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Therapeutic Antibodies
31 January - 1 February 2007
Therapeutic Antibodies
SAE Media Group’s 7th Annual Therapeutic Antibodies Conference will provide a forum for leading industry experts from major pharmaceutical companies to discuss and evaluate the latest challenges and problems facing the therapeutic antibodies market.

As one of the fastest growing segments of the pharma market, the value of therapeutic antibodies is expected to more than triple in value. The success of current marketed products has led to escalation in antibody development, with more than 370 programs currently in the pipeline. Evolutions in innovation and business model dynamics will drive the sector's dominant position.

SAE Media Group’s Therapeutic Antibodies Conference is a must-attend event and will provide an excellent opportunity to network, enhance your company’s profile and keep you up-to-date on the latest issues in the market.

The two-day conference programme will be delivered by a panel of expert speakers, including:
  • Professor Rolf Werner, Head, Corporate Division, Biopharmaceuticals & Corporate Senior Vice President, Boehringer-Ingelheim
  • Dr Joseph Bolen, Senior Vice President, Research & Drug Discovery, Millennium Pharmaceuticals
  • Dr Nitin Damle, Director, Oncology Discovery Research, Wyeth Pharmaceuticals
  • Dr Tristan Vaughan, Director, Discovery, Respiratory & Inflammation, Cambridge Antibody Technology
  • Dr W. David Shen, Director, Amgen
  • Dr Hennie Hoogenboom, Chief Scientific Officer, Ablynx NV
  • Stephen Ingham, Patent Attorney, Eli Lilly
  • Dr Jan ter Meulen, Executive Director, Infectious Diseases, Crucell
By attending this conference, you will learn about:
INTELLECTUAL PROPERTY: The current status of regulations affecting the pharmaceutical industry
LICENSING ANTIBODIES: Discover how to optimise business opportunities and form strategic collaborations with major companies that result in successful partnerships
TREATMENTS FOR DISEASE: Hear practical examples and case studies on the innovative uses of antibodies in cancer treatment and what toxin-conjugated approaches for antibody-based therapeutics are doing for the industry
NOVEL TECHNOLOGIES: See the positive effect new and innovative technologies are having on businesses
DEVELOPING THE NEXT STAGE OF ANTIBODIES: Review the challenges faced by major pharma companies whilst developing antibodies
EXCLUSIVE INFORMAL NETWORKING: Collaborate with industry peers in an environment promoting information exchange

PLUS AN ASSOCIATED HALF-DAY POST-CONFERENCE EXECUTIVE BRIEFING
Regulatory Requirements for Recombinant Therapeutic Antibodies: The European Perspective
2nd February 2007, Central London

In association with: ERA Consulting

Conference agenda

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8:30

Registration & Coffee

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9:00

CMC/ product quality regulatory expectations

  • Characterisation and issues associated with post-translational modifications
  • Cell banking and viral safety issues
  • Process validation and the importance of in-process controls for process evaluation
  • The effects of changing the manufacturing process - Case studies
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    10:00

    Pre-clinical and clinical development

  • Pre-clinical programme - A biological approach
  • What are the key pre-clinical considerations for therapeutic antibodies?
  • Clinical testing considerations from a European perspective
  • Minimum requirements for a Phase I clinical study
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    10:50

    Opportunities within the EU regulatory framework

  • Scientific Advice procedures in Europe
  • Orphan designation in the EU
  • New provisions for SMEs
  • Other opportunities such as accelerated assessment, conditional approval and compassionate use
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    11:00

    Morning Coffee

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    11:30

    T cell-recruiting bi- and tri-specific antibodies

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    12:30

    Discussion & questions – review of the session

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    13:00

    Close of Executive Briefing

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Nitin Damle

    Nitin Damle, Director, Oncology Research, Wyeth Pharmaceuticals

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    9:10

    MODULAR TIME-TO-MARKET PROCESS DEVELOPMENT CONCEPT FOR MONOCLONAL ANTIBODIES

    Rolf G Werner

    Rolf G Werner, Head, Corporate Division Biopharmaceuticals, Boehringer-Ingelheim

  • Media development
  • High titer fermentation technology
  • High yield downstream processing
  • Process validation oriented at clinical success
  • Scalability and robustness of pilot scale
  • Royalty load for in-licensed IP
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    9:50

