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SMi are proud to present their 11th annual Clinical Trials in CNS conference, scheduled for the 5th and 6th of November, 2012.

With increasing average life expectancy, the wide range of potential disorders (from Alzheimer’s, to Parkinson’s, MS, dementia and depression) that arise from the multiple targets of the CNS, are becoming increasingly widespread in the population. This creates an ever greater need for new treatments and therapies in the industry. Clinical trials in the CNS industry must therefore operate the minefield of varying regulations, ethical and logistical difficulties, in order to develop a drug from discovery to market.


 

This year the SMi Group's Clinical Trials in CNS conference will cover the essential topics in the CNS industry, including: clinical trial optimisation, modelling and efficiency, preclinical discovery of biomarkers and implementation of these novel innovations as well as a talk on the safety of CNS drugs from a former member of the MHRA.

This groundbreaking conference will give delegates an opportunity to gain insights into the best practices in clinical trials, as well as examples and case studies of previous techniques and methods. This is an opportunity not to be missed, as we delve into the complex and exciting world of Central Nervous System discovery, allowing delegates to learn, explore and debate the key areas of CNS, its preclinical discovery and its clinical trials.

The Clinical Trials in CNS conference offers a fantastic opportunity to discuss and debate the industry's hot topics with the key members of the CNS industry. The conference is one not to be missed out on for anyone who is a member of the CNS, neurology or clinical trials industry.
 

  • Discuss the best optimisation techniques for clinical trials: how to improve efficiency, adapt a clinical trial and ensure the smooth running of a trial via pre-clinical techniques
  • Explore the latest innovations in pre-clinical discovery and biomarker identification and how these can lead to a more cost-effective and efficient clinical trial
  • Evaluate the best mechanisms for implementation of theoretical ideas into the clinical trial, and how this will translate to a better clinical trial overall
  • Learn of the latest drug developments combating the key diseases in CNS, from Alzheimer's and dementia, to depression and schizophrenia
  • Hear talks on case studies of clinical trial results and developments, hearing firsthand experiences of how companies dealt with issues and managed clinical trials in specific diseases in the CNS industry


 

Industry Profile:

CEO’s, Executive Directors, Heads, Team Leaders and Consultants in the fields of:

  • Clinical trial management and logistics
  • CNS research
  • Epigenetics in CNS disorders
  • Research and development
  • Pain therapeutics
  • Biomarker discovery
  • Preclinical optimisation and modelling
  • Biobanking for research and development
  • Clinical trial safety and evaluation
  • Clinical trial design
  • Biomarker research and development
  • Treatment of Alzheimer's, Parkinson's, Dementia, multiple sclerosis, depression, schizophrenia, and other CNS disorders

Previous Companies in Attendance:

Abbott Laboratories; Alzheimer’s Research UK; AstraZeneca; Biogen Idec; Biomedical Systems Europe; Bracket Global; Bristol-Myers Squibb Pharmaceuticals Ltd; BTG; Cambridge Cognition ; Eli Lilly ; Eli Lilly & Company Ltd; F. Hoffmann - La Roche; Glaxo Manufacturing Services Limited; GLAXOSMITHKLINE; Grunenthal Gmbh; GSK; Hoffman La Roche; Imperial College London; Janssen Strategic Marketing; Kings College London; Lilly Research Centre Ltd; Maastricht University; Medicines & Healthcare Products Regulatory Agency (MHRA) ; Merck & Co; Merck Serono International S.A.; MRC Technology; MS4 Research Institute; MSD; Myriad RBM Inc; Myriad RBM, Inc.; Nuffield Depr of Clinical Nuerosciences, University of Oxford; Oxford University; Parexel International; Pfizer; Pfizer Regenerative Medicine; QCTR Ltd; Roche Products Ltd; SC Lorentina 2102 SRL; Servier Research & Development; Shire Pharmaceuticals Group Plc; South West DeNDRoN; Surrey Satellite Technology Ltd (S S T L); Takeda Pharmaceuticals Europe Ltd; United BioSource Corporation (UCB); University Claude Bernard of Lyon 1 ; University Of Bristol; University of Copenhagen; University of Glasgow and University of Oxford

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Lars Bauer

Lars Bauer, Senior Medical Director , UCB GmbH

9:10 Management of a Global Clinical Program: Challenges and Opportunities

Bruno Pitrosky

Bruno Pitrosky, Adjoint Director SNC, Pfizer Inc

  • Global partnerships: challenges in an international investment
  • Structuring a global clinical project team: the issues faced and how to overcome them to maximise trials efficiency
  • The cultural differences of differing countries and how this affects their attitudes towards trials and program
  • Addressing the objectives of a global clinical trial/program by integrating the countries/area specificities
  • 9:50 What are the properties of cognitive function tests that determine their suitability to identify time-based changes in clinical trials?

