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NB Don't miss the 2 associated Executive Briefings on the 21st November

Therapeutics for CNS disorders are second only to cardiovascular therapies in terms of sales, representing an extremely valuable area to the Pharmaceutical industry. With increasing understanding of psychiatric disorders and ageing populations increasing the need for viable treatments for neurodegenerative disorders, the market for CNS drugs is on the increase.

There are a great number of new innovations, with approximately 1350 compounds in the pipeline but, in many cases, a complex and expensive clinical trial process lies between the discovery and a new drug on the market. SMi has identified the need to take a closer look at how clinical trials for CNS drugs are designed, managed and assessed.

The event will consider what can be learnt from past mistakes in CNS trials and how the industry can work towards more successful approaches. The Conference will evaluate the relative success of various assessment techniques and will include a focus on the latest in imaging as an assessment tool for psychiatric and neurodegenerative disorders.

In bringing together leaders in the field, the Conference will stimulate discussion on the aspects of CNS trials that cause most difficulty such as proving a drug's effectiveness rather than just its efficiency and the difficulties involved in measuring disease progresssion.

Hear from leaders in the field including:

  • Prof David Brooks, Chief Medical Officer, Imanet, Amersham Health & Hartnett Professor of Neurology, Imperial College London
  • Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline
  • Dr Mark Schmidt, Senior Director, Novartis
  • Dr Joseph Frey, Director, Clinical Pharmacology, CNS/Pain, AstraZeneca
  • Prof Tonmoy Sharma, Director, Clinical Neuroscience Research Centre
  • Dr Derrick McKinley, Therapeutic Director, CNS, Kendle
  • Dr Judith Abdalla, Medical Director, Neurology Global Product Development Unit, Serono
  • Dr Remy Luthringer, Chief Executive Officer, Forenap
  • Marie Luby, CNS Director, Perceptive Informatics
  • Dr Marguirguis (Georges) Gharabawi, Group Director, CNS Medical Affairs, Janssen

Hot topics to be covered by this event include:
  • CLINICAL ASSESSMENT TOOLS: Understand the advantages and disadvantages of different assessment techniques
  • IMAGING: Evaluate the role of functional imaging in CNS drug development and determine its predictive value
  • COMBINATION TREATMENTS: Assess the evidence for effective use of combined therapies in psychiatric and neurodegenerative disorders
  • CLINICAL DATA SYSTEMS: Learn how to validate data systems in order to comply with regulations
  • ADULT VS PAEDIATRIC INDICATIONS: Consider how the gap can be bridged in terms of safety, efficacy and trial management

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Prof Tonmoy Sharma

Prof Tonmoy Sharma, Director, Clinical Neuroscience Research Centre

9:10 KEYNOTE ADDRESS

Prof Hermann Fuder

Prof Hermann Fuder, President & Principal Consultant Clinical Pharmacology, Parexel

  • CNS pipelines
  • Marketing CNS drugs
  • Identifying the main problem areas for 2003 and beyond
  • The role of pharma companies
  • 9:40 CNS SHARE OF TOTAL CLINICAL RESEARCH MARKET

    Renata Knichnicka

    Renata Knichnicka, Strategic Account Manager, Fast Track Systems

  • Complexity of CNS protocols (as measured by number of patient visits and assessments) vs other therapeutic areas
  • Complexity of protocols for individual CNS indications
  • Proportion of CNS protocols that are multi-country vs other therapeutic areas
  • CNS costs per patient vs other therapeutic areas
  • CNS costs per patient by individual CNS indication
  • Lessons learned from managers of CNS trials at leading companies (large and small)
  • 10:20 CLINICAL DEVELOPMENT OF COMPOUNDS IN EARLY PHASES

    Dr Michael Herschel

    Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline

  • ‘Classical’ development
  • New enabling tools and practices
  • Revolutionising early developments
  • Managing risks
  • 11:00 Morning Coffee

    11:20 VALIDATION OF CLINICAL DATA SYSTEMS

    Charles Lankford

    Charles Lankford, General Manager, PharmaSys

  • Overview of regulations
  • The validation life cycle as it relates to clinical data systems
  • Complying with 21 CFR Part 11
  • Special considerations for validating RDE systems
  • Staying in a validated state with system change control
  • 12:00 MAIN CNS STUDY DESIGN CHALLENGES

    Dr Marguirguis (Georges) Gharabawi

    Dr Marguirguis (Georges) Gharabawi, Group Director, CNS Medical Affairs, Janssen

  • How to reduce baseline rating scale bias
  • Is there an ideal dosing design? How to reconcile convenience and clinical outcomes
  • The role of ancillary studies in CNS trial design
  • 12:40 Networking Lunch

    13:40 THE ROLE OF FUNCTIONAL IMAGING IN CNS TRIALS

    Prof David Brooks

    Prof David Brooks , Chief Medical Officer, Imanet, Amersham Health & Hartnett Professor of Neurology, Imperial College London

  • Functional imaging can aid CNS drug development by:
  • Proof of principle
  • Dose finding
  • Following disease progression
  • Monitoring inflammation and abnormal protein aggregation
  • Studying downstream effects of drugs
  • 14:20 THE APPLICATION OF IMAGING TO CNS DRUG DEVELOPMENT

