This document provides information about the "CNS Clinical Trials" conference taking place on September 16-17, 2010 in London. The conference will examine strategies for successful CNS drug development and overcoming challenges in clinical trial design, management, and recruitment. Key topics will include novel cognitive assessment methods, advances in neuroimaging, adaptive trial design, and the use of biomarkers to demonstrate early drug effects in CNS trials. Speakers will include representatives from pharmaceutical and biotechnology companies as well as academic institutions. Attendees will gain insights on improving various aspects of CNS clinical trials from development through regulatory approval. The conference also provides sponsorship and exhibition opportunities for companies to promote their products and services.

1. CNS Clinical Trials
Optimising development, management and recruitment for clinical trials in CNS
16th - 17th September 2010, BSG Conference Centre, London, UK BOOK NOW!
Key Speakers
Dr Erik Buntinx, Managing Director and Chief Scientific Officer, PharmaNeuroBoost
Dr Samuel Agus, Global Medical Affairs Director, Neurology, Solvay Pharmaceuticals Marketing and Licensing
Dr Stig Johan Wiklund, Statistical Science Director, AstraZeneca R&D
Dr Fabrizio Gasparini, Sr Research Investigator, Novartis Institutes for BioMedical Research
Dr Mark Tricklebank Director, Lilly Centre for Cognitive Neuroscience, Eli Lilly and Co
Dr Karl Herholz Director, Wolfson Molecular Imaging Centre/ Professor of Clinical Neuroscience,
University of Manchester
Professor Elaine Rankin, Medical Oncology, University of Dundee
Professor Alan M Palmer, Chief Scientific Officer, MS Therapeutics
Gaynor Anders Vice President Global Operations, MMG
Professor Mehdi Adineh, Scientific Director Diagnostic Imaging Core Laboratory, American College of Radiology
Dr. Michael G. Palfreyman, Head, Translational R&D, ChemDiv, Executive Program Director,
Senior Scientific Advisor, EnVivo Pharmaceuticals
Associate Sponsors
Driving the Industry Forward | www.futurepharmaus.com Organised By
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/cns-trials