    IMPROVING EFFECTOR FUNCTIONS OF ANTIBODIES

    Peter Sondermann

    Peter Sondermann, Head, Process Biochemistry, GLYCART biotechnology (part of the Roche group)

  • Variety of genetic engineering methods used to enhance effector function of an antibody in order to suit the strategy for its clinical application
  • Structural basis of antibody effector function
  • Superior specific target cell killing in vitro and in vivo
  • Increasing the potency of antibodies regardless of the receptor phenotype
  • Substantial clinical benefits when used with therapeutic antibodies
  • Yielding better results
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    10:30

    Morning Coffee

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    10:50

    SYNTHETIC HUMAN ANTIBODIES

    Sachdev Sidhu

    Sachdev Sidhu, Senior Scientist, Genentech Inc

  • Design principles for highly functional antibody libraries       
  • Structure-based design of antibody diversity       
  • Selection and formatting strategies for antagonist and agonist activity
  • High throughput analysis and production of novel antibodies
  • Applications for controlling cell proliferation and cell death
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    11:30

    THERAPEUTIC ANTIBODY DISCOVERY

    Tristan Vaughan

    Tristan Vaughan, Director Discovery, Respiratory & Inflammation, Cambridge Antibody Technology

  • Comparing and contrasting the complementary technologies of phage and ribosome display
  • Their key usage in therapeutic antibody discovery strategy
  • Critical success factors
  • Diversity of lead antibodies
  • Potencies of optimised antibodies
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    12:10

    Networking Lunch

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    13:40

    NANOBODIES AS NEW THERAPEUTIC ENTITIES

    Hennie Hoogenboom

    Hennie Hoogenboom, CSO, Ablynx

  • Nanobodies: single variable domains derived from camelids
  • Picomolar affinity leads by direct sorting of antigen-specific B-cells from immunised llamas
  • Examples of designs of nanobody-based protein drugs
  • Nanobodies efficacious in animal models of rheumatoid arthritis, cancer and thrombosis
  • Advantages of nanobodies compared to monoclonal antibodies
  • Easy formatting, tailoring of half-life and low cost of goods
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    14:20

    ANTIBODY MANUFACTURING AND PURIFICATION

    Lothar Jacob

    Lothar Jacob, Marketing Manager, Merck KgaA

  • Antibody purification methods
  • Manufacturing regulatory issues
  • Ensuring adequate manufacturing capacity
  • Developing strategic plans to ensure they have adequate resources
  • Purifying any antibodies quickly and efficiently
  • Types of strategies used
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    15:00

    Afternoon Tea

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    15:20

    HUMAN MONOCLONAL ANTIBODIES FOR PROPHYLAXIS AND THERAPY OF INFECTIOUS DISEASES

    Jan ter Meulen

    Jan ter Meulen, Executive Director, Infectious Diseases, Crucell

  • Humoral immune response in infectious diseases
  • Rapid generation of human mAbs by phage display
  • Importance of antigen and assay formats
  • Applications and business cases
  • clock

    16:00

    TUMOUR-SPECIFIC ANTIBODY-TARGETED CHEMOTHERAPY USING IMMUNOCONJUGATES OF CALICHEAMICIN

    Nitin Damle

    Nitin Damle, Director, Oncology Research, Wyeth Pharmaceuticals

  • Tumour-specific delivery of potent chemotherapeutic agents may be therapeutically beneficial
  • Calicheamicin is a potent DNA-minor groove-binding radiomimetic cytotoxic agent
  • Strong evidence of anti-tumour efficacy of calicheamicin-conjugated antibodies in various preclinical models
  • CD33-specific and targeted Mylotarg®, also known as gemtuzumab ozogamicin, is the first cytotoxic immunoconjugate to be approved by the US FDA and has provided the first clinical proof of concept in the treatment of patients with relapsed acute myeloid leukaemia
  • CD22-specific inotuzumab ozogamicin is presently in advanced stage of clinical evaluation in patients with relapsed B -cell non-Hodgkin’s lymphoma and has demonstrated clinical activity with reversible and manageable side effects profile
  • A number of targeting opportunities with immunoconjugates of calicheamicin specific for solid tumors being explored are in various stages of preclinical advancement
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    17:20