    Keith Wesnes

    Keith Wesnes, Practice Leader, Bracket Global

  • Analyses of neuropsychological tests used in high-profile longitudinal ageing studies (eg ADNI) have shown apparent year on year improvements in the elderly.
  • These ‘gold-standard’ tests are widely regarded to have excellent ‘psychometric properties’; so why are many not fit for the purpose of assessing change when administered repeatedly?
  • Could computerised administration of these neuropsychological tests improve their capabilities?
  • How do such tests perform in comparison to automated cognitive tests specifically designed for repeated administration?
  • 10:30 Morning Coffee

    11:00 Neuroscience - Strategies for Success

    Lubor Gaal

    Lubor Gaal, Executive Director, Neuroscience, Strategic Transactions Group, Bristol-myers Squibb

  • Innovation in Neuroscience- What is it? Where is it?
  • What are current trends?
  • Where should company focus R&D?
  • What strategy leads to success?
  • 11:40 Optimizing clinical trial designs using ideas from optimal design theory

    Frank Miller

    Frank Miller, Senior Statistician and Principal Scientist, AstraZeneca R&D

  • Optimal choice of doses in a dose-finding trial
  • An Phase IIa/b adaptive design in a chronic pain setting
  • Choosing the time points for cognitive assessments in Alzheimer's disease trials 
  • Important steps when theoretical ideas are implemented in real clinical trials
  • 12:20 Networking Lunch

    13:30 Ethical Decision Making in Clinical Drug Development

    Mike Emanuel

    Mike Emanuel , Managing Director, SintoPharm

  • What are the principles behind ethical behaviour and practice?
  • How have these been translated into clinical research codes of ethics?
  • What do we need to consider to ensure ethical decision making?
  • What are some of the key study design factors that lead to ethical dilemmas?
  • 14:10 The value of brain banking for CNS research

    Claire Troakes

    Claire Troakes, Brain Bank Coordinator, London Neurodegenerative Diseases Brain Bank , Kings College London

  • Brain banking in the UK: tissue collection, diagnosis, quality and access
  • Cohort recruitment and longitudinal assessment: increasing the scientific value of donated tissue
  • The importance of tissue banking in clinical trials and biomarker validation
  • The future: centralised coordination and multi-sample biobanks in order to increase research potential
  • 14:50 Afternoon Tea

    15:20 Clinical trial design: ensuring efficiency and adaptability, with a focus on MS as an example

    Jeremy Chataway

    Jeremy Chataway, Honorary Clinical Senior Lecturer, Imperial College London

  • Changes in Trials of Relapsing-Remitting MS over time
  • The big challenge-Progressive MS
  • Measuring Progressive MS
  • Increasing efficiency in trials and the current and recent trials in Progressive MS
  • 16:00 Preclinical models and translational approaches for the treatment of neurodegenerative diseases

    Michael  O'Neill

    Michael O'Neill, Senior Research Advisor , Eli Lilly & Co

  • Summary of mechanisms in Neurodegenerative diseases
  • Overview of key animal models used for Alzheimer’s Disease and Parkinson’s Disease
  • Examples of data for projects/mechanisms in these animal model systems
  • Examples of measures and end-points to aid in progression of projects to the clinic
  • Importance of target engagement and pharmacodynamic biomarkers for CNS drug targets
  • 16:40 Quantifying the safety of CNS drugs

    John Warren

    John Warren, Former Expert Medical Assessor, MHRA and Director, Medicines Assessment Ltd

  • Inaccessibility of the CNS for biomarkers
  • Subtle consequences of psyche pharmacology
  • Composite endpoints in CNS clinical trials
  • Absence of harm on mortality
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Keith Wesnes

    Keith Wesnes, Practice Leader, Bracket Global

    9:10 The latest developments and discoveries in neurodegenerative disorders: a case study of Parkinson’s Disease

    Florian Von Raison

    Florian Von Raison, Global Program Head, Novartis

  • Motor complications in PD : Why it’s so complex?
  • L-dopa induced dyskinesia (LID)  : reduction of dyskinesia as  goal of PD management and therapy
  • LID. From the pathways to predictive animal models
  • Last developments in humans. Which target to choose?
  • 9:50 Preclinical monitoring of neurophysiology/behaviour as a Translational Biomarker of CNS Activity

    Jennifer Li

    Jennifer Li, Associate Senior Biologist, Lilly Research Centre Ltd

  • Lack of success in clinical trials of psychiatric disorders due to the difficulty in interpreting drug effects on rodent behaviour alone
  • Monitoring physiological responses during behavioural tasks to validate animal assays and disease models 
  • Using oxygen amperometry to identify brain circuitry engaged in complex behavioural tasks and the response to drug exposure in the freely moving rat as a correlate of neuroimaging techniques
  • 10:30 Morning Coffee

    11:00 Non-motor symptoms in Parkinson´s disease

    Lars Bauer

    Lars Bauer, Senior Medical Director , UCB GmbH

  • Clinical features of Parkinson´s disease
  • The patient´s burden of non-motor symptoms
  • How to address non-motor symptoms
  • Examples from recent clinical trials
  • 11:40 Clinical trials in Multiple Sclerosis

