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Following the success of last year's event, SMi will be bringing together leading industry experts to explore the current and future opportunities within CNS drug development. Representing the second largest therapeutic segment of the pharmaceutical market it is also one of the fastest growing. This year SMi’s conference aims to cover preclinical drug discovery activity as well as effective CNS drug development strategies and problems encountered in clinical trials, with in-depth discussions and case study presentations from the key industry players.

As CNS therapies become more complex and difficult to bring to market, the need to consider issues involved in effective trial design is increasingly important. Key issues include discussion on clinical research- the preclinical to clinical interface; clinical trials in disease specific therapeutics (with a focus on Alzheimer’s, Multiple Sclerosis, Pain & Anxiety); regulatory updates; effective measurement and the placebo effect, as well as case study presentations on the management of specific CNS drugs during the development stage.

Speakers at this Year's Event include:

  • Dr Claudio Carini, Vice President, Global Head Biomarkers and Development, Roche
  • Dr Gerard Marek, Chief Scientific Officer, Psychiatric Disorders, Discovery Biology, Eli Lilly
  • Dr Boris Chizh, Director, Exploratory Pain Medicine, GlaxoSmithKline
  • Dr Scot Styren, Director, CNS Studies, Therapeutic Area Technology Leader, Global Clinical Platforms, Pfizer
  • Dr Mark Schmidt, Director & Clinical Expert, Psychiatry, Johnson & Johnson
  • Professor David Leppert, Clinical Stream Leader, Neurology, Medical Diagnostics, GE Healthcare
  • Dr Warren Stern, Senior Vice President, Drug Development, DOV Pharmaceutical

Learn why CNS clinical trials and drug development are among the most challenging in all areas of medicine and how your business can overcome this and produce effective treatments for a range of CNS diseases today. With constant changing dynamics in the CNS market this is a must attend event for pharmaceutical executives to keep abreast of the current and future market developments in the area.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Amir Kalali

Amir Kalali, Vice President, Medical & Scientific Services & Global Scientific Head CNS, Quintiles

9:10 EARLY PHASE COMPOUNDS

Remy Luthringer

Remy Luthringer, Chief Executive Officer, FORENAP Pharma

  • What are the potential problems?
  • What solutions are available?
  • What CNS compounds will be approved in the near future?
  • Discovery and development re-engineering of CNS drugs
  • 9:50 WHERE ARE THE NOVEL ANTIDEPRESSANTS/ANXIOLYTICS?

    Gerard Marek

    Gerard Marek, Chief Scientific Officer, Discovery Biology Psychiatric Disorders, Eli Lilly And Company

  • Monoamine-based innovation
  • Glutamatergic-based innovation
  • Combination therapy for novel psychiatric drug development
  • 10:30 Morning Coffee

    11:00 TRANSLATIONAL MEDICINE IN CNS DISORDERS

    Dr Orest Hurko

    Dr Orest Hurko, Assistant VP, Translational Research, Wyeth Pharmaceuticals

  • Identification of responsive subjects
  • Optimisation of receptor occupancy
  • Sensitive indicators of efficacy
  • Prediction of toxicity
  • 11:40 CLINICAL BIOMARKERS IN DRUG DEVELOPMENT

    Claudio Carini

    Claudio Carini, Global Head of Biomarkers, Roche Inc

  • Large scale attrition and trial rates
  • Establishing a proof of concept before progression – challenges and limitations
  • Translational medicine in CNS trials
  • Identifying and validating clinically relevant biomarkers
  • Studies developing principals for therapeutic strategies
  • Making transitional medicine more than an interesting idea
  • 12:20 Networking Lunch

    13:50 PET IMAGING AT THE PRECLINICAL/CLINICAL INTERFACE

    Mark Schmidt

    Mark Schmidt, Director & Clinical Expert, CNS, Johnson & Johnson Pharmaceutical Research & Development

  • Benefits of PET
  • Animal and human PET for preclinical transition
  • What can PET do for CNS applications?
  • Neuroscience and drug development using PET
  • 14:30 MEASUREMENT IN TRIALS WHERE THERE IS A DEFICIT OF COGNITION

    Geoffrey Dunbar

    Geoffrey Dunbar, Senior Vice President, Clinical Development & RA, Targacept*

  • CNS diseases where cognitive deficit is a primary or secondary phenomenon will be considered
  • AAMI, MCI and dementia form a continuum of deficit in the elderly and available instruments will be critically reviewed. The need for appropriate sensitivity will be stressed
  • Assessment instruments in depression are frequently criticised. Specific measurement of cognition may be a useful alternative
  • Disturbance of the sleep/wake cycle is often seen in CNS disorders. Tapping into this may offer new and more sensitive measures
  • 15:10 Afternoon Tea

    15:40 PANEL DISCUSSION

  • What can we do to ensure patient safety?
  • Effective dose selection strategies
  • Is there an alternative to dose selection?
  • Warren Stern

    Warren Stern, Senior VP, Drug Development, DOV Pharmaceutical, Inc.

