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There are currently more than 170 pyschotherapeutic agents in development, including products for depression, schizophrenia, anxiety and dipolar disorder. The effect of these disorders on the economy, both directly and in terms of loss of productivity, is staggering. In the US, for example, depression is estimated to cost approximately $53 billion annually. Drugs to cure or control disorders of the central nervous system therefore represent an extremely valuable area and indeed, this is reflected by recent investment from pharmaceutical companies.

With so many new drugs under development, SMi has identified the need to take a closer look at how clinical trials for these treatments are designed, managed and assessed. The conference will include a focus on practical, ethical, commercial and regulatory issues. Some of the areas to be considered include patient recruitment ideas, novel or updated methodologies for monitoring efficacy of treatments, new approaches to overcoming the problems associated with the placebo effect, lessons that can be learnt from previous trials, efficient data capture and an update in the regulatory guidelines governing clinical trials.

You will have plenty of opportunity to network and exchange ideas with experts in this industry involved in all aspects of running clinical trials for treatment of disorders of the CNS.

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Amir Kalali

Dr Amir Kalali, Executive Director, Medical & Scientific Services, Quintiles

9:10 AN INTRODUCTION TO CNS DRUG DEVELOPMENT

Dr Terrence Sills

Dr Terrence Sills, CNS Diseases & General Medecine, Boehringer Ingelheim

  • Overcoming practical challenges to maximise trial success
  • Maintaining consistency in operational procedures
  • Identifying the problems: why do so many CNS trials fail?
  • The importance of learning from past experiences
  • Enhancing the statistical and clinical power of existing research protocols
  • The role of pharma companies in the development and validation of new tools: the cutting edge in clinical research
  • 9:40 STRATEGIES TO EXPEDITE CNS DRUG DEVELOPMENT

    Dr Ravi Anand

    Dr Ravi Anand, Head, Clinical Projects, CNS, Organon

  • Applicability of pre-clinical findings to patients
  • Defining the dose-range for therapeutic trials
  • Alternative designs for dose-finding studies
  • Designing phase III for expedited development
  • Use of surrogate markers in phase II/III trials
  • New approaches to effectiveness research
  • 10:20 THE USE OF SURROGATE MARKERS IN DRUG DEVELOPMENT

    Prof Tonmoy Sharma

    Prof Tonmoy Sharma, Director, Clinical Neuroscience Research Centre

  • Surrogate markers in phase I: how can they help us identify novel compounds?
  • The role of cognition in drug development: safety and efficacy
  • Using the startle response to delineate drugs with CNS effects
  • Functional imaging as a tool for drug development
  • Combining novel populations and surrogate markers early in development
  • 11:00 Morning Coffee

    11:20 MAXIMISING THE VALUE OF EARLY DRUG TRIALS

    Dr Richard Peck

    Dr Richard Peck, Director, European Clinical Pharmacology, Eli Lilly

  • MDSS in the target population
  • Candidate selection based on clinical data
  • Studying multiple indications
  • Dose selection based on biomarkers
  • When FED is POC
  • 12:00 THE INCREASING USE OF COGNITIVE ASSESSMENT IN CNS CLINICAL TRIALS

    Dr Andrew Silverman

    Dr Andrew Silverman, Senior Director, CNS Scientific Affairs, INC Research

  • Exploring the reasons for conducting cognitive assessment
  • Defining the parameters of cognitive assessment
  • Reviewing the current view of cognitive assessment at the FDA and NIH
  • Evaluating the available tools for selecting cognitive assessments
  • Using cognitive tools to evaluate efficacy and safety in clinical trials
  • Computerised versus traditional administration: strategies for decision making

    Assessing the level of detail in cognitive data required in a clinical trial

  • 12:40 Networking Lunch

    13:40 AMPAKINE® CX516 CROSS NATIONAL COLLABORATIVE MILD COGNITIVE IMPAIRMENT STUDY

    James Coleman

    James Coleman, Senior Vice President, Cortex Pharmaceuticals

  • New pharmacology
  • 31 sites, 2 continents
  • E-CRF, electronic data capture
  • Central lab, central drug distribution
  • 14:20 MEASURING EFFICACY OF NOVEL TREATMENTS FOR PSYCHOSES: BIPOLAR DISORDER AND SCHIZOPHRENIA

    Dr Jill Rasmussen

    Dr Jill Rasmussen, Director, psynapse

  • Defining the parameters for measuring drug efficacy
  • Viable assessment: frequency and intensity of symptoms
  • An update in tools for quantitative assessment of efficacy
  • Developments in CNS imaging technologies
  • Advances in cognitive testing in CNS
  • Impact of trial design on assessment of efficacy
  • 15:00 THE INTERSEPT STUDY

    Prof Robert Kerwin

    Prof Robert Kerwin, Professor of Clinical Neuropharmacology, Institute of Psychiatry

  • First ever major trial to do parallel analysis of surrogate outcomes versus hard outcomes in a psychiatric arena
  • First ever prospective study of suicide in schizophrenia
  • First ever genuine equipoise study in psychiatry because of the ethical implication of the end points
  • Major relicensing implications for a drug that is niched because of safety concerns
  • Good example of collaboration with regulatory authorities and the pharmaceutical industry
  • 15:40 Afternoon Tea

    16:00 AUGMENTATION THERAPY IN SCHIZOPHRENIA

    Dr Jens Heisterberg

    Dr Jens Heisterberg, Section Head, International Clinical Research, Psychosis, H Lundbeck

