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Following the success of last year's event, SMi will be bringing together leading industry experts to explore the current and future opportunities within CNS drug development. Representing the second largest therapeutic segment of the pharmaceutical market it is also one of the fastest growing. This year SMi’s conference aims to cover preclinical drug discovery activity as well as effective CNS drug development strategies and problems encountered in clinical trials, with in-depth discussions and case study presentations from the key industry players including, Johnson & Johnson, Eli Lilly and Novartis.

As CNS therapies become more complex and difficult to bring to market, the need to consider issues involved in effective trial design is increasingly important. Key issues include discussion on clinical research- the preclinical to clinical interface; clinical trials in disease specific therapeutics (with a focus on Alzheimer’s, Multiple Sclerosis, Pain, Anxiety, ADHD and Sleep disorders); regulatory updates; effective measurement and the placebo effect, as well as case study presentations on the management of specific CNS drugs during the development stage.

Learn why CNS clinical trials and drug development are among the most challenging in all areas of medicine and how your business can overcome this and produce effective treatments for a range of CNS diseases today. With constant changing dynamics in the CNS market this is a must attend event for pharmaceutical executives to keep abreast of the current and future market developments in the area.

Speakers at this year's event include:

  • Dr Mark Schmidt, Johnson & Johnson
  • Dr Craig Earl, Senior Director, Clinical Research, Cephalon
  • Dr Pim Drinkenburg, Head, Biomonitoring Research RED Europe & Research Fellow, Johnson & Johnson
  • Dr Andrew Grupe, Director, CNS Research, Celera Diagnostics
  • Dr Thomas Steckler, Therapeutic Area Leader, Psychiatry & Biology Head, Johnson & Johnson
  • Dr Anthony Basile, Senior Director, Pharmacology, DOV Pharmaceuticals
  • Dr Rico Nil, Medical Director, H Lundbeck
  • Dr Christian Czech, Senior Research Scientist, CNS Research, Pharmaceutical Division, F. Hoffmann La Roche
  • Dr Craig Mallinckrodt, Research Advisor, Eli Lilly

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Mark Schmidt

Mark Schmidt, , Johnson & Johnson PRD

9:10 COGNITIVE TESTING IN CNS TRIALS

Keith Wesnes

Keith Wesnes, Chief Executive, CDR Limited

  • CNS drugs for cognitive function market trends - what areas are growing and which are shrinking?
  • Identifying the main problem areas for 2005/6 and beyond
  • Why do so many CNS trials fail?
  • Beyond CNS trials - bringing products onto the market
  • The role of pharma companies in drug development
  • CNS drugs of tomorrow
  • 9:50 RECENT DRUG DISCOVERY IN CNS

    Thomas Steckler

    Thomas Steckler, Therapeutic Area Leader, Psychiatry & Biology Head, Johnson & Johnson

  • Potential problems and innovative solutions
  • An overview of Phase I clinical trials – the issues involved
  • Novel CNS compounds for the near future
  • Re-engineering discovery and development
  • 10:30 Morning Coffee

    11:00 PRECLINICAL DRUG DISCOVERY

  • Target the amyloid cascade to delay disease progression
  • Emerging targets addressing neurodegeneration in AD
  • Analyse current approaches for AD disease modification
  • Monitor side effects of Alzheimer therapies
  • Identification and validation of biomarkers for clinical trials
  • Christian Czech

    Christian Czech, Senior Research Scientist, CNS Research, Pharmaceutical Division, F Hoffmann La Roche Ltd

    11:40 BRIDGING THE GAP FROM PRECLINICAL TO CLINICAL

    Pim Drinkenburg

    Pim Drinkenburg, Head, Biomonitoring Research, RED Europe & Research Fellow, Johnson & Johnson

  • Streamlining the transition to de-risk NMEs
  • Examples of preclinical/clinical integrative technology
  • Use and usefulness of appropriate biomarkers
  • Future implications for the drug development process
  • 12:20 Networking Lunch

    13:50 PANEL DISCUSSION

  • What effect do current regulations have on the clinical trial process internationally?
  • Potential technologies/strategies/solutions?
  • Can we create a global outlook with standardisation?
  • What are the future trends and predictions?
  • Marie Luby

    Marie Luby, CNS Programme Director, Perceptive Informatics

    Amir Kalali

    Amir Kalali, Vice President, Medical & Scientific Services & Global Scientific Head, Quintiles

