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Immunogenicity

SAE Media Group is proud to announce the return of their 3rd annual Immunogenicity event to London in 2016!  Biologics is a leading growth area in the Pharmaceutical industry with growth rates 2 -3 times as fast as chemical entities.* The challenges for the biopharmaceutical market are different to those from traditional chemical entities. Immunogenicity continues to be a major concern for the field of science, due to its impact on safety and efficacy. The challenging task of immunogenicity assessment of a biopharmaceutical drug’s immunogenic potential remains at the forefront of challenges.


Immunogenicity of an antigen is frequently encountered in the context of vaccine development, an area of intense interest currently due to the emergence or re-emergence of infectious pathogens with the potential for worldwide spread. With the global vaccine market expected to reach $84.44 billion by 2022, now is the time engage with industry experts to addresses the real challenges with immunogenicity including assay assessment, the role of aggregation, the introduction of nanobodies and many more!
 


*http://www.biosciencetechnology.com/articles/2010/06/top-trends-life-science-need-immunogenicity-testing
 

FEATURED SPEAKERS

Adnan Khan

Adnan Khan

Senior Scientist Immunology/Pharmacology, UCB
Daniel  Sikkema

Daniel Sikkema

Head BioPharma Clinical Immunology, GSK
Jochem Gokemeijer

Jochem Gokemeijer

Associate Director, Bristol Myers Squibb

Adnan Khan

Senior Scientist Immunology/Pharmacology, UCB
Adnan Khan

Andreas Herrmann

CEO, Baliopharm AG
Andreas Herrmann

Annie De Groot

CEO/CSO, EpiVax, Inc.
Annie De Groot

Chloe Ackaert

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

Cornelis Melief

Chief Scientific Officer, ISA Pharmaceuticals
Cornelis  Melief

Daniel Sikkema

Head BioPharma Clinical Immunology, GSK
Daniel  Sikkema

Jeremy Derrick

Professor, University Of Manchester
Jeremy Derrick

Jeremy Fry

Director of Sales, ProImmune Ltd.
Jeremy Fry

Jochem Gokemeijer

Associate Director, Bristol Myers Squibb
Jochem Gokemeijer

Machteld Tiemessen

Senior Scientist, Janssen
Machteld Tiemessen

Mantas Malisauskas

Manager R&D, Baxalta
Mantas  Malisauskas

Mark Fogg

Immunology Group Leader, Abzena
Mark Fogg

Meenu Wadhwa

Head, Cytokines & Growth Factors, Biotherapeutics Group, , NIBSC, MHRA
Meenu Wadhwa

Petr Ilyinskii

Director of Biology , Selecta Biosciences
Petr Ilyinskii

Sue Charlton

Scientific Lead, Vaccine Research Group, , Public Health England
Sue Charlton

Timothy Hickling

Immunogenicity Sciences Discipline Lead, Pfizer Pharmaceuticals
Timothy Hickling

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Conference agenda

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8:30

Registration & Coffee

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9:00

Workshop Leaders Introduction

Hishani Kirby

Hishani Kirby, Founder & Director, Hishany Kirby Associates Ltd

Daniel  Sikkema

Daniel Sikkema, Head BioPharma Clinical Immunology, GSK

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9:10

Overview of historical approaches for drug and ADA measurement: Fit for purpose?

  • Which format?
  • What are the parameters?
  • Constraints and challenges
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    10:30

    Morning Coffee

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    11:00

    Looking beyond - technological developments

  • Future standardization of methods
  • Advanced quantification techniques for biotherapeutics and application on immunogenicity
  • Associated challenges and solutions
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    12:00

    Q&A

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    12:30

    Closing Remarks from Workshop Leader and End of Workshop

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    13:30

    Registration & Coffee

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    14:00

    Workshop Leaders Introduction

    Arno Kromminga

    Arno Kromminga, CEO/CSO, IPM BIOTECH GmbH

    Sofie Pattijn

    Sofie Pattijn, Chief Technology Officer, ImmunXperts

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    14:05

    The immunology of immunogenicity

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    14:45

    Tools for early non-clinical immunogenicity assessment

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    15:30

    Afternoon Tea

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    16:00

    Neautralising anti-drug antibodies: Emerging trends and clinical impact

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    16:45

    Lessons learned and future challenges

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    17:20

    Chairman’s Closing Remarks and Close of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Jeremy Fry

    Jeremy Fry, Director of Sales, ProImmune Ltd.

