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Asthma is one of the most common chronic diseases worldwide, affecting more than 130 million people. In the EU and the United States asthma is thought to affect 38 million people, with the highest rate of increase amongst children under 5 years old. It has been estimated that 90% of patients with severe persistent asthma are given prescription drugs, while only 5-8% of mild intermittent cases receive prescriptions.

The huge increase in cases in recent years has fuelled the rapid growth of global therapeutic markets and, whilst drugs already on the market remain relatively effective, new therapies that offer significant advantage over existing drugs hold the key to an extremely lucrative market.

This event will provide an update of the latest advances in the search for effective asthma therapeutics, addressing the challenge of the discovery of new drug classes with improved efficacy and reduced side effects. The event will look at how to raise the level of patient compliance, will evaluate research into preventative therapeutics and assess the developments in orally active agents with favourable profiles.

In addition to an evaluation of emerging drug targets and their limitations, this event will assess products in the pipeline of leading companies in the field and deal with the challenges of clinical trials with a focus on the significance of the paediatric rule in the US and possible regulatory changes in the EU.

A unique opportunity to learn from leading industry experts including:
· Dr John Warren, Medical Assessor, Medicines & Healthcare Products Regulatory Agency (MHRA)
· Prof Malcolm Johnson, Global Director, Respiratory Science, GlaxoSmithKline
· Dr Sandy Goldman, Director, Respiratory Diseases, Wyeth
· Dr Noel Snell, Global Clinical Expert, Respiratory, AstraZeneca
· Dr Heribert Staudinger, Vice President, Clinical Development, Allergy, Respiratory & Clinical Immunology, Schering Plough
· Dr Claudia Zuany, Senior Project Leader, Pfizer
· Dr Dirk Bredenbröker, Head, Clinical Research Pulmonology, Altana Pharma
· Dr Brian Champion, Vice President, Research, Lorantis
· Dr Merdad Parsey, Senior Director, Immunology, Regeneron

Programme highlights include:
· THE CPMP ASTHMA GUIDELINE: Discover the latest regarding the European guideline from the MHRA
· ANTAGONISTS IN ASTHMA: Hear about CPLA2 in vitro activities and the preclinical evaluations
· COMBINATION THERAPY: Gain an insight into long-acting beta2-agonists and corticosteroids
· CLINICAL ENDPOINTS IN ASTHMA: Learn about the regulatory requirements and how to select the appropriate endpoint
· DRY POWDER INHALATION: Assess recent innovations in response to current challenges
· CASE STUDIES: Understand the latest developments in drug development from leading companies in the field

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Alan Davies

Dr Alan Davies, Therapeutic Director, Kendle

9:10 THE LATEST TRENDS IN THE ASTHMA MARKET

Dr Kularisi Gunawardena

Dr Kularisi Gunawardena, Director, Clinical Research, Chiltern International

  • Unmet clinical needs
  • Potential areas for growth
  • Domination of asthma therapeutics by combination drugs
  • New directions in asthma
  • New delivery solutions and improving patient compliance
  • 9:40 EUROPEAN CPMP ASTHMA GUIDELINE

    Dr John Warren

    Dr John Warren, Medical Assessor, Medicines & Healthcare Products Regulatory Agency (MHRA)

  • Pharmacology first
  • Endpoints, grades and GINA
  • Paediatric obligations
  • Pitfalls in trial design
  • 10:20 REGULATING THE IMMUNE SYSTEM TO TREAT ASTHMA

    Dr Brian Champion

    Dr Brian Champion, Vice President, Research, Lorantis

  • Immunology of asthma
  • Role of regulatory T-cells
  • Possible therapeutic approaches to modulating T-cell dependent airway inflammation
  • Notch signalling in immune cells
  • Immunotherapeutics based on the Notch ligand Delta 1
  • 11:00 Morning Coffee

    11:20 USING HUMAN GENETICS TO IDENTIFY G PROTEIN-COUPLED RECEPTORS (GPCRs) LINKED TO INFLAMMATORY DISEASE

    Dr Roy Pettipher

    Dr Roy Pettipher, Director, Therapeutics, Oxagen

  • In addition to being excellent drug targets GPCRs are prime candidates for influencing genetic susceptibility to disease
  • Single nucleotide polymorphisms (SNPs) occur in GPCRs with remarkably high frequency and many of these SNPs have been shown to affect receptor function and precipitate disease
  • Given the druggability and polymorphic nature of GPCRs, Oxagen has focussed its drug discovery pipeline on receptors selected by genetic association in relevant clinical populations
  • Data will be presented on an asthma target selected on the basis of genetic association
  • 12:00 MAP KINASE INHIBITORS IN ASTHMA

    Dr Kate Blease

    Dr Kate Blease, Scientist, Celgene

  • MAP kinase pathways as targets for novel asthma therapies
  • Role for JNK in asthma
  • Inflammation
  • Smooth muscle and fibroblast function
  • T-cell function
  • 12:40 Networking Lunch

    14:00 CPLA2 ANTAGONISTS IN ASTHMA

    Dr Sandy Goldman

    Dr Sandy Goldman, Director, Respiratory Diseases, Wyeth

  • cPLA2-related pathways in asthma
  • In vitro activities
  • Preclinical evaluations
  • 14:40 PDE IV INHIBITORS

    Dr Dirk Bredenbröker

    Dr Dirk Bredenbröker, Head, Clinical Research Pulmonology, Altana Pharma

  • PDE IV as an important target for the development of novel asthma therapies
  • Novel PDE IV inhibitors under clinical development
  • Efficacy of selective PDE IV inhibitors in asthma and COPD, exemplified by Roflumilast
  • Results of phase III clinical development of Roflumilast in asthma
  • 15:20 Afternoon Tea

