Clnical trials in CNS

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montgomm
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Clnical trials in CNS

Early Booking offer for SMis 4th Annual Conference on..
Clinical Trials in CNS
5th & 6th December, London

Following the success of last years event, SMi will be bringing together
leading industry experts to explore the current and future opportunities
within CNS. The conference this year aims to cover preclinical drug
discovery activity as well as effective CNS drug development strategies and
problems encountered in clinical trials, with indepth discussions and case
study presentations. 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.

Issues to be covered will include clinical research, clinical trials in
disease specific therapeutics, regulatory updates, effective measurement
and overcoming the placebo effect as well as case study talks on the
management of specific drug formulations at various stages of development.

This is a great opportunity to meet and network with key industry leaders
and specialists in the CNS field.

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EARLY BIRD DISCOUNT AVAILABLE
**********************************************************************
The early bird registration deadline is 16th September. Please register
before this date to receive 100 off your delegate place
**********************************************************************

To register simply go to:
http://www.smi-online.co.uk/goto/cnstrials.asp?emref=T11ES191678979

Discounts are available for group bookings, contact James Holland on tel:
+44 (0)20 7827 6180 or mailto:jholland@smi-online.co.uk
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A unique opportunity to learn from leading industry experts including:

- Dr Mark Schmidt, Principal Imaging Fellow, Novartis
- Dr Craig Earl, Senior Director, Clinical Research, Cephalon
- Dr Thomas Steckler, Therapeutic Area Leader, Psychiatry & Biology Head,
Johnson & Johnson
- Dr Pim Drinkenburg, Head, Biomonitoring Research RED Europe & Research
Fellow, Johnson & Johnson
- Dr Andrew Grupe, Director, CNS Discovery Research, Celera Diagnostics
- Dr Magnus Sjgren, Disease Area Clinical Expert, Neurology, AstraZeneca
(Tentatively confirmed)
- Dr Christian Czech, Senior Research Scientist, CNS Research,
Pharmaceutical Division, F. Hoffmann La Roche
- Dr Craig Mallinckrodt, Principal Research Scientist, Eli Lilly
- Dr Anthony Basile, Senior Director, Pharmacology, DOV Pharmaceutical
- Dr Rico Nil, Regional Medical Director, H Lundbeck
- Dr Amir Kalali, Vice President, Medical & Scientific Services, Global
Scientific Head, CNS Therapeutics, Quintiles
- Marie Luby, CNS Director & Consultant, Perceptive Informatics

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For the full conference programme please scroll down:

DAY ONE - 5th December 2005

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks
Dr Mark Schmidt, Principal Imaging Fellow, Novartis

KEYNOTE ADDRESS
9.10 A market overview
- CNS market trends - what areas are growing and which
are shrinking?
- Identifying the main problem areas for 2005/6 and beyond
- Why do so many CNS trials fail?
- Beyond CNS trials - bringing products onto the market
- The role of pharma companies in drug development
- CNS drugs of tomorrow

A REGULATORY UPDATE
9.50 Key issues to consider in CNS clinical trials
- The requirements for different indications
- Recent focus on Multiple Sclerosis, Alzheimers and Schizophrenia
- The use of surrogate endpoints
- What other CNS markets are going to be reviewed in the near future?
- Positive and negative commercial impacts of the rulings
- How will the market shape up in 2006 and beyond

10.30 Morning Coffee

RECENT DRUG DISCOVERY IN CNS
11.00 A look at compounds in early phases
- Potential problems and innovative solutions
- An overview of Phase I clinical trials - the issues involved
- Novel CNS compounds for the near future
- Re-engineering discovery and development
Thomas Steckler, Therapeutic Area Leader, Psychiatry & Biology Head,
Johnson & Johnson

PRECLINICAL DRUG DISCOVERY
11.40 Therapeutic strategies for disease modification in Alzheimer's disease
- Target the amyloid cascade to delay disease progression
- Emerging targets addressing neurodegeneration in AD
- Analyze current approaches for AD disease modification
- Monitor side effects of Alzheimer Therapies
- Identification and validation of biomarkers for clinical trials
Dr Christian Czech, Senior Research Scientist, CNS Research, Pharmaceutical
Division, F. Hoffmann La Roche

12.20 Networking Lunch

BRIDGING THE GAP FROM PRECLINICAL TO CLINICAL
1.50 Can CNS drug discovery and development already benefit from
translational medicine?
- Streamlining the transition to de-risk NMEs
- Examples of preclinical/clinical integrative technology
- Use and usefulness of appropriate biomarkers
- Future implications for the drug development process
Pim Drinkenburg, Head, Biomonitoring Research RED Europe & Research Fellow,
Johnson & Johnson

