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Immunogenicity

SAE Media Group are launching an Immunogenicity Conference, a two day event designed to become the leaders’ favourite with an ever growing demand for biologic therapeutics in the Pharmaceutical Industry. 


We ask the questions;

What stimulates an immune response?  How does the system cope with immunogenic compounds?  And how do you screen for potential problems?

The Conference will address all these concerns and enable Clinical Immunologists, Physicians and Specialists within the field of Immunogenicity to discuss the major challenges currently being faced within the pharmaceutical industry.
 

The focus is on pre-clinical analysis and assessing treatments for clinical development. It will endeavour to look at the assessment of early risks in immunogenicity and the evaluation of in silico tools for determining immunogenicity. With an insight into the safety, development and validation of Monoclonal Antibodies.


Further to this, the main interest emerging is the tissue quality and preservation in which the therapeutics are being put into. The conference will evaluate what happens to them in vivo along with a regulatory perspective.
A key session on Immunomodulation will enable delegates to get an understanding of how to evaluate the best read outs and best elements of immune response. Immunogenicity is a hurdle one looks to overcome and with the likes of aggregation being a factor when handling proteins, a key session on immunological tolerance will look to address this.


From a clinical perspective, the conference will assess consideration and design of biologic therapeutics, clinical Implications and review what the clinical outcomes are from using these immune modulatory approaches.
The conference will also look at, how to benefit the patient by assessing efficacy and toxicological concerns alongside the management of immunogenic responses. With regulators supposing that animal studies are not good predictors – how can predictability be shown with pre-clinical in-vitro tools? 
 

FEATURED SPEAKERS

Anne De Groot

Anne De Groot

President & CEO, EpiVax Inc
David  Scott

David Scott

Professor and Vice Chair for Research, Uniformed Services University of Health Sciences
John Chappel

John Chappel

Head of Immunoassay, CPR Services
Martin Lechmann

Martin Lechmann

Bioanalytics , Roche Diagnostics
Melody Sauerborn

Melody Sauerborn

Senior Expert Immunogenicity, TNO Triskelion
Robert Dodge

Robert Dodge

Scientific Professional, BMS
Takashi Kei Kishimoto

Takashi Kei Kishimoto

Chief Scientific Officer, Selecta Biosciences

Anne De Groot

President & CEO, EpiVax Inc
Anne De Groot

Chloe Ackaert

Project Manager, ImmunXperts
Chloe Ackaert

David Scott

Professor and Vice Chair for Research, Uniformed Services University of Health Sciences
David  Scott

David Wraith

Chief Scientific Officer and Founder, Apitope Technology Ltd
David Wraith

John Chappel

Head of Immunoassay, CPR Services
John Chappel

Martin Lechmann

Bioanalytics , Roche Diagnostics
Martin Lechmann

Matthew Baker

Chief Scientific Officer and Co-Founder, Antitope Ltd
Matthew Baker

Melody Sauerborn

Senior Expert Immunogenicity, TNO Triskelion
Melody Sauerborn

Philippe Stas

Consultant , BLA Consult
Philippe Stas

Robert Dodge

Scientific Professional, BMS
Robert Dodge

Ronit Mazor

Research Fellow , National Cancer Institute N I H
Ronit Mazor

Shaheda Ahmed

Senior Scientific Officer, Alcyomics ltd
Shaheda Ahmed

Takashi Kei Kishimoto

Chief Scientific Officer, Selecta Biosciences
Takashi Kei Kishimoto

Thomas Lee

Scientific Investigator, Clinical Immunology, GSK
Thomas Lee

Conference agenda

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8:30

Registration & Coffee

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9:00

Immunogenicity: Overview Clinical Impacts

Melody Sauerborn

Melody Sauerborn , Senior Expert Immunogenicity, TNO Triskelion

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9:30

The tiered approach

Melody Sauerborn

Melody Sauerborn , Senior Expert Immunogenicity, TNO Triskelion

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10:30

Coffee Break

Melody Sauerborn

Melody Sauerborn , Senior Expert Immunogenicity, TNO Triskelion

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11:00

The risk assessment approach and what that means for each clinical phase

Melody Sauerborn

Melody Sauerborn , Senior Expert Immunogenicity, TNO Triskelion

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11:30

Translational value of preclinical data

Melody Sauerborn

Melody Sauerborn , Senior Expert Immunogenicity, TNO Triskelion

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12:30

Close of Workshop

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13:30

Registration & Coffee

John Chappel

John Chappel , Head of Immunoassay, CPR Services

Bracha Timan

Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

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14:00

Importance of Immunogenicity Assesments

  • Clinical Considerations
  • John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