2. Conference Introduction
CNS Clinical Trials
16th - 17th September 2010, London, UK
CNS is one of the largest and fastest growing therapeutic areas of the Associate Sponsors:
pharmaceutical market. The ageing of the baby-boom generation combined
with new and emerging treatments for neurodegenerative disorders, ACR Image Metrix, an imaging contract research organization (CRO)
including multiple sclerosis, Alzheimer’s disease and Parkinson’s disease, located in the American College of Radiology Clinical Research
will lead to further expansion of the neurodegenerative therapies market. Center in Philadelphia, applies imaging techniques to improve
(Source: Visiongain - World Neurodegenerative Diseases Market 2009 -2024) the efficiency of drug and medical device development programs. The world-class team of
radiologists and imaging scientists, at ACR Image Metrix, work with pharmaceutical, biotech
Dear Colleague, and medical device companies to integrate the appropriate imaging technologies, modalities
and clinical design techniques into their imaging studies. ACR Image Metrix has years of
t Visiongain’s CNS Clinical Trials conference you will examine the strategies offering
A experience utilizing state-of-the-art technologies to provide a complete line of imaging
the greatest potential for success in CNS drug development, and understand the specific services from site qualification and training, study initiation, image management, reader
challenges currently faced by developers in this market. In order to enhance productivity studies and much more.
in this field, there has been an increased awareness of the need to align clinical and For further information please visit: www.acr-imagemetrix.net
preclinical research to facilitate rapid development of new CNS drug therapies. Medical
imaging is increasingly being used as a surrogate endpoint or biomarker of drug efficacy ERT is a provider of technology and services to the pharmaceutical,
in all phases of CNS trials, enabling CNS developers to make more timely decisions. biotechnology and medical device industries. The Company is a market
leader in providing centralized core-diagnostic electrocardiographic
s part of this 2-day event, leading industry and academic authorities will address how
A (ECG) technology and services to evaluate cardiac safety in clinical development. Further,
to balance risk and how attrition can be reduced to increase the chances of success in ERT’s ePRO Solutions™ provide a simple, immediate conduit to the Sponsor’s most valuable
CNS clinical trials. Participants will look at overcoming some of the hurdles arising in asset – the patient. This phone based system captures throughout the Complete Patient
designing, managing and recruiting for CNS clinical trials, and examine the tools and Experience – from Recruiting and Screening, Assessments and Diaries through to Safety and
technologies to best enhance clinical development. Suicidality Monitoring. ERT harnesses internet and telecommunications technology and services
to streamline the clinical trials process by enabling its customers to automate the collection,
By attending this conference you will: analysis and distribution of clinical data in all phases of clinical development.
• Examine novel approaches for assessing cognitive function For further information please visit: www.ERT.com
• Explore the latest advances in neuroimaging Media Partners:
• Develop effective methods for improved patient recruitment and retention PharmiWeb.com is the leading industry-sponsored portal for
• Understand statistical thinking for designing adaptive trials the pharmaceutical sector. Supported by most of the leading
pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features,
• Review Good Clinical Practice GCP guidelines events listings and international jobs to industry professionals across Europe and the US.
• Address the regulatory challenges for CNS drug approval For further information please email: corporate@pharmiweb.com
• Utilise biomarkers for Proof of Concept in CNS clinical trials
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD.
• mprove trial outcomes through increased communication, ethical consent and
I It is based and located in Warsaw, Poland. Biotechnology World was
patient care founded in 2007 to provide the world’s biotech and pharma information and market to
• mplement translational methods to bridge the gap between pre-clinical and clinical
I make it universally accessible and useful for scientific and business processes. Its first step
to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will
CNS trials allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers
• Be part of a major networking opportunity companies completed internet public relations, publication and marketing solutions. One of
the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector
I look forward to meeting you at the conference in Europe to global biotechnology, pharmaceutical and life science activities.
Best regards For further information please visit: www.biotechnology-europe.com
Driving the Industry Forward | www.futurepharmaus.com
Future Pharmaceuticals has forged powerful relationships with key
industry leaders to provide a platform for successful brand recognition,
and for senior decision-makers to have the means to procure and plan implementation
Andrea Charles strategies based on the topics covered. Positioned to be an authoritative resource within top
Head of Conferences pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine
is geared to create a deep penetration into a highly targeted and responsive audience, bridging
the gap between the industries’ top issues and the solutions top-tier vendors can provide.
For further information please visit: www.futurepharmaus.com
Target Audience: InPharm is the online platform for exclusive pharmaceutical news,
• Pharmaceutical and biotech companies comment, contracts, services, jobs and events and is home to
• Clinical research organisations InPharmjobs.com, Pharmafile and Pharmafocus.
• Regulatory agencies/ associations
For further information please visit: www.In-Pharm.com
Who will be there? Pharma Connections Worldwide® is the leading professional
Senior VPs, VPs, Chief Scientific Officers, Directors, Heads and business networking website focused in the Pharmaceutical,
Managers of: Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for
• CNS Trials delivery of premiere content coupled with the right clientele in order to facilitate business
• Clinical Trials development opportunities among industry professionals responsible for making key
• Clinical Research & Development decisions in a global marketplace.
• Clinical Operations For further information please visit: www.pharmaconnections.com
• CNS
• CNS Clinical Biomarker Group
• Clinical Pharmacology
• Neurobiology
• Neuromedical Oncology Sponsorship and exhibition opportunities:
• Neurology/ Neuroscience Research This event offers a unique opportunity to meet and do business with some of the key
• Psychiatry
• Psychology players in the pharmaceutical and biotech industries. If you have a service or product to
• CNS Ageing Research promote, you can do so at this event by:
• Dementia
• Imaging/ Neuroimaging • Hosting a networking drinks reception
• Movement Disorders • Taking an exhibition space at the conference
• CNS Global Marketing & Medicine
• Preclinical R&D • Advertising in the delegate documentation pack
• Translational Medicine • Providing branded bags, pens, gifts, etc.
• Biostatistics
• Experimental Therapeutics If you would like more information on the range of sponsorship or exhibition possibilities
• Clinical Technology for visiongain's CNS Clinical Trials Conference, please contact us:
• Outcomes Research
• Regulatory Affairs Christopher Clegg, +44 (0)20 7549 9964
• Product Development christopher.clegg@visiongainglobal.com
• Neurologists

3. Day 1
CNS Clinical Trials
Thursday 16th September 2010
09:30 Registration and refreshments 14:30 mGluR5 Allosteric Antagonists: Preclinical profile
and choice of therapeutic indication
• haracterization of mGluR5 antagonist in preclinical paradigm
C
10:00 Opening address from the chair
• Validation of objective markers for monitoring drug action
• se of preclinical profiling and proof-of-concept clinical trials to
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10:10 The discovery and development of CNS medicines select therapeutic indications for full development
• rogress in CNS medicines research
P Dr Fabrizio Gasparini
• Market landscape Sr Research Investigator
Novartis Institutes for BioMedical Research
• The challenges for CNS R&D
• Future prospects
15:10 Suicidality: Ensuring quality in mandated
Professor Alan M Palmer
Chief Scientific Officert
prospective monitoring
MS Therapeutics • verview of the Columbia-Suicide Severity Rating Scale (C-SSRS)
O
• otential pitfalls with collection of suicidality monitoring data
P
10:50 Addressing specific challenges arising in the clinical • C-SSRS - electronically modeling and reproducing the optimal
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human interview
trials of neuroprotective agents
• C-SSRS – meeting the goals of excellent science and clinical care
e
• C-SSRS – a clinical trial case study
e
11:30 Morning refreshments Dr John Greist
Distinguished Senior Scientist, Madison Institute of Medicine
Clinical Professor of Psychiatry, University of Wisconsin
11:50 Clinical value of accelerated anti-depressant effect School of Medicine and Public Health
• Lag time of antidepressants: an unmet medical need
• arly and Sustained Full Response: A new FDA approved
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efficacy paradigm 15:50 Afternoon refreshments
• harmacological considerations to induce accelerated
P
antidepressant effect
16:10 CNS clinical trials beyond registration
• reatment adherence in relation to an antidepressant with an
T
• rials beyond registration a tool for assessing a drug in real-life setting
T
accelerated effect
• ypes of post-registration studies, goals, deliverables and methods
T
Dr Erik Buntinx
Managing Director and Chief Scientific Officer • When should trials beyond registration begin?
PharmaNeuroBoost • ife cycle management and drug safety- 2 sides for the same coin
L
• ho initiates investigator-initiated-trials and what is their purpose
W
12:30 Considerations for design and statistical analysis Dr Samuel Agus
of CNS trials Global Medical Affairs Director, Neurology
Solvay Pharmaceuticals Marketing and Licensing
• Analysis and design for disease modification
• Missing data issues
• Adaptive design issues when applied in CNS trials 16:50 Closing remarks from the chair
Dr Stig Johan Wiklund
Statistical Science Director
AstraZeneca R&D
17:00 Networking drinks
13:10 Networking Lunch Take your discussions further and build new
relationships in a relaxed and informal setting.
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010

