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"We live in times of great challenges and opportunities for developing new drugs for CNS disorders.  While traditional clinical outcomes remain necessary, the information captured by these outcomes is often noisy, dated, and superficial.  Methods such as biomarkers, imaging, and cognitive performance testing are promising endpoints for CNS trials however implementation, interpretation, and validation are major issues.  Moreover, the development of standards for these technologies is a task that must be shared by sponsors, vendors, and investigators.  The conference on Clinical Trials in CNS organized by SMi is an excellent opportunity to learn from each other as we confront these tasks."  Mark Schmidt, Director and Clinical Expert, CNS, Johnson & Johnson


With recent media attention focussed on the clinical trials of anti-depressants, CNS drugs and their trials have come under fire. Following last year's success, SMi are proud to present their 7th Annual Clinical Trials in CNS conference which will bring you the latest on clinical trial optimisation, pitfalls and considerations. Don't miss this opportunity to hear the latest developments in CNS clinical trials from reknowned industry experts including:

 Stephen Wright, Director, Research and Development, GW Pharmaceuticals
Malcolm Barratt-Johnson, Managing Partner, The BJ Partnership LLP &Consulting Medical Assessor, MHRA

  • Mark Schmidt, Director and Clinical Expert, CNS, Johnson & Johnson
  • J Findlay Walker, Vice President, EU Administration, Daiichi Sankyo
  • Fiona Guillard, Drug Development Sciences, GlaxoSmithKline
  • Boris Chizh, Director, Exploratory Pain Medicine, GlaxoSmithKline
  • Corinne Hagger, Clinical Research Scientist, Merck Serono
  • Keith Wesnes, Chief Executive, Cognitive Drug Research
  • Sophie Dix, Group Leader, Eli Lilly
  • Alan Lenox-Smith, Senior Medical Advisor, Wyeth
  • Malek Bajbouj,Director and Principal Consultant CNS Services Clinical Pharmacology,Parexel

Who should attend:

  • Medical Directors
  • Director of Metabolic Diseases
  • Senior Scientists - CNS Diseases
  • Directors of Clinical Research
  • Senior Clinical Project Managers
  • Benefits of attending:
    • Hear the latest in anti-depression drugs and how recent developments have affected current clinical trials
    • Discover the newest in imaging analyses: monitoring and predictive capabilities
    • Gain insight into patient recruitment for CNS Clinical Trials
    • Evaluate the prediction of human efficacy in animal models

    Conference programme

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Malcolm Barratt-Johnson

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

    9:10 IMPROVED ASSESSMENT OF PROOF OF CONCEPT

    Stephen Wright

    Stephen Wright, Director of Research & Development, GW Pharmaceuticals

  • Pharmacodynamics in animal models
  • Assessment of drug efficacy
  • Costs and benefits of assessment improvements
  • Improving the chances for success and identifying failures
  • 9:50 INDUSTRY VIEWPOINT ON THE CURRENT STATUS OF ANTI-DEPRESSANTS

    Alan Lenox-Smith

    Alan Lenox-Smith, Senior Medical Advisor, Wyeth Research

  • What does 3 points difference on a Hamilton Scale mean to a patient
  • Which endpoints should we be using in Depression
  • Understanding the media fuss over antidepressants
  • 10:30 Morning Coffee

    11:00 COGNITION IN ALZHEIMER'S DISEASE (AD) AND SCALES TO ASSESS COGNITION IN AD

    Corinne Hagger

    Corinne Hagger, Clinical Research Scientist, Merck Serono

  • Available treatment
  • Ongoing Research and Development
  • Cognition in AD
  • Scales to assess cognition in AD
  • 11:40 COMPUTERISED COGNITIVE FUNCTION ASSESSMENT COMES OF AGE IN DRUG DEVELOPMENT

    Keith Wesnes

    Keith Wesnes, Chief Executive, Cognitive Drug Research

    Computerised tests are becoming widely used in all areas of drug development, from basic safety testing to helping establish the efficacy of anti-dementia drugs. This review will provide an update on the range applications of such techniques, from Phase I through to Phase IV.
  • Learn how cognition enhancement can this be established in Phase I
  • Evaluate case studies of successful translational medicine in dementia, ADHD and schizophrenia
  • Decide for yourself whether there is a credible computerised alternative to the ADAS-Cog
  • Hear about novel areas for automated cognitive testing, from CABG to hyponatremia.
  • Understand the value of screening for cognitive toxicity as well as drug-drug and drug-alcohol interactions.
  • Appreciate the new opportunities that internet based cognitive testing can bring to Phase IV
  • 12:20 Networking Lunch

    13:30 MRI IN CNS TRIALS: MULTIMODAL APPROACHES AND COMPLEX DISEASE

    Mike O'Sullivan

    Mike O'Sullivan, Medical Research Council Clinician Scientist, Institute of Cognitive Neuroscience

  • Quantifying vascular damage
  • Trials in cerebrovascular disease – lessons from CADASIL
  • The hippocampus – beyond Alzheimer’s disease
  • Combining imaging and cognitive markers
  • Single networks to final common pathways
  • 14:10 MAGNETIC RESONANCE IMAGE DATA ANALYSIS IN DEMENTIA TRIALS