    Dr Mark Schmidt

    Dr Mark Schmidt, Senior Director, Novartis

  • The different methods of imaging that can contribute to CNS drug development
  • Predictive value of imaging
  • Using imaging techniques to measure disease progression in Alzheimer’s
  • Future issues in the use of imaging in the assessment of CNS disorders
  • 15:00 THE VALUE OF ASSESSING COGNITIVE FUNCTION

    Dr Claire Pincock

    Dr Claire Pincock, Managing Director, Cognitive Drug Research

  • Valuable early information to be gained in phase I studies
  • Proof of Concept in phase IIa and phase IIb studies
  • Cognitive function testing in pivotal phase III studies
  • Further information from phase IV studies
  • 15:40 Afternoon Tea

    16:00 MEASUREMENT OF PSYCHIATRIC ENDPOINT DATA USING INTERACTIVE VOICE RESPONSE SYSTEMS

    Dr Bill Byrom

    Dr Bill Byrom, Director, Product Development, ClinPhone

  • The use and validation of computerised interviews to measure psychiatric endpoints
  • Hamilton depression rating by IVR interview
  • Cognitive function testing using IVR
  • The utility of these measures in clinical trials
  • The value of pre-qualification tools in trials of subjective endpoint data
  • Validated screening tools for pre-study diagnostic confirmation
  • Using IVR as a patient recruitment application
  • 16:40 SURROGATE MARKERS IN CNS DRUG DEVELOPMENT

    Prof Tonmoy Sharma

    Prof Tonmoy Sharma, Director, Clinical Neuroscience Research Centre

  • The use of the startle response in CNS drug development
  • EEG and evoked potential in early detection and efficacy studies
  • How does assessment of cognition help in determining efficacy and safety?
  • The regulatory view of cognition in schizophrenia
  • The use of eye movements in CNS phase I and IIa studies
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Joseph Frey

    Dr Joseph Frey, Director, Experimental Medicine, AstraZeneca

    9:10 HUMAN MODELS IN CNS DRUG DEVELOPMENT

    Dr Remy Luthringer

    Dr Remy Luthringer, Chief Executive Officer, Forenap Pharma

  • POC: patients or HV studies?
  • Models as part of an enhanced development plan
  • Models in development
  • Limitations
  • 9:40 DEVELOPING CNS MEDICINE FOR USE IN PAEDIATRIC POPULATIONS

    Dr Graham Birrell

    Dr Graham Birrell, Senior Director, Parexel

  • The current regulatory framework
  • CNS indications relevant to paediatric populations
  • Preclinical requirements
  • Clinical safety requirements
  • Clinical efficacy and proof of concept
  • Managing paediatric clinical trials
  • 10:20 OVERCOMING THE PLACEBO EFFECT

    Dr Erik Buntinx

    Dr Erik Buntinx, Director, Research & Development, Vesalius Systems
    View Bio

  • State vs trade
  • Quantitative vs qualitative assessment
  • Finding the right patient and effectiveness by NI:CT
  • 11:00 Morning Coffee

    11:20 CLINICAL TRIALS IN DEMENTIA

    12:00 STATE OF THE ART IN MS CLINICAL TRIALS

    Dr Judith Abdalla

    Dr Judith Abdalla, Medical Director, Neurology Global Product Development Unit, Serono

  • Design issues:
    -Non-inferiority vs superiority trials
    -Choosing the appropriate comparators
    -Determining the most appropriate endpoints
  • Regulatory issues in 2003
  • Strategies to maximise successful implementation
  • The need for better PD markers
  • 12:40 Networking Lunch

    14:00 A NOVEL METHOD FOR EVALUATING OUTCOMES – CASE STUDY

    Stefan Asberg

    Stefan Asberg, Director of Marketing & S, NeoPharma

  • Improved quality in QoL measurements by the use of an eDiary
  • New method for standardized “UPDRS” video scoring with blinded rating
  • 14:40 APPLICATION OF MRI TO STROKE DRUG DEVELOPMENT

    Marie Luby

    Marie Luby, Director, CNS Program, Perceptive Informatics

  • Lessons learned from past clinical trials in stroke
  • Selection of MRI sequences to follow lesion evolution in stroke
  • Discussion of imaging biomarkers
  • Characteristics of optimal trial
  • Future applications of MRI in stroke clinical trials
  • 15:20 ABUSE LIABILITY TESTING IN CNS DRUG DEVELOPMENT

    Dr Joseph Frey

    Dr Joseph Frey, Director, Experimental Medicine, AstraZeneca

  • Survey of preclinical and clinical methods
  • A brief look at the regulatory environments
  • Integrating abuse liability assessment into the development plan
  • Choosing useful endpoints and comparators to facilitate scheduling decisions
  • 17:00 Chairman's Closing Remarks and Close of Conference

    +

    Workshops

    Surrogate Markers To Improve Signal Detection In CNS Drug Development
    Workshop

    Surrogate Markers To Improve Signal Detection In CNS Drug Development

    The Hatton, at etc. venues
    21st November 2003
    London, United Kingdom

    A New Paradigm To Improve CNS Clinical Trials
    Workshop

    A New Paradigm To Improve CNS Clinical Trials

    The Hatton, at etc. venues
    21st November 2003
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    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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