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Clinical Trials in CNS
15 November - 16 November 2010
Clinical Trials in CNS

This event is now in it's 10th year and currently in production. Please

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This years' conference on Clinical Trials in CNS will bring 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 SAE Media Group's conference aims to cover clinical drug discovery activities, new therapeutic targets, 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.


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- Biomarkers and imaging in CNS; The preclinical to clinical interface; Clinical trials in disease specific therapeutics (with a focus on Alzheimer's, Dementia, Depression & Suicidality); Industry and regulatory viewpoints; understanding and measuring cognition, as well as case study presentations on research consortiums and clinical trial developments.


"Treating neurodegenerative diseases already costs European health services some EUR 72 billion annually. There are few treatments for these conditions and those that are available tend to treat the symptoms rather than the underlying cause. Many of these diseases are linked to age, and the proportion of the European population aged over 65 is likely to rise to 25% by 2030 (from 16% today). The incidence of these conditions, as well as the social and financial costs of treating them, is therefore likely to rise in the coming years."

Brian Cummings, JPND Disease Research

 

Jonathan Stewart

Disease Area Head, Neuroscience, Immunology and Pain

Bristol-Myers Squibb 


  Babak Boroojerdi

Head of CNS Therapeutic Area

UCB Pharmaceuticals 

 

 Samuel Agus

Global Medical Affairs Director, Neurology

Abbott

 

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Chas Bountra

Chas Bountra, Chief Scientist, Structural Genomics Consortium, University of Oxford

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9:10

WHAT CAN CLINICAL TRIALS IN DEPRESSION TELL US ABOUT SUICIDALITY

  • Assessing suicidality
  • Suicidality as an endpoint
  • Do antidepressants cause suicide?
  • Alan Lenox-Smith

    Alan Lenox-Smith, Senior Clinical Research Physician, Eli Lilly

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    9:50

    CAN WE TREAT CHRONIC CNS DISEASES BY MODULATING CHROMATIN CHANGES?

    Chas Bountra

    Chas Bountra, Chief Scientist, Structural Genomics Consortium, University of Oxford

  • Breadth of potential epigenetic targets
  • Evidence for a role in schizophrenia, depression, drug abuse and neurodegeneration
  • Can we design selective modulators?
  • What are likely downsides of this approach?
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    10:30

    Morning coffee

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    11:00

    PROSPECTIVE SUICIDALITY MONITORING IN CLINICAL TRIALS

  • Better suicidality monitoring and the FDA
  • The Columbia - Suicide Severity Rating Scale (C-SSRS)
  • A unique self-rated approach
  • How the eC-SSRS interview has been validated
  • Coordinating self-rating at the site, reducing time and effort
  • Can the eC-SSRS reduce this monitoring cost?
  • John Greist

    John Greist, Director, Healthcare Technology Systems LLC

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    11:40

    SYMPTOMATIC CLINICAL TRIALS IN ALZHEIMER’S: CHALLENGES AND RECENT LESSONS

    Marina Zvartau-Hind

    Marina Zvartau-Hind, Director of clinical neurology, GlaxoSmithKline

  • Lessons from recent clinical trials
  • Measuring cognition and ADLs
  • Stratification of subjects by genetic and other factors
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    12:20

    Networking lunch

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    13:40

    LATEST DEVELOPMENTS IN ALZHEIMER’S DISEASE RESEARCH

    Jonathan Stewart

    Jonathan Stewart, Disease Area Head, Neuroscience, Immunology and Pain, Bristol-Myers Squibb / St Mary's Hospital

  • Novel targets
  • Late stage clinical trials
  • What’s new on the horizon
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    14:20

    BIOMARKERS IN ALZHEIMER'S CLINICAL STUDIES

    Frank Boess

    Frank Boess , Senior Clinical Research Scientist, Eli Lilly

  • Opportunities for the use of biomarkers in AD research and development
  • Imaging biomarkers
  • CSF biomarkers
  • Blood biomarkers
  • Outlook and new developments
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    15:00

    Afternoon Tea

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    15:30

    ANTIVIRAL AGENTS IN ALZHEIMER’S: HOPE FOR THE FUTURE?