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Re-registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Joseph Bolen

    Joseph Bolen, CSO, Millennium Pharmaceuitcals Inc

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    9:10

    TOXIN-CONJUGATED APPROACHES FOR ANTIBODY-BASED CANCER THERAPEUTICS

    Joseph Bolen

    Joseph Bolen, CSO, Millennium Pharmaceuitcals Inc

  • Target selection
  • Antibody generation
  • Toxin and linker selection
  • Preclinical efficacy and safety assessments
  • Clinical experience
  • clock

    9:50

    ENGINEERING DESIRABLE MODIFICATIONS ON THERAPEUTIC ANTIBODIES

    W.David Shen

    W.David Shen, Director, Amgen

  • Humanise or germline rodent or human antibodies with less immunogenicity
  • Engineer lead antibodies with less aggregation issues
  • Modify lead antibodies with better expression
  • Engineer lead antibodies with better stability
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    10:30

    Morning Coffee

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    11:00

    FUNCTIONAL DIFFERENCES IN CLASSES OF TNF ANTAGONISTS

    Taruna Arora

    Taruna Arora, Senior Scientist, Amgen

  • Soluble TNF receptor (Etanercept) and anti-TNF monoclonal antibodies
  • All of these agents bear Fc region of IgG1, which has potential to elicit effector functions
  • Objective was to assess ability of the TNF antagonists to bind soluble and membrane-bound TNF and to mediate cell killing
  • TNF antagonists exhibited functional differences in in-vitro models
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    11:40

    IMMUNOGENICITY

    Philippe Stas

    Philippe Stas, Chief Operating Officer, AlgoNomics N V

  • Immunogenicity and possible consequences
  • Immunogenicity identification and testing
  • Current regulatory guidelines
  • Addressing the challenges of antibody immunogenicity
  • Selected case studies on antibody therapeutics
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    12:20

    Networking Lunch

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    13:50

    INTELLECTUAL PROPERTY ISSUES

    Stephen Ingham

    Stephen Ingham, Patent Attorney, Eli Lilly

  • Obtaining patents to antibodies - recent developments in the granting of patents to antibodies
  • How to build an antibody patent portfolio
  • What is a reasonable scope of protection for an antibody patent claim?
  • Strategies for enforcing patents to antibodies
  • How to avoid infringing competitor antibody patents
  • Potential effects of antibody patents of broad scope on the biotechnology industry
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    14:30

    ANTIBODY DISCOVERY AND DEVELOPMENT

    Alejandro Aruffo

    Alejandro Aruffo, Vice President, Global Pharmaceutical Development, Abbott Laboratories

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    15:10

    Afternoon Tea

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    15:40

    NATURAL ANTIBODY DERIVATIVES

    Serge Muyldermans

    Serge Muyldermans, Professor, Vrije Universiteit Brussel

  • Challenges faced with classical antibodies
  • Naturally occurring antibody alternatives
  • Advantages of novel antibody format
  • Technology involved
  • Application in cancer therapy
  • Therapeutic application in trypanosomiasis
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    16:20

    PRODUCT DEVELOPMENT

    Patrick Bauerle

    Patrick Bauerle, Chief Scientific Officer & Senior Vice President, Research & Development, Micromet Inc

  • Basic biology of molecules
  • The principle of polyclonal T cell therapy
  • Results from clinical trials
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    17:00

    Chairman’s Closing Remarks and Close of Conference

    Workshops

    Regulatory requirements for recombinant therapeutic antibodies

    Regulatory requirements for recombinant therapeutic antibodies

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    2 February 2007
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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, 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

    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@saemediagroup.com

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