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.
Hotel accommodation
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.
Avenida da Liberdade 185
1269-050 Lisboa
Portugal
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.
Rua Júlio César Machado 7/9
1250-135 Lisboa
Portugal
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).
Avenida Fontes Pereira de Melo No 5
1069-114 Lisboa
Portugal
Program
Download the program as a PDF
Wednesday, April 26th 2023 |
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| 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 |
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| 10:30 | Coffee Break | |||
| 11:00 |
Immunogenicity - Always a Concern? EIP Experts |
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| 12:00 | 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 |
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| 15:00 | 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 |
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Thursday, April 27th 2023 |
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| 09:00 |
Welcome and introduction by the EIP chairman Daniel Kramer, Sanofi |
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| 09:15 |
Keynote Speaker to be confirmed |
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Session 1: Immunogenicity Assay Strategies Chair: Veerle Snoeck |
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| 10:00 |
EIP Immunogenicity Strategy Working Group Update Joanna Grudzinska-Goebel, Bayer on behalf of EIP |
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| 10:15 |
EIP Immunogenicity Assays Working Group Update Linlin Luo, Merck Sharp & Dome on behalf of EIP |
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| 10:30 |
S/N versus Titer to Quasi-Quantify Immunogenicity – Industry Perspective Daniel Baltrunkonis, Pfizer |
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| 11:00 | Coffee Break | |||
| 11:30 |
S/N versus Titer to Quasi-Quantify Immunogenicity – Statistical Perspective Viswanath Devanarayan, Eisai |
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| 12:00 |
S/N versus Titer to Quasi-Quantify Immunogenicity – Regulatory Perspective Joao Pedras-Vasconcelos, FDA |
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| 12:30 |
Singlicate Analysis for Immunogenicity Johannes Stanta, Celerion |
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| 13:00 | Lunch Break | |||
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Session 2: Prediction of Immunogenicity Chair: Sebastian Spindeldreher on behalf of EIP |
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| 14:00 |
EIP NCIRA Working Group update Sebastian Spindeldreher, Integrated Biologix |
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| 14:30 |
Number of Donors Needed to Adequately Assess in-vitro Assays Sofie Denies, SD Analytics |
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| 15:00 | Coffee Break | |||
| 15:30 |
Current FDA Thinking on Predicting Immunogenicity Risk for Biologics – title to be confirmed Daniela Verthelyi, FDA |
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| 16:00 |
Opportunities and Challenges in Quantitative Systems Pharmacology: IG Simulator Evaluation Tim Hickling, Roche |
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| 16:30 |
Standardization of in-vitro Assays Laurent Malherbe, Eli Lilly Sofie Pattijn, ImmuneXperts |
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Session 3: Social Event Chair: Barbara Vercruyssen |
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| 17:30 | Get Together | |||
| 23:00 | Good Night | |||
Friday, April 28th 2023 |
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Session 4: Immunogenicity of New Modalities Chair: Arno Kromminga |
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| 09:00 |
Role of the Innate and Adaptive Immune System to Immunogenicity in Gene Therapy Laura Salazar-Fontana, NDA |
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| 09:30 |
Aspects of the Immunogenicity Assessment Against mRNA Based Products Arno Kromminga, BioNTech |
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| 10:00 |
Immunogenicity risk assessments for Cellular and Gene Therapies – title to be confirmed Zuben Sauna, FDA |
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| 10:30 | Coffee Break | |||
| 11:15 |
CAR-T Cell Therapy – Immunogenicity – title to be confirmed Lydia Michaut, Novartis |
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| 11:45 | Lunch Break | |||
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Session 5: Clinical Relevance of Immunogenicity Chair: Gregor Lotz |
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| 13:00 |
Integrated PK/PD/ADA Approach Instead of NAb Assays Karin Nana Weldingh, NovoNordisk |
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| 13:30 |
Characterization of ADA Responses to Understand Impact of Immunogenicity on Bispecific Drug Exposure and Activity Gregor Lotz, Roche |
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Session 6: Regulatory Chair: Daniel Kramer |
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| 14:00 |
Current thinking on Immunogenicity Risk Assessment (IRA) and Integrated Summary of Immunogenicity (ISI) from EMA Speaker to be confirmed |
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| 14:30 |
Current thinking on IRA and ISI from Health Canada Speaker to be confirmed |
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| 15:00 |
Conference Summary & Outlook by the EIP Chairman Daniel Kramer, Sanofi |
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| 15:15 | Close of the conference | |||