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15th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

22nd — 24th April 2024

Lisbon, Portugal

We look forward to seeing you in Lisbon for another great conference.

Registration has now closed for our 2024 symposium.

Program

Download the program as a PDF
 

Monday, April 22nd 2024

Workshop Day
09:00 Coming Together
Immunogenicity Risk Assessment
09:15 Consolidated EIP Proposal for Immunogenicity Risk Assessment
Veerle Snoeck, Joanna Grudzinska Goebel on behalf of EIP
10:15 coffee Coffee Break
In-silico and in-vitro Assays as Part of the Immunogenicity Risk Assessment
10:45 Immunogenicity potential assessment at Novartis
Anette Karle, Novartis
11:15 Immunogenicity potential assessment at Pfizer
Sophie Tourdot, Pfizer
11:45 Design and Implementation of a Risk-Based Strategy for Reducing Immunogenicity Risk of Protein Therapeutics
Karen Heyninck, Sanofi
12:15 cutlery 77 Lunch
13:30 Bring Your own Problems (Breakout Sessions)
Daniel Kramer, Sanofi
Arno Kromminga, BioNTech
Sebastian Spindeldreher, Integrated Biologix
Sofie Pattijn, ImmunXperts
Sophie Tourdot, Pfizer
Veerle Snoeck, UCB
Tim Hickling, Roche
Lydia Michaut, Novartis
15:00 coffee Coffee Break
15:30 Continue “Bring Your own Problems (Breakout Sessions)”
16:30 Closing of the Workshop Day
17:00 – 18:30 Meeting of the EIP Working Groups
Members of EIP working groups
 

Tuesday, April 23rd 2024

09:00 Welcome and Introduction by the EIP Chairman
Daniel Kramer, Sanofi
09:15 Spotlight Presentations: MHC Class I and its Importance for the Immunogenicity of Novel Modalities
Morten Nielsen, Technical University of Denmark
Zuben Sauna, FDA
Session 2: Prediction of Immunogenicity
Chair: Sebastian Spindeldreher
10:15 EIP NCIRA Working Group Update
Sebastian Spindeldreher, Integrated Biologix on behalf of EIP
10:30 Immunogenicity: It’s Personal
Annie de Groot, EpiVax
11:00 coffee Coffee Break
11:00 canvas Poster Presentation
Short Talks
(15 minutes each)
11:30 High-Sensitive MAPPS Analysis for High-Confident Immunogenicity Risk Assessment
Elise Pepermans, ImmuneSpec
11:45 Standardization of in-Vitro Assays — Update from the HESI Collaboration
Sofie Pattyn, ImmunXperts
12:00 Immunogenicity of Therapeutic Antibodies: Role of Aggregation in T Lymphocyte Response
Marc Pallardy, INSERM
12:15 cutlery 77 Lunch Break
13:30 Expanding the MAPPs Assay to MHC-II-DR, -DP and DQ Receptors
Axel Ducret, Roche
14:00 Naive and Memory FVIII-Specific Regulatory and Conventional CD4 T Cells Share Common Epitopes in Healthy Individuals
Bernard Maillere, CEA
Session 3: Immunogenicity Assays
Chair: Veerle Snoeck
14:30 EIP Immunogenicity Assays Working Group Update
Linlin Luo, Merck Sharp & Dome on behalf of EIP
14:45 coffee Coffee Break
14:45 canvas Poster Presentation
15:15 Domain Characterization of Bi-specifics in the ADA and in the NAb Assay
Issa Jyamubandi, Resolian Bioanalytics
15:45 Case study: Developing an ADA assay with enhanced Free Drug Tolerance for Octreotide
René Wuttke, Debiopharm
16:15 Phase-appropriate implementation of a domain specificity strategy
Matthias Reichel, BioAgilytix
16:45 The IVDR and its Impact on Clinical Immunogenicity Assay Development
Robert Nelson, BioAgilytix
Session 3: Social Event
Chair: Barbara Vercruyssen
18:00 toast Get Together
23:00 moon stars Good Night
 

Wednesday, April 24th 2024

Session 4: Immunogenicity of New Modalities
Chair: Arno Kromminga
09:00 Development of an ELISpot Assay for the Assessment of AAV Peptides to Examine Immune Safety
Alison Johnson, Boehringer Ingelheim
09:30 Immunogenicity Risk Assessment for mRNA/LNP Therapies
Joanna Grudzinska Goebel, Bayer
10:00 Total or Neutralizing Antibodies Against Adeno-Associated Virus, What is the Best
Sabrina Lory, UCB
10:30 Orthogonal Approach for AAV Immunogenicity Assessment: Evaluating Total and Neutralizing Antibodies
Michael Tovey, SVAR
11:00 coffee Coffee Break
11:00 canvas Poster Presentation
Session 5: Clinical Relevance of Immunogenicity
Chair: Lydia Michaut
11:30 Overcoming Magic Bullet Approaches for Immune Tolerance Induction for Complex Diseases: Application to Immunogenicity of Biological Therapeutics
Amy Rosenberg, EpiVax
12:00 ADA Monitoring Strategy for Repetitive High Doses of Biologics Therapies: Efficiently Integrating Scientific, Technical, and Regulatory Aspects
Manisha Saxena, Novartis
12:30 The Wonderful World of Immunogenicity; Scientific Understanding, Clinical Relevance, and Regulatory Necessity
Floris Loeff, Sanquin
13:00 cutlery 77 Lunch Break
Short Talks
(15 minutes each)
14:15 Drug T Cell Reactivity in Delayed Type Hypersensitivity – Evaluation with Cyto-LTT
Lester Thoo, ADR-AC
14:30 Evaluating Immediate Type Drug Allergy and Immunostimulation in Vitro with the Basophil Activation Test (BAT)
Daniel Yerly, ADR-AC
Session 6: Regulatory
Chair: Daniel Kramer
14:45 How CDER reviews Immunogenicity for Biologics- the Integrative Immunogenicity Assessment paradigm
Joao A. Pedras-Vasconcelos, FDA
15:30 New approaches to assess immunogenicity risk: Regulatory considerations
Daniela Verthelyi, FDA
16:00 Conference Summary & Outlook by the EIP Chairman
Daniel Kramer, Sanofi
16:15 Close of the conference