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    14:30

    Immunogenicity rates for the originator

  • PK profile
  • Disease populations
  • Risk based strategy
  • John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

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    15:00

    Afternoon Tea

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    15:30

    Regulatory Guidance's and White Papers

  • EMA and FDA Guidance's
  • Industry White Papers
  • AAPS Biosimilar APC committee
  • John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

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    16:00

    In-vitro Immune Stimulation Assays

     

    Screening and confirmatory Assays
    ·         What Assays to use
    ·         Development of 1 Assays v 2 Assays
    ·         Positive Control Selection
    ·         Calculation of Cut points
    ·         Statistical Requirements (do you need a Biostatistician)
    ·         Drug Tolerance
    ·         Sensitivity
    ·         Stability
     
    Neutralising Assays
    ·         Choice of Assays
    ·         Functional Assays v Competition Ligand Binding

    John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

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    16:30

    PK Assays in support of Biosimilar Development

  • Biomarker Assays in support of Biosimilar development
  • John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

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    17:00

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Matthew Baker

    Matthew Baker, Chief Scientific Officer and Co-Founder, Antitope Ltd

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    9:10

    Understanding Immunogenicity

    Melody Sauerborn

    Melody Sauerborn , Senior Expert Immunogenicity, TNO Triskelion

  • Defining immunogenicity and what it’s all about
  • Immunogenicity from an immunological point of view
  • Immunological toerlance and how to break it
  • Evaluating immunological response and the reasons for immunogenicity  
  • Assessing the factors affecting immunogenicity – Where do we go from here? 
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    9:50

    Tregitopes an Immunomodulation Powerhouse:regulating Immune Responses to Biologics

    Anne De Groot

    Anne De Groot, President & CEO, EpiVax Inc

  • Modulation of T cell responses in the context of protein therapy and inflammation may contribute to the design of improved biologic therapeutics for a wide range of clinical conditions.

  •  A critical flaw in most predictions of immunogenicity is the failure tofactor regulatory T cell epitopes (Tregitopes) into the assessment
  • The presenter will provide several case studies that validate the critical importance of Tregitopes to biologics, including but not limited to protein replacement therapies, blood factor replacement therapies, monoclonal antibodies as well as mitigation of auto-inflammatory and autoimmune responses.

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    10:30

    Morning Coffee

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    11:00

    Generation of non-immunogenic proteins with full biological activity

    Matthew Baker

    Matthew Baker, Chief Scientific Officer and Co-Founder, Antitope Ltd

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    11:40

    Inducing immunological tolerance – reviewing the flip side

    David Wraith

    David Wraith, Chief Scientific Officer and Founder, Apitope Technology Ltd

  • Reviewing the problem of immunogenicity and asking why a protein is immunogenic in certain individuals and not others?
  • What do we understand about immunological tolerance
  • Can proteins be modified to become less immunogenic?
  • Designing peptides that switch off immune responses and promote tolerance
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    12:20

    Networking Lunch

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    13:20

    Chairs Afternoon Opening Remarks

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    13:30

    Human In Vitro models to assess Immunogenicity

    Chloe Ackaert

    Chloe Ackaert, Project Manager, ImmunXperts

  • The application of human In Vitro models during early drug developments
  • Technical challenges and standardisation of In Vitro models
  • Relevance of In Vitro models
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    14:10

    Assessing Adverse Reactions in Biosimilars and Antibodies

    Shaheda Ahmed

    Shaheda Ahmed, Senior Scientific Officer, Alcyomics ltd

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    14:50

    Identifying and removing T cell epitopes in immunotoxins

    Ronit Mazor

    Ronit Mazor , Research Fellow , National Cancer Institute N I H

    - Immunotoxins are therapeutic proteins that are used to treat cancer. Immunogenicity is their main stumbling block in the clinic.

    - We used a comprehensive experimental method to identify and eliminate the T cell epitopes in the immunotoxin.

    - We designed a new immunotoxin that has significantly diminished T cell immunogenicity and yet an excellent anti tumor effect.

     

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    15:30

    Round Table Discussion - What are the fundamental aspects of the mechanisms of tolerance

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    16:00

    Chairs Closing Remarks

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    16:10

    Afternoon Tea

    What are the fundamental aspects of the mechanissm of tolerance?

