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Therapeutic Antibodies
27 June - 28 June 2001
Therapeutic Antibodies
Antibodies produced as natural protection against infection and disease are making their way out of clinical laboratories where they have been used for the last twenty five years to quantify blood levels of diagnostic markers such as hormones, cancer antigens and human antibodies against viruses and antibodies. They are moving into the laboratories of molecular biologists and microbiologists for biochemical studies on gene products, or to detect pathogenic organisms in food and in water supplies.

One of the major issues with antibodies for therapeutic use is how to effectively manage the product lifecycle of therapeutic antibodies. These issues will be addressed with an additional half-day workshop to take place on the 29th June entitled “Proactively Managing the Lifecycle of Therapeutic Antibodies for Enhanced Results”. Comparisons will be made with other products and actual case studies will illustrate the specific interventions required to successfully manage this class of product to maximise profit.

As a key industry representative, you are aware of the commercial possibilities of Therapeutic Antibodies and how they could benefit your company. Couple this with the fantastic networking opportunities offered to all our delegates and you can see that this conference Magic Bullets: An update on Therapeutic Antibodies is an opportunity waiting to be exploited.

Conference agenda

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8:30

Registration and Coffee

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9:00

How do the rules change in managing the lifecycle of a biological?

  • Drivers for biologicals vs traditional products
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    10:00

    Establishing the optimum mix and timing of new product and market introductions

  • Legal protection
  • Line extensions / new indications
  • Manufacturing cost effectiveness
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    11:00

    Morning Coffee

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    11:15

    Building the Lifecycle Management implementation plan

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    12:10

    Discussion and questions-review of the session

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    12:30

    Close of workshop

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    8:30

    Registration and Coffee

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    9:00

    Chairman's Opening Remarks

    Dr Katherine Bowdish

    Dr Katherine Bowdish, President, Alexion Antibody Technologies

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    9:10

    ANTIBODY BACKGROUNDER

    Dr Kevin Johnson

    Dr Kevin Johnson, Chief Technology Officer, Cambridge Antibody Technology

  • What is the significance of antibodies as a class of therapeutic drugs?
  • How therapeutic antibodies will increase the pharmaceutical pipeline
  • How to improve target identification and validation using antibodies
  • What are the future growth opportunities in therapeutic antibodies?
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    9:40

    THE PIPELINE FOR THERAPEUTIC ANTIBODIES

    Dr David Mack

    Dr David Mack, Vice President, Genomics Research, Eos Biotechnology

  • The bulging pipeline for therapeutic antibodies
  • Therapeutic value of antibodies -New therapies -Improving side effect profile of drugs
  • Trends in approach to treatment with therapeutic antibodies
  • Issues of shelf life
  • Commercial success
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    10:20

    HUMAX-CD4 – A FULLY HUMAN MONOCLONAL ANTIBODY FOR THE TREATMENT OF INFLAMMATORY DISEASES

    Dr Claus Moller

    Dr Claus Moller, Chief Operating Officer, Genmab

  • HuMax-CD4 a fully human monoclonal antibody created with the HuMab Mouse
  • Getting a fully human antibody through pre-clinical development and ready for clinical trials
  • Results of first clinical study
  • Accelerating time from first study to late stage development
  • Expanding indication areas for an anti-inflammatory monoclonal antibody against CD4
  • Manufacturing considerations and timing
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    11:00

    Morning Coffee

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    11:20

    VALIDATING ANTIBODY TARGETS

    Dr Donny Strosberg

    Dr Donny Strosberg, Chief Executive Officer, Hybrigenics

  • Providing high-throughput, quality controlled information about the functional role of proteins in cellular pathways
  • The PIM Technology® identifies actual domains
  • SID® responsible for protein interactions providing a wealth of epitopes
  • SIDs are derived from extra and intracellular as well as secreted proteins
  • Using SIDs to functionally validate new drug and antibody target
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    12:00

    LEVERAGING BIOLOGY EFFECTIVELY

    Dr Don Perryman

    Dr Don Perryman, Vice President and Chief Business Officer, Raven Biotechnologies

  • To date, how has biology been integrated into antibody target discovery?
  • In light of the impending sequencing of the genome, how will this change?
  • What are the newest methods being developed to include biology earlier?
  • What are the technologies by which the discovery process can be speeded up?
  • Can target discovery/validation and therapeutic antibody discovery be combined?
  • What impact can these new approaches have on the industry?
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    12:40

    Lunch

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    13:00

    ANTIBODY DISCOVERY AND PRODUCTION

    Dr Dan Allison

    Dr Dan Allison, Director, Production Development, ICOS

  • Use of a homologous transcription control region (CHEF1) for rapid high-level production of antibodies in CHO cells
  • Use of CHEF1 vectors to optimise antibody expression by stoichiometric adjustment of heavy and/or light chain synthesis
  • Use of CHEF1 vectors for rapid expression of antibody targets such as cell surface receptors
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    14:40

    ANTIBODY CYTOKINE CONCEPT

    Dr Stephen Gillies

    Dr Stephen Gillies, President, Lexigen Pharmaceuticals

  • What is the current therapeutic potential of antibody-cytokine proteins?
  • How to go about manipulating the IL-2 protein to increase half-life of and efficacy
  • What is the potential immunogenicity of these manipulated proteins?
  • The development of an anti-tumor targeting immunocytokine
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    15:20

