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Recent developments in vaccine research have included many compounds reaching the market and several compounds are in late stages of clinical trials. It has been estimated that the vaccine market will grow to $10 billion by 2010.

SMi’s conference Vaccines aims to cover:
The recent developments in the vaccine market
The developments in therapeutic areas such as infectious diseases and cancer
New areas of research such as dendritic cells and immunotherapies: case studies of compounds and where these are leading
Manufacturing problems and strategies to overcome them

Hear contributions from experienced industry speakers:
· Dr Stephen Lockhart, Senior Director, Head, Bacterial Vaccine Clinical Research, Wyeth Vaccine Research
· Dr Derek O’Hagan, Senior Director, Vaccine Delivery, Chiron
· Dr Michael Watson Executive Director, Clinical Development, Europe, Aventis Pasteur
· Dr Anne-Marie Georges, Director, Regulatory Affairs, Legal & Information, GlaxoSmithKline Biologicals
· Dr Brian Ledwith, Director, Biologics Safety Assessment, Merck Research Laboratories
· Dr George Kemble, Senior Director, Research, MedImmune
· Dr David Urdal, President & Chief Scientific Officer, Dendreon
· Dr Arthur Krieg, Chief Scientific Officer, Coley Pharmaceutical

Key issues that will be addressed at the Conference:
· THE VACCINE MARKET: review the marketplace by assessing its drivers and challenges
· REGISTERING NEW VACCINES: hear about obstacles and challenges you may encounter
· THE CLINICAL TRIALS DIRECTIVE: assess what effect it will have on the vaccines market and how to streamline regulations in the US & Europe
· NOVEL VACCINES APPROACHES: get an update on vaccines developments for Cancer, SARS, Influenza, Hepatitis B and C
· MANUFACTURING VACCINES: understand problems & challenges when producing vaccines
· SAFETY & EFFICACY: how big and how long do studies need to be? Will the need for ‘gold-standard’ end-points inhibit new vaccine development?

“Very good speakers, collegial environment, well run Conference”
Dr Jennifer Cygan, Genencor, delegate at SMi’s Conference Vaccines 2002

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Philip Minor

Dr Philip Minor, Head, Division Virology, National Institue for BIological Standards and Control

9:10 KEYNOTE ADDRESS

Dr John Savopoulos

Dr John Savopoulos, Head, Infectious Diseases (ID) Business Unit, Datamonitor Healthcare (Europe)

  • Who is doing what?
  • Which are the most promising approaches?
  • The challenges that have been overcome since 2003
  • Which are the emerging trends in the vaccine market?
  • Where is the market heading?
  • Review the FDA process and international issues regarding the development of new vaccines and related delivery systems
  • 9:40 CLINICAL DEVELOPMENT CHALLENGES

    Dr Stephen Lockhart

    Dr Stephen Lockhart, Senior Director, Head, Bacterial Vaccine Clinical Research, Wyeth Vaccine Research

  • Meeting clinical trial regulatory needs
  • Dealing with multiple paediatric vaccines recommendations
  • Defining non-inferiority in comparisons of study vaccines and concomitant vaccines
  • Safety: how big and how long do studies need to be?
  • Efficacy: will the need for ‘gold-standard’ end-points inhibit new vaccine development?
  • 10:20 THE CLINICAL TRIALS DIRECTIVE AND ITS APPLICATION TO VACCINES

    Dr Anne-Marie Georges

    Dr Anne-Marie Georges, Director, Regulatory Affairs, Legal and Information, GlaxoSmithkline Biologicals

  • General issues with the Directive in comparison to the US
  • Ethics Committee approval
  • Regulatory dossier requirements
  • Approval procedure by regulatory authorities
  • Delays to clinical research with vaccines
  • Generics to biologicals: new rule in the EU
  • 11:00 Morning Coffee

    11:20 CASE STUDY

    Dr Derek O’Hagan

    Dr Derek O’Hagan, Senior Director, Vaccine Delivery, Chiron

  • Safety and efficacy of a wide range of vaccines, including influenza vaccine in the elderly (Fluad)
  • Potential for use against flu strains
  • Safety in young patients
  • Development of new generation of vaccine
  • 12:00 MOLECULAR CHARACTERISATION AND PRODUCTION OF COLD-ADAPTED, LIVE ATTENUATED INFLUENZA VACCINE, FLUMIST

    Dr George Kemble

    Dr George Kemble, Senior Director, Research, MedImmune

  • Molecular genetics of the temperature sensitive and attenuation phenotypes
  • Use of plasmid technologies to generate vaccine strains
  • Mechanisms of immune response to vaccine strains
  • 12:40 Networking Lunch

    14:00 CASE STUDY: IMMUNOTHERAPIES

    Dr Steve Chatfield

    Dr Steve Chatfield, Chief Scientific Officer, Microscience

  • Challenges with the development of live vaccines
  • Choice of antigens
  • Optimisation of expression of antigens
  • Preclinical/clinical data
  • 14:40 TOWARDS AN HCV VACCINE

    Prof Willy Spaan

    Prof Willy Spaan, Scientific Co-ordinator, European HCV Consortium

  • Hepatitis C virus
  • Correlates of protection
  • Vaccines
  • Animal studies
  • EU-FP5
  • 15:20 Afternoon Tea

