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Global Proteins Summit
23 June - 24 June 2010
Global Proteins Summit

 

Protein biotherapeutics have gone from a seldom used subset of treatments to a multi-billion dollar global industry. With the ever-expanding protein therapeutic market, SAE Media Group's 6th annual Global Proteins Summit is well timed to investigate the latest developments in protein therapeutics, cell culture expression and immunogenicity.

The conference will explore the next generation of protein therapeutics, how they are being developed and reassess the technology, discovery and delivery trends. Also covered will be expression optimisation, case studies looking at successful drugs along with immunogenic considerations and safety assessment.

Reassess the latest therapeutics, developments, technologies, and methods that work in an interactive, networking friendly environment with major players from the biotech industry.

This meeting will feature talks from experts who will address:

  • Optimisation of pre-formulation approaches, expression and glycosylation
  • Next generation nanobodies
  • Generating therapeutic antibodies to multi-transmembrane receptors
  • Case studies in successful innovative biotherapeutics
  • In silico methods to reduce development risks
  • Recognising and combating immunogenicity
  • Regulatory perspectives

For speaker opportunities, contact SAE Media Groupproduction@SAE Media Group-online.co.uk

For sponsorship and exhibitioning opportunities, contact  sponsorshipdept@SAE Media Group-online.co.uk


 

Bernardo Perez-Ramirez
Senior Scientific Director, BioFormulations
Genzyme

Darren Hart
Team Leader
European Molecular Biology Laboratory (EMBL)

Dorothea Reilly
Senior Scientist and Associate Director
Genentech 

Paul Parren
Sr. Vice President, Research & Pre-Clinical Development
Genmab 

Jesús Zurdo 
Head of Advanced Protein Technologies
Lonza Biologics

See the full lineup...

 


 

CEOs, CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

  • Biochemistry
  • Biophysics
  • Clinical Affairs
  • Drug Surveillance/Product Safety
  • Gene expression
  • Immunogenicity / Immunology / Immune Response
  • International Clinical Safety
  • Marketing/Business Development
  • Medical Affairs
  • Medical Science
  • Molecular Biology
  • Non-clinical Research and Development
  • Pharmacovigilance
  • Project Management
  • Protein expression/purification
  • Proteomics
  • Quality Assurance
  • Regulatory Affairs
  • Scientific Affairs

  

Crowne Plaza St James Hotel

45-51 Buckingham Gate
London
SW1E 6AF
 
 Tel: +44 (0) 207 834 6655
Fax: +44 (0) 207 6307
www.london.crowneplaza.com
 Crowne Plaza St James Hotel

Crowne Plaza St James London is a traditional deluxe hotel right in the heart of the city, perfectly situated for all your business and leisure needs. In the heart of Westminster, it is just a stone's throw away from Buckingham Palace, The Houses of Parliament, the London Eye and Victoria Station.  

The hotel boasts three excellent restaurants. Bistro 51 

Conference agenda

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12:30

Registration & Coffee

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13:00

Welcome & Introductions

  • Ana T. Menendez 's experience and qualifications
  • Purpose and scope of the workshop
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    13:10

    Fundamentals of Immunogenicity

  • Self versus non-self
  • Regulatory expectations
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    13:45

    Required Methods

  • Basic Screen & Quantitation
  • Confirmatory Methods
  • Neutralization Methods
  • Characterization Methods
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    14:30

    Morning Coffee

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    15:00

    Method Standardization

  • Cut-Point Selection
  • Cut-Point & Normalization Exercise
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    15:45

    Risk Analysis

  • External & Internal Parameters
  • Phase & Risk Appropriate Patient Sampling
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    16:30

    Discussion Session

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    17:00

    Close of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Bernardo Perez-Ramirez

    Bernardo Perez-Ramirez, Senior Scientific Director, BioFormulations Development, Genzyme Corporation

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    9:10

    Optimizing Pre-formulation Approaches for Successful Development of Therapeutic Proteins

    Bernardo Perez-Ramirez

    Bernardo Perez-Ramirez, Senior Scientific Director, BioFormulations Development, Genzyme Corporation

  • Early assessment of "developmentability" potential
  • Maximizing data collection and output with minimal amount of protein
  • Global analysis and thermodynamic assessment
  • Choosing proper stress conditions
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    9:50

    Multi-Specific Adnectins

    Ray Camphausen

    Ray Camphausen, Associate Vice President of Protein Design, Adnexus, a Bristol-Myers Squibb R&D Company

  • Advantages compared to traditional targeted biologics
  • Challenges in modulating two distinct targets
  • Engineering and optimisation
  • Clinical potential
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    10:30

    Morning Coffee

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    11:00

    DARPin Therapeutics

    H. Kaspar Binz

    H. Kaspar Binz, Vice President Technology, Molecular Partners A G

  • Combining the favourable properties of antibodies with those of small molecule drugs
  • Engineering of novel types of drugs superior to currently known biologics
  • Updates on MP0112, a best-in-class therapeutic DARPin for the treatment of ocular neovascularization diseases
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    11:40

    Case Study: Arzerra (Ofatumumab)

    Paul Parren

    Paul Parren, Senior Vice President, Research & Pre-Clinical Development, Genmab B.V.

