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It is estimated that as many as 1.5 billion people worldwide, are suffering, at any given time from some type of CNS Disorder and therefore there is a strong demand from patients for effective treatments. Pharmaceutical companies have taken note of this demand and have invested heavily in this area.

This conference aims to identify the challenges facing companies trying to develop new therapies, including difficulties in the clinical trial process, proving a drug effectiveness over it’s efficacy and the ongoing placebo effect. SMi’s Clinical Trials in CNS will also attempt to unearth the causes for failed clinical trials in order to learn how the industry can move forward to more successful approaches. There will also be some discussion on how strict FDA regulations will effect the development of CNS therapeutics.

A unique opportunity to learn from leading industry experts including:

  • Dr Chas Bountra, Vice President & Head, Biology, N&GI CEDD, GlaxoSmithKline
  • Dr Roger Pinder, Vice President, Medical Affairs, Organon
  • Dr Neil Buckholtz, Chief, Dementias of Aging Branch, Neuroscience & Neuropsychology of Aging Programme, National Institute on Aging, National Institutes of Health (NIH)
  • Dr Mark Schmidt, Clinical Imaging Expert, Biomarker Development, Novartis
  • Dr Michael Krams, Director, Pfizer
  • Dr Dieter Meier, Director, Clinical Drug Evaluation, Johnson & Johnson
  • Dr Alexandre Gerebtzoff, International Medical Manager, F. Hoffmann-La Roche
  • Dr Craig Karson, Senior Distinguished Scientist, CNS, Aventis
  • Marie Luby, CNS Director & Consultant, Perceptive Informatics

The essential event on:
CONDUCTING CLINICAL TRIALS IN CNS: Hear about the importance of preclinical to clinical trials and the current practices- what we can learn and what we can improve
THE USE AND APPLICATION OF FUNCTIONAL IMAGING: The latest developments, research and new techniques and their application to current CNS disorders
THE ROLE OF COGNITION TEST: Exploring the utility of computerised cognitive testing in clinical trials. The way forward and the integral role they play in today's medical field
CASE STUDIES: Hear from leading companies and their present reports, innovations and clinical applications
KEY INDUSTRY PERSONNEL: Meet the leaders in the field, make valuable contacts and learn from their experience and expertise

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Mark Schmidt

Dr Mark Schmidt, Clinical Imaging Expert, Biomarker Development, Novartis

9:10 KEYNOTE ADDRESS

Dr Dieter Meier

Dr Dieter Meier, Director, Clinical Drug Evaluation, Johnson & Johnson

  • Disease definitions
  • Prediction from preclinical evidence
  • Tools, markers, surrogates
  • Relevant and measurable clinical effects
  • Differentiation of progression
  • 9:50 HOW WELL DOES PRECLINICAL INFORMATION TRANSLATE INTO THE CLINIC?

    Dr Chas Bountra

    Dr Chas Bountra, Vice President & Head, Biology N&GI, CEDD, GlaxoSmithKline

  • In terms of molecular target/efficacy
  • In terms of dose prediction
  • In terms of estimating therapeutic index
  • 10:30 Morning Coffee

    11:00 ASSESSING CNS EFFECTS IN PHASE I CLINICAL TRIALS

    Dr Emma Spencer

    Dr Emma Spencer, Clinical Physiologist, Quintiles

  • Overview of phase I clinical trials in CNS
  • Novel CNS compounds in phase I studies
  • Typical CNS investigations in phase I
  • Advantages of CNS investigations in phase I
  • 11:40 COPING WITH PLACEBO RESPONSE IN DEPRESSION CLINICAL TRIALS

    Dr Alexandre Gerebtzoff

    Dr Alexandre Gerebtzoff, International Medical Manager, F Hoffman-La Roche

  • Placebo response in depression trials- an increasing problem?
  • The players (patients, personnel, ethical committees, regulators, sponsors)
  • Strategies which have failed repeatedly
  • Strategies possibly successful
  • The future?
  • 12:20 Networking Lunch

    13:50 AN INTERNATIONAL PERSPECTIVE ON CNS CLINICAL TRIALS

    Lewis Cameron

    Lewis Cameron, Head, Global Project Manager & General Manager, Chiltern International

  • Overview of trial requirements and options
  • Use of electronic diaries in CNS area
  • Case study: migraine
  • Case study: pain management
  • Case study: multiple sclerosis
  • Future directions
  • 14:30 THE VALUE OF COMPUTER-ADMINISTERED SELF-REPORT DATA IN CNS CLINICAL TRIALS

    Dr Bill Byrom

    Dr Bill Byrom, Product Development Director, ClinPhone Ltd

  • The use of IVR systems in collecting patient reported outcomes data
  • Case studies illustrating the use of IVR-delivered clinical assessments in depression, anxiety and other CNS disorders
  • Protection against baseline score inflation in trials with investigator-assessed subjective endpoints
  • 15:10 Afternoon Tea