    15:40 CHIMIGEN™ VACCINES: A NOVEL CLASS OF THERAPEUTIC VACCINES FOR THE TREATMENT OF CHRONIC VIRAL INFECTIONS

    Dr Antoine Noujaim

    Dr Antoine Noujaim, President & Chief Executive Officer, ViRexx Research

  • ChimigenTM vaccines are recombinant fusion proteins with attributes of both a viral antigen and a monoclonal antibody
  • Unique chimeric design facilitates the formation of antibody like structure and appropriate antigen presentation
  • Adaptable platform, can be used to develop vaccines against any infectious agent
  • Targets the proper compartments of the antigen presenting cells to elicit cellular as well as humoral immune response
  • Generates broad immune response, both cellular (class I presentation) and humoral (class II presentation) to attack the infectious agent and break tolerance to the antigens
  • Can be used as either a therapeutic or a prophylactic vaccine
    Several therapeutic vaccine candidates at preclinical stage for the treatment of chronic Hepatitis B and C infections
  • 16:20 STRATEGIC DEVELOPMENT AND MANUFACTURING

    Dr Ronald Ellis

    Dr Ronald Ellis, Senior Vice President, Research & Development & General Manager, Shire Biologics

  • Defining strategic issues early in a development program
  • Types of vaccine technologies
  • Development and clinical needs for these technologies
  • Long-term planning for manufacturing
  • Practical examples
  • 17:00 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Prof Willy Spaan

    Prof Willy Spaan, Scientific Co-ordinator, European HCV Consortium

    9:10 CANCER VACCINES AND OTHER RETRO FASHIONS IN BIOTECH

    Mark Leuchtenberger

    Mark Leuchtenberger, President & Chief Executive Officer, Therion Biologics

  • The therapeutic cancer vaccine field has seen several clinical trials failures in recent years
  • Therapeutic vaccine development may mirror the bumpy road to commercialisation taken by monoclonal antibody technology, which endured its own high-profile failures before becoming fashionable again as biotech's leading technology
  • Review how Therion Biologics is driving to proof-of-concept phase II trials
  • 9:40 IMMUNOTHERAPY FOR CANCER

    Dr David Urdal

    Dr David Urdal, President & Chief Scientific Officer, Dendreon

  • Results from a double-blind, placebo-controlled clinical study of a therapeutic prostate cancer vaccine
  • Strategies for optimisation of cancer vaccines
  • Induction of cancer-specific immunity in humans
  • 10:20 ANTIBODIES AS VACCINES

    Dr Antoine Noujaim

    Dr Antoine Noujaim, President & Chief Executive Officer, ViRexx Research

  • Monoclonal antibodies in cancer treatment
  • Mechanisms of immune activation by low-dose xenotypic monoclonal antibodies
  • Critical components to target activating receptors on dendritic cells
  • Broad technology application for cancer and infectious diseases
  • Documented proof of principle in ovarian cancer
  • Clinical challenges for immune therapeutic approaches to cancer
  • 11:00 Morning Coffee

    11:20 CANCER VACCINE CASE STUDY: TROVAX

    Dr Miles Carroll

    Dr Miles Carroll, Vice President, Immunotherapy, Oxford BioMedica

  • TroVax: highly attenuated poxvirus expressing the novel TAA 5T4
  • Pre-clinical package
  • Results from a colorectal cancer phase I/II clinical trial
  • Future clinical development
  • 12:00 ENHANCING VACCINATION BY ADDITION OF ADJUVANTS THAT ACTIVATE DENDRITIC CELLS IN VIVO THROUGH TLR9

    Grayson B. Lipford

    Grayson B. Lipford, Director, Basic Research, Coley Pharmaceutical

  • The mechanisms through which TLR9 activation with CpG oligos trigger innate and adaptive immunity
  • The ways in which activating TLR9 differs from other vaccine adjuvants
  • The preclinical data with CpG in animal vaccine models
  • Clinical data with CpG 7909 in human vaccine trials, showing accelerated seroconversion and reduced non-responders
  • 12:40 Networking Lunch

    14:00 ADVANCES IN TECHNOLOGIES FOR THE PURIFICATION AND MANUFACTURING OF VACCINES

    Sandra Merino

    Sandra Merino, Business Development Manager, Alfa Wassermann

  • Historical evolution of vaccine development and manufacturing methodologies
  • Overview and examples of current methods used in vaccine purification
  • Approaches to enable process scalability – from development through to manufacturing
  • 14:40 STRATEGIC AND PRACTICAL CONSIDERATIONS TO THE DEVELOPMENT OF COMBINATION VACCINES

    Dr Michael Watson

    Dr Michael Watson , Executive Director, Clinical Development, Europe, Aventis Pasteur MSD

  • Efficacy vs immunogencity
  • Safety
  • Concomitant administration; antigens vs products
  • Post licensure commitments
  • Future combinations
  • 15:20 NON-CLINICAL SAFETY TESTING OF NOVEL VACCINE AND ADJUVANT TECHNOLOGIES

    Dr Frank Brennan

    Dr Frank Brennan, Project Director, Biopharmaceuticals, Huntingdon Life Sciences

  • General considerations in demonstrating safety, pharmacology and efficacy of vaccines and adjuvants
  • Design of in silico, in vitro and in vivo studies to support safety
  • Design of studies to assess systemic and local toxicity, immunogenicity and immunotoxicity, reproductive toxicity, safety pharmacology and genotoxicity
  • Safety considerations for novel mucosal and parenteral adjuvants
  • Safety testing of novel vaccines: recombinant protein vaccines, live attenuated vaccines and vectors, DNA and gene therapy based vaccines, whole mammalian cell vaccines
  • 16:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Bioterrorism - Meeting the New Challenged Posed by Bioterrorism with Vaccines
    Workshop

    Bioterrorism - Meeting the New Challenged Posed by Bioterrorism with Vaccines

    The Hatton, at etc. venues
    26th March 2004
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    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:

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