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14th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

26th — 28th April 2023

Lisbon, Portugal

This year's sponsors

We are looking forward to meeting up with you face to face in Lisbon for our 14th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals.

Registration prices

Members Non members Academics
Symposium & Workshop 700€ 1,100€ 600€
Conference only 600€ 900€ 500€
Workshop only 250€ 300€ 250€

The EIP Board invites you to be our guest at the social event. If you wish to attend, please ensure that you select this option when booking.

NOTE: Upon confirmation of attendance to the social event, please note that in case of no show a fee of 75.00€ will be charged to cover the costs incurred by EIP.

Deadline for registration

19th April 2023

Hotel accommodation

Hotel photo
Hotel Tivoli Liberdade (5 star)

The conference location.

The preferential rate of 270.00€ per night (breakfast included) is available until March 24th and can be booked using the Book now button below. The total price will be charged to your credit card once the booking process is complete. This is a non refundable payment and your reservation cannot be cancelled or modified once made.

After March 24th, please contact the hotel directly to book at the standard rate.

Address

Avenida da Liberdade 185
1269-050 Lisboa
Portugal

Phone
+351 21 319 8900
Email
avenidaliberdade@tivoli-hotels.com
Hotel photo
Hotel Avani (4 star)

Situated just behind the Tivoli hotel, a 2 minute walk.

The preferential referential rate of 165.00€ per night (breakfast included) is available until March 24th and can be booked using the Book now button below. The total price will be charged to your credit card once the booking process is complete. This is a non refundable payment and your reservation cannot be cancelled or modified once made.

After March 24th, please contact the hotel directly to book at the standard rate.

Address

Rua Júlio César Machado 7/9
1250-135 Lisboa
Portugal

Phone
+351 21 359 1000
Email
lisbon@avani-hotels.com
Hotel photo
Hotel Ibis Pombal (3 star)

A 10 minute walk from the Tivoli hotel.

There is no preferential rate, the standard rate is +/- 114.00€ (breakfast included).

Address

Avenida Fontes Pereira de Melo No 5
1069-114 Lisboa
Portugal

Phone
+351 21 350 3900
Email
ha9r8@accor.com

Program

Download the program as a PDF
 

Wednesday, April 26th 2023

Training Course
09:00 Coming together
In-Study Cut-Points
09:15 Practical Advice When and How to Perform in-Study Cut-points
Viswanath Devanarayan, Eisai
EIP Experts
10:30 coffee Coffee Break
11:00 Immunogenicity - Always a Concern?
EIP Experts
12:00 cutlery 77 Lunch Break
Assay validation and immunogenicity assessment
13:30 Bring your own problems (break out sessions)
Daniel Kramer, Sanofi
Arno Kromminga, BioNTech
Sebastian Spindeldreher, Integrated Biologix
Sofie Pattijn, ImmunXperts
Sophie Tourdot, Pfizer
15:00 coffee Coffee Break
15:30 Continue “Bring your own problems (break out sessions)”
16:30 Close of the Training Course
17:00 18:30 Meeting of the EIP Working Groups
Members of EIP working groups
 

Thursday, April 27th 2023

09:00 Welcome and introduction by the EIP chairman
Daniel Kramer, Sanofi
09:15 Keynote
Speaker to be confirmed
Session 1: Immunogenicity Assay Strategies
Chair: Veerle Snoeck
10:00 EIP Immunogenicity Strategy Working Group Update
Joanna Grudzinska-Goebel, Bayer on behalf of EIP
10:15 EIP Immunogenicity Assays Working Group Update
Linlin Luo, Merck Sharp & Dome on behalf of EIP
10:30 S/N versus Titer to Quasi-Quantify Immunogenicity – Industry Perspective
Daniel Baltrunkonis, Pfizer
11:00 coffee Coffee Break
11:30 S/N versus Titer to Quasi-Quantify Immunogenicity – Statistical Perspective
Viswanath Devanarayan, Eisai
12:00 S/N versus Titer to Quasi-Quantify Immunogenicity – Regulatory Perspective
Joao Pedras-Vasconcelos, FDA
12:30 Singlicate Analysis for Immunogenicity
Johannes Stanta, Celerion
13:00 cutlery 77 Lunch Break
Session 2: Prediction of Immunogenicity
Chair: Sebastian Spindeldreher on behalf of EIP
14:00 EIP NCIRA Working Group update
Sebastian Spindeldreher, Integrated Biologix
14:30 Number of Donors Needed to Adequately Assess in-vitro Assays
Sofie Denies, SD Analytics
15:00 coffee Coffee Break
15:30 Current FDA Thinking on Predicting Immunogenicity Risk for Biologicstitle to be confirmed
Daniela Verthelyi, FDA
16:00 Opportunities and Challenges in Quantitative Systems Pharmacology: IG Simulator Evaluation
Tim Hickling, Roche
16:30 Standardization of in-vitro Assays
Laurent Malherbe, Eli Lilly
Sofie Pattijn, ImmuneXperts
Session 3: Social Event
Chair: Barbara Vercruyssen
17:30 toast Get Together
23:00 moon stars Good Night
 

Friday, April 28th 2023

Session 4: Immunogenicity of New Modalities
Chair: Arno Kromminga
09:00 Role of the Innate and Adaptive Immune System to Immunogenicity in Gene Therapy
Laura Salazar-Fontana, NDA
09:30 Aspects of the Immunogenicity Assessment Against mRNA Based Products
Arno Kromminga, BioNTech
10:00 Immunogenicity risk assessments for Cellular and Gene Therapiestitle to be confirmed
Zuben Sauna, FDA
10:30 coffee Coffee Break
11:15 CAR-T Cell Therapy – Immunogenicitytitle to be confirmed
Lydia Michaut, Novartis
11:45 cutlery 77 Lunch Break
Session 5: Clinical Relevance of Immunogenicity
Chair: Gregor Lotz
13:00 Integrated PK/PD/ADA Approach Instead of NAb Assays
Karin Nana Weldingh, NovoNordisk
13:30 Characterization of ADA Responses to Understand Impact of Immunogenicity on Bispecific Drug Exposure and Activity
Gregor Lotz, Roche
Session 6: Regulatory
Chair: Daniel Kramer
14:00 Current thinking on Immunogenicity Risk Assessment (IRA) and Integrated Summary of Immunogenicity (ISI) from EMA
Speaker to be confirmed
14:30 Current thinking on IRA and ISI from Health Canada
Speaker to be confirmed
15:00 Conference Summary & Outlook by the EIP Chairman
Daniel Kramer, Sanofi
15:15 Close of the conference
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