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SMi 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? 
 

Gain insight into the assessment of early risks in immunogenicity and major hurdles in clinical development
Assess considerations and design of biologic therapeutics and the clinical Implications
Hear the latest on in silico tools being utilised for the determination of immunogenicity
Enhance immunomodulation understanding on how to evaluate the best read outs for immune response
Hear how predictability can be shown with pre-clinical in-vitro tools from a regulatory perspective

 

CEO, CSO, Vice President, Director, Biology Research, Associate Scientific Director, Head of R&D, Research Associate, Research Scientist, Senior Scientist, Clinical Immunologists in the field of:
• Rheumatology
• Immunology
• Auto Immune Disease
• Oncology
• Pathology
 

Allergan; BTG; Crossoak Pharma; Danish Medicines Agency; Dexcel Pharma Ltd; Diamond PV Services; Dong-A ST Co., Ltd.; Eisai; Eisai Europe Ltd; Eli Lilly & Company Ltd; Eli Lilly & Company Ltd.; Eli Lilly And Company; Eli Lilly Europe; Eli Lilly Suisse SA; EudraVigilance Consultants; Federal Agency for Medicines and Health Products; Genzyme Therapeutics; Gilead Sciences; Harefield Pharmacovigilance; Johnson and Johnson; Labatec Pharma S.A.; Lilly Research Centre Ltd; Martindale Pharmaceuticals; Medicines & Healthcare Products Regulatory Agency (MHRA) ; MedImmune; Merck Serono; MHRA; MorphoSys AG; NDA Group; Novo Nordisk; OXON Epidemiology; PharSafer Associates; Professional Information Ltd; Quantum Solutions India; Quintiles (UK) Ltd; Reckitt Benckiser; Renova Pharma Safety; Roche; Shionogi & Co., Ltd.; Sidley Austin Brown & Wood; Takeda Chemical Industries Ltd; TEVA Pharmaceuticals; Teva Pharmaceuticals Ltd; University Hospitals Of Geneva; University of Hertfordshire;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Matthew Baker

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

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? 
  • 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.

  • 10:30 Morning Coffee

    11:00 Generation of non-immunogenic proteins with full biological activity

    Matthew Baker

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

    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
  • 12:20 Networking Lunch

    13:20 Chairs Afternoon Opening Remarks

    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
  • 14:10 Assessing Adverse Reactions in Biosimilars and Antibodies

    Shaheda Ahmed

    Shaheda Ahmed, Senior Scientific Officer, Alcyomics ltd

    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.

     

    15:30 Round Table Discussion - What are the fundamental aspects of the mechanisms of tolerance

    16:00 Chairs Closing Remarks

    16:10 Afternoon Tea

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Martin Lechmann

    Martin Lechmann , Bioanalytics , Roche Diagnostics

    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.
  • 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
  • 10:30 Morning Coffee

    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
  • 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
  • 12:20 Nanoparticles for the induction of Immunological Tolerance

    Takashi Kei Kishimoto

    Takashi Kei Kishimoto , Chief Scientific Officer, Selecta Biosciences

    13:00 Networking Lunch

    14:00 Insight into the development of Biologic Therapeutics - Part Two

    Martin Lechmann

    Martin Lechmann , Bioanalytics , Roche Diagnostics

    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 
  • 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

    15:30 Chairman’s Closing Remarks

    15:40 Afternoon Tea

    +

    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

    Workshops

    Clinical Impact of Immunogenicity and Predictive Tools
    Workshop

    Clinical Impact of Immunogenicity and Predictive Tools

    Holiday Inn Regents Park
    16th July 2014
    London, United Kingdom

    Immunogenicity of Biosimilars
    Workshop

    Immunogenicity of Biosimilars

    Holiday Inn Regents Park
    16th July 2014
    London, United Kingdom

    Interview with Chloé Ackaert

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    Interview with John Chappell

    Download

    Interview with Dr. Melody Sauerborn

    Download

    Interview with Ronit Mazor

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    Holiday Inn Regents Park

    Carburton Street
    London W1W 5EE
    United Kingdom

    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.

    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, SMI 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@smi-online.co.uk

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