HALF-DAY PRE-CONFERENCE WORKSHOPTuesday 22th November 2011, Marriott Regent’s Park, London

Innovation, superiority and best practice proof-of-conceptin CNS clinical development

Hosted by: Erik Buntinx CEO – Managing Director, PharmaNeuroBoost12.30pm – 5.30pm

SMi present their 10th conference on…

Clinical Trials in CNSWednesday 23rd and Thursday 24th November 2011Marriott Hotel Regent’s Park, Central London, UK

REGISTER BY 1ST JULY AND RECEIVE A £300 DISCOUNTREGISTER BY 9TH SEPTEMBER AND RECEIVE A £100 DISCOUNT

www.clinicaltrials-research.com Register online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Georg TerstappenDirector and Department Head, Neuroscience DiscoveryAbbott

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 DexterReader in NeuroPharmacology Department of MedicineImperial College London

BY ATTENDING YOU WILL BE ABLE TO:• Hear the latest developments in CNS clinical development• Focus on a variety of therapeutic areas in neurodegenerative

disorders• Study specific trials consideration for psychiatric conditions • Learn about cutting edge translational research and its impact

on clinical study• Network with some of the most important industry experts

working in the field

OUR EXCEPTIONAL SPEAKER LINE-UP INCLUDES:

Sponsored By

This year will address clinicaldrug discovery activities, newtherapeutic targets, as well aseffective CNS drug developmentstrategies and problemsencountered in clinical trials,with in-depth discussions andcase study presentations fromthe key industry players.

Clinical Trials in CNS 2011Day One | Wednesday 23rd November 2011

Register online at www.clinicaltrials-research.com • Alternatively

www.clinicaltria

8.30 Registration and Coffee

9.00 Chairman's opening remarksGeorg Terstappen, Director and Department Head, NeuroscienceDiscovery, Abbott

9.10 Cognition Strategy in Research & Early Development• Cognitive Performance: Translatable across species?• Cognitive Impairment: Translatable across different

neuropsychiatric diseases?• The pseudospecificity puzzle: is cognition a biomarker or an

independent (treatable) symptom cluster?Wim Riedel, Research & Early Development – Neuroscience,Hoffmann-La Roche *

9.50 Indentifying cognition enhancement: Expanding opportunities indrug development• What are the optimal cognitive tests and trial methodologies?• Traditional and emerging target populations: from dementia

through to oncology and schizophrenia• Case studies in pathological ageing, sleep disorders, MS and

oncologyKeith Wesnes, Practice Leader Specialty Clinical Services, UnitedBioSource Corporation

10.30 Morning Coffee

10.50 Current challenges in translational CNS research • Identification and validation of disease-relevant target molecules • Design of disease-relevant 'screening cascades' • Crossing the blood-brain barrier • Identification of 'translatable' biomarkers • Improving the success rate of clinical Phase 2 (POC) studiesGeorg Terstappen, Director and Department Head, NeuroscienceDiscovery, Abbott

11.30 Development of OncologyMAP®: A Public-Private PartnershipDedicated to Providing a Powerful New Tool for Discovery ofBiomarker Patterns in Cancer • OncologyMAP is the newest service offering in Rules-Based

Medicine’s portfolio of Multi-Analyte Profiles (MAPs). • Developed in partnership with the National Cancer Institute’s

Proteomics Initiative, OncologyMAP contains 101 quantitative,multiplexed immunoassays for measuring cancer-related proteinsin serum, plasma or tissue extracts.

• This novel tool offers an unparalleled platform to aid in thediscovery and development of novel therapies and diagnostics inoncology.

• The OncologyMAP is powered by RBM’s data-driven approach toefficiently and cost-effectively discover useful biomarker patterns.

