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Immunogenicity

Understanding immunogenicity is a key challenge in the development of therapeutics with many biologics inducing undesirable immune responses directed towards the therapeutic resulting in reduced efficacy, anaphylaxis and occasionally life threatening autoimmunity. This conference explores the latest updates on the prediction and reduction of immunogenicity, clinical results and interpetations and optimising bioassays.

Led by selected case studies from leading drug developement teams, bioanalytical experts, and academics we aim to provide the insights and sharing necessary to deliver safe, efficacious large molecule drugs to improve the lives of patients.

FEATURED SPEAKERS

Chloe Ackaert

Chloe Ackaert

Postdoctoral Researcher, Cellular and Molecular Immunology, Free University Of Brussels
David Wraith

David Wraith

Chief Scientific Officer and Founder, Apitope International NV
Gerhard Niederfellner

Gerhard Niederfellner

Head of Tumour Cell Biology, Pharma Research & Early Development , Roche Innovation Center Penzberg
Margareta Wiken

Margareta Wiken

Bioanalytical Manager, Swedish Orphan Biovitrum
Morten Nielsen

Morten Nielsen

Associate Professor, The Technical University Of Denmark
Sandra Garces

Sandra Garces

Rheumatologist Consultant and Researcher , Garcia de Orta’s Hospital

Bassam Hallis

Head of Pre-Clinical Development, Public Health England
Bassam Hallis

Bernard Maillere

Research Director and Head, Immunology Laboratory, Institute of Biology and Technologies
Bernard Maillere

Chloe Ackaert

Postdoctoral Researcher, Cellular and Molecular Immunology, Free University Of Brussels
Chloe Ackaert

David Wraith

Chief Scientific Officer and Founder, Apitope International NV
David Wraith

Emma Smith

Senior Group Leader, UCB
Emma Smith

Farnaz Fallah-Arani

Group Leader, Pharmacology, UCB
Farnaz Fallah-Arani

Gary Bembridge

Business Development Manager, Antitope
Gary Bembridge

Gerhard Niederfellner

Head of Tumour Cell Biology, Pharma Research & Early Development , Roche Innovation Center Penzberg
Gerhard Niederfellner

Grzegorz Kijanka

Postdoctoral Researcher , Leiden Academic Centre for Drug Research, Leiden University
Grzegorz Kijanka

Guilhem Richard

Computational Immunologist, EpiVax Inc
Guilhem Richard

Jeremy Fry

Assay Specialist , ProImmune Ltd.
Jeremy Fry

Kei Kishimoto

Chief Scientific Officer, Selecta Biosciences
Kei  Kishimoto

Linglong Zou

Director of Experimental Immunology, Teva Pharmaceuticals
Linglong Zou

Margareta Wiken

Bioanalytical Manager, Swedish Orphan Biovitrum
Margareta Wiken

Marsilio Adriani

Postdoctoral Research Associate, University College London
Marsilio  Adriani

Morten Nielsen

Associate Professor, The Technical University Of Denmark
Morten Nielsen

Sandra Garces

Rheumatologist Consultant and Researcher , Garcia de Orta’s Hospital
Sandra Garces

Shivanthy Visvalingam

Manager EU Regulatory Strategy for Biosimilars, Pfizer
Shivanthy  Visvalingam

Sofie Pattijn

Chief Technology Officer, ImmunXperts
Sofie Pattijn

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Guilhem Richard

Guilhem Richard, Computational Immunologist, EpiVax Inc

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9:10

How to switch off unwanted immune responses

David Wraith

David Wraith, Chief Scientific Officer and Founder, Apitope International NV

• Immunogenicity is unavoidable e.g. enzyme replacement therapy
• Immunological tolerance mechanisms control immune responses to self and foreign antigens
• The mechanisms of tolerance induction are now being revealed: here we will discuss novel insights into tolerance induction with peptide antigens
• Examples will be given from the fields of allergy, autoimmune disease and blood clotting disorders
 

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9:50

Synthetic Vaccine Particles (SVPs) for the prevention of anti-drug antibodies

Kei  Kishimoto

Kei Kishimoto , Chief Scientific Officer, Selecta Biosciences

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10:30

Morning Coffee

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11:00

Achieving immunological tolerance – are we there yet?

