Home
overview

 

 * SMi's Clinical Trials in CNS conference is now in its 9th year - click below to view our 2010 event *

 

 


 


2009 Past Event Details:

“The topics of the lectures are well balanced, and the speakers are selected very well. It was a pleasure to participate. Thank you.”
Petr Kopecek, Clinical Scientist, Boehringer Ingelheim, SMi’s 2008 Clinical Trials in CNS Conference
 

More than 26 million people worldwide were estimated to be living with Alzheimer's disease in 2006, and it is estimated that the global prevalence of Alzheimer's disease will grow to more than 106 million by 2050. SMi’s 8th annual event on Clinical Trials in CNS, will look at new advances in the treatment of this disorder of the central nervous system, as well as examining others.

Experts will consider emerging disease targets, use of biomarkers and imaging techniques in clinical trials, cognitive testing, translational medicine, as well as safety and regulatory issues.  There will also be an update on progress of the recent Alzheimer's Disease Neuroimaging Initiative (ADNI).

  • GAIN insight into appropriate safety measures
  • HEAR the latest progress of ADNI
  • UNDERSTAND how to design better CNS trials
  • EVALUATE different end-point methods
  • DISCOVER recent advances in disease method understanding and target identification
  • Clinical Trials Directors
  • Medical Directors
  • Clinical Development Directors
  • Clinical Research Directors
  • Senior Scientists
  • Chief Scientific Officers

Organisations registered so far this year include:

  • Averion International
  • BTG
  • Celentyx
  • Cytox
  • Eisai
  • F. Hoffmann-La Roche
  • GlaxoSmithKline
  • Imperial College
  • Lundbeck
  • Merck Sharp & Dohme
  • NeuroSearch
  • Noscira
  • Otsuka Pharmaceutical
  • Pharmaneuro Boost
  • Proximagen
  • Roche Products
  • Schering-Plough
  • Takeda Europe
  • Teva Pharmaceuticals
  • UK Trade and Investment
 

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Karl Herholz

Karl Herholz, Professor of Clinical Neuroscience, The University Of Manchester

9:10 EMERGING TARGETS FOR ALZHEIMER’S

Steve Jacobsen

Steve Jacobsen, Associate Director, Neuroscience Discovery, Wyeth Research

  • Disease modifying approaches
  • Basic disease mechanisms
  • New mechanisms
  • Current programmes in discovery and clinical trials
  • 9:45 NOVEL THERAPIES FOR SYMPTOMATIC TREATMENT OF ALZHEIMER’S

    Sophie Dix

    Sophie Dix, Senior Research Scientist, Eli Lilly

  • Current therapies - are they working? 
  • Nicotinics 
  • Phosphodiesterase inhibitors 
  • Dimebon 
  • New directions
  • 10:20 EARLY PHASE CLINICAL TRIALS FOR NOVEL THERAPIES

    Jill Rasmussen

    Jill Rasmussen, Director, psi-napse

  • PK profile: peripheral and central
  • Pharmacodynamic considerations
  • Biomarker read-outs: target, drug effect, disease effect
  • 10:55 Morning Coffee

    11:15 CHALLENGES IN DESIGNING SMALL CLINICAL EFFICACY STUDIES IN ALZHEIMER’S DISEASE

    Nicola Scott

    Nicola Scott, Principal Statistician, GlaxoSmithKline

  • Challenges of designing efficacy studies in AD
  • Using a cognitive test battery as the primary endpoint
  • Using simulation methods to aid design of small clinical efficacy studies
  • 11:50 SUICIDALITY MONITORING – AN INDUSTRY OVERVIEW OF THE FDA’S DIRECTIVE

    David Katzelnick

    David Katzelnick , Director, Healthcare Technology Systems LLC

  • Assessing the need for suicidality monitoring by therapeutic area
  • An overview of the FDA requirement for assessments at every visit in every trial
  • Reducing the site burden whilst maintaining reproducibility across your study
  • Outlining a pragmatic and powerful approach to address this critical need
  • 12:25 Networking Lunch

    13:40 OVERVIEW OF CLINICAL TRIALS IN THE BALKAN REGION

    Josip Aralica

    Josip Aralica, Chief Executive Officer, Altiora

  • Overview of CNS potential in the Balkan region
  • The region in numbers
  • Therapeutic opportunities
  • Regulatory challenges
  • 14:20 VIGILANCE, ATTENTIONAL & COGNITIVE DISRUPTION

    Remy Luthringer

    Remy Luthringer, Chief Executive Officer, Forenap

  • Functional imaging
  • Behavioural methods
  • Complementary use with traditional biomarkers 
  • Using sleep-wake EEG with Neuro-Psychiatric patients
     
  • 15:00 ALZHEIMER’S DISEASE NEUROIMAGING INITIATIVE (ADNI)

    Mark Schmidt

    Mark Schmidt, Senior Director and Clinical Expert CNS, Johnson & Johnson Pharmaceutical

  • Status update and outcomes
  • How far have we come?
  • What’s the future for this initiative?
  • Have we achieved what we set out to do?
  • 15:40 Afternoon Tea

