15th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals
22nd — 24th April 2024
Lisbon, Portugal
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 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 | 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 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 Break | |||
| 11:00 | 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 | 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 Break | |||
| 14:45 | 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 | Get Together | |||
| 23:00 | 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 Break | |||
| 11:00 | 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 | 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 | |||
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