SMi’s 10th annual conference on Clinical Trials in CNS will bring together leading industry experts to explore the current and future opportunities within CNS drug development. With 35% of the global disease burden due to CNS disorders, this event addresses a vital area of research.

1. REGISTER BY 1ST JULY AND RECEIVE A £300 DISCOUNT
REGISTER BY 9TH SEPTEMBER AND RECEIVE A £100 DISCOUNT
SMi present their 10th conference on…
Clinical Trials in CNS
Wednesday 23rd and Thursday 24th November 2011
Marriott Hotel Regent’s Park, Central London, UK
OUR EXCEPTIONAL SPEAKER LINE-UP INCLUDES:
Georg Terstappen
Director and Department Head, Neuroscience Discovery
Abbott
Sophie Dix
Senior Research Scientist, Neurodegenerative Diseases Drug Hunting Team
Lilly
Ge Ruigt
Director Experimental Medicine Neuroscience
MSD
Paul Thompson
Associate, Director Discovery Medicine Unit
GSK
Florien von Raison
Head of Global Clinical Development Unit Parkinson’s Disease
Merck Serono
David Dexter
Reader in NeuroPharmacology Department of Medicine
This year will address clinical Imperial College London
drug discovery activities, new
therapeutic targets, as well as BY ATTENDING YOU WILL BE ABLE TO:
effective CNS drug development • Hear the latest developments in CNS clinical development
strategies and problems • Focus on a variety of therapeutic areas in neurodegenerative
disorders
encountered in clinical trials, • Study specific trials consideration for psychiatric conditions
with in-depth discussions and • Learn about cutting edge translational research and its impact
case study presentations from on clinical study
• Network with some of the most important industry experts
the key industry players. working in the field
Sponsored By HALF-DAY PRE-CONFERENCE WORKSHOP
Tuesday 22th November 2011, Marriott Regent’s Park, London
Innovation, superiority and best practice proof-of-concept
in CNS clinical development
Hosted by: Erik Buntinx CEO – Managing Director, PharmaNeuroBoost
12.30pm – 5.30pm
www.clinicaltrials-research.com
Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

2. Clinical Trials in CNS 2011
Day One | Wednesday 23rd November 2011 www.clinicaltria
8.30 Registration and Coffee 1.30 Targeting the brain Renin Angiotensin System - future prospects for
Alzheimer’s disease and Vascular dementia
9.00 Chairman's opening remarks • Rationale for renin angiotensin system (RAS) targeting in forms
Georg Terstappen, Director and Department Head, Neuroscience
dementia.
Discovery, Abbott
• Lessons learned from Stroke trials and outcome measures of
9.10 Cognition Strategy in Research & Early Development cognition.
• Cognitive Performance: Translatable across species? • Considerations for protocol development for trials of RAS targeting
• Cognitive Impairment: Translatable across different drugs and common forms of dementia
neuropsychiatric diseases?
Patrick Kehoe, Reader in Translational Dementia Research,
• The pseudospecificity puzzle: is cognition a biomarker or an
independent (treatable) symptom cluster? University of Bristol
Wim Riedel, Research & Early Development – Neuroscience,
Hoffmann-La Roche * 2.10 Challenges and opportunities in dementia research: the Alzheimer’s
Research UK perspective
9.50 Indentifying cognition enhancement: Expanding opportunities in • A summary on recent progress in dementia research
drug development
• Current barriers to disease-modifying treatments, from the
• What are the optimal cognitive tests and trial methodologies?
• Traditional and emerging target populations: from dementia laboratory to the clinic
through to oncology and schizophrenia • What is being done to address these challenges
• Case studies in pathological ageing, sleep disorders, MS and Simon Ridley, Head of Research, Alzheimer’s Research UK