    15:40 CONDUCTING PHASE II AND PHASE III CLINICAL TRIALS

    Dr Alan Davies

    Dr Alan Davies, Therapeutic Director, Kendle

  • Regulatory environment
  • Outcome measures
  • Clinical endpoints
  • Other endpoints
  • Paediatric studies
  • 16:20 CLINICAL ENDPOINTS IN ASTHMA

    Dr Noel Snell

    Dr Noel Snell, Global Clinical Expert, Respiratory Medicine, AstraZeneca

  • Regulatory requirements: lung function and symptoms
  • Secondary endpoints
  • Surrogate endpoints for proof-of-principle
  • Endpoints for potential disease-modifying agents
  • Specific safety assessments
  • 17:00 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Professor Joel Kline

    Professor Joel Kline, Associate Professor, Director, Asthma Centre, University of Iowa

    9:10 ARE INHALED CORTICOSTEROIDS ADMINISTERED BID MORE EFFECTIVE THAN ADMINISTERED ONCE DAILY?

    Dr Heribert Staudinger

    Dr Heribert Staudinger, Vice President, Clinical Development Allergy, Respiratory & Clinical Immunology, Schering-Plough Research Institute

  • The role of compliance in the treatment of asthma
  • Chronobiology and chronopharmacology of asthma
  • Published studies on once daily administration of ICS
  • Once daily administration of mometasone furoate in adults
  • Once daily administration of mometasone furoate in children
  • Safety data
  • 9:40 COMBINATION THERAPY WITH LONG-ACTING BETA2 –AGONISTS AND CORTICOSTEROIDS

    Prof Malcolm Johnson

    Prof Malcolm Johnson, Global Director Respiratory Science, GlaxoSmithKline

  • Asthma is a multi-component disease
  • LABA and CS affect different aspects of the underlying pathophysiology
  • Combination therapy offers opportunities for addictive and synergistic effects
  • Clinical efficacy is superior to monotherapy
  • Combination therapy is more effective than concurrent therapy
  • 10:20 COMBINED IL-4 AND IL-13 BLOCKADE IN ASTHMA

    Dr Merdad Parsey

    Dr Merdad Parsey, Senior Director, Immunology, Regeneron

  • The IL-4/13 ‘cytokine trap’ is a IgG Fc fusion molecule containing the extracellular domains of both IL-4 (IL-4Ra) and IL-13 (IL-13Ra1) receptors and binds both IL-4 and IL-13 with high affinity
  • A double blind, placebo-controlled, sequential, first-in-human study consisting of single and multiple dose treatment arms of IL-4/13 Trap was conducted
  • IL-4/13 Trap was generally well tolerated
  • The mean Cmax and AUC for IL-4/13 Trap increased approximately linearly with dose. The IL-4/13 Trap had a prolonged plasma half life
  • IL-4/13 Trap is a novel therapeutic with potential for the treatment of patients with asthma and other disorders which may be responsive to combined antagonism of IL-4 and IL-13
  • 11:00 Morning Coffee

    11:20 SAFETY PROFILE OF A NEW INHALED CORTICOSTEROID

    Dr James Fish

    Dr James Fish, Senior Distinguished Scientist, Aventis

  • Characteristics of an ideal inhaled corticosteroid
  • Pharmacologic attributes predicting topical and systemic safety
  • Pharmacodynamic studies of HPA axis function
  • Safety and efficacy in phase III clinical studies
  • 12:00 POTENTIAL IMMUNOTHERAPEUTIC APPROACHES

    Dr Claudia Zuany

    Dr Claudia Zuany, Senior Project Leader, Pfizer

  • Allergen-specific immunotherapy
  • Recombinant allergens
  • T-cell peptides
  • DNA vaccines
  • CpG ODN
  • Bacterial vaccines
    Toll-like receptor-based treatment strategies in asthma
  • 12:40 Networking Lunch

    14:00 TREATING ALLERGIC DISORDERS BY ACTIVATING REGULATORY T CELLS

    Prof Graham Rook

    Prof Graham Rook, Professor, Medical Microbiology / Research Director, Royal Free & University College Medical School /SR Pharma

  • Allergies are increasing because of defective immunoregulatory function in developed countries
  • The ‘hygiene hypothesis’ is explained by defective immunoregulation, not by Th1/Th2 imbalance
  • Which micro-organisms activate Treg and why do they do it?
  • SRP299 activates Treg in mice
  • Clinical studies in man
  • Mechanism of action in man
  • 14:40 CpG OLIGONUCLEOTIDES IN THE TREATMENT OF ASTHMA

    Professor Joel Kline

    Professor Joel Kline, Associate Professor, Director, Asthma Centre, University of Iowa

  • Environmental/epidemiologic rationale
  • Asthma prevention
  • Therapeutic vaccines
  • Mechanisms of action
  • Early human experience
  • 15:20 Afternoon Tea

    15:40 RECENT INNOVATIONS IN DRY POWDER INHALATION

    Mark Rowlands

    Mark Rowlands, Business Development Manager, Innovata Biomed

  • Innovation drivers
  • Major issues
  • Regulatory challenges
  • Device innovation
  • Combination drug delivery
  • 16:20 COMMERCIALISATION OF A NEW ASTHMA INHALER

    Dr Carsten Niederlaender

    Dr Carsten Niederlaender, Head, Technical Research Development & Production, Skyepharma

  • Ideas and patent protection
  • Development of first products: optimization and selection of formulation and device
  • Meeting the regulatory challenge
  • From first clinical trial material to commercial production
  • 17:00 Chairman’s Closing Remarks and Close of Conference

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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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