Mike Spain, VP and Chief Medical Officer, Myriad RBM

12.10 Networking lunch

1.30 Targeting the brain Renin Angiotensin System - future prospects forAlzheimer’s disease and Vascular dementia• Rationale for renin angiotensin system (RAS) targeting in forms

dementia.• Lessons learned from Stroke trials and outcome measures of

cognition.• Considerations for protocol development for trials of RAS targeting

drugs and common forms of dementiaPatrick Kehoe, Reader in Translational Dementia Research,University of Bristol

2.10 Challenges and opportunities in dementia research: the Alzheimer’sResearch UK perspective• A summary on recent progress in dementia research• Current barriers to disease-modifying treatments, from the

laboratory to the clinic • What is being done to address these challengesSimon Ridley, Head of Research, Alzheimer’s Research UK

2. 50 Revival of EEG as a translational biomarker for the development ofNeuroscience drugs• Can EEG be used as a biomarker of central activity?• The value of EEG as a target engagement biomarker for specific

receptors• Diagnostic and prognostic biomarker properties of EEG in

depression and neurocognitive disorders• Revaluation of EEG as a response biomarkerGe Ruigt, Director Experimental Medicine Neuroscience, MSD

3.30 Afternoon Tea

3.50 CNS repair in MS: Role of biomarkers• Treatment goals beyond immunomodulation• Imaging approaches for demonstrating repair• Biofluid markers to support repairPaul Thompson, Associate, Director Discovery Medicine Unit, GSK

4.30 Recent Clinical Trials in MS -Achievements and Challenges• Overview of research at the MS4 institute• Current trials and results• Common challenges in this therapeutic area• Lessons to learn Peter Joseph, Jongen Founding Director, MS4 Research Institute

5.10 Chairman's Closing Remarks and Close of Day One

Supported by

Rules-Based Medicine® (RBM) is a CLIA-certified biomarker testing laboratory that uses multiplexed immunoassays to provide innovativeproducts and services. Enabled by microsphere technology and decades of experience, our proprietary Multi-Analyte Profiling (MAP) platformmakes drug discovery and development more efficient and effective. Using extremely small sample volumes, we provide discovery, pre-clinicaland clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of biomarkers. The RBM Approach utilizesDiscoveryMAP®, our largest MAP providing quantitative data for 266 biomarkers, as a hypothesis-generating tool in the primary study. Onceidentified, the biomarker pattern of interest is evaluated in subsequent studies to validate its utility. Data acquired helps support subsequent trialdesigns and critical go/no go decisions. At each step, assay precision and reproducibility are the keys to success. RBM’s fully automated platformis analytically validated to clinical laboratory standards that we provide as a service to pharmaceutical, biotech and central laboratories. The RBMapproach to biomarker testing delivers advantages that are changing the way therapeutics are developed, people are diagnosed and patients aretreated. www.rulesbasedmedicine.com

United BioSource Corporation (UBC), is a global scientific and medical affairs organization that partners with life science companies to developand commercialize biopharmaceuticals, medical devices, and other health care products. We help deliver authoritative, real-world evidence tocharacterize product effectiveness, address safety risk, and demonstrate value. www.unitedbiosource.com

Sponsored by

*Subject to final confirmation

8.30 Re-registration and Coffee

9.00 Chairman's opening remarksChas Bountra, Chief Scientist, Structural Genomics Consortium,University of Oxford

9.10 Trialling neuroprotection in Parkinson’s: Translating basic science intoclinical trials• Drawbacks of currents symptomatic therapies and goals of

neuroprotective strategies• Current concepts in understanding neurodegenerative mechanisms in

Parkinson’s and developing suitable drug targets• Are animal models good predictors of effective therapies• Translating effective neuroprotective approaches in in vivo animal

models of Parkinson’s to clinical trialsDavid Dexter, Reader in NeuroPharmacology Department of Medicine,Imperial College London

9.50 Parkinson’s disease and non-motor symptoms. Challenges in theevaluation of non-motor symptoms in clinical trials and developmentprograms • New concept of Parkinson’s disease• Non-motor symptoms overlooked in the past development of PD drugs• What makes non-motor symptoms so interesting to look at• Translating of motor as non-motor symptoms into clinical studies and

labelsFlorien von Raison , Head of Global Clinical Development UnitParkinson’s Disease, Merck Serono

10.30 Morning Coffee

10.50 Potential novel targets for neuropsychiatric disorders• Role of proteins modifying chromatin and hence gene expression• Why is targeting these proteins likely to deliver better therapeutics? • Are they chemically tractable? • Will they be safe on chronic dosing in patients?Chas Bountra, Chief Scientist, Structural Genomics Consortium,University of Oxford

11.30 Disease biomarkers for schizophrenia - from laboratory to patientbeside• The identification of significant peptides and proteins that distinguish

first-onset paranoid schizophrenia patients from healthy controls,leading to a candidate biomarker panel in patient serum.