  • Introduction to CD20 and Arzerra
  • Mechanism of action of tumour cell killing activity in vitro and in vivo
  • Update on progress in the clinic
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    12:20

    Networking Lunch

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    13:20

    Next Generation Nanobodies

    Serge Muyldermans

    Serge Muyldermans, Professor, Department of Molecular and Cellular Interactions, Vrije Universiteit Brussel

  • Distinct structural and functional properties
  • Advantages over other designed target binders
  • Engineering to broaden utility
  • Future therapeutics
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    14:00

    MetMAb: One-Armed 5D5 Anti-c-Met Antibody

    Dorothea Reilly

    Dorothea Reilly, Senior Scientist, Genentech

  • Optimising the level of foreign gene expression
  • Background
  • Production issues and solutions
  • Optimisation
  • Future novel molecules
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    14:40

    Anticalins®

    Andreas Hohlbaum

    Andreas Hohlbaum, CTO, Pieris Proteolab AG

  • Modified human lipocalins as unique scaffold
  • PRS-050 (VEGF antagonist) entering human studies
  • Anticalins against hapten targets
  • Formulation and formatting flexibility
  • CMC advantages
  • Alternative delivery
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    15:20

    Afternoon Tea

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    15:50

    Alternates Approaches to Preclinical Safety Assessment of Biologics: Case Studies

    Rakesh Dixit

    Rakesh Dixit, Global Head, Biologics Safety Assessment & Exp. Pathology, Medimmune

  • Selecting the right animal model to test toxicology
  • Alternatives to in vivo animal testing
  • Looking ahead
  • clock

    16:30

    Soluble Fc Receptor (SM101) for the treatment of autoimmune diseases

    Peter Sondermann

    Peter Sondermann, CSO, SuppreMol GmbH

  • Inclusion body based expression in E. coli & subsequent refolding of SM101 were optimised to a high yield process
  • The production method allows a tag-free purification
  • SM101 has finished a Phase I study in healthy volunteers
  • Clinical development in autoimmune diseases is ongoing
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    17:10

    Chairman’s Closing Remarks and Close of Day One

    Rakesh Dixit

    Rakesh Dixit, Global Head, Biologics Safety Assessment & Exp. Pathology, Medimmune

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Darren Hart

    Darren Hart, Team Leader, European Molecular Biology Laboratory

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    9:10

    Library-Based Construct Screening

    Darren Hart

    Darren Hart, Team Leader, European Molecular Biology Laboratory

  • Directed evolution strategies for protein expression
  • ESPRIT (Expression of Soluble Proteins by Random Incremental Truncation)
  • Expression analysis using high throughput robotics
  • Case study: expression, purification and structural studies on drug targets & vaccine candidates
  • clock

    9:50

    High-Throughput Eukaryotic Protein Expression

    Opher Gileadi

    Opher Gileadi, Principal Investigator, Oxford University

    Optimizing the level of foreign gene expression
    The impact of protein engineering
    Expression of human integral membrane proteins

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    10:30

    Morning Coffee

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    11:00

    Protein Tools for Drug Discovery; Lessons Learnt

    Ian Hunt

    Ian Hunt, Group Leader, Protein Production Group, Novartis Institutes for BioMedical Research

  • Technologies and innovations
  • Accelerating the generation of recombinant proteins for small molecule drug discovery
  • Tricks of the trade - expression of difficult to make protein
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    11:40

    New ways of Establishing Production Cell Lines for Structural Biology

  • Site-specific recombination allows shuttling of genes of interest to favourable genetic loci
  • Preparative FACS of GFP positive cells identifies highly productive and genetically stable clones
  • Glycosylation deficient CHO lines produce homogenous glycoproteins
  • The resulting glycoproteins can be deglycosylated enzymatically and crystallized efficiently
  • Konrad Büssow

    Konrad Büssow, Head of Mammalian Protein Expression Group, Helmholtz Centre For Infection Research

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    12:20

    Networking Lunch

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    13:20

    Optimising Glycosylation for Antibody Therapeutics

    Roy Jefferis

    Roy Jefferis, Professor of Molecular Immunology, University Of Birmingham

  • Co- and post- translational modifications
  • Antibody therapeutics as autoantibodies
  • Immune complexes/aggregation
  • Cell engineering & glycoform profiles
  • Human IgG subclasses & polymorphisms
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    14:00

    In silico Methods to Reduce Development Risks in Biotherapeutics

    Jesús Zurdo

    Jesús Zurdo, Head of Advanced Protein Technologies, Lonza Biologics plc

  • Development challenges in biopharmaceuticals. Aggregation and stability issues
  • Upstream risk assessment to improve potential outcome of projects
  • Opportunities for designing quality in the product & expand the DSP design space
  • In silico aggregation prediction, opportunities for selection of optimal leads
  • Engineering biopharmaceuticals for improved developability
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    14:40

    Immunogenicity Aspects & Risk-Based Approaches

    Arno Kromminga

    Arno Kromminga, CEO, IPM BIOTECH GmbH

  • Novel proteins as foreign antigens
  • Allergic risk factors
  • Clinical consequences of ADA
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    15:20

    Afternoon Tea

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    15:50

    Generation of Therapeutic Antibodies against Inflammatory Disease and Cancer Targets

    Matthew Baker

    Matthew Baker, CEO & CSO, Antitope

  • Problem of anti-therapeutic antibody responses
  • Importance of ex vivo T cell epitope mapping
  • Engineering proteins to avoid T cell epitopes
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    16:30

    Regulatory Guidance - an EU Perspective

    Meenu Wadhwa

    Meenu Wadhwa, Head, Cytokines & Growth Factors & Biotherapeutics, National Institute For Biological Standards And Control

  • Existing and Upcoming EMEA guidelines
  • Comparing immunogenicity
  • Best practices and common problems with immunogenicity assessment
     
  • clock

    17:10

    Chairman’s Closing Remarks and Close of Day Two

    Workshops

    Immunogenicity Programs: Not Just Another Box to Check

    Immunogenicity Programs: Not Just Another Box to Check

    Crowne Plaza Hotel - St James
    22 June 2010
    London, United Kingdom

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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)

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    GLOBAL CPD

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