    Mark Schmidt

    Mark Schmidt, , Johnson & Johnson PRD

    14:30 COGNITIVE TESTING IN CLINICAL TRIALS

    Alex Collie

    Alex Collie, Senior Clinical Scientist, Cogstate Ltd

  • Cognitive tests are widely used as primary and secondary outcomes in CNS trials
  • As trial design and methods vary with phase of clinical development, cognitive tests used in one phase may be inappropriate for use later in the development process
  • Selection of appropriate tests for a given trial requires detailed knowledge of the target disease, trial methods, test design, test limitations and constraints, as well as methods of test development and validation
  • This presentation will summarise the key features of cognitive tests for use in phase I to IV CNS research
  • Examples from numerous CNS trials involving the CogState computerised cognitive test system will be provided
  • 15:10 Afternoon Tea

    15:40 DISCONTINUATION SYMPTOMS IN DEPRESSION AND ANXIETY DISORDERS

    Rico Nil

    Rico Nil, Medical Director, H Lundbeck

  • Regulatory guidelines
  • Definitions and assessment instruments
  • Potential study designs and examples
  • Are discontinuation symptoms drug or disorder specific?
  • Implications for clinical development
  • 16:20 GENETIC MARKERS

  • The need for replication
  • Genetics and target identification
  • Pros and cons of clinical trial stratification
  • The timetable requires co-development of the therapeutic product and diagnostic tests
  • Andrew Grupe

    Andrew Grupe, Director, CNS Research, Celera Diagnostics

    17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Amir Kalali

    Amir Kalali, Vice President, Medical & Scientific Services & Global Scientific Head, Quintiles

    9:10 PROOF OF CONCEPT IN CNS

    Remy Luthringer

    Remy Luthringer, Chief Executive Officer, Forenap Pharma

  • Identifying the clinical potential of a drug at the early stages of development
  • An innovative technology platform – how effective? How successful?
  • Efficacy vs tolerability in the development of NCE’s
  • Strategies for planning a successful trial
  • Combining PK/PD
  • 9:50 CLINICAL TRIAL DESIGN

    Craig Earl

    Craig Earl, Senior Director, Clinical Research, Cephalon Inc

  • Analysis of current market and recent developments
  • Where trials can be adapted
  • Regulatory considerations and guidelines
  • The search for effective drug development
  • Difficulties with trials in children and adolescents
  • 10:30 Morning Coffee

    11:00 STROKE TRIAL DESIGN

    Marie Luby

    Marie Luby, CNS Programme Director, Perceptive Informatics

  • Imaging-based criteria – inclusion and exclusion considerations
  • Imaging-based assessments for secondary analyses
  • MRI vs CT advantages
  • Role of centralised imaging in secondary analyses
  • 11:40 IMAGING IN CNS DRUG DEVELOPMENT

  • The role of functional imaging in CNS trials
  • Imaging in diagnosis and progression of disease
  • Selection of methods and outcome measures
  • Impact of imaging on the conduct of trials
  • A focus on Alzheimer’s
  • Future implications
  • Mark Schmidt

    Mark Schmidt, , Johnson & Johnson PRD

    12:20 Networking Lunch

    13:50 SIGNAL DETECTION IN CNS CLINICAL TRIALS: PAST, PRESENT AND FUTURE

  • An historical look at how well we can distinguish active drugs from placebo
  • The impact of placebo response on signal detection
  • Recent developments for improving signal detection
  • Designs and approaches of the future
  • Putting the pieces together
  • Craig Mallinckrodt

    Craig Mallinckrodt, Research Advisor, Eli Lilly & Co

    15:10 Afternoon Tea

    15:40 DEVELOPMENT OF THE NON-OPIOID ANALGESIC

    Anthony Basile

    Anthony Basile, Senior Director, Pharmacology, DOV Pharmaceutical, Inc.

  • Molecular mechanism
  • Efficacy in preclinical models of acute and chronic pain
  • Efficacy in models of inflammatory pain
  • Efficacy in models of neuropathic pain
  • Regulatory requirements for demonstration of clinical efficacy: the bicifadine experience
  • Regulatory requirements for assessment of abuse potential
  • Choice of clinical models of analgesia
  • 16:20 HOW CAN SPONSORS AND SITES IMPACT PLACEBO RESPONSE AND STUDY SUCCESS?

    Amir Kalali

    Amir Kalali, Vice President, Medical & Scientific Services & Global Scientific Head, Quintiles

  • What factors at the site level might impact placebo response and study success?
  • What methodological factors might impact placebo response and study success?
  • What factors at the sponsor level might impact placebo response and study success?
  • What can be done to address these issues?
  • 17:00 Chairman’s Closing Remarks and Close of Day One

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    Workshops

    Tools and Methods to Enhance Proof of Concept in CNS Drug Development
    Workshop

    Tools and Methods to Enhance Proof of Concept in CNS Drug Development

    Millennium Gloucester Hotel
    7th December 2005
    London, United Kingdom

    Millennium Gloucester Hotel

    Harrington Gardens
    London SW7 4LH
    United Kingdom

    Millennium Gloucester Hotel

    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:

    ‘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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