• A panel of 51 markers was found to yield an average sensitivity andspecificity of >85% across five clinical centres comprising 572 first-onset drug-naive and recent onset schizophrenia patients versus 235matched healthy control samples.

• As part of the EU Innovative Medicine Initiative NewMeds we have alsoevaluated the serum protein signatures of 17 animal models ofschizophrenia (as used by the pharmaceutical industry in preclinicalstudies) and compared the changes with schizophrenia patients. Wefound that only few animal models show significantly similar serumsignatures to the human disease.

Sabine Bahn, Director, Cambridge Centre for Neuropsychiatric Research,University of Cambridge

12.10 Networking lunch

1.30 Prediction of efficacy in depression• Antidepressant drugs may affect the behavioral and neural processing

of emotional information prior to clinical changes in mood, emotionalbiomarker tests for use in drug development may therefore be possible.

• Patients with depression and those with subclinical dysphoria shownegative biases in emotional processing both in a behavioural test battery(the emotional test barry, ETB) and in neuroimaging paradigms with fMRI

• Negative affective biases in the ETB and fMRI paradgims are resolvedwith antidepressant drug treatment before changes in mood are seen.Similar effects are seen in healthy (non-depressed) controls.

• The importance to the therapeutic action of antidepressant treatmentsin depression: a new translational approach to screening anddeveloping novel candidate treatments

Catherine Harmer, Head of Group, Psychopharmacology and EmotionResearch Laboratory, Oxford University

2.10 The allosteric binding site for antidepressants in the serotonintransporter is located to the conserved extracellular vestibule• Using experimentally verified induced fit docking models we have

mapped an allosteric binding site for antidepressants on the serotonintransporter.

• The most pronounced effect was observed for escitalopram inhibitingescitalopram dissociation with a potency of 4.3 μM.

• This dual action of escitalopram could be responsible for the higherefficacy and faster onset observed in clinical trials for escitalopram ascompared to racemic citalopram.

• On the basis of these results, it is now possible to develop drugsselective for the allosteric binding site posing a different clinical profile

Claus Juul Loland, Associate Professor, Department of Neuroscienceand Pharmacology, University of Copenhagen

2.50 Afternoon Tea

3. 10 Sleeping with the enemy: Facilitating and establishing industry andacademic partnering • Overcoming the high attrition of new CNS drugs through industry-

academic collaborations • Experiences from collaborations: IMI and CCN • The Pharma perspectiveSophie Dix, Senior Research Scientist, Neurodegenerative Diseases DrugHunting Team, Lilly

3.50 Patient recruitment and retention issues in CNS clinical trials • Features of CNS trials that affect patient recruitment and retention.• Getting the patient into the trial in the first place.• Retaining the enrolled patient in the trial.• Recruitment and retention issues in Alzheimer’s Disease and dementia

clinical trials.Hitendra Parmar, European Medical Director for Alzheimer’s Disease, Pfizer

4.30 CNS tissue banking for neuroscience research• Introduction to brain banking in the UK: achieving high standards in

tissue collection, diagnosis, quality and access• Clinical assessment and cohort recruitment: increasing the scientific

value of donated tissue• Importance of tissue banking in clinical trials and biomarker validation• Aspirations for the future: centralised coordination, multi-sample biobanksClaire Troakes, Brain Bank Coordinator London NeurodegenerativeDiseases Brain Bank, King's College London

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

Clinical Trials in CNS 2011Day Two | Thursday 24th November 2011ls-research.com

Want to know how you can get involved? Interested in promoting your pharmaceutical services

to this market?Contact Margaret Mugema,

SMi Marketing on +44 (0) 20 7827 6072,or email mmugema@smi-online.co.uk

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and brandingpackages, uniquely tailored to complement your company’smarketing strategy. Prime networking opportunities exist toentertain, enhance and expand your client base within the contextof an independent discussion specific to your industry. Should youwish to join the increasing number of companies benefiting fromsponsoring our conferences please call: Alia Malick on +44 (0) 207827 6168 or email: almalick@smi-online.co.uk

