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The World Health Organisation estimates that depression is the second biggest cause of disability in developed countries, a problem which costs the US economy about $53 billion annually. Antidepressants have become a large source of revenue for the pharmaceutical industry since the launch of Prozac, this revolution has moved depression from a taboo condition to what has become a socially acceptable condition; consequently the rate of diagnosis is soaring.

The conference Depression & Anxiety will cover the new directions in the treatment of depression and anxiety: specifically the role of: Nicotinics, GABAA receptors, the HPA axis and Substance P. In addition to this the conference will also cover:
· The role of Clinical Trials and how to improve clinical trial results in this complex industry
· Overcoming the problems of the placebo effect
· The role of co-morbidity in drug development
· The market dynamics, potential niches and entry strategies for the depression and anxiety industry
· Regulatory affairs: US & European
· Strategies to improve the antidepressant market and pipelines

This conference will appeal to people in the pharmaceutical industry, involved in drug discovery, clinical trials, regulations and marketing. It is designed to be attractive to academics and consultants in this field.

A unique opportunity to learn from leading industry experts including:
Dr Alexandre Gerebtzoff, International Medical Manager, F Hoffman-La Roche
Dr Franco Borsini, Head, Preclinic Psychiatric Research, Boehringer Ingelheim
Dr John Atack, Senior Investigator, Merck Sharp & Dohme
Dr Alan Lenox-Smith, Senior Medical Adviser, Wyeth
Prof Tonmoy Sharma, Director, Clinical Neuroscience Research Centre
Dr Ida Niklson, Head, TG CNS, UCB Pharma
Dr Roger Pinder, Vice President, Medical Affairs CNS & Thrombosis, Organon International
Dr Amir Kalali, Global & Scientific Head, CNS Therapeutics, Quintiles
Dr Sandra Hogg, Head, Psychopharmacology Depression, H Lundbeck
Dr Phil Skolnick, Senior Vice President, Research & Chief Scientific Officer, DOV Pharmaceutical
Dr Geoffrey Dunbar, Vice President, Clinical Development & Regulatory Affairs, Targacept

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Geoffrey Dunbar

Dr Geoffrey Dunbar, Vice President, Clinical Development & Regulatory Affairs, Targacept

9:10 THE EVOLUTION OF THE ANTIDEPRESSANT MARKET

Nick Alcock

Nick Alcock, Senior Psychiatry Analyst, Datamonitor

  • Overview of the historical and current market
  • Focus on specific symptoms as a growth driver
  • Co-morbid disorders in the treated population
  • Niches in the depression and anxiety market
  • Potential entry strategies
  • 9:40 SURROGATE MARKERS IN DEPRESSION AND ANXIETY: IMPLICATION FOR DRUG DEVELOPMENT

    Prof Tonmoy Sharma

    Prof Tonmoy Sharma, Director, Clinical Neuroscience Research Centre

  • Use of surrogate markers in depression explained
  • How these can provide indications of efficacy in smaller samples before phase II studies
  • Use of startle response in investigating effects of antidepressants and antianxiety compounds
  • How can cognitive function assessment help in the estimating of side effects and efficacy
  • Use of functional MRI as a tool to investigate the neurobiology and drug effects in depression and anxiety
  • Role of critical flicker fusion and eye movements in drug development
  • 10:20 EU REGULATORY REQUIREMENTS FOR TRIALS IN DEPRESSION & ANXIETY

    Dr Sandy Eisen

    Dr Sandy Eisen, Principal Consultant, Worldwide Regulatory Affairs Group, Parexel

  • How useful are the guidelines?
  • Where are changes possible or likely?
  • 11:00 Morning Coffee

    11:20 STRATEGIES TO IMPROVE ANTIDEPRESSANT THERAPY

    Dr Phil Skolnick

    Dr Phil Skolnick, Senior Vice President, Research & Chief Scientific Officer, DOV Pharmaceutical

  • Reducing time to onset (therapeutic lag)
  • Increasing efficacy
  • The rationale for a ‘broad spectrum’ antidepressant (an agent that increases the synaptic availability of norepinephrine, serotonin and dopamine)
  • Non biogenic-amine based approaches
  • 12:00 DEPRESSION: A NEW APPROACH TO DRUG DISCOVERY

    Dr David Horrobin

    Dr David Horrobin, Chairman, Laxdale

  • In vitro and in vivo models of depression
  • Human Biochemistry in the search for new drugs
  • Novel compounds: ethyl eicosapentaenoate
  • Effects in treatment-resistant depression, bipolar disorder and personality disorder
  • The role of folic acid and the placebo effect
  • 12:40 Networking Lunch

    14:00 GABAA RECEPTOR SUBTYPE-SELECTIVE MODULATORS

    Dr John Atack

    Dr John Atack, Senior Investigator, Merck Sharp & Dohme

  • Generalised Anxiety Disorder (GAD) – the nature of the problem
  • Current treatments for GAD and their limitations
  • Benzodiazepines and GABAA receptors
  • Which GABAA subtypes are associated with anxiety?
  • Characteristics of a GABBA subtype-selective non-sedating anxiolytic
  • 14:40 HYPOTHALAMIC PITUITARY ADRENAL (HPA) AXIS

    Dr Roger Pinder

    Dr Roger Pinder, Vice President, Medical Affairs, CNS & Thrombosis, Organon International

  • Abnormalities in the HPA axis
  • The roles of CRH, vasopressin and glucocorticoid receptors
  • How this knowledge may improve the treatment of depression and anxiety
  • New targets for antidepressants and anxiolytics based upon the HPA axis
  • 15:20 Afternoon Tea