    Ruth Itzhaki

    Ruth Itzhaki, Professorial Fellow in Molecular Neurobiology, University of Manchester

  • Evidence for a major role of a herpes virus in Alzheimer’s disease
  • Apolipoprotein E is a determinant of extent of viral damage
  • Antiviral agents counteract viral damage
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    16:10

    MAGNETIC RESONANCE IMAGING AS A MEASURE OF PROGRESSION AND INTERVENTION IN THE DEGENERATIVE DEMENTIAS

    Martin Rossor

    Martin Rossor, Professor of Clinical Neurology, University College London

  • Serial MRI can provide a reliable measure of whole brain and regional atrophy as a surrogate of neuronal loss
  • Studies of presymptomatic early and established AD and other degenerative dementias can establish the disease trajectory
  • The reliability of structural measures offers a biomarker for assessing therapeutic interventions
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    16:50

    Chairman’s closing remarks and close of day one

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Samuel Agus

    Samuel Agus, Global Medical Affairs Director, Neurology, Abbott Pharmaceuticals

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    9:10

    THE MEDICAL RESEARCH COUNCIL COGNITIVE FUNCTION AND AGEING STUDY

    Blossom Stephan

    Blossom Stephan, Research Associate, Cambridge Neuroscience

  • Overview and goals of the MRC CFAS
  • Data gathered and key findings
  • Normative data on cognitive tests and estimates, to assist in future participant selection and ensure representativeness of clinical trial samples
  • Ancillary studies as an important part of the remit of MRC CFAS
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    9:50

    OVERCOMING THE HIGH ATTRITION RATE OF ANTIDEPRESSANTS AND ANTIPSYCHOTICS FROM A CLINICAL POINT OF VIEW

    Ion-George Anghelescu

    Ion-George Anghelescu, Director of Clinical Science, Johnson & Johnson

  • Understanding the problem: safety and efficacy issues
  • Balance between better validated and novel targets
  • Translational research and its limitations
  • Developing viable R&D strategies to improve productivity
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    10:30

    Morning coffee

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    10:50

    DISEASE MODIFICATION STRATEGIES FOR PARKINSON'S DISEASE

    Babak Boroojerdi

    Babak Boroojerdi, Head of CNS Therapeutic Area, UCB

  • Analysing historical data and new developments
  • Identifying and overcoming trial design issues
  • Reviewing recent regulatory guidelines
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    11:30

    RG3487: ENHANCING COGNITION IN DISEASE

    Richard  Porter

    Richard Porter, R&D Project Leader, Hoffmann-La Roche

  • A novel nicotinic alpha7 receptor agonist therapy for cognitive impairments
  • The development of RG3487
  • Alzheimer’s
  • Schizophrenia
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    12:10

    NOVEL TECHNIQUES FOR PRECLINICAL STUDIES OF COGNITION

    Sophie Dix

    Sophie Dix, Senior Research Scientist, Eli Lilly

  • Why do we need new approaches for cognitive testing?
  • Application of novel techniques to drug discovery including: Touchscreens , Biosensors, Sleep Deprivation, Ketamine
  • Where next for cognitive testing to ensure translation into the clinic?
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    12:50

    Networking lunch

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    13:50

    DISCOVERY BIOMARKERS IN CNS CLINICAL AND/OR DRUG DEVELOPMENT

    Hassan Rahmoune

    Hassan Rahmoune, Head of Translational Medicine & Discovery Biomarkers, University of Cambridge

  • Multi approach strategy for biomarkers discovery in CNS
  • Biology/markers arm into CNS clinical trials
  • Translational (and reverse translation) strategy in CNS
  • Development of a serum based marker as an aid in the confirmation of Schizophrenia or companion diagnostic
  • Lessons learned from biomarkers discovery and  study design
  • clock

    14:30

    LATE PHASE STUDIES

    Samuel Agus

    Samuel Agus, Global Medical Affairs Director, Neurology, Abbott Pharmaceuticals

  • How late? It is never too early for a late phase study
  • How to provide a 'real life' pictures of the product
  • The long term: safety and performance- defining the risk-benefit ratio
  • How to define and show cost-effectiveness for neuroscience products
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    15:10

    Afternoon Tea

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    15:30

    THE GREAT DIVIDE: ESTABLISHING PROOF OF PRINCIPLE FOR NOVEL CNS TARGETS

    Mark Smith

    Mark Smith, Medical Director, AstraZeneca

  • Predictive validity of animal models
  • Establishing brain penetrance
  • Pharmacodynamic endpoints
  • Patient subpopulations and endophenotypes
  • Optimizing Phase IIa trials
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    16:10

    STROKE IMAGING REPOSITORY (STIR) RESEARCH CONSORTIUM

    Marie Luby

    Marie Luby, Post Doctoral Scientist , National Institutes of Health

  • The foundation of STIR
  • Repository tools and current projects
  • Results of perfusion algorithm project
  • Future goals of STIR
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    16:50

    Chairman’s Closing Remarks and Close of Conference

    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    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, 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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