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It is estimated that central nervous system disorders affect approximately 1.5 billion people worldwide. Aging population and the improved understanding of psychiatric disorders result in an increasing need for viable treatments. Finding a cure or a control for a variety of CNS disorders represents an ever-growing challenge for the pharmaceutical industry, and it is one of the fastest growing and largest therapeutic areas facing the industry today.
        
The 6th Annual Clinical Trials in CNS Conference  offers a unique opportunity to hear about the latest developments from industry leaders,
providing insights on design, management and assessment of clinical trials for CNS targets. 
     

A panel of industry and academic experts will explore a range of timely topics:

  • Prediction of Human Efficacy in Animal Models
  • Paediatric CNS Clinical Trials and the European Paediatric Committee
  • Microdosing Clinical Studies for CNS Drug Design
  • Imaging Analysis: Monitoring and Predictive Capabilities
  • Patient Recruitment for CNS Clinical Trials
  • Pharmacogenetic Approaches and Diagnostic Tests
      
Confirmed Speakers Include:
  • Dr Tanya Ramey, Clinical Lead, Neurosciences, Pfizer
  • Dr Mark Schmidt, Director and Clinical Expert, CNS, Johnson& Johnson
  • Dr Judith Dunn, Senior Medical Director, CNS, Sepracor
  • Dr Michel Dib , Medical Director, CNS, Sanofi-Aventis
  • Dr Paul Thompson, CPDM-Neurology Biomarker Group, GlaxoSmithKline

Who Should Attend the SMi Clinical Trials in CNS Conference?

  • Medical Directors
  • Director of Metabolic Diseases
  • Senior Scientists - CNS Diseases
  • Directors of Clinical Research
  • Senior Clinical Project Managers

For Speaking opportunities please contact Venus Simbulan at vsimbulan@smi-online.co.uk

For Sponsorship opportunities please contact Alia Malick at amalick@smi-online.co.uk

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Prof Keith Wesnes

Prof Keith Wesnes, Chief Executive, Cognitive Drug Research

9:10 PREDICTION OF HUMAN EFFICACY IN ANIMAL MODELS

Dr Thomas Stoehr

Dr Thomas Stoehr, Senior Scientist, Pharmacology, Schwarz Biosciences

  • Pharmacodynamics in animal models - factoring the contribution
  • Leaps and loopholes – sensitivity of mechanisms
  • Improved assessments of proof of concept
  • 9:50 PREDICTION OF PATIENT EFFICACY IN HUMAN VOLUNTEER MODELS OF PSYCHIATRIC DISORDERS

    Dr Colin T Dourish

    Dr Colin T Dourish, Chief Executive Officer, P1Vital

  • Pre-clinical models of psychiatric disorders have poor predictive validity and often provide only a weak rationale to support progress of NCEs through expensive late stage clinical trials
  • Use of human volunteer models employing experimental design in a laboratory setting to introduce rigour and harder endpoints for measurement and provide an early read on potential efficacy
  • Urgent need to develop new models to determine potential efficacy of NCEs for schizophrenia, depression, anxiety and cognitive disorders
  • Validation of models with standards and development of  processes to enable rapid, accurate and reliable throughput of compounds
  • Establishment of a Pre-Competitive Pharma Consortium sharing costs and risks and enabling access to a comprehensive results database
  • 10:30 Morning Coffee

    11:00 ALIGNING PRECLINICAL DEVELOPMENT WITH CLINICAL STRATEGY: BENCH TO BEDSIDE AND BACK AGAIN

    Dr Mark Schmidt

    Dr Mark Schmidt, Director and Clinical Expert, CNS, Johnson & Johnson

    -'cross-cultural' issues when clinical and preclinical departments meet
    -translational models versus translational medicine
    -costs and benefits of early integration of clinical strategy in preclinical development

    11:40 PHASE II TRIAL DESIGN FOR TRAUMATIC BRAIN INJURY

    Dr Rowland  Furcha

    Dr Rowland Furcha, Clinical Project Director, Xytis Pharmaceuticals

  • Failures of previous clinical trials: difficulty to enrol and variability of the enrolled patients
  • Current trial design
  • Challenge of obtaining ethical approval for the informed consent of patients
  • 12:20 Networking Lunch

    13:50 IMPROVING MEASUREMENTS IN ANTI-DEPRESSION TRIALS

    Dr Gail Farfel

    Dr Gail Farfel, Vice President and CNS Therapeutic Area Head, Novartis

  • Rating scales, Investigators and trial population: how best to improve signal detection?
  • Reversing the effect of over-sensitive measurements
  • Novel approaches to evaluating antidepressant efficacy
  • 14:30 HUMAN MODEL INVESTIGATIONS IN CNS DISORDERS

    Dr Remy Luthringer

    Dr Remy Luthringer, Chief Executive Officer, Forenap

  • Translational strategies
  • Enhanced clinical pharmacology studies
  • Biomarkers/surrogate end points
  • Enriched POC or POP studies
  • Human disease models
  • Pharmacodynamic end points
  • PK/PD relationships
  • Definition of links between development steps
  • Practical examples through depression, anxiety, panic, schizophrenia, cognition, insomnia, pain
  • State of the art of Positive predictive value
  • 15:10 Afternoon Tea

