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SMi is delighted to announce that its highly anticipated and respected 12th annual Clinical Trials in CNS Conference is coming to London. With an ever increasing average life expectancy, neurodegenerative diseases are increasingly becoming more prevalent in society. With this comes a need for new and improved therapies for treating these neurodegenerative conditions. From Alzheimer's to Parkinson's disease, the target and mechanism by which a disease manifests itself presents unique challenges in how to approach such treatments not to mention ethical and legal issues behind treatment and trial design.

Join SMi as we look at new approaches taken in this field towards a number of neurodegenerative disorders. From clinical trial modelling and simulation to the role of biomarkers, SMi takes a detailed look into many aspects of drug discovery and delivery of CNS therapeutics.This exciting  conference will give delegates an opportunity to gain insights through case studies and interactive discussion into best practices in clinical trials. 

Join SMi's fantastic forum for discussion whereby industry peers can discuss and debate a number of issues surrounding drug development in CNS disorders.

Discover through real life case studies how companies have managed clinical trials in a broad range of CNS diseases

Discuss latest technologies and advances in this area of research

Hear from industry leaders and learn about best practice applied to clinical trials in CNS

Evaluate the best approaches taken towards trial design and successful implementation of such trials

Learn about the latest drug developments targeted at CNS diseases
 

CEOs, 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
 

AstraZeneca R&D; BioMed Central; Biomedical Systems Europe; Biotie Therapies; Blizard Institute of Cell & Molecular Science; BMS; Bracket Global; Bristol Myers Squibb; Bristol-myers Squibb; Canbex; Chronos Therapeutics Limited; deMello Research Group; Eli Lilly & Co; ePharmaSolutions; GLAXOSMITHKLINE; GSK; Hermo Pharma Oy Ltd; IDEA Pharma UK; Imperial College London; INC Research; Kings College London; Lilly Research Centre; Lilly Research Centre Ltd; Massachusetts General Hospital; Medicines Assessment Ltd ; MHRA; MS4 Research Institute; Newcastle University; Novartis; Oxford University; Parexel International; Pfizer Inc; Phytopharm; QCTR Ltd; Quintiles (UK) Ltd; Quintiles Ltd; Roche Products; SintoPharm; Takeda Pharmaceuticals Europe Ltd; The Cure Parkinsons Trust; Thievon-Wright Consulting Group; UCB GmbH; University of Basel - MIAC AG;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's opening remarks

Gary  Sachs

Gary Sachs, Therapeutic Area Lead, Bracket

9:10 Opportunities for improving CNS clinical trials

Gary  Sachs

Gary Sachs, Therapeutic Area Lead, Bracket

  • Overcoming obstacles to patient recruitment
  • Automated processes for clinical trial data collection
  • Diagnostic and other eligibility validation
  • Endpoint reliability
  • 9:50 CNS tissue banking for neuroscience 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 co-ordination and multi-sample biobanks in order to increase research potential
  • 10:30 Morning Coffee

    11:00 Stroke Imaging Repository (STIR)

    Marie Luby

    Marie Luby, Post Doctoral Scientist, NIH/NINDS

    11:40 Drug safety in the CNS

    John Warren

    John Warren, Director, Medicines Assessment

  • CNS specific issues

    - Inaccessibility of the CNS for biomarkers

    - Subtle consequences of psyche pharmacology

  • Regulatory debates

    - Composite endpoints in CNS clinical trials

    - Defining absence of harm

  • 12:20 Networking Lunch

    13:50 New frontiers in schizophrenia clinical trial design

    Larry Alphs

    Larry Alphs, Therapeutic Area Leader, Ortho-McNeil Janssen Scientific Affairs, LLC

  • Comparative effectiveness

    - What are they?

    -When do you need them?

    - How do they differ from traditional designs?

    - Key design considerations

    - Some Examples

  • Novel indications or endpoints

    - Treatment failure vs symptomatic changes vs outcomes

    - Cognition in schizophrenia

    - Disease modification

  • 14:30 Post-registration trials and registries in multiple sclerosis

    Peter Joseph Jongen

    Peter Joseph Jongen, Founding Director, MS4 Research Institute

  • Recent and ongoing Phase III trials in multiple sclerosis
  • The EMA and post registration requirements
  • Post registration MS trials
  • MS registries: an overview
  • 15:10 Defining clinical significance in CNS clinical trials