Hotel accommodation

Hotel photo
Altis Grand Hotel

The conference venue. Special rates have been negotiated for conference attendees. Please book via the link for these rates to be applied.

Address

Rua Castilho 11
1269-072 Lisboa
Portugal

Phone
+351 21 310 6000
Hotel photo
Ibis Lisboa Centro Liberdade

Just next door to the conference venue, a 2 minute walk.

Address

Rua Barata Salgueiro 53
1250-043 Lisboa
Portugal

GPS:38.720182, -9.150316

Phone
+351 21 330 0630
Hotel photo
Avani Avenida Liberdade Lisbon Hotel

A 10 minute walk to the conference venue.

Address

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

GPS: 38.720430, -9.147490

Hotel photo
Ibis Styles Lisboa Centro Marquês de Pombal

A 15 minute walk to the conference venue.

Address

Av. Fontes Pereira de Melo 5
1069-114 Lisboa
Portugal

Sponsors

We are very happy to have the support of these sponsors for this year’s Symposium.

Agro-Bio

Since 1975, Agro-Bio provides Antibody services for life sciences industries. We generate your customized anti-idiotype and anti-drug monoclonal or polyclonal antibodies (for Pk, immunogenicity, receptor occupancy…). We test the pharmacokinetics and the immunogenicity of your candidate drug by using our customized anti-idiotype and anti-drug antibodies. We monitor and quantify the HCP in your bioproduction system with the coverage 2D, our specific anti-HCP antibodies and HCP ELISA kits. We analyze the binding capacities of your antibodies against a target (affinity and kinetics), determine and monitor your critical quality attributes (CQA: active concentration, Fc receptor binding…) on our Biacore platform.

For more information, please visit the Agro-Bio website

BioAgilytix

As a leading global bioanalytical laboratory, BioAgilytix is the partner trusted most for bioanalytical services from discovery through every phase of the drug development process. Serving emerging biotech to large pharma, the company maintains compliance to GLP, GCP, GMP, and CLIA accreditations and provides diagnostic, pharmacokinetic (PK), immunogenicity, biomarkers, and cell-based assay services, from laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany.

For more information, please visit the BioAgilytix website

Celerion

Celerion, an early clinical research organization, has the experience and capacity to exceed your bioanalytical expectations from method development and validation through rapid sample analysis supporting studies from late discovery through preclinical and late stage clinical development. With over 40 years’ experience, laboratories in Zürich, Switzerland and Lincoln, Nebraska USA, combining state-of-the-art technology and scientific expertise to accelerate the drug development by rapidly delivering high-quality data for comprehensive immunogenicity assessments, pharmacokinetics and biomarkers.

For more information, please visit the Celerion website

ImmunXperts

ImmunXperts a Q2 Solutions Company, provides immunogenicity risk assessment services, including in silico methods and in vitro methods like T cell activation/proliferation, cytokine release, MAPPS and pre-existing ADA Assays. The team also performs functional screening assays for drug candidates in immuno-oncology, auto-immunity, inflammation/infection, cell and gene therapy and other immune-related disease areas. Finally, our ImmunAcademy provides training, protocol review, assay transfer and PBMC network services.

For more information, please visit the ImmunXperts website

PEPperPRINT

PEPperPRINT is an innovative biotech company from Heidelberg, Germany, and the leading provider of high-density peptide microarrays for antibody characterization or the fingerprint analysis of antibody responses from biological samples. The product and service portfolio was recently complemented by T cell epitope mapping and monitoring, making PEPperPRINT a one-stop solution provider for the fingerprint analysis of immune responses. PEPperPRINT’s peptide microarrays and screening services have been used by researchers around the world with over 250 peer-reviewed publications.

For more information, please visit the PEPperPRINT website

QPS

Whether your focus is small molecules, protein biotherapeutics, vaccines, or gene therapy, QPS provides a full range of bioanalytical solutions to support all drug development from discovery, through clinical development and regulatory filing. Let’s discuss how we can meet the growing demand for the development of next-generation drug therapies together.

For more information, please visit the QPS website

SVAR

Svar Life Science is a Swedish group of companies that invents, develops, and applies the best assay technology for drug development and clinical diagnostics with the goal of delivering new solutions tailored to customer requirements. They offer advanced technology platforms such as Functional Complement Biomarker and Screening assays and Cell-based Reporter Gene assays, as well as unique service models for Bioassays Customization, Custom Cell line Development in combination with GxP Laboratory Services, all designed to meet their customers’ specific project needs.

For more information, please visit the SVAR website

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