisbon, Portugal, where we have negotiated special rates.
Details can be found on the website http://autumnfocus.e-b-f.eu/travel-lodging/
Note: There will be no Call for Speakers. The Workshop Organizing Committee is reaching out to industry expert in the field, who will present their company’s current strategies and vision. Together with your input, the latter will be the basis of the workshop discussion.
More details can be found on the website: http://autumnfocus.e-b-f.eu/