    Peter Joseph Jongen

    Peter Joseph Jongen, Founding Director , MS4 Research Institute

  • The new drugs of 2012-2013
  • Perspectives on future drugs in MS and recent changes in trial methodology
  • Reimbursement and pharmaco-economics in MS clinical trials
  • Self-assessment and monitoring of therapeutic value
  • 12:20 Networking Lunch

    13:50 An overview of clinical trials currently being conducted worldwide in Parkinsons disease (PD)

    Richard Wyse

    Richard Wyse, Director of Research and Development, The Cure Parkinsons Trust

  • Driven by GWAS, new drug targets recently found to be relevant to PD biochemistry are now being actively developed
  • Groundbreaking results of recent trials (such as drug repositioning programmes using anti-diabetic drugs with PD-relevant biochemistry) promise to change the trajectory of neurological decline, and revolutionize treatment
  • A new global initiative, led by CPT, involving pilot proof-of-concept clinical screening in PD patients of drugs targeting these new pharmaceutical approaches, will dramatically increase the number of PD clinical trials
  • The Parkinsons charities, far more than governments or pharmaceutical companies, now set the global agenda for choosing what therapeutic interventions advance into PD clinical trials
  • 14:30 Identifying novel biomarkers in the central nervous system

    Catherine Harmer

    Catherine Harmer, Department of Psychiatry, Oxford University

  • Negative biases in emotional processing measured in a behavioural test battery and in neuroimaging paradigms with fMRI
  • Antidepressant drugs affect the behavioural and neural processing of emotional information prior to clinical changes in mood.  
  • Emotional biomarker tests for drug development and screening of novel compounds for depression  
  • Early changes in emotional processing  in therapeutic actions of antidepressant treatments in depression
  • 15:10 Afternoon Tea

    15:40 Enhanced signal detection: using tandem assessments of psychiatric symptoms in RCTs

    Gary  Sachs

    Gary Sachs, Founding Director, Bipolar Clinic and Research Program, Massachusetts General Hospital

  • The case for Tandem Ratings in clinical trials
  • Enhancing Signal detection with Tandem Ratings administered by site based raters and computer.
  • Application of Tandem Rating to subject eligibility assessments
  • Obtaining validated learning for improved trial design 
  • 16:20 Successful Implementation of CNS Studies

    Steve Satek

    Steve Satek, Senior Vice President, Thievon-Wright Consulting Group

  • Challenges of increasing complexity
  • Effective communication between sponsors, CROs, vendors and sites
  • Subject recruitment:  pressures to find the ideal research participants
  • Proposed solutions to streamlining CNS research processes
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Bruno Pitrosky

    Bruno Pitrosky

    Adjoint Director SNC, Pfizer Inc
    Florian Von Raison

    Florian Von Raison

    Global Program Head, Novartis

    Bruno Pitrosky

    Adjoint Director SNC, Pfizer Inc
    Bruno Pitrosky

    Catherine Harmer

    Department of Psychiatry, Oxford University
    Catherine Harmer

    Claire Troakes

    Brain Bank Coordinator, London Neurodegenerative Diseases Brain Bank , Kings College London
    Claire Troakes

    Florian Von Raison

    Global Program Head, Novartis
    Florian Von Raison

    Frank Miller

    Senior Statistician and Principal Scientist, AstraZeneca R&D
    Frank Miller

    Gary Sachs

    Founding Director, Bipolar Clinic and Research Program, Massachusetts General Hospital
    Gary  Sachs

    Graham Cox

    Principal IDEAtor, IDEA Pharma UK
    Graham Cox

    Jennifer Li

    Associate Senior Biologist, Lilly Research Centre Ltd
    Jennifer Li

    Jeremy Chataway

    Honorary Clinical Senior Lecturer, Imperial College London
    Jeremy Chataway

    John Warren

    Former Expert Medical Assessor, MHRA and Director, Medicines Assessment Ltd
    John Warren

    Keith Wesnes

    Practice Leader, Bracket Global
    Keith Wesnes

    Lars Bauer

    Senior Medical Director , UCB GmbH
    Lars Bauer

    Lubor Gaal

    Executive Director, Neuroscience, Strategic Transactions Group, Bristol-myers Squibb
    Lubor Gaal

    Michael O'Neill

    Senior Research Advisor , Eli Lilly & Co
    Michael  O'Neill

    Mike Emanuel

    Managing Director, SintoPharm
    Mike Emanuel

    Peter Joseph Jongen

    Founding Director , MS4 Research Institute
    Peter Joseph Jongen

    Richard Wyse

    Director of Research and Development, The Cure Parkinsons Trust
    Richard Wyse

    Steve Satek

    Senior Vice President, Thievon-Wright Consulting Group
    Steve Satek

    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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