CNS Clinical Trials
Optimising development, management and recruitment for
clinical trials in CNS
16th - 17th September 2010, BSG House, London, UK
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Background Info
• Dr Samuel Agus, Global Medical Affairs Director, Neurology, Abbott
• Dr Stig Johan Wiklund, Statistical Science Director, AstraZeneca R&D
• 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 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
Imaging Network (ACRIN)
• Dr. Michael G. Palfreyman, Head, Translational R&D, ChemDiv / Executive Program Director, Senior Scientific
Advisor, EnVivo Pharmaceuticals
• Elizabeth (Liz) Moench, President & CEO, MediciGlobal
• Stephan Mittermeyer, Business Development Manager, BrainLAB
• Helen Dawes, Associate Research Fellow, Oxford Brookes University
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Conference Agenda
Day 1, Thursday 16th September 2010, London, UK
09:30 Registration and refreshments
10:00 Opening address from the chair
Elizabeth (Liz) Moench
President & CEO
MediciGlobal
10:10 The discovery and development of CNS medicines
• Progress in CNS medicines research
• Market landscape
• The challenges for CNS R&D
• Future prospects
Professor Alan M Palmer
Chief Scientific Officer
MS Therapeutics
10:50 Patient recruitment for Complex CNS studies
Many CNS studies require patients to be experiencing more than one neurological condition, adding to the
complexity of patient recruitment and narrowing the pool of patients. In a review of 2 case studies of two distinctly
different disorders; one study involving pediatrics and the other involving adults, this presentation will review the
strategic similarities and differences and review the outcomes of each.
• How a patient centric approach to recruitment planning and implementation in CNS improves study success
• How patient feasibility drives the recruitment strategy
• The role of the internet in recruiting patients for CNS clinical trials
• How strategies can impact patient recruiting costs and response rates
Elizabeth (Liz) Moench
President & CEO
MediciGlobal
11:10 Morning refreshments
11:30 Patient recruitment and retention strategies for CNS clinical trials
• Patient population insights that need to be considered in designing recruitment and retention programs for CNS
trials
• Strategies for overcoming global CNS patient recruitment challenges
• Updates on evolving trends in patient recruitment and retention methodologies
• Illustrative case studies of effective tactics
Gaynor Anders
Vice President Global Operations
MMG
12:10 Considerations for design and statistical analysis of CNS trials
• Analysis and design for disease modification
• Missing data issues
• Adaptive design issues when applied in CNS trials
Dr Stig Johan Wiklund
Statistical Science Director
AstraZeneca R&D
12:50 Networking Lunch
14:00 Presentation to be announced
Senior Representative
Pharmidex
14:20 Suicidality: Ensuring quality in mandated prospective monitoring
• Overview of the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Potential pitfalls with collection of suicidality monitoring data
• eC-SSRS - electronically modeling and reproducing the optimal human interview
• eC-SSRS – meeting the goals of excellent science and clinical care
• eC-SSRS – a clinical trial case study
Dr John Greist
Distinguished Senior Scientist, Madison Institute of Medicine
Clinical Professor of Psychiatry, University of Wisconsin School of Medicine and Public Health
15:00 Afternoon refreshments
15:20 Getting over the blood brain barrier – Local drug delivery to the CNS
• Limitations on drug delivery to the CNS
• Crucial components for a successful direct drug delivery trial
• Technology for direct drug delivery
• Services to manage direct drug delivery trials
• CED - Convection Enhanced Delivery
Stephan Mittermeyer
Business Development Manager
BrainLAB
15:40 CNS clinical trials beyond registration
• Trials beyond registration a tool for assessing a drug in real-life setting
• Types of post-registration studies, goals, deliverables and methods
• When should trials beyond registration begin?
• Life cycle management and drug safety- 2 sides for the same coin
• Who initiates investigator-initiated-trials and what is their purpose
Dr Samuel Agus
Global Medical Affairs Director, Neurology
Abbott
16:20 Closing remarks from the chair
16:40 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting
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Day 2, Friday 17th September 2010, London, UK
09:30 Registration and refreshments
10:00 Opening address from the chair
Stephan Mittermeyer
Business Development Manager
BrainLAB
10:10 Bridging the gap between pre-clinical and clinical CNS trials
• Translational assays of cognition
• Animal models of cognitive impairment
• Use of preclinical biomarkers to enhance assay translation
• Clinical testing of preclinical hypotheses
Dr Mark Tricklebank
Director, Lilly Centre for Cognitive Neuroscience,
Eli Lilly and Co
10:50 Rapid quantitative monitoring of neurological disorders using gait
• Use of Gait to measure CNS function
• Strengths and weaknesses of existing gait assessment tools
• Inertial measurement unit based systems as quick and easy gait measurement tools
• Results from recent projects monitoring multiple sclerosis, Parkinson's disease, muscle dystrophy and motor
neuron disease
Professor Helen Dawes
Associate Research Fellow
Oxford Brookes University
11:30 Morning refreshments
11:50 Novel imaging approaches in clinical trials and the role of an imaging CRO
• Novel Imaging Approaches including Structural, Functional and Molecular in CNS Drug Discovery including PET,
DTI, fMRI and vCT.