    15:40 CNS DRUG DELIVERY ACROSS BLOOD-BRAIN BARRIER

    Dr Mohammad Alavijeh

    Dr Mohammad Alavijeh, Co-founder and Managing Director, Pharmidex

  • CNS drug discovery rewards are high for companies who are not put off with the lower chance of success compared to other therapeutics
  • The blood brain barrier is a major obstacle to successful delivery of many potential drugs to the brain
  • NeuroPK® a successful and tested screening process ensures that most appropriate drugs are taken into clinics
  • CerenseSM combines a breakthrough brain delivery technology with comprehensive  assessment of the brain penetration of CNS drug candidates
  • 16:20 DELIVERING CNS DRUGS VIA THE PULMONARY ROUTE TO ACHIEVE RAPID BLOOD LEVELS AND CLINICAL EFFECT

    Dr James V Cassella

    Dr James V Cassella, Senior Vice President, Research and Development, Alexza Pharmaceuticals

  • Data in migraine and agitation in schizophrenic patients: Phase 2 clinical results
  • Ongoing effort in panic research
  • Platform technology and possible future directions in the CNS space
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    17:20 DRINKS RECEPTION

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Colin T Dourish

    Dr Colin T Dourish, Chief Executive Officer, P1Vital

    9:10 BIOMARKERS IN CNS R&D - A CLINICAL PERSPECTIVE

    Dr Johannes  Lampe

    Dr Johannes Lampe, Consultant,

  • - Predictive capabilities of diagnostic tests
    - Variation in response to medication
    - Benefits of using BRMs in clinical trials
  • 9:50 COGNITIVE MEASUREMENTS AS CLINICAL PREDICTORS OF PROGRESSION IN CNS DISEASES

    Susan De Santi

    Susan De Santi, Research Advisor, The Cognition Group

  • Comparative predictive measurements
  • Personalized cognitive measurements
  • Predictive accuracy
  • 10:30 Morning Coffee

    11:00 COGNITIVE TESTING IN DRUG DEVELOPMENT

    Prof Keith Wesnes

    Prof Keith Wesnes, Chief Executive, Cognitive Drug Research

  • Automated equivalents to the MATRICS Consensus Cognitive Battery
  • Selective nicotinic agonists for cognition enhancement
  • Wakefulness’: a new therapeutic target
  • Is there a viable automated alternative to the ADAS?
  • Cognitive testing in translational medicine comes of age
  • 11:40 CRITICAL CONSIDERATIONS IN SELECTING COMPUTER-BASED COGNITIVE TESTS FOR CNS CLINICAL TRIALS

    Dr Gary G Kay

    Dr Gary G Kay , President, Cognitive Research Corporation

  • In selecting computer-based cognitive tests for use in clinical trials, pharmaceutical sponsors and academic researchers need to be familiar with key methodological issues inherent in the application of these tests
  • This presentation will provide illustrations of these factors using examples taken from Cognitive Research Corporation’s assessment methodologies; the Psychologix® and CogScreen® test batteries
  • RELIABILITY:  What are the practice effects?  Has the battery demonstrated adequate test-retest reliability? 
  • VALIDITY:  How does the test compare to conventional, paper-and-pencil tests?
  • DATA CONSIDERATIONS:  How has the reliability of the computer testing station been evaluated?
  • SUBJECT CONSIDERATIONS:  How simple and intuitive are the test instructions and response input devices?
  • 12:20 Networking Lunch

    13:50 PHARMACODYNAMIC MARKERS IN AD TRIALS

    Dr Paul  Thompson

    Dr Paul Thompson, CPDM-Neurology Biomarker Group, GlaxoSmithkline

  • Imaging of disease using MRI and PET
  • Biofluid markers - Abeta, tau, isoprostanes
  • Novel approaches to mechanistic investigation of drug action
  • 14:30 MAGNETIC RESONANCE IMAGE DATA PROCESSING AND ANALYSIS IN CNS TRIALS

    Chahin Pachai

    Chahin Pachai, Executive Director, Bio-Imaging Technologies S.A.S (ex Theralys)

    -         Requirements for image quality and site qualification
    -         Review of key image processing steps
    -         Automatic 3D image registration
    -         3D image segmentation (lesion detection)
    -         Quantification of brain atrophy
    -         Quantification of hippocampal atrophy
    -         Analysis of Perfusion, Diffusion, Diffusion-Tensor Imaging data
    -         Optimization of centralized image evaluation operations

    15:40 ISSUES IN THE DESIGN AND ANALYSIS OF CNS TRIALS

    Dr Stig Johan  Wiklund

    Dr Stig Johan Wiklund, Director, Statistical Science, Technical and Scientific Development, AstraZeneca

  • Design and analysis for disease modification and symptomatic treatment
  • Methods for dealing with drop-outs (and missing data) in analysis
  • Pros and cons of Adaptive Design approaches
  • 16:20 COMBINATION COMPOUNDS IN CNS AND EFFICACY BOOSTING

    Erik Buntinx

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

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

    +

    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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