Farnaz Fallah-Arani

Farnaz Fallah-Arani, Group Leader, Pharmacology, UCB

• Can immunological tolerance be achieved clinically?
• Pro’s and Con’s of in vitro and in vivo assays of modelling immunological tolerance pre-clinically will be discussed
• How well do these pre-clinical models translate into the clinic
 

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11:40

Evaluation of the immunogenicity of orally administered recombinant human BSSL in a phase III clinical study in pre-term infants

Margareta Wiken

Margareta Wiken, Bioanalytical Manager, Swedish Orphan Biovitrum

• Challenges and limitations due to the vulnerable nature of the pre-term infant population
• Experience gained from preclinical safety studies
• Outcome from the clinical study during a 1 year follow up period
 

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12:20

Networking Lunch

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13:20

Early immunogenicity assessment of biotherapeutics: a decade at a glance

Sofie Pattijn

Sofie Pattijn, Chief Technology Officer, ImmunXperts

• Prediction versus assessment?
• A time for standardisation and harmonisation
• Managing expectations
• Innovations and developments

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14:00

Predicting T cell immunogenicity; Moving beyond MHC binding

Morten Nielsen

Morten Nielsen, Associate Professor, The Technical University Of Denmark

• T cell epitopes must bind one or more of the host's MHC molecules
• For CTL epitope, this binding event is highly predictive for T cell immunogenicity, for T helper responses this is the case only to a limited extend
• Overview of recent advances in tools for prediction of peptide binding to MHC class II molecule and limitations in improving the accuracy of these methods
• Explore features other than MHC binding that might be critical for identification of T cell epitopes
 

 

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14:40

Afternoon Tea

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15:20

Immune tolerant mice as the model for studying immunogenicity?

Grzegorz Kijanka

Grzegorz Kijanka, Postdoctoral Researcher , Leiden Academic Centre for Drug Research, Leiden University

• Types of immune tolerant mouse models
• What can we learn from immune tolerant mice about the immunogenicity mechanism?
• Can immune tolerant mice be used for immunogenicity prediction?
• Future of immune tolerant mice models
 

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16:00

Validation of cell based antibody neutralisation assays

Bassam Hallis

Bassam Hallis, Head of Pre-Clinical Development, Public Health England

• Challenges of development of validation of cell based assays
• Can cell based assays be quantitative?
• Which parameters can be validated?
• System suitability for cell based assays
 

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16:40

Mission Impossible? Tweaking Bridging ELISA to Achieve Required Drug Tolerance for ADA Detection of Therapeutic Antibodies

Linglong Zou

Linglong Zou, Director of Experimental Immunology, Teva Pharmaceuticals

• An updated view of drug tolerance requirement for an ADA assay
• Benefit of achieving adequate drug tolerance for immunogenicity testing and data reporting
• Advantage of non-acid dissociation method for drug tolerance improvement
• Case study illustrating how to tweak Bridging ELISA to enhance drug tolerance
 

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17:20

Chair’s Closing Remarks and Close of Day One

Guilhem Richard

Guilhem Richard, Computational Immunologist, EpiVax Inc

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Marsilio  Adriani

Marsilio Adriani, Postdoctoral Research Associate, University College London

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9:10

Predicting Immunogenicity in the Era of Personalized Medicine: A Need for Individual Risk Assessment

Guilhem Richard

Guilhem Richard, Computational Immunologist, EpiVax Inc

  • Immunogenicity of biologics is widely acknowledged to be a barrier to clinical success.
  • Means for pre-screening patients and identifying those as risk of developing anti-drug antibodies (ADA) have been lacking.
  • Our proprietary in silico tools can identify pairs of high-, moderate-, and low-risk HLA haplotypes for a given protein.
  • We analyzed data from patients exposed to monoclonal antibody, and observed higher ADA responses in patients with high-risk HLA haplotypes compared to patients with low-risk haplotypes.
     
  • clock

    9:50

    RG7787 - The coming of age of immunotoxins for solid tumour therapy. Are we there yet?

    Gerhard Niederfellner

    Gerhard Niederfellner, Head of Tumour Cell Biology, Pharma Research & Early Development , Roche Innovation Center Penzberg

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    10:30

    Morning Coffee

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    11:00

    Immunogenicity prediction and assessment of nanobodies

    Chloe Ackaert

    Chloe Ackaert, Postdoctoral Researcher, Cellular and Molecular Immunology, Free University Of Brussels

    • Nanobodies: an emerging, promising class of biotherapeutics
    • Interaction between nanobodies and primary dendritic cells
    • ADA assessment towards nanobodies in Phase I
     

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    11:40

    Peptide immunotherapy for the treatment of autoimmune disease – closer to a cure?