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    9:10

    Improving the efficacy and safety profile of biotherapeutics by addressing product immunogenicity with tolerogenic nanoparticles

    Petr Ilyinskii

    Petr Ilyinskii, Director of Biology , Selecta Biosciences

    • The development of anti-drug antibodies (ADAs) is a common cause for treatment failure and adverse events associated with biologic therapies. 
    • Addressing product immunogenicity has the potential to improve efficacy and safety profile of novel biologics; reduce catastrophic late stage clinical failure due to ADAs; provide life cycle management for existing products; and differentiate products from biosimilars.
    • Selecta Biosciences is a clinical stage company that has developed a novel platform of Synthetic Vaccine Particles (SVP) to induce durable antigen-specific immune tolerance for the prevention of ADAs
     

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    9:50

    How to switch off unwanted immune responses

    Adnan Khan

    Adnan Khan, Senior Scientist Immunology/Pharmacology, UCB


    • Is it possible to switch off an unwanted immune response?
    • Revealing the mechanisms of tolerance induction are now being revealed
    • Novel insights into tolerance induction with peptide antigens
     

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    10:30

    Morning Coffee

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    11:00

    A harmonised approach to interpretation and reporting of clinical immunogenicity data

    Daniel  Sikkema

    Daniel Sikkema, Head BioPharma Clinical Immunology, GSK


    • How can we harmonise data?
    • Should we be able to compare trial results that use different ranking methods
    • The benefits a harmonised approach can bring to the reporting of clinical immunogenicity data
     

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    11:40

    Towards harmonisation of immunogenicity assays

    Meenu Wadhwa

    Meenu Wadhwa, Head, Cytokines & Growth Factors, Biotherapeutics Group, , NIBSC, MHRA


    • Wide variation in ADA incidence and titres often reported for a therapeutic
    • Should we produce reference panels or standardise methods to harmonise data?
    • Availability of a WHO reference panel for erythropoietin antibody assays
     

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    12:20

    Networking Lunch

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    13:30

    Integrating best-in-class in vitro and ex vivo assays to manage immunogenicity risk in biologics

    Jeremy Fry

    Jeremy Fry, Director of Sales, ProImmune Ltd.

    • Learn how data from cell-based assays, physical MHC-peptide binding assays and mass spectrometry antigen presentation assays can be integrated to characterise immune responses against, or caused by, biotherapeutic drugs
    • Mitigate the risk of first infusion reactions using whole-blood cytokine release assays.
    • Improve decision-making in lead selection, lead characterisation and re-engineering options
     

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    14:10

    Nanobodies, a promising new class of biopharmaceuticals: What about their immunogenicity?

    Chloe Ackaert

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

    • Nanobodies originate from camelids, but does their humanisation make sense?
    • Different methods for ADA assessment towards nanobodies
    • In vitro immunogenicity risk assessment of nanobodies
     

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    14:50

    Afternoon Tea

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    15:20

    Understanding the role of aggregation in the immunogenicity of biotherapeutic proteins

    Jeremy Derrick

    Jeremy Derrick, Professor, University Of Manchester

  • Comparison of the immunological responses to immunisation with recombinant biologics in monomeric and aggregated forms in a mouse model
  • The results were generally indicative of skewing towards a Th1-type response
  • Can HCPs also play a role in modulating the immune response?

     

  • clock

    16:20

    Chairman’s Closing Remarks and Close of Day One

    Annie De Groot

    Annie De Groot, CEO/CSO, EpiVax, Inc.

    clock

    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Adnan Khan

    Adnan Khan, Senior Scientist Immunology/Pharmacology, UCB

    clock

    9:10

    A computational pipeline for personalised cancer vaccine development

    Annie De Groot

    Annie De Groot, CEO/CSO, EpiVax, Inc.