    15:40 NICOTINIC NEURONAL RECEPTOR (NNR) MODULATION IN DEPRESSION AND ANXIETY

    Dr Geoffrey Dunbar

    Dr Geoffrey Dunbar, Vice President, Clinical Development & Regulatory Affairs, Targacept

  • Background on diversity of nicotinic acetylcholine receptor and function
  • Proof of concept for a variety of therapeutic indications observed from tobacco use
  • Neuropsychiatric disorders most likely to respond to NNR modulation: preclinical and clinical data
  • 16:20 THE ROLE OF PEPTIDES IN DEPRESSION

    Dr Alexandre Gerebtzoff

    Dr Alexandre Gerebtzoff, International Medical Manager, F Hoffman-La Roche

  • The promise of neurokinines
  • Physiological activities of Substance P
  • NK1 receptors
  • Clinical trial results with Substance P antagonists
  • Will Substance P be developed into a new class of drugs?
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Amir Kalali

    Dr Amir Kalali, Global Scientific Head, CNS Therapeutics, Quintiles

    9:10 IN VIVO PHARMACOLOGY OF ANTIDEPRESSANTS AND ANXIOLYTICS

    Dr Sandra Hogg

    Dr Sandra Hogg, Head, Psychopharmacology Depression, H Lundbeck

  • Unmet needs in depression and anxiety
  • Modelling the unmet needs
  • Differentiating classical and novel agents
  • The challenge of ‘the new receptors’
  • A plethora of anxiety disorders
  • 9:40 BRIDGING THE GAP BETWEEN PRECLINIC AND CLINIC

    Dr Franco Borsini

    Dr Franco Borsini, Head, Preclinic Psychiatric Research, Boehringer Ingelheim

  • Problems of responders, onset of action and relapse and how to face these aspects in preclinic; limits of preclinic methods
  • Animal models: the necessity of integrating in vitro and in vivo disciplines
  • From pre-clinic and clinic, the choice of clinical doses
  • Future directions, transgenic animals and genetics and current pipelines
  • 10:20 DRUG REGULATORY AFFAIRS

    Dr Kathryn Jason

    Dr Kathryn Jason, Director, Drug Regulatory Affairs, Boehringer Ingelheim

  • Regulatory requirements for approval of antidepressants and anxiolytics
  • Use of placebo in antidepressant and anxiolytic drug registration trials
  • Use of comparator drugs in antidepressant and anxiolytic drug registration trials
  • Current thinking of the FDA and European agencies
  • 11:00 Morning Coffee

    11:20 THE GABBA RECEPTOR COMPLEX AS A TARGET FOR ANXIOLYTIC DRUGS

    Dr Naheed Mirza

    Dr Naheed Mirza, Director, In-Vivo Pharmacology, NeuroSearch

  • Targets on the GABAA receptor complex
  • Some novel dual mechanism modulators of the GABAA receptor
  • NS2710 – a compound with interesting in vitro mechnaism of action at the GABAA receptor
  • In vivo implications of NS2710’s in vitro actions
  • Future directions
  • 12:00 THE ASSESSMENT OF DEPRESSION IN CLINICAL TRIALS

    Dr Amir Kalali

    Dr Amir Kalali, Global Scientific Head, CNS Therapeutics, Quintiles

  • Discuss current collaborative efforts to improve current gold standard assessments
  • Discuss collaborative efforts to develop new instruments that may be more appropriate for novel antidepressant compounds
  • 12:40 Networking Lunch

    13:40 DESIGNING CLINICAL TRIALS

    Dr Ida Niklson

    Dr Ida Niklson, Head, TG CNS, UCB Pharma

  • Trial methodology
  • Choice of investigators
  • Strategies to improve clinical trials in depression
  • Obstacles to overcome
  • Failed clinical trials
  • 14:20 THE CLINICAL RELEVANCE OF CLINICAL TRIALS IN DEPRESSION AND ANXIETY

    Dr Alan Lenox-Smith

    Dr Alan Lenox-Smith, Senior Medical Adviser, Wyeth

  • Controlled vs naturalistic studies
  • Efficacy vs effectiveness
  • Endpoints - which should be primary?
  • Interpreting meta-analyses
  • Beyond tolerability
  • 15:00 OVERCOMING THE PROBLEM OF PLACEBO

    Dr Erik Buntinx

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

  • The effect of placebo on clinical trials
  • New methodologies to design clinical trials
  • Using expert technologies to optimise the design of clinical trials
  • Conducting clinical trials by NECT
  • 15:40 Afternoon Tea

    16:00 IMPACT OF CO-MORBIDITY IN DEPRESSION AND ANXIETY

    Dr Jill Rasmussen

    Dr Jill Rasmussen, Director, psynapse

  • Evidence from epidemiological data
  • Effect on patient selection and trial design
  • Effect on clinical trial results
  • Regulatory considerations
  • Pros and cons of current broad spectrum antidepressants
  • 16:40 FROM BIOCHEMISTRY TO BEHAVIOUR

    Dr Michael Krause

    Dr Michael Krause, Director, Electrophysiology, Tensor Biosciences

  • Primary bottlenecks in psychiatric drug discovery
  • The need for broad-spectrum physiological assays
  • Correlating in vitro and in vivo drug responses
  • Identifying best in class therapeutics
  • 17:20 Chairman's Closing Remarks and Close of Conference

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    WHAT IS CPD?

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