• CNS Clinical Discovery/Nervous System Research• Clinical Trial Management and Operation • CNS Therapeutics and Molecular Profiling • Neurology/Neuroscience • Medical Directors • Pain Research/Management • Biomarkers and Imaging

Who should attend:You should attend this event if you are a Director, Area Head, CSO, or VP from within thePharmaceutical or Healthcare industry with responsibilities in the following areas:

• Pre-Clinical/Clinical R&D • Clinical Pharmacology • Patient Recruitment • Translational Medicine • Biostatistics and Modelling • Emerging Targets/Lead Optimisation • Genomics/Bioinformatics/Neuroinformatics

HALF DAY PRE-CONFERENCE WORKSHOPTuesday 22nd November 2011

12.30pm – 5.30pmMarriott Hotel Regent’s Park, Central London

Innovation, superiority and best practiceproof-of-concept in CNS clinical development

Overview of WorkshopThis session shall provide unique insight into establishingbest practise in POC trials, innovation in CNS discoveryand PNB boosting, by utilising a data driven case study into antidepressant therapy and our host’s vast expertise inmid to late phase CNS development.

Workshop agenda12.30 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 hostErik Buntinx, MD, CEO, founded the BelgianCNS specialty company PharmaNeuroBoost(PNB) in December 2006 and has raised up tilldate EUR 25 M. PNB’s platform technology isbased on Buntinx’s discovery of the boostingcapabilities of highly-selective serotonin 2A

and dopamine 4 receptor antagonists. Buntinx is aqualified psychiatrist, and previously founded the AnimaCenter, an outpatient psychiatric clinic and integratedclinical research unit. He obtained his MD degree from theCatholic University of Leuven (KUL), Belgium andcompleted his psychiatric residency at the KUL and theUniversity of Maastricht, The Netherlands.

About the organisationPharmaNeuroBoost (PNB) creates NCE’s out of existingtherapeutics combined with the company’s proprietaryboosting technology. PNB has granted CoM and use patentcoverage in different countries around the world for theindividual compounds in its pipeline. Over its first five yearsof life, PharmaNeuroBoost has proved its innovative fixed-dose combination concepts in preclinical and clinical proofof concept trials, and has shown support from the FDA fora pivotal trial that uses a new endpoint demonstratingsuperior efficacy over standard of care. During 2011, thecompany will initiate phase III trials for PNB01 and phaseIIa trials for PNB02, respectively in the treatment of majordepression and schizophrenia.

In association with

ABOUT THE SMi PHARMACEUTICAL TEAMSMi have been involved in the pharmaceutical industrysince 1993 and have developed a series of informativeand niche events, covering the latest issues anddevelopments surrounding the industry. Events bringtogether senior industry professionals and servingcompanies who have a focus on being at the forefrontof developments in this area. SMi aim to generateinformed and topical discussion through the mediumof both conferences and executive briefings. Ourpharmaceutical events are research-based andcontent driven with regular contact with majorindustry personnel and cover a wide range of industrysectors. For more information, please visit www.smi-online.co.uk/pharma.asp

June 201127/28 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 201106/07 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 201119/20 Biomarkers in Clinical Trials

26/27 Biosimilars and Biobetters

28/29 KOL Liaison and MSL Best Practice

October 201103/04 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 201131 Oct/1 Nov European Pharmaceutical Pricing

& Reimbursement (Switzerland)16/17 Clinical Trials in CNS

21/22 Cell Based Assay

December 20115/6 Cold Chain Distribution

All conferences take place in central London, UK - Unless

indicated otherwise in brackets.

2011 PHARMACEUTICAL FORWARD PLANNER

CLINICAL TRIALS IN CNSConference: Wednesday 23rd & Thursday 24th November 2011, Marriott Hotel Regent’s Park, Central London Workshop: Tuesday 22nd November 2011, London

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