oncology
Keith Wesnes, Practice Leader Specialty Clinical Services, United
2. 50 Revival of EEG as a translational biomarker for the development of
BioSource Corporation
Neuroscience drugs
10.30 Morning Coffee • Can EEG be used as a biomarker of central activity?
• The value of EEG as a target engagement biomarker for specific
10.50 Current challenges in translational CNS research receptors
• Identification and validation of disease-relevant target molecules • Diagnostic and prognostic biomarker properties of EEG in
• Design of disease-relevant 'screening cascades'
depression and neurocognitive disorders
• Crossing the blood-brain barrier
• Identification of 'translatable' biomarkers • Revaluation of EEG as a response biomarker
• Improving the success rate of clinical Phase 2 (POC) studies Ge Ruigt, Director Experimental Medicine Neuroscience, MSD
Georg Terstappen, Director and Department Head, Neuroscience
Discovery, Abbott 3.30 Afternoon Tea
11.30 Development of OncologyMAP®: A Public-Private Partnership
Dedicated to Providing a Powerful New Tool for Discovery of 3.50 CNS repair in MS: Role of biomarkers
Biomarker Patterns in Cancer • Treatment goals beyond immunomodulation
• OncologyMAP is the newest service offering in Rules-Based • Imaging approaches for demonstrating repair
Medicine’s portfolio of Multi-Analyte Profiles (MAPs). • Biofluid markers to support repair
• Developed in partnership with the National Cancer Institute’s Paul Thompson, Associate, Director Discovery Medicine Unit, GSK
Proteomics Initiative, OncologyMAP contains 101 quantitative,
multiplexed immunoassays for measuring cancer-related proteins
in serum, plasma or tissue extracts. 4.30 Recent Clinical Trials in MS -Achievements and Challenges
• This novel tool offers an unparalleled platform to aid in the • Overview of research at the MS4 institute
discovery and development of novel therapies and diagnostics in • Current trials and results
oncology. • Common challenges in this therapeutic area
• The OncologyMAP is powered by RBM’s data-driven approach to
• Lessons to learn
efficiently and cost-effectively discover useful biomarker patterns.
Mike Spain, VP and Chief Medical Officer, Myriad RBM Peter Joseph, Jongen Founding Director, MS4 Research Institute
12.10 Networking lunch 5.10 Chairman's Closing Remarks and Close of Day One
*Subject to final confirmation
Register online at www.clinicaltrials-research.com • Alternatively
Sponsored by
Rules-Based Medicine® (RBM) is a CLIA-certified biomarker testing laboratory that uses multiplexed immunoassays to provide innovative
products and services. Enabled by microsphere technology and decades of experience, our proprietary Multi-Analyte Profiling (MAP) platform
makes drug discovery and development more efficient and effective. Using extremely small sample volumes, we provide discovery, pre-clinical
and clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of biomarkers. The RBM Approach utilizes
DiscoveryMAP®, our largest MAP providing quantitative data for 266 biomarkers, as a hypothesis-generating tool in the primary study. Once
identified, the biomarker pattern of interest is evaluated in subsequent studies to validate its utility. Data acquired helps support subsequent trial
designs and critical go/no go decisions. At each step, assay precision and reproducibility are the keys to success. RBM’s fully automated platform
is analytically validated to clinical laboratory standards that we provide as a service to pharmaceutical, biotech and central laboratories. The RBM
approach to biomarker testing delivers advantages that are changing the way therapeutics are developed, people are diagnosed and patients are
treated. www.rulesbasedmedicine.com
United BioSource Corporation (UBC), is a global scientific and medical affairs organization that partners with life science companies to develop
and commercialize biopharmaceuticals, medical devices, and other health care products. We help deliver authoritative, real-world evidence to
characterize product effectiveness, address safety risk, and demonstrate value. www.unitedbiosource.com
Supported by

3. Clinical Trials in CNS 2011
ls-research.com Day Two | Thursday 24th November 2011
8.30 Re-registration and Coffee 1.30 Prediction of efficacy in depression
• Antidepressant drugs may affect the behavioral and neural processing
9.00 Chairman's opening remarks of emotional information prior to clinical changes in mood, emotional
Chas Bountra, Chief Scientist, Structural Genomics Consortium, biomarker tests for use in drug development may therefore be possible.
University of Oxford • Patients with depression and those with subclinical dysphoria show
negative biases in emotional processing both in a behavioural test battery
9.10 Trialling neuroprotection in Parkinson’s: Translating basic science into (the emotional test barry, ETB) and in neuroimaging paradigms with fMRI
clinical trials • Negative affective biases in the ETB and fMRI paradgims are resolved
• Drawbacks of currents symptomatic therapies and goals of with antidepressant drug treatment before changes in mood are seen.
neuroprotective strategies Similar effects are seen in healthy (non-depressed) controls.
• The importance to the therapeutic action of antidepressant treatments
• Current concepts in understanding neurodegenerative mechanisms in in depression: a new translational approach to screening and
Parkinson’s and developing suitable drug targets developing novel candidate treatments
• Are animal models good predictors of effective therapies Catherine Harmer, Head of Group, Psychopharmacology and Emotion
• Translating effective neuroprotective approaches in in vivo animal Research Laboratory, Oxford University
models of Parkinson’s to clinical trials
David Dexter, Reader in NeuroPharmacology Department of Medicine, 2.10 The allosteric binding site for antidepressants in the serotonin
Imperial College London transporter is located to the conserved extracellular vestibule
• Using experimentally verified induced fit docking models we have
9.50 Parkinson’s disease and non-motor symptoms. Challenges in the mapped an allosteric binding site for antidepressants on the serotonin
evaluation of non-motor symptoms in clinical trials and development transporter.
programs • The most pronounced effect was observed for escitalopram inhibiting
• New concept of Parkinson’s disease escitalopram dissociation with a potency of 4.3 μM.