    Chahin Pachai

    Chahin Pachai, Executive Director, Bio-Imaging Technologies

  • Requirements for image quality and site qualificatioN
  • Review of key image processing steps
    o        Automatic 3D image registration
    o        Quantification of brain atrophy
    o        Quantification of hippocampal atrophy
    o        Evaluation of reproducibility rates of quantification techniques
  • 14:50 Afternoon Tea

    15:20 DEVELOPING THERAPIES FOR PARKINSON’S DISEASE

    Babak Boroojerdi

    Babak Boroojerdi, Senior Director, UCB

     
  • Challenges in trials addressing disease modification
  • Recent EU regulatory guidelines
  • Emerging therapies
  • 16:00 ADAPTIVE DESIGN IN CLINICAL TRIALS, A CASE STUDY

    Fiona Guillard

    Fiona Guillard, Manager, Statistics, GlaxoSmithKline

    • A brief introduction to adaptive design
    • Designing the trial to answer the questions
    • Putting the design into practice

    16:40 ROLE OF CANNABINOID RECEPTORS IN ANXIETY DISORDERS

    Aldemar Degroot

    Aldemar Degroot, Translational Scientist, Astellas Pharma Europe

  • Controversy: anxiolytic or anxiogenic
  • Cannabinoid receptor facilitation and anxiety
  • Cannabinoid receptor blockade and anxiety
  • Cannabidiol and anxiety
  • Concluding remarks
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Malcolm Barratt-Johnson

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

    9:10 FIRST DO NO HARM - PHARMACOVIGILANCE IN CLINICAL TRIALS, CAN WE DO MORE? ..... ARE WE DOING TOO MUCH?

    Malcolm Barratt-Johnson

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

  • The current status of the regulatory framework for EU clinical trials
  • Identifying factors which influence approval by the regulatory bodies
  • Successful strategies to ensure compliance with current regulatory affairs
  • Companies, market shares and delayed regulatory approval
  • 9:50 MEDICAL IMAGING CORE LABORATORY

    Sophie Winandy

    Sophie Winandy, Imaging Specialist, Biomedical Systems, Biomedical Systems

  • Core Imaging laboratory: Imaging Process Workflow in CNS Clinical Trials
  • How to adopt a comprehensive approach to Central Imaging in a CNS Clinical trial Project,
  • How to collect and standardize images collection(pitfalls),
  • Clinical Site qualification practical consideration for imaging (Harmonization across imaging sites), Case Studies can be discusse
  • Central Reading processes and tools for aiding central reader.
  • Central Imaging interpretation,
  • Imaging data submission to Regulatory Authorities.
  • 10:30 Morning Coffee

    11:00 RECRUITMENT ISSUES IN CLINICAL TRIALS

    J Findlay Walker

    J Findlay Walker, Vice President, EU Administration, Daiichi Sankyo Development

  • The challenges involved in meeting recruitment timetables for CNS trials
  • Ensuring informed consent
  • Retention of subjects
  • Understanding regional variations in recruitment to perfect strategy
  • 11:40 THE USE OF BIOMARKERS FOR DISEASE MODIFICATION IN CLINICAL TRIALS

    Peter Boeijinga

    Peter Boeijinga, Clinical EEG & MEG Expert , Forenap

  • Biomarkers to improve the accuracy of diagnosis
  • Biomarkers to support evidence of disease modification
  • Evaluating existing and emerging biomarkers
  • Imaging biomarkers: volumetric MRI and PET to assess glucose utilisation or ligand binding to amyloid plaques
  • 12:20 Networking Lunch

    13:20 CELL CYCLE SOLUTIONS FOR ALZHEIMER'S DISEASE AND MILD COGNITIVE IMPAIRMENT TRIALS

    Richard Hadden

    Richard Hadden, Chief Executive Officer, Cytox

    ·         The role of the cell cycle in AD and associated biomarkers in blood

    ·         Patient screening and selection for AD and MCI trials

    ·         Patient stratification and companion diagnostic applications

    ·         Towards a clinical IVD for AD dementia risk in MCI patients

    14:00 NEUROPHYSIOLOGICAL APPROACHES IN CNS TRIALS

    Malek Bajbouj

    Malek Bajbouj, Director and Principal Consultant, CNS Services, Parexel

  • routine EEG as a safety measure
  • quantitative EEG in early drug development
  • event related potentials as a proof-of-concept
  • neurophysiological approaches towards motor functions
  • 14:40 Afternoon Tea

    15:10 BENCH TO BEDSIDE AND BACK AGAIN: ALIGNING PRECLINICAL DEVELOPMENT WITH CLINICAL STRATEGY

    Mark Schmidt

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

  • ‘Cross cultural’ issues when clinical and preclinical departments meet
  • Translational models versus translational medicine
  • Potential new directions in clinical and preclinical development
  • 15:50 PRECLINICAL COGNITIVE TESTING IN CNS DRUG DEVELOPMENT

    Sophie Dix

    Sophie Dix, Senior Research Scientist, Eli Lilly

    • Evaluating a drug's effect upon memory, attention and executive function
    • Cognitive testing in translational medicine
    • Recent advances in cognitive drug development: touchscreen paradigms in the rodent

    16:30 Chairman’s Closing Remarks and Close of Conference

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    Workshops

    Assessing Cognitive Enhancement in Clinical Trials
    Workshop

    Assessing Cognitive Enhancement in Clinical Trials

    Copthorne Tara Hotel
    27th November 2008
    London, United Kingdom

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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