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Martin Lechmann

    Martin Lechmann , Bioanalytics , Roche Diagnostics

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    9:10

    Case Study on Pre-Exisiting Antibodies

    Thomas Lee

    Thomas Lee, Scientific Investigator, Clinical Immunology, GSK

  • Pre-existing antibodies in treatment - naive subjects have been often detected during clinical ADA assessments. However, limited information on prevalence, physiological effect and impact on post-treatment ADA induction is available.
  • This talk will address pre-existing antibody characterisation and implications for immunogenicity management and strategies during clinical studies.
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    9:50

    Case Study: Clinical Considerations in the ue of Immunogenic therapeutics

    Robert Dodge

    Robert Dodge, Scientific Professional, BMS

  • Assessing the implications of screening of early compounds
  • Evaluating the consequences of immunogenicity in clinical development testing
  • Assessing strategies and considerations for clinical trial design
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    10:30

    Morning Coffee

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    11:00

    Immunogenicity Analytical considerations when supporting Biosimilar Drug Development

    John Chappel

    John Chappel , Head of Immunoassay, CPR Services

  • Presentation will assess what Immunogenicty assays that need to be developed in support of Biosimilar Clinical Development.
  • Some of the considerations include choice of methodology, Development of 1 Assay v 2 Assays, Positive controls,  Neutralising Assays. 
  • Presentation will include case study data
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    11:40

    Novel methods to Induce Tolerance for Adverse Immune Reactions

    David  Scott

    David Scott, Professor and Vice Chair for Research, Uniformed Services University of Health Sciences

  • Immune tolerance mechanisms versus reducing immunogenciity
  • Application of B cell presentation for tolerance
  • Fc fusion proteins and the role of IgG epitopes
  • Application of specific T regulatory cells to control immune responses
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    12:20

    Nanoparticles for the induction of Immunological Tolerance

    Takashi Kei Kishimoto

    Takashi Kei Kishimoto , Chief Scientific Officer, Selecta Biosciences

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    13:00

    Networking Lunch

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    14:00

    Insight into the development of Biologic Therapeutics - Part Two

    Martin Lechmann

    Martin Lechmann , Bioanalytics , Roche Diagnostics

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    14:40

    Predictive/preclinical Immunogenicity Risk Mitigation: Sense and non-sense

    Philippe Stas

    Philippe Stas, Consultant , BLA Consult

  • Unwanted immunogenicity is a critical hurdle during drug development
  • Assessing immunogenicity at an early stage can significantly reduce the risk of failure later on
  • Standardisation and regulation of early assessment tools 
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    15:20

    Panel Discussion - Predictability using pre-clinical tools

  • What is classed as important in the decision making process?
  • Is the replacement of animals a way of assessing immunogenicity?
  • How importnat are cell based assays when assessing newutralisation of ligand binding assays?
  • Evaluating the translational value and whether a minimal approach should be utilised up until phase II/III
  • Ronit Mazor

    Ronit Mazor , Research Fellow , National Cancer Institute N I H

    Chloe Ackaert

    Chloe Ackaert, Project Manager, ImmunXperts

    David  Scott

    David Scott, Professor and Vice Chair for Research, Uniformed Services University of Health Sciences

    clock

    15:30

    Chairman’s Closing Remarks

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    15:40

    Afternoon Tea


    President & CEO
    EpiVax Inc
    Project Manager
    ImmunXperts
    Professor and Vice Chair for Research
    Uniformed Services University of Health Sciences
    Chief Scientific Officer and Founder
    Apitope Technology Ltd
    Head of Immunoassay
    CPR Services
    Bioanalytics
    Roche Diagnostics
    Chief Scientific Officer and Co-Founder
    Antitope Ltd
    Senior Expert Immunogenicity
    TNO Triskelion
    Consultant
    BLA Consult
    Scientific Professional
    BMS
    Research Fellow
    National Cancer Institute N I H
    Senior Scientific Officer
    Alcyomics ltd
    Chief Scientific Officer
    Selecta Biosciences
    Scientific Investigator, Clinical Immunology
    GSK

    Workshops

    Immunogenicity of Biosimilars

    Immunogenicity of Biosimilars

    Holiday Inn Regents Park
    16 July 2014
    London, United Kingdom

    Interview with Chloé Ackaert

    Download

    Interview with John Chappell

    Download

    Interview with Dr. Melody Sauerborn

    Download

    Interview with Ronit Mazor

    Download

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    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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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.

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    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)

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    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

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