4. Day 2
CNS Clinical Trials
Friday 17th September 2010
09:30 Registration and refreshments 13:10 Networking Lunch
14.10 Use of biomarkers for demonstrating CNS effects of
10:00 Opening address from the chair
drugs early in clinical development
• Using animal PK/PD data to set dose range finding in Phase 1
10:10 Bridging the gap between pre-clinical and • Use of QEEG to demonstrate CNS activity
clinical CNS trials
• Computer measures of cognition
• Translational assays of cognition • Evoked potentials to demonstrate clinical potential
• Animal models of cognitive impairment Dr. Michael G. Palfreyman
• Use of preclinical biomarkers to enhance assay translation Head, Translational R&D, ChemDiv
Executive Program Director, Senior Scientific Advisor, EnVivo
• linical testing of preclinical hypotheses
C Pharmaceuticals
Dr Mark Tricklebank
Director, Lilly Centre for Cognitive Neuroscience 14:50 Recruiting strategies for Huntington’s Disease
Eli Lilly and Co clinical trials
• he importance of identifying unique barriers to participation in HD
T
clinical trials
10:50 Reducing the gap between preclinical PK/PD and
• rass-roots social marketing for HD trials can speed enrollment:
G
CNS clinical trials a pilot study
• dding value to the discovery of CNS active drugs through the application
A
• reating the HD trial participant as VIP is a cost-effective approach.
T
of mechanistic PK/PD principles
Dr LaVonne Veatch Goodman
• nderstanding the key drivers of in-vivo pharmacological effects and
U
Co-founder
ensuring they are prominent in the lead optimisation paradigm Huntington’s Disease Drug Works (HDDW)
• stablishing the link between blood concentration, receptor occupancy
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and drug efficacy 15:30 Afternoon refreshments
11:30 Morning refreshments 15:50 Patient recruitment and retention strategies for
CNS clinical trials
• atient population insights that need to be considered in designing
P
11:50 Novel imaging approaches in clinical trials and the recruitment and retention programs for CNS trials
role of an imaging CRO • trategies for overcoming global CNS patient recruitment challenges
S
• ovel Imaging Approaches including Structural, Functional and Molecular
N
• pdates on evolving trends in patient recruitment and retention methodologies
U
in CNS Drug Discovery including PET, DTI, fMRI and vCT. • llustrative case studies of effective tactics
I
• maging Drug Actions Including Neuroreceptor Mapping
I
Gaynor Anders
Vice President Global Operations
• he role of an Imaging CRO in Managing an Imaging Clinical Trial
T
MMG
Professor Mehdi Adineh
Scientific Director Diagnostic Imaging Core Laboratory 16.30 Successful strategies for accelerating
American College of Radiology patient recruitment
• Preparing for successful enrolment
12:30 Utilising PET imaging biomarkers • The ideal set-up
• Dementia: glucose metabolism, amyloid tracers, acetylcholine analogues • Avoiding the pitfalls for a pharma-driven trial
• Parkinson’s disease: dopamine synthesis & storage capacity • Enlisting support from patients
• Psychiatric disorders: dopamine & serotonin receptor occupancy Professor Elaine Rankin
Medical Oncology
• Brain tumours: progression and infiltration
University of Dundee
• Tracers and techniques for quantitative standardised analysis will be presented
Dr Karl Herholz
17:10 Chair’s closing remarks
Director, Wolfson Molecular Imaging Centre/ Professor of
Clinical Neuroscience
17:20 End of conference
University of Manchester

5. Registration Form
CNS Clinical Trials
16th - 17th September 2010, London, UK
Angel
For multiple bookings Pentonville Road
Photocopy this form Conf. code VG CNS Clinical Trials
Ci
ty
Ro
ad
Standard Prices 16th - 17th September 2010
Conference only Fee: £1299 VAT: £227.33 Total: £1526.33 Location: SG Conference Centre
B Old Street
Address: Old Street
226-236 City Road
London
EC1V 2TT
City Road
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UK
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Fee: £999 VAT: £174.83 Total: £1173.83
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