CLINICAL DEVELOPMENT PLANS
2.30 Phase II and III development planning in CNS
- A review of the market situation, current standards
- Regulatory expectations in planning clinical trials
- Analysis of the programme life-cycle
- Monitored performance of programme versus strategic goals
- Customising the programme to support the therapy area and individual
product

3.10 Afternoon Tea

AN ASESSMENT OF WITHDRAWAL DISCONTINUATION
SYMPTOMS
3.40 Development programmess in anxiety disorders and depression
Dr Rico Nil, Regional Medical Director, H Lundbeck

GENETIC MARKERS
4.20 Utilizing genetic information for preclinical development and
clinical trial design
- The need for replication
- Genetics and target identification
- Pros and cons of clinical trial stratification
- The timetable requires co-development of the therapeutic product and
diagnostic tests
Dr Andrew Grupe, Director, CNS Discovery Research, Celera Diagnostics

5.00 Chairmans Closing Remarks and Close of Day One

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DAY TWO - 6th December 2005

8.30 Re-registration & Coffee

9.00 Chairman's Opening Remarks
Dr Amir Kalali, Vice President, Medical & Scientific Services, Global
Scientific Head, CNS Therapeutics, Quintiles

CLINICAL TRIAL DESIGN
9.10 Novel trial designs for ADHD and sleep disorders
- Analysis of current market and recent developments
- Where trials can be adapted
- Regulatory considerations and guidelines
- The search for effective drug development
- Clinical trial design of antidepressants across the major markets
Dr Craig Earl, Senior Director, Clinical Research, Cephalon

DEVELOPMENT OF THE NON-OPIOID ANALGESIC
9.50 A case study on Bicifadine
- Molecular mechanism
- Efficacy in preclinical models of acute and chronic pain:
- Efficacy in models of inflammatory pain
- Efficacy in models of neuropathic pain
- Regulatory requirements for demonstration of clinical efficacy: the
bicifadine experience
- Regulatory requirements for assessment of abuse potential
- Choice of clinical models of analgesia
Dr Anthony Basile, Senior Director, Pharmacology, DOV Pharmaceutical

10.30 Morning Coffee

STATE OF THE ART MS CLINICAL TRIALS
11.00 Challenges in trials of therapies in MS
- Design issues - comparators and endpoints
- Regulatory issues for 2005 and beyond
- Strategies to maximise successful implementation
- The need for better markers
- How recent developments will affect clinical trials across Europe
- Predictions for the next 5 years

COMBINATION THERAPY IN MS
11.40 An overview of recent developments
- Understanding the rationale for combining treatments
- Who, when and why?
- Recent regulatory implications and how to deal with them
- Evidence from various diseases
- Overcoming the pitfalls and potential problems

12.20 Networking Lunch

MULTI-CAN STRATEGY
1.50 Exploratory IND

IMAGING IN CNS DRUG DEVELOPMENT
2.30 The role of imaging in CNS trials
- The role of functional imaging in CNS trials
- Imaging in diagnosis and progression of disease
- Selection of methods and outcome measures
- Impact of imaging on the conduct of trials
- A focus on Alzheimers
- Future implications
Dr Mark Schmidt, Principal imaging Fellow, Novartis

3.10 Afternoon Tea

SURROGATE ENDPOINTS
3.40 Case studies of current progress and future direction
- Why use a surrogate?
- Selecting the appropriate endpoint
- Duration of clinical trials
- The relationship between surrogates and clinical status
- Surrogate markers and their weaknesses
- Expected advances and developments

HOW CAN SPONSORS AND SITES IMPACT PLACEBO AND STUDY SUCCESS?
4.20 What can we do to optimise these factors?
- What factors at the site level might impact placebo response and study
success?
- What methodological factors might impact placebo response and study
success?
- What factors at the sponsor level might impact placebo response and study
success?
- What can be done to address these issues?
Dr Amir Kalali, Vice President, Medical & Scientific Services, Global
Scientific Head, CNS Therapeutics, Quintiles

5.00 Chairmans Closing Remarks and Close of Conference

**********************************************************************
EARLY BIRD DISCOUNT AVAILABLE
**********************************************************************
The early bird registration deadline is 16th September Please register
before this date to receive 100 off your delegate place
**********************************************************************

To register simply go to:
http://www.smi-online.co.uk/goto/cnstrials.asp?emref=T11ES191678979

Discounts are available for group bookings, contact James Holland on tel:
+44 (0)20 7827 6180 or mailto:jholland@smi-online.co.uk
======================================================================

SPONSORSHIP OPPORTUNITIES:

SMi Conferences offers an excellent opportunity to profile your company
through tailored sponsorship opportunities. For details contact Adrian
Johnston on tel: +44 (0)20 7827 6074 or mailto:ajohnston@smi-online.co.uk
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