    15:40 NEW APPROACHES TO ASSESSING PROGRESSION IN ALZHEIMER'S DISEASE

    Dr Mark Schmidt

    Dr Mark Schmidt, Clinical Imaging Expert, Biomarker Development, Novartis

  • New developments in treatments targeting disease progression
  • Early assessment of drug effects
  • Selection of methods and outcome measures
  • Validation of new methods
  • Impact on trial design and execution
  • Acceptance of new outcome measures
  • 16:20 POTENTIAL APPLICATION OF IMAGING AS A SURROGATE ENDPOINT

    Dr Neil Buckholtz

    Dr Neil Buckholtz, Chief, Dementias of Aging Branch, Neuroscience & Neuropsychology of Aging Programme, National Institute on Aging, National Institutes of Health (NIH)

  • Imaging in diagnosis and progression of disease
  • Mild cognitive impairment as a focus of imaging
  • Impact of imaging on the conduct of clinical trials
  • New techniques for visualising brain pathology
  • Future directions: Alzheimer's disease neuroimaging initiative
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Roger Pinder

    Dr Roger Pinder, Private Consultant,

    Roger Pinder

    Roger Pinder, Private Consultant, .

    9:10 STROKE TRIAL DESIGN

    Marie Luby

    Marie Luby, Director, CNS Program, Perceptive Informatics

  • MRI and CT considerations
  • MRI based protocol criteria
  • CT based protocol criteria
  • Defining target population with imaging criteria
  • Usage of multiparametric models
  • 9:50 COGNITIVE TESTING IN DRUG DEVELOPMENT

    David Secker

    David Secker, Chief Scientific Officer, Cambridge Cognition

    10:30 Morning Coffee

    11:00 CURRENT CHALLENGES IN THE CLINICAL DEVELOPMENT OF ANTI-DEMENTIA DRUGS

    Peter Schüler

    Peter Schüler, , PRA International

  • Epidemiology of dementia and Alzheimer’s disease
  • Clinical features, pathology and natural history of Alzheimer’s disease
  • Assessment and diagnosis of Alzheimer’s disease
  • A unifying hypothesis of the pathogenesis and pathophysiology of Alzheimer’s disease
  • Challenges for designing trials of disease modifying agents in Alzheimer’s disease
  • 11:40 INNOVATIVE DESIGNS IN CNS DRUG DEVELOPMENT

    Dr Michael Krams

    Dr Michael Krams, Director, Pfizer

  • Combination therapies
  • Real time learning
  • Translational research
  • A case study in acute ischemic stroke
  • 12:20 Networking Lunch

    13:50 RESPONSE AND REMISSION IN ANTIDEPRESSANT TRIALS

  • Response and remission in depression
  • Traditional clinical trial design unsuited to measure rate of response
  • Review of statistical methods with focus on survival analysis
  • Response and remission with modern antidepressants
  • There are real differences in efficacy between antidepressants
  • Dr Roger Pinder

    Dr Roger Pinder, Private Consultant,

    Roger Pinder

    Roger Pinder, Private Consultant, .

    14:30 PHARMACOGENETICS IN PSYCHIATRY

    Prof Ad Sitsen

    Prof Ad Sitsen, Professor, Clinical Pharmacology, Utrecht University & Founder, ClinPharMed

  • Many psychotropic drugs are effective in only a proportion of patients treated
  • Psychiatric patients (like other patients) may need treatment tailored to the individual needs
  • These needs are likely to be at least in part genetically determined
  • Both pharmacokinetic and pharmacodynamic polymorphisms are probably involved
  • Pharmacogenetic research may eventually help understand intra-individual treatment differences
  • Results of such investigations may in the future improve drug treatment of psychiatric patients
  • 15:10 Afternoon Tea

    15:40 SETTING KEY CRITERIA FOR PROOF OF CONCEPT

    Dr Remy Luthringer

    Dr Remy Luthringer, Chief Executive Officer, Forenap Pharma

  • Define proof of concept in CNS drugs (Parkinson/Alzheimer)
  • Examine methodological issues related to: end points, populations and risk taking
  • Choosing models to show drug efficacy quickly
  • Go/no-go decisions after proof of concept: what are the best models?
  • 16:20 CNS CLINICAL TRIALS IN CHILDREN

    Sandy Eisen

    Sandy Eisen, Principal Consultant, Worldwide Regulatory Affairs, Parexel Inernational

  • The paediatric market
  • Regulatory considerations
  • Preclinical testing
  • Phase II and Phase III trials
  • 17:00 Chairman's Closing Remarks and Close of Conference

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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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