    Susan McGoldrick

    Susan McGoldrick, Managing Director, QCTR Ltd

  • What is clinical relevance?
  • Why should you be thinking about this in your clinical trials?
  • Understanding clinical relevance is essential to avoid unnecessary co-primary endpoints or very large expensive studies and/or push back from the regulatory authorities as they question the clinical meaning of a measurement or biomarker. This talk will look at the regulatory requirements for clinical significance and give some pointers on what to consider at the trial design stage

     

     

  • 15:30 Afternoon Tea

    16:00 Transdermal patch: overcoming challenges to develop a room temperature stable formulation

  • Rotigotine- a dopamine agonist given as a transdermal patch
  • Regulatory background
  • Clinical studies conducted receive approval
  • Conclusions
  • Lars Bauer

    Lars Bauer, Senior Medical Director, UCB GmbH

    16:40 A Gene Therapy for Parkinson's disease – modifying ProSavin® to increase specific activity

    Kyriacos Mitrophanous

    Kyriacos Mitrophanous, Head of Research, Oxford BioMedica plc

  • Data on the completed Prosavin Phase I/II clinical trial in PD
  • Data in improved efficacy of next generation Prosavin in gold standard model of PD
  • in vivo pet imaging using two ligands to assess gene expression and efficacy of gold standard model of PD
  • Plans for future Phase IIa clinical trial
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Johannes Streffer

    Johannes Streffer , Director of Experimental Medicine Europe, Neurologist, Johnson & Johnson Pharmaceutical

    9:10 KEYNOTE: The legalities, ethics and implications in sham surgery

    Tom Isaacs

    Tom Isaacs, Co-Founder, The Cure Parkinsons Trust

  • Is it fair and effective?
  • Are there alternatives?
  • The patient perspective of sham surgery
  • 9:50 Collaborations, partnerships and new treatments in Parkinson's disease

    Richard Wyse

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

  • Latest developments in treatments for PD
  • The results of the latest clinical trials in PD
  • The driving forces behind PD R & D
  • 10:30 Morning Coffee

    11:00 CDNF protein therapy for treatment of Parkinsons disease

    Henri Huttunen

    Henri Huttunen, Chief Scientific Officer, Hermo Pharma Ltd

  • Novel neurotrophic factors
  • Proof-of-concept in animal models of PD
  • Towards clinical trials
  • 11:40 LRRK2 as a therapeutic target for Parkinson's disease: Development of kinase inhibitors and their use in translational biology

    Warren Hirst

    Warren Hirst, Associate Research Fellow & Group Leader, Pfizer

  • Genetic mutations in Leucine Repeat Kinase 2 (LRRK2) have been linked to Parkinson's Disease (PD). One of the most prevalent mutations, G2019S, results in increased LRRK2 kinase activity, which is believed to play a major role in the etiology of PD
  • However, to date, the physiological and pathophysiological roles of this protein remain elusive, primarily as endogenous substrates and interaction partners are relatively poorly characterised. Despite these challenges, we, and others, are developing LRKK2 Kinase inhibitors which will be critical to increase our understanding of LRRK2 function and may potentially be developed into novel therapeutics for PD.
  • We have identified potent, selective, brain penetrant LRRK2 Kinase inhibitors that show in vivo pharmacodynamic effects and have allowed us to generate PK/PD models which may be translated into clinical studies
  • Some of these compounds have been radiolabeled and we have started their characterisation, which will provide the knowledge base for the development of LRKK2 target engagement (PET) ligands
  • 12:20 Networking Lunch

    13:50 Translational medicine models in neurodegenerative diseases. Continuous CSF measurements: indwelling CSF catheters for monitoring CNS effects

    Johannes Streffer

    Johannes Streffer , Director of Experimental Medicine Europe, Neurologist, Johnson & Johnson Pharmaceutical

  • Do we measure drug effects or just the variability we induce?
  • 14:30 Alzheimer’s disease, dementia risk and the path to stratified medicine

    Richard Pither

    Richard Pither, CEO, Cytox Ltd
    View Bio

  • There are currently no reliable tests to detect risk of cognitive decline and Alzheimer’s Disease early in the disease process
  • The lack of blood-based risk and disease biomarkers has hampered efforts to develop effective disease-modifying therapies for Alzheimer’s Disease and Dementia
  • Emerging research has highlighted the importance of dysregulation of the mTOR signalling pathway and associated effects on cell cycle biology, as a risk factor in Alzheimer’s Disease
  • Validation of mTOR pathway and cell cycle dysregulation biomarkers in clinical studies offers the prospect of new approaches to the identification of subjects for early clinical intervention and clinical trial stratification
  • 15:10 Amyloid cascade hypothesis and developing drugs for AD: Past, present and future