    • Checkpoint inhibitors are changing cure rates for cancer and generating excitement in the cancer field
    • While cure rates are improving, personalised cancer vaccines may improve cure rates even further
    • Personalised cancer vaccines are feasible using available computational tools
    • Participants will learn how personalised cancer vaccines will move the needle on cancer cures of the future
     

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    9:50

    Integration of immunogenicity risk data to forecast clinical outcomes

    Timothy Hickling

    Timothy Hickling, Immunogenicity Sciences Discipline Lead, Pfizer Pharmaceuticals

    • Immune responses to biologics as a normal response to drug exposure
    • Identifying key risk factors for immunogenicity
    • Working with protein engineers to reduce immunogenicity of biotherapeutics
    • Utilising non-clinical assays for immunogenicity assessment
     

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    10:30

    Morning Coffee

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    11:00

    Influence of Aggregates on in vitro T Cell Responses

    Mark Fogg

    Mark Fogg, Immunology Group Leader, Abzena

    • Immunogenicity of therapeutic protein products can elicit unwanted ADA
    • Protein aggregation can result in enhanced immunogenicity
    • In vitro methods that measure the impact of these aggregates on enhanced immunogenicity will be useful tools in screening processes to avoid or reduce problems associated with ADA
     

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    11:40

    T cell amplification assays for immunogenicity prediction: T cell repertoire and epitopes

    Machteld Tiemessen

    Machteld Tiemessen, Senior Scientist, Janssen

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

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    12:20

    Networking Lunch

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    13:50

    Correlation of T-cell responses induced by therapeutic cancer vaccines with clinical responses

    Cornelis  Melief

    Cornelis Melief, Chief Scientific Officer, ISA Pharmaceuticals

     

    • In premalignant disease caused by high risk HPV,
    therapeutic vaccination-induced T-cell responses
    correlate with clinical responses
    • In late stage HPV-induced cancer myeloid cell
    depletion by standard chemotherapy fosters robust
    vaccine-induced T cell responses
    • Therapeutic vaccines works as monotherapy in premalignant
    disease, but treatment of late stage cancer
    requires combination of vaccination with immunomodulation

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    14:30

    Afternoon Tea

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    15:00

    Development and validation of cell based antibody neutralisation assays

    Sue Charlton

    Sue Charlton, Scientific Lead, Vaccine Research Group, , Public Health England

    • Examples of validation of cell based neutralisation assays
    • Their application to release / stability testing of vaccines
    • Consideration of the assay life cycle
     

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    15:40

    “Protein aggregates: why do we need to study them? Quantification and characterization of sub-visible particles in protein therapeutics”

    Mantas  Malisauskas

    Mantas Malisauskas, Manager R&D, Baxalta

    • Biopharmaceutical and problems never seen with non-protein substances

    • Protein aggregates structure and function

    • Strategy in analysis and characterization of protein aggregates
     

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    16:20

    Chairman’s Closing Remarks and Close of Day Two

    Adnan Khan

    Adnan Khan, Senior Scientist Immunology/Pharmacology, UCB


    Senior Scientist Immunology/Pharmacology
    UCB
    CEO
    Baliopharm AG
    CEO/CSO
    EpiVax, Inc.
    Postdoctoral Researcher, Cellular and Molecular Immunology
    Free University Of Brussels
    Chief Scientific Officer
    ISA Pharmaceuticals
    Head BioPharma Clinical Immunology
    GSK
    Professor
    University Of Manchester
    Director of Sales
    ProImmune Ltd.
    Associate Director
    Bristol Myers Squibb
    Senior Scientist
    Janssen
    Manager R&D
    Baxalta
    Immunology Group Leader
    Abzena
    Head, Cytokines & Growth Factors, Biotherapeutics Group,
    NIBSC, MHRA
    Director of Biology
    Selecta Biosciences
    Scientific Lead, Vaccine Research Group,
    Public Health England
    Immunogenicity Sciences Discipline Lead
    Pfizer Pharmaceuticals

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    Abzena

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    Abzena offers a suite of complementary services and technologies. Its range of technologies include immunogenicity assessment, antibody drug conjugation, protein engineering, PEGylation, cell line development , GMP manufacturing and a range of bespoke assays to enables the development of better biopharmaceuticals which will have a greater chance of reaching the market.

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