• Non-motor symptoms overlooked in the past development of PD drugs • This dual action of escitalopram could be responsible for the higher
• What makes non-motor symptoms so interesting to look at efficacy and faster onset observed in clinical trials for escitalopram as
• Translating of motor as non-motor symptoms into clinical studies and compared to racemic citalopram.
labels • On the basis of these results, it is now possible to develop drugs
Florien von Raison , Head of Global Clinical Development Unit selective for the allosteric binding site posing a different clinical profile
Parkinson’s Disease, Merck Serono Claus Juul Loland, Associate Professor, Department of Neuroscience
and Pharmacology, University of Copenhagen
10.30 Morning Coffee 2.50 Afternoon Tea
10.50 Potential novel targets for neuropsychiatric disorders 3. 10 Sleeping with the enemy: Facilitating and establishing industry and
• Role of proteins modifying chromatin and hence gene expression academic partnering
• Why is targeting these proteins likely to deliver better therapeutics? • Overcoming the high attrition of new CNS drugs through industry-
• Are they chemically tractable? academic collaborations
• Will they be safe on chronic dosing in patients? • Experiences from collaborations: IMI and CCN
Chas Bountra, Chief Scientist, Structural Genomics Consortium, • The Pharma perspective
University of Oxford Sophie Dix, Senior Research Scientist, Neurodegenerative Diseases Drug
Hunting Team, Lilly
11.30 Disease biomarkers for schizophrenia - from laboratory to patient
beside 3.50 Patient recruitment and retention issues in CNS clinical trials
• The identification of significant peptides and proteins that distinguish • Features of CNS trials that affect patient recruitment and retention.
first-onset paranoid schizophrenia patients from healthy controls, • Getting the patient into the trial in the first place.
leading to a candidate biomarker panel in patient serum. • Retaining the enrolled patient in the trial.
• A panel of 51 markers was found to yield an average sensitivity and • Recruitment and retention issues in Alzheimer’s Disease and dementia
specificity of >85% across five clinical centres comprising 572 first- clinical trials.
onset drug-naive and recent onset schizophrenia patients versus 235 Hitendra Parmar, European Medical Director for Alzheimer’s Disease, Pfizer
matched healthy control samples.
4.30 CNS tissue banking for neuroscience research
• As part of the EU Innovative Medicine Initiative NewMeds we have also • Introduction to brain banking in the UK: achieving high standards in
evaluated the serum protein signatures of 17 animal models of tissue collection, diagnosis, quality and access
schizophrenia (as used by the pharmaceutical industry in preclinical • Clinical assessment and cohort recruitment: increasing the scientific
studies) and compared the changes with schizophrenia patients. We value of donated tissue
found that only few animal models show significantly similar serum • Importance of tissue banking in clinical trials and biomarker validation
signatures to the human disease. • Aspirations for the future: centralised coordination, multi-sample biobanks
Sabine Bahn, Director, Cambridge Centre for Neuropsychiatric Research, Claire Troakes, Brain Bank Coordinator London Neurodegenerative
University of Cambridge Diseases Brain Bank, King's College London
12.10 Networking lunch 5.10 Chairman’s closing remarks and close of conference
fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding
Who should attend: packages, uniquely tailored to complement your company’s
You should attend this event if you are a Director, Area Head, CSO, or VP from within the marketing strategy. Prime networking opportunities exist to
Pharmaceutical or Healthcare industry with responsibilities in the following areas: entertain, enhance and expand your client base within the context
of an independent discussion specific to your industry. Should you
• CNS Clinical Discovery/Nervous System Research • Pre-Clinical/Clinical R&D wish to join the increasing number of companies benefiting from
• Clinical Trial Management and Operation • Clinical Pharmacology sponsoring our conferences please call: Alia Malick on +44 (0) 20
7827 6168 or email: almalick@smi-online.co.uk
• CNS Therapeutics and Molecular Profiling • Patient Recruitment
• Neurology/Neuroscience • Translational Medicine Want to know how you can get involved?
• Medical Directors • Biostatistics and Modelling
Interested in promoting your pharmaceutical services
to this market?