    16:00 PREDICTIVE VALUE OF PET IMAGING BIOMARKERS

    Karl Herholz

    Karl Herholz, Professor of Clinical Neuroscience, The University Of Manchester

  • Tracers and analysis techniques for PET imaging biomarkers
  • Quantification of dementia risk in MCI
  • Potential and limitations of PET biomarkers as outcome parameter
     
  • 16:35 CASE STUDY: STROKE IMAGING ANALYSIS

    Marie Luby

    Marie Luby, Post-doctoral Scientist, National Institute of Neurological Disorders and Stroke, National Institutes of Health

  • Pros and cons of using CT and MRI in the acute clinical setting of stroke
  • Emphasis on the image analysis of MRIs for the diagnosis of stroke and enrolment of patients into clinical trials 
  • Usage of MRI data for prediction of patient outcomes in terms of stroke severity
     
  • 17:10 SAFETY AND REGULATORY ISSUES IN CNS STUDIES

    Malcolm Barratt-Johnson

    Malcolm Barratt-Johnson, Managing Partner, The BJ Partnership LLP

  • Current regulatory issues in Phases I to III
  • Pharmacovigilance - old problems - new paradigms ?
  • Can pharmacovigilance ever be predictive in a clinical trial setting?
  • 17:45 Chairman’s Closing Remarks

    17:50 Complimentary Drinks Reception

    19:00 Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Mark Schmidt

    Mark Schmidt, Senior Director and Clinical Expert CNS, Johnson & Johnson Pharmaceutical

    9:10 DRUG DEVELOPMENT FOR COGNITIVE DISORDERS

    Andrew Blackwell

    Andrew Blackwell, Chief Scientific Officer, Cambridge Cognition

  • Screening for cognitive toxicity
  • Measuring cognitiveefficacy in healthy volunteers
  • Demonstrating remediation of cognitive dysfunction in Alzheimer's disease, Schizophrenia and ADHD
  • Translational approaches - gathering convergent evidence of cognitive effects through the development lifecycle
  • Casestudies
  • 9:50 COMPUTERISED COGNITIVE ASSESSMENT IN DRUG DEVELOPMENT

    Keith Wesnes

    Keith Wesnes, Practice Leader, United BioSource Corporation

  • Overcoming barriers into patient trials
  • The five main systems commercially available
  • Utility in phase I 
  • The CDR system versus the MATRICS
  • A MATRICS approach to the dementias, could one system fit all?
  • 10:30 Morning Coffee

    11:00 TRANSLATIONAL MEDICINE

    Magnus Sjogren

    Magnus Sjogren, Global Head Translational Medicine, Schering-Plough

  • Filling the gap between discovery and early development
  • Biomarkers for early decision making
  • Quality of POC trail paradigms
  • CNS specific issues in translational medicine
  • 11:40 OPTIMIZING AND ENSURING SCIENTIFICALLY VALID STUDY RESULTS IN CNS CLINICAL TRIALS WITH APPROPRIATE RATER SELECTION

    Alan Kott

    Alan Kott, Clinical Director, United BioSource Corporation

  • Optimal rater characteristics
  • Disease specific considerations for rater selection
  • Surveillance methods for limiting rater drift
  • 12:20 Networking Lunch

    13:50 CHALLENGES IN ALS AND SMA CLINICAL TRIALS - EXAMPLE OF OLESOXIME

    Jean-Louis Abitbol

    Jean-Louis Abitbol, Chief Medical Officer, Trophos

  • Translational issues in motor-neuron diseases
  • ALS function and survival phase 2/3 trials: are futility designs useful ?
  • Breaking new ground in SMA phase 2 clinical trials
  • 14:30 DISEASE MODIFYING AND SYMPTOMATIC APPROACHES IN PARKINSON’S DISEASE

    Babak Boroojerdi

    Babak Boroojerdi, Senior Director, UCB TA

  • New approaches
  • Disease modifying
  • Symptomatic treatment
  • 15:10 Afternoon Tea

    15:40 CLINICAL VALUE OF ACCELERATED ANTI-DEPRESSANT EFFECT

    Erik Buntinx

    Erik Buntinx, Managing Director and Chief Scientific Officer, Pharmaneuro Boost

  • The impact on treatment adherence in moderate to severely depressed patients
  • Lag time of antidepressants: an unmet medical need
  • Early onset of action versus accelerated antidepressant effect: how to define the difference?
  • Pharmacological considerations to induce accelerated antidepressant effect
  • Treatment adherence in relation to an antidepressant with an accelerated effect
     
  • 16:20 HERPES SIMPLEX VIRUS TYPE 1 IN BRAIN: A NOVEL TARGET IN ALZHEIMER’S DISEASE

    Ruth Itzhaki

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

  • Evidence implicating HSV1 ( AD plaques in brain of  APOE-e4 carriers) as a major cause of Alzheimer’s disease
  • Treatment strategies for combating the proposed viral cause in Alzheimer’s disease
  • Antiviral agents prevent accumulation of β-amyloid and phosphorylation of tau
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    Effective Project Management in Clinical Trials
    Workshop

    Effective Project Management in Clinical Trials

    Crowne Plaza Hotel - St James
    24th November 2009
    London, United Kingdom

    Suicidality: Clinician and computer assessment
    Workshop

    Suicidality: Clinician and computer assessment

    Crowne Plaza Hotel - St James
    24th November 2009
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.