    Afternoon Tea

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    15:40

    LICENSING OPPORTUNITES

    Ken Fyvie, Life Sciences and Technology , PA Consulting Group

  • Why are therapeutic proteins attractive to generic manufacturers?
  • What is the competition in therapeutic antibodies?
  • What are the barriers to penetrating the generic antibody market?
  • How can the effects of patent expiry be forecast in advance?
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    16:20

    ANTIBODY THERAPY IN VIRAL INFECTIOUS DISEASE THERAPIES

    Dr Shlomo Dagan

    Dr Shlomo Dagan, Chief Scientific Officer, XTL Biopharmaceuticals

  • The Trimera system as a tool for generation of animal models for human diseases
  • Development of human antibodiesto hepatitis B
  • Preclinical and clinical data from phase I/II study
  • Development of antibodies to HCV for treatment of chronic HCV patients
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    17:00

    Chairman's Closing Remarks and Close of Day One

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    17:10

    Networking Drinks Reception

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    8:30

    Re-registration and Coffee

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    9:00

    Chairman's Opening Remarks

    Dr Andrew Heath

    Dr Andrew Heath, Chief Executive Officer, Protherics Molecular Design

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    9:10

    TRANSGENIC TECHNOLOGY IN THE PRODUCTION OF THERAPEUTIC PROTEINS

    Marlise Potell

    Marlise Potell, Director, Commercial Development, Genzyme Transgenics Corporation

  • An enabling technology that supports the production of large quantities of biopharmaceuticals
  • The benefits of producing antibodies in the milk of transgenic animals
  • Therapeutic protein recovery from milk
  • Transgenic production economies
  • Safety considerations
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    9:40

    DERIVING ANTIBODIES FROM GENETICALLY ENHANCED PLANTS

    Dr Kris Briggs

    Dr Kris Briggs, Director, Antibody Expression, Epicyte

  • How to obtain a neutralizing human antibody
  • Determining antibody gene sequences
  • Engineering antibody genes into plant germline
  • Expanding to field scale production
  • Proving safety & efficacy in regulated clinical trials
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    10:20

    XENOMOUSE TECHNOLOGY FOR THE GENERATION OF FULLY HUMAN MONOCLONAL ANTIBODIES

    Dr Larry Green

    Dr Larry Green, Senior Scientist, Collaborations, Abgenix

  • The XenoMouse technology
  • XenoMouse + SLAM technology: more efficient isolation of high-potency human antibodies
  • Using XenoMouse to validate genomic targets
  • XenoMouse-derived antibodies in the clinic
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    11:00

    Morning Coffee

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    11:20

    HIGH AFFINITY FULLY HUMAN MONOCLONAL ANTIBODIES

    Dr Isao Ishida

    Dr Isao Ishida, Group Leader, Human Antibody Business Development Group, Kirin Brewery

  • The development of the TransChromo (TM) technology
  • The development of the TM mouse to: -carry human immunoglobulin genes producing fully human antibodies -generate high affinity fully human antibodies -generate hybridoma clones for the majority of Ig subclasses
  • The continuing development of TC MouseTM technology
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    12:00

    DELIVERY ISSUES OF MONOCLONAL ANTIBODIES

    Adam Levy

    Adam Levy, Business Development Manager, Weston Medical

  • Introduction to needlefree injection
  • Needlefree injection of antibodies
  • In vivo data - no change in antibody properties
  • Pre-clinical data - bioequivalent to needle and syringe
  • Why novel delivery - the commercial forces in the antibody market: rheumatoid arthritis as a model
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    12:40

    Lunch

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    14:00

    CHRONIC TREATMENT WITH ANTIBODIES

    Prof Eskil Soderlind

    Prof Eskil Soderlind, Director, Technology Application, BioInvent Therapeutic

  • Bioinvent’s proprietary n-CoDeRä library provides specific antibody fragments (scFv) against a variety of relevant therapeutic antibodies
  • Rapid development for the construction of all human IgG molecules
  • Successful in house manufacturing under GMP conditions
  • Selected scFv have significantly fewer T cells epitopes as compared to naïve human antibodies
  • High therapeutic potential of the IgG molecules from the n-CoDeR system
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    14:40

    PRODUCTION OF MONOCLONAL ANTIBODIES

    Dr Bram Bout

    Dr Bram Bout, Director Protein Production, Crucell

  • High yields and scaleability of the production system
  • Comparison of other cell based systems
  • Influence of culture media on glycosylation
  • The relation between glycosylation and biological activity
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    15:20

    Afternoon Tea

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    15:40

    ACCELERATED TARGET DISCOVERY AND DRUG DEVELOPMENT

    Dr Christine Rothe

    Dr Christine Rothe, Associate Director Research and Development, MorphoSys

  • MorphoSys proprietary HuCAL® technology: HuCAL®-scFv and HuCAL®-Fab
  • HT-antigen generation (AutoCALTM) and anti-est-antibody program for target validation
  • Generation and maturation of biologically active fully human antibodies
  • Results from HuCAL® antibodies in pre-clinical functional assays
  • Production of HuCAL® antibodies for HT-screening and pre-clinical assays
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    16:20

    T-CELL RECRUITING ANTIBODIES

    Dr Christian Itin

    Dr Christian Itin, Vice President, Corporate Development, Micromet

  • T cell recruitment - tapping an unused effector cell population for antibody mediated cellular cytotoxicity
  • Scientific and technical challenges of T cell recruitment
  • Bispecific T cell Engagers (BiTEs) - an antibody-derived class of molecules with unique properties
  • Examples of BiTE action: Using T cells to target lymphoma and chronic inflammation
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    17:00

    Chairman's Closing Remarks and Close of Conference

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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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.

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    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.

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