  • What is add-on therapy?
  • Pharmacological and clinical rationale
  • Clinical experiences so far
  • Methodological problems in the clinical development of an add-on therapy
  • Can add-on trials substitute placebo-controlled trials?
  • 16:40 INTERACTIVE VOICE RESPONSE (IVR) PATIENT SELF-REPORT ASSESSMENTS IN CLINICAL TRIALS

    Dr John Greist

    Dr John Greist, Chief Executive Officer, Healthcare Technology Systems

  • Models for use of IVR across phases I-IV of clinical trials
  • Research results and compelling arguments for use of direct patient computer interviews for data collection
  • Pros and cons of IVR assessments and vendor issues
  • Clinical validation issues: when and how does a scale need to be validated?
  • Foreign language issues and validation scenarios
  • Sample application based on trial phase (I-IV)
  • 17:20 CHALLENGES OF CNS CLINICAL TRIALS WITH CELLULAR AND IMPLANTED THERAPEUTICS

    Dr Frank Valone

    Dr Frank Valone, Executive Vice President, Clinical Development & Regulatory Affairs, Titan Pharmaceuticals

  • Targeted proof of concept: preclinical studies to guide clinical development
  • Gleaning efficacy as early as Phase I
  • Unique regulatory issues facing cell therapy
  • How to control and blind trials with a surgical component
  • 18:00 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Prof Stephen Oppenheimer

    Prof Stephen Oppenheimer, Professor of Neurology, Medicine & Neuroscience, Pharmanet

    9:10 PERCEPTION AND PRECISION

    Prof Stephen Oppenheimer

    Prof Stephen Oppenheimer, Professor of Neurology, Medicine & Neuroscience, Pharmanet

  • Why use a surrogate?
  • The nature of surrogate markers of neurological disease activity
  • Consideration of the relationship between surrogates and clinical status
  • Common extrapolative errors
  • Future directions
  • 9:40 OUTCOME MEASURES IN CLINICAL TRIALS OF MULTIPLE SCLEROSIS

    Dr Alfred Sandrock

    Dr Alfred Sandrock, Senior Director, Medical Research, Biogen

  • Clinical measures
  • MRI measures
  • Validation, sensitivity and regulatory considerations
  • 10:20 LESSONS LEARNT FROM PAST SUCCESSES: TOWARDS THE IMPROVEMENT OF FUTURE TRIALS

    Dr Judith Abdala

    Dr Judith Abdala, Medical Director, Neurology Clinical Development Unit, Serono

  • Challenges in trials of disease modifying therapies in MS
  • Challenges of the orphan drug act
  • Design issues: prisms and evidence: -choosing the appropriate comparators -accurate results through the continuous clinical and MRI assessment during the course of treatment -determining appropriate end points
  • Implementation strategies to maximise successful completion of MS trials
  • Interpretation: what the results tell us about interferons in MS
  • 11:00 Morning Coffee

    11:20 CLINICAL TRIALS IN TRAUMATIC BRAIN INJURY

    Dr Nadim Kassem

    Dr Nadim Kassem, Vice President Clinical & Regulatory Affairs, Pharmos

  • Problems and failures in previous TBI clinical trials
  • Parameters of efficacy
  • Why Dexanabinol?
  • Pharmos’ ongoing clinical TBI trial
  • Impact for the industry
  • 12:00 DOES THE HEAD FOLLOW THE HEART?

    Dr Michael Wess

    Dr Michael Wess, Vice President, Scientific & Medical Affairs, Amarin Pharmaceuticals

  • Similarities in pathophysiology between major CNS and CV diseases: myocardial infarction vs ischaemic stroke; cardiac arrhythmia vs epilepsy; end-organ failure (heart failure vs dementia)
  • End point selection in CV and CNS clinical trials
  • The role of ‘megatrials’ in CV diseases: a model for CNS?
  • Device development: case study of a ‘pacemaker-like’ device developed for refractory epilepsy
  • Tissue at risk: ‘stunned’ myocardium and the ‘penumbra’ of stroke
  • 12:40 Networking Lunch

    14:00 NEUROPROTECTION FOR ISCHAEMIC STROKE: AN ATTAINABLE GOAL

    Dr Ole Graff

    Dr Ole Graff, Medical Director, Neurosearch

  • Overcoming practical issues
  • What type of patients should be included?
  • What could be an end point?
  • 14:40 PROSAPTIDETM: A NOVEL ANALGESIC FOR NEUROPATHIC PAIN

    Dr Fred Esch

    Dr Fred Esch, Senior Director, Myelos

  • Background
  • Animal models
  • Toxicology
  • Clinical development
  • Summary
  • 15:20 Afternoon Tea

    15:40 A NEW FRAMEWORK FOR COLLABORATION ON METHODOLOGICAL ISSUES IN CNS DRUG DEVELOPMENT

    Dr Amir Kalali

    Dr Amir Kalali, Executive Director, Medical & Scientific Services, Quintiles

  • Learn about on-going collaboration in CNS drug development
  • Hear how these initiatives may impact your programmes
  • Receive information on how to contribute to these collaborations
  • 16:20 CNS DRUGS OF TOMORROW

    Dr Marie-Louise Jacques

    Dr Marie-Louise Jacques, Senior Vice President, CNS Therapeutics, Boston Life Sciences

  • Global CNS market size and growth by therapeutic area
  • Target CNS disease focus against relative unmet medical need
  • New drugs currently under development in the CNS area broken down by development phase
  • Projected product launches and timings for major CNS drugs by 2005
  • Product portfolio: focus versus diversity?
  • New paradigms of success

    Future opportunities

  • 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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