    Eric Karran

    Eric Karran, Director of Research, Alzheimer’s Research UK

  • The amyloid cascade hypothesis has largely driven therapeutic investigation in AD
  • All of the amyloidocentric drugs have reached phase 3 testing and failed
  • what lessons can we learn from these failed trials?
  • Has the amyloid cascade hypothesis yet been tested in man?
  • 15:50 Afternoon Tea

    16:05 Defining the genetic architecture of Alzheimer's disease

    Lesley Jones

    Lesley Jones, Professor of Neurogenetics, Director of Postgraduate Research, CARDIFF UNIVERSITY

  • 27 genes influence the development of AD
  • 23 of which have been indentified in the last 4 years
  • These recent findings are making us reassess the causes of common forms of Alzheimer's implicating several novel disease mechanisms, including differences in immunity, endocytosis, unbiquitination and lipid processing
  • Future research now needs to focus on a better understanding of these mechanisms and how they react with environmental/ lifestyle factors
  • 16:45 Early detection of Alzheimer’s disease in mid-life

    Craig Ritchie

    Craig Ritchie, Clinical Senior Lecturer, Imperial College London

  • Highlight the evidence regarding pathological changes in mid-life which lead to dementia in older people
  • Discuss the rationale behind the early identification of risk status for dementia and opportunity for intervention
  • Outline UK-based infrastructure initiatives to support translational medicine innovations in dementia reserach around mid-life and early dementia
  • Note the emerging prevention environment from a social, political and economic perspective for dementia in the UK and beyond
  • 17:25 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Eric Karran

    Eric Karran

    Director of Research, Alzheimer’s Research UK
    Gary  Sachs

    Gary Sachs

    Therapeutic Area Lead, Bracket
    Kyriacos Mitrophanous

    Kyriacos Mitrophanous

    Head of Research, Oxford BioMedica plc
    Tom Isaacs

    Tom Isaacs

    Co-Founder, The Cure Parkinsons Trust
    Warren Hirst

    Warren Hirst

    Associate Research Fellow & Group Leader, Pfizer

    Claire Troakes

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

    Craig Ritchie

    Clinical Senior Lecturer, Imperial College London
    Craig Ritchie

    Eric Karran

    Director of Research, Alzheimer’s Research UK
    Eric Karran

    Gary Sachs

    Therapeutic Area Lead, Bracket
    Gary  Sachs

    Henri Huttunen

    Chief Scientific Officer, Hermo Pharma Ltd
    Henri Huttunen

    Johannes Streffer

    Director of Experimental Medicine Europe, Neurologist, Johnson & Johnson Pharmaceutical
    Johannes Streffer

    John Warren

    Director, Medicines Assessment
    John Warren

    Kyriacos Mitrophanous

    Head of Research, Oxford BioMedica plc
    Kyriacos Mitrophanous

    Larry Alphs

    Therapeutic Area Leader, Ortho-McNeil Janssen Scientific Affairs, LLC
    Larry Alphs

    Lars Bauer

    Senior Medical Director, UCB GmbH
    Lars Bauer

    Lesley Jones

    Professor of Neurogenetics, Director of Postgraduate Research, CARDIFF UNIVERSITY
    Lesley Jones

    Marie Luby

    Post Doctoral Scientist, NIH/NINDS
    Marie Luby

    Peter Joseph Jongen

    Founding Director, MS4 Research Institute
    Peter Joseph Jongen

    Richard Pither

    CEO, Cytox Ltd
    Richard Pither

    Richard has been involved in the development diagnostic and therapeutic products for more than twenty years and held senior R&D and leadership positions in global companies including GE Healthcare, UCB, Lorantis and Amersham. Richard has been involved in the development of a novel 18F-PET amyloid imaging radiopharmaceutical product for Alzheimer’s Disease for more than ten years. Richard has a BSc and PhD from Bristol University, and undertook post-doctoral research at Harvard Medical School.

    Richard Wyse

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

    Susan McGoldrick

    Managing Director, QCTR Ltd
    Susan McGoldrick

    Tom Isaacs

    Co-Founder, The Cure Parkinsons Trust
    Tom Isaacs

    Warren Hirst

    Associate Research Fellow & Group Leader, Pfizer
    Warren Hirst

    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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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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