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SMi 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
 

 


• Gain insight into how tackle the challenges involved with the assessment of early risks in immunogenicity

• Hear key feedback from regulatory authorities on how to increase your speed to market

• Participate in insightful discussions on; nanobodies, ADCs, biosimilars and many more!
 

   

You should attend this event if you are a working within the fiel d of immun with responsibilities in the following areas:

 Immunologists
 Chief Scientific Officer
 Head of Bioanalytical Services
Director of Immunology
 Professor of Immunology/Immunogenicity
 Professor of Experimental Pathology
 Senior Expert Immunogenicity
 Head of Advanced Protein Technologies
 Global head of Exploratory Statistics
 Scientific Investigator, Clinical Immunology 
Development DMPK Project Leader
 

AL Taqwaa Hospital; Antitope; Antitope Ltd; Apitope International NV; Chiesi Farmaceutici S. P. A. ; Circassia; EpiVax Inc; Free University Of Brussels; Garcia de Orta’s Hospital ; GSK; ImmunXperts; ImmusanT, Inc; Institute of Biology and Technologies ; Leiden University; Lonza Biologics; MedImmune; Novartis; Novo Nordisk A S; Pfizer; ProImmune Ltd.; Public Health England; Roche Innovation Center Penzberg; Selecta Biosciences; SQI Diagnostics Inc; Swedish Orphan Biovitrum; Technical University of Denmark; Teva Pharmaceuticals; Texcell; The Technical University Of Denmark; UCB; UCB Pharma Limited; UCL; University College London; University College London Medical School;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Jeremy Fry

Jeremy Fry, Director of Sales, ProImmune Ltd.

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
 

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
 

10:30 Morning Coffee

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
 

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
 

12:20 Networking Lunch

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
 

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
 

14:50 Afternoon Tea

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?

     

  • 16:20 Chairman’s Closing Remarks and Close of Day One

    Annie De Groot

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

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Adnan Khan

    Adnan Khan, Senior Scientist Immunology/Pharmacology, UCB

    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
     

    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
     

    10:30 Morning Coffee

    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
     

    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?
     

    12:20 Networking Lunch

    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

    14:30 Afternoon Tea

    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
     

    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
     

    16:20 Chairman’s Closing Remarks and Close of Day Two

    Adnan Khan

    Adnan Khan, Senior Scientist Immunology/Pharmacology, UCB

    +

    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

    Sponsors and Exhibitors

    Official Media Partner

    Official Publication

    Supporters

    Workshops

    Unwanted immunogenicity from bench to bedside
    Workshop

    Unwanted immunogenicity from bench to bedside

    Holiday Inn Kensington Forum
    15th June 2016
    London, United Kingdom

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

    Interview with UCB

    Download

    Sponsors and Exhibitors


    Abzena

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

    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.

    Media Partners


    BioChem Adda

    Official Media Partner
    https://www.biochemadda.com/

    BioChem Adda is a Not-just-for-Profit organization which aims to bring out the most reliable and transparent information about everything related to jobs, careers, education, news, articles, and events from the field of BioSciences and Chemistry!

    Media Partners


    International Journal of Nano and Biomaterials

    Official Publication
    http://www.inderscience.com/ijnbm

    In recent years, frontiers of research in engineering, science and technology have been driven by developments in nanomaterials, encompassing a diverse range of disciplines such as materials science, biomedical engineering, nanomedicine and biology, manufacturing technology, biotechnology, nanotechnology, and nanoelectronics. IJNBM provides an interdisciplinary vehicle covering these fields. Advanced materials inspired by biological systems and processes are likely to influence the development of novel technologies for a wide variety of applications from vaccines to artificial tissues and organs to quantum computers.


    International Journal of Biomedical Engineering and Technology

    Official Publication
    http://www.inderscience.com/ijbet

    IJBET addresses cutting-edge research in the multi-disciplinary area of biomedical engineering and technology. Medical science incorporates scientific/technological advances combining to produce more accurate diagnoses, effective treatments with fewer side effects, and improved ability to prevent disease and provide superior-quality healthcare. A key field here is biomedical engineering/technology, offering a synthesis of physical, chemical, mathematical and computational sciences combined with engineering principles to enhance R&D in biology, medicine, behaviour, and health. IJBET includes the Asia-Pacific Chapter in Biomedical Wireless Technology (APC-BWT).


    Int. J. of Biotechnology

    Official Publication
    http://www.inderscience.com/ijbt

    IJBT provides an international forum and refereed authoritative source of information in the field of Biotechnology and Biotechnics, with emphasis on management and economics, as well as the political and social issues. It aims to disseminate knowledge, provide a learned reference in the field, and establish channels of communication between academic and research experts, policy makers and executives in industry, commerce and investment institutions.


    Int. J. of Immunological Studies

    Official Publication
    http://www.inderscience.com/ijis

    IJIS publishes a broad range of papers on all aspects of immunology from scientists in academic and non-academic organisations as well as business and government worldwide. IJIS is the flagship journal of the Frontiers in Immunology Research Network.

    Media Partners


    Select Science

    Supporters
    http://www.selectscience.net/

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
    Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Conference Service

    Supporters
    https://www.conference-service.com/

    COMS is a web based system for managing delegate registration, payment, paper submission, review and the book of abstracts. It is a comprehensive and powerful, yet easy to use solution for online conference management including event planning and creation of the detailed agenda.


    Technology Networks

    Supporters
    http://www.technologynetworks.com

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare is the most comprehensive, in-depth, and objective website for life science product information. Thousands of scientists use Biocompare daily to quickly find the right product for their experiments rather than looking through multiple print catalogs. Visit Biocompare to find the products you need, stay informed of new technologies, read product reviews, watch product videos, and keep up-to-date on life science news. Visit: www.biocompare.com


    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Expert Review of Clinical Immunology

    Supporters
    http://www.tandfonline.com/toc/ierm20/current

    The Expert Review of Clinical Immunology journal (Impact Factor 2.484) provides expert analysis and commentary regarding the performance of new therapeutic and diagnostic modalities in clinical immunology: http://www.tandfonline.com/toc/ierm20/current


    BioPharm Insight

    Supporters
    http://www.infinata.com/biopharma-solution/by-product/biopharm-insight.html

    BioPharm Insight is your definitive guide to the global life sciences community. Subscribers take action on forward-looking intelligence uncovered by an independent team of investigative journalists, and make strategic business decisions using the most comprehensive and powerful real-time database of market analytics and key contacts. Featuring an intuitive online interface and exclusive Active IntelT relational content technology, BioPharm Insight provides an unrivaled capability to segment and analyze the industry with detailed and searchable profiles.

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    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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