    Remy Luthringer

    Remy Luthringer, Chief Executive Officer, FORENAP Pharma

    Professor Dr David  Leppert

    Professor Dr David Leppert, Clinical Stream Leader, Neurology, Medical Diagnostics, GE Healthcare

    16:20 ENHANCING CLINICAL TRIAL DESIGN IN STROKE AND THE DEMENTIAS

    Keith Wesnes

    Keith Wesnes, Scientific Director & Chief Executive, Cognitive Drug Research

  • Recognising the importance of attentional impairment in stroke and dementia
  • Contrasting the cognitive impairment profiles in the disorders
  • Identifying tests which are sensitive to disease progression
  • The nature of tests which can identify cognition enhancement
  • The relevance of cognitive function changes to everyday activities
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Mark Schmidt

    Mark Schmidt, Director & Clinical Expert, CNS, Johnson & Johnson Pharmaceutical Research & Development

    9:10 EMPLOYING A MULTI-MODAL APPROACH IN ASSESSING DISEASE PROGRESSION: DIAGNOSTIC AND THERAPEUTIC IMPLICATIONS

    Scot Styren

    Scot Styren, Director, Global Clinical Technologies, Pfizer Inc

  • Assessment of longitudinal subject data
  • Cross modality data analysis
  • Determination of appropriate modalities for assessing therapeutic response
  • How these modalities may provide a path forward for diagnostic development
  • 9:50 MEASURING FUNCTIONAL OUTCOME IN CNS PATIENT GROUPS

    Paul Maruff

    Paul Maruff, Chief Scientific Officer, CogState

  • Selecting disease appropriate endpoints
  • Case study 1: Negative symptoms and cognition in Schizophrenia
  • Case study 2: Alzheimer’s disease
  • Electronic/automated collection of functional outcome data
  • Issues specific to paediatric patient groups
  • Issues with repeated assessment
  • 10:30 Morning Coffee

    11:00 THE ROLE OF THE CLINICAL RATER IN REDUCING PLACEBO RESPONSE AND IMPROVING SIGNAL DETECTION IN MULTI-CENTER CLINCIAL CNS TRIALS

    Joshua  Lipsitz

    Joshua Lipsitz, Assistant Clinical Professor, Department of Psychiatry, Columbia University , MedAvante, Inc

  • Advances in evaluation and training of clinical raters
  • Sources of bias in clinical ratings
  • Reliability of clinical ratings
  • Centralised ratings: a novel solution
  • 11:40 FAILED CNS CLINICAL TRIALS ACROSS MULTIPLE INDICATIONS

    Amir Kalali

    Amir Kalali, Vice President, Medical & Scientific Services & Global Scientific Head CNS, Quintiles

  • This presentation will review a number of failed trials reported in CNS drug development
  • What can we do to increase the chance of success?
  • The factors that may have led to these results will be examined
  • Possible ways to mitigate these factors will be discussed
  • 12:20 Networking Lunch

    13:50 COMBINATION THERAPIES IN MS

  • Novel therapeutic approaches
  • Targeting the adaptive immune-system ("T-cell mediated")
  • Targeting the innate immune system (non-adaptive)
  • Perspectives and rational for combination therapies
  • Medical aspects
  • Socio-economic aspects
  • Professor Dr David  Leppert

    Professor Dr David Leppert, Clinical Stream Leader, Neurology, Medical Diagnostics, GE Healthcare

    14:30 EXPERIMENTAL APPROACHES IN EARLY DEVELOPMENT OF NEW ANALGESICS

    Boris Chizh

    Boris Chizh, Director, Exploratory Pain Medicine, GlaxoSmithKline

  • Current problems in the chronic pain area
  • Why has development of new analgesics been so difficult?
  • What can we learn from failures?
  • Promising new targets and approaches
  • How to maximise chances for success?
  • 15:40 DEVELOPMENT OF A NOVEL NONOPIATE/NONNSAID ANALGESIC (BICIFADINE) FOR CHRONIC AND ACUTE PAIN

    Warren Stern

    Warren Stern, Senior VP, Drug Development, DOV Pharmaceutical, Inc.

  • Clinical trial design and statistical analysis aspects of studies in chronic pain
  • Outcome measures
  • Factors affecting the placebo response
  • FDA stance on efficacy requirements for chronic and acute pain NCEs
  • Study results using a novel reuptake inhibitor (bicifadine) in acute and chronic pain studies
  • 16:20 Chairman’s Closing Remarks, followed by Afternoon Tea

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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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