    Emma Smith

    Emma Smith, Senior Group Leader, UCB

    • Why peptide immunotherapy over conventional treatments?
    • Peptide immunotherapy in preclinical models
    • Translating efficacy from preclinical models into the clinic
     

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    12:20

    Networking Lunch

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    13:20

    ABIRISK: using immunological signatures to predict immunogenicity

    Marsilio  Adriani

    Marsilio Adriani, Postdoctoral Research Associate, University College London

    • Aims of ABIRISK immunology program
    • Using a high throughput flow cytometry platform to identify novel predictive markers
    • Progress with MS patients treated with Interferon-beta
     

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    14:00

    Afternoon Tea

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    14:30

    The two main outcomes of T cell amplification assays for immunogenicity prediction: T cell repertoire and epitopes

    Bernard Maillere

    Bernard Maillere, Research Director and Head, Immunology Laboratory, Institute of Biology and Technologies

    • Why are T cell assays performed to predict immunogenicity?
    • What kind of data do they produce?
    • Do they have been already confronted to clinical observations?
    • Are they really useful as compared to other predictive approaches?

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    15:10

    An integrated approach to managing immunogenicity risk and drug immune modulation

    Jeremy Fry

    Jeremy Fry, Assay Specialist , ProImmune Ltd.

    • Learn how data from cell-based assays, physical MHC-peptide binding assays, mass spectrometry antigen presentation assays and whole blood   cytokine storm risk management assays can be integrated to characterize immune responses against, or caused by, biotherapeutic drugs
    • Improve decision-making in lead selection, lead characterisation and re-engineering options
     

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    15:50

    Designing therapeutic drugs with reduced immunogenicity

    Gary Bembridge

    Gary Bembridge, Business Development Manager, Antitope

  • The importance of T cell help has been widely accepted as a significant risk factor in the development of anti-drug antibodies (immunogenicity).
  • Case study data will be presented on the deimmunisation of naturally immunogenic non-human protein therapeutics.
  • clock

    16:30

    Chair's Closing Remarks and Close of Day Two

    Sandra Garces

    Sandra Garces, Rheumatologist Consultant and Researcher , Garcia de Orta’s Hospital


    Head of Pre-Clinical Development
    Public Health England
    Research Director and Head, Immunology Laboratory
    Institute of Biology and Technologies
    Postdoctoral Researcher, Cellular and Molecular Immunology
    Free University Of Brussels
    Chief Scientific Officer and Founder
    Apitope International NV
    Senior Group Leader
    UCB
    Group Leader, Pharmacology
    UCB
    Business Development Manager
    Antitope
    Head of Tumour Cell Biology, Pharma Research & Early Development
    Roche Innovation Center Penzberg
    Postdoctoral Researcher
    Leiden Academic Centre for Drug Research, Leiden University
    Computational Immunologist
    EpiVax Inc
    Assay Specialist
    ProImmune Ltd.
    Chief Scientific Officer
    Selecta Biosciences
    Director of Experimental Immunology
    Teva Pharmaceuticals
    Bioanalytical Manager
    Swedish Orphan Biovitrum
    Postdoctoral Research Associate
    University College London
    Associate Professor
    The Technical University Of Denmark
    Rheumatologist Consultant and Researcher
    Garcia de Orta’s Hospital
    Manager EU Regulatory Strategy for Biosimilars
    Pfizer
    Chief Technology Officer
    ImmunXperts

    Sponsors and Exhibitors

    Official Media Partner

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    Sponsors and Exhibitors


    Antitope

    Sponsors and Exhibitors
    http://www.antitope.com/

    Antitope is a leading provider of solutions to enable the development of better biopharmaceuticals. Our mission is to apply these technologies as a comprehensive service for the preclinical prediction of immunogenicity, and for the generation of non-immunogenic fully humanized antibodies, non-immunogenic therapeutic proteins and high yielding manufacturing cell lines. To date, we have entered into multiple agreements with pharmaceutical and biotechnology companies worldwide to apply our technologies for the development of improved biologics. Following its recent merger with PolyTherics Ltd., we now provide an extensive suite of technologies for development of more homogeneous and stable antibody drug conjugates (ADCs) through ThioBridge™, site-specific PEGylation and low viscosity polymers.


    SQI Diagnostics, Inc.

    Sponsors and Exhibitors
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    SQI Diagnostics is a life sciences company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics. SQI has automated, miniaturized, and multiplexed immunogenicity and bioanalytics testing using patented technology making it the only company in the world capable of ADA, epitope mapping, multiplexed PK assays, and many other assays all in one well. The Company’s proprietary microarray tests and fully-automated systems are designed to simplify workflow, increase throughput, reduce costs and provide excellent data quality. With products in both the IVD and pharmaceutical space, SQI is able to serve both marketplaces with the unparalleled level of quality researchers and clinical laboratorians have come to expect.

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    Marriott Hotel Regents Park

    128 King Henry’s Road
    London NW3 3ST
    United Kingdom

    Marriott Hotel Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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