• Pain Research/Management • Emerging Targets/Lead Optimisation
Contact Margaret Mugema,
• Biomarkers and Imaging • Genomics/Bioinformatics/Neuroinformatics SMi Marketing on +44 (0) 20 7827 6072,
or email mmugema@smi-online.co.uk

4. HALF DAY PRE-CONFERENCE WORKSHOP
Tuesday 22nd November 2011
12.30pm – 5.30pm
Marriott Hotel Regent’s Park, Central London
Innovation, superiority and best practice
proof-of-concept in CNS clinical development
In association with
Overview of Workshop
This session shall provide unique insight into establishing
best practise in POC trials, innovation in CNS discovery
and PNB boosting, by utilising a data driven case study in
to antidepressant therapy and our host’s vast expertise in
mid to late phase CNS development.
Workshop agenda
12.30 Registration & Coffee
1.00 Welcome & Introductions
1.10 Innovative CNS Drugs:
To Be Superior of Not to Be!
• Unmet Medical Needs and New Clinical
Paradigms
• Regulatory Requests
• Designing ‘superior’ clinical trials
• New End Points
1.45 The PNB Boosting Concept:
Demonstrating Superiority
• Pharmacological Considerations
• Clinical Goals
• IP Matters
• Pipeline
2.45 Coffee
3.00 The PNB01 Clinical Development Program
– A Novel Boosting Antidepressant Therapy
• Objectives
• Phase II Proof of Concept Data showing
beneficial effects
• The New Pivotal End Point: Early and
Sustained Response Rate (ESR)
• The Phase III Study: Outline
4.10 Discussion Session
5.30 Close of Workshop
About the workshop host
Erik Buntinx, MD, CEO, founded the Belgian
CNS specialty company PharmaNeuroBoost
(PNB) in December 2006 and has raised up till
date EUR 25 M. PNB’s platform technology is
based on Buntinx’s discovery of the boosting
capabilities of highly-selective serotonin 2A
and dopamine 4 receptor antagonists. Buntinx is a
qualified psychiatrist, and previously founded the Anima
Center, an outpatient psychiatric clinic and integrated
clinical research unit. He obtained his MD degree from the
Catholic University of Leuven (KUL), Belgium and
completed his psychiatric residency at the KUL and the
University of Maastricht, The Netherlands.
About the organisation
PharmaNeuroBoost (PNB) creates NCE’s out of existing
therapeutics combined with the company’s proprietary
boosting technology. PNB has granted CoM and use patent
coverage in different countries around the world for the
individual compounds in its pipeline. Over its first five years
of life, PharmaNeuroBoost has proved its innovative fixed-
dose combination concepts in preclinical and clinical proof
of concept trials, and has shown support from the FDA for
a pivotal trial that uses a new endpoint demonstrating
superior efficacy over standard of care. During 2011, the
company will initiate phase III trials for PNB01 and phase
IIa trials for PNB02, respectively in the treatment of major
depression and schizophrenia.

5. 2011 PHARMACEUTICAL
FORWARD PLANNER
June 2011
27/28 RNAi, miRNA, siRNA
29/30 Pharmaceutical Portfolio & Product
Life Cycle Management
29/30 Pharmaceutical Nanotechnology
29/30 KOL Management and MSL
Best Practice in Europe (Munich, Germany)
July 2011
06/07 ADMET
06/07 Social Media in the Pharmaceutical Industry
11/12 BioBanking
18/19 Pharmaceutical and Clinical Trial Logistics Asia
Pacific (Singapore)
20/21 Pre Filled Syringes Asia (Singapore)
September 2011
19/20 Biomarkers in Clinical Trials
26/27 Biosimilars and Biobetters
28/29 KOL Liaison and MSL Best Practice
October 2011
03/04 Partnerships with CROs
10/11 Pharmaceutical m-Health
12/13 GP Commissioning
19/20 COPD: Novel Therapeutics and Management
Strategies
24/25 Point of Care Diagnostics - Market Opportunities
and Technology Trends
November 2011
31 Oct/1 Nov European Pharmaceutical Pricing
& Reimbursement (Switzerland)
16/17 Clinical Trials in CNS
21/22 Cell Based Assay
December 2011
5/6 Cold Chain Distribution
All conferences take place in central London, UK - Unless
indicated otherwise in brackets.
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6. CLINICAL TRIALS IN CNS
Conference: Wednesday 23rd & Thursday 24th November 2011, Marriott Hotel Regent’s Park, Central London Workshop: Tuesday 22nd November 2011, London
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