• Imaging Drug Actions Including Neuroreceptor Mapping
• The role of an Imaging CRO in Managing an Imaging Clinical Trial
Professor Mehdi Adineh
Scientific Director, Diagnostic Imaging Core Laboratory
American College of Radiology Imaging Network (ACRIN)
12:30 Utilising PET imaging biomarkers
• Dementia: glucose metabolism, amyloid tracers, acetylcholine analogues
• Parkinson’s disease: dopamine synthesis & storage capacity
• Psychiatric disorders: dopamine & serotonin receptor occupancy
• Brain tumours: progression and infiltration
• Tracers and techniques for quantitative standardised analysis will be presented
Dr Karl Herholz
Director, Wolfson Molecular Imaging Centre/ Professor of Clinical Neuroscience
University of Manchester
13:10 Networking Lunch
14.10 Use of biomarkers for demonstrating CNS effects of drugs early in clinical development
• Using animal PK/PD data to set dose range finding in Phase 1
• Use of QEEG to demonstrate CNS activity
• Computer measures of cognition
• Evoked potentials to demonstrate clinical potential
Dr. Michael G. Palfreyman
Head, Translational R&D, ChemDiv
Executive Program Director, Senior Scientific Advisor, EnVivo Pharmaceuticals
14:50 Recruiting strategies for Huntington’s Disease clinical trials
• The importance of identifying unique barriers to participation in HD clinical trials
• Grass-roots social marketing for HD trials can speed enrollment: a pilot study
• Treating the HD trial participant as VIP is a cost-effective approach
Dr LaVonne Veatch Goodman
Co-founder
Huntington's Disease Drug Works (HDDW)
15:30 Afternoon refreshments
15:50 Addressing specific challenges arising in the clinical trials of neuroprotective agents
• Challenges in translating the efficacy of neuroprotective agents
• Reducing human error in CNS clinical trials
16:30 Chair’s closing remarks
16:40 End of conference
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-PricingStandard Rate for 2 day Conference(Special discount if you book by 16th August 2010)
£750 + VAT:£131.30 = Total:£881.30
If you would like to send more than 1 person then take advantage of the 3 for 2 offers on standard rate. Send 3
people but only pay for 2.
- How to book Booking is simple! All you need to register is contact Bijal.
You can either call me on TEL:+44 (0)20 7549 9946
or email: bijal.patel@vgpharma.com
Please feel free to contact me should you have any questions, I look forward to hearing from you.
Kind Regards,
Bijal Patel
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CNS is one of the largest and fastest growing therapeutic areas of the pharmaceutical market. The ageing of the
baby-boom generation combined with new and emerging treatments for neurodegenerative disorders, including
multiple sclerosis, Alzheimer's disease and Parkinson's disease, will lead to further expansion of the
neurodegenerative therapies market. Increasing disease prevalence and a robust pipeline make that sector
dynamic, and highly promising for pharmaceutical and biotechnology companies worldwide. (Source: our report World Neurodegenerative Diseases Market 2009 -2024)
At our CNS Clinical Trials conference you will examine the strategies offering the greatest potential for success in
CNS drug development, and understand the specific challenges currently faced by developers in this market. In
order to enhance productivity in this field, there has been an increased awareness of the need to align clinical and
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 in all phases of CNS trials, enabling CNS
developers to make more timely decisions.
As part of this 2-day event, leading industry and academic authorities will address how to balance risk and how
attrition can be reduced to increase the chances of success in CNS clinical trials. Participants will look at
overcoming some of the hurdles arising in designing, managing and recruiting for CNS clinical trials, and examine
the tools and technologies to best enhance clinical development.
By attending this conference you will:
• Examine novel approaches for assessing cognitive function
• Explore the latest advances in neuroimaging
• Develop effective methods for improved patient recruitment and retention
• Understand statistical thinking for designing adaptive trials
• Review Good Clinical Practice GCP guidelines
• Address the regulatory challenges for CNS drug approval
• Utilise biomarkers for Proof of Concept in CNS clinical trials
• Improve trial outcomes through increased communication, ethical consent and patient care
• Implement translational methods to bridge the gap between pre-clinical and clinical CNS trials
• Be part of a major networking opportunity
Target Audience:
• Pharmaceutical and biotech companies
• Clinical research organisations
• Regulatory agencies/ associations
Who will be there?
Senior VPs, VPs, Chief Scientific Officers, Directors, Heads and Managers of:
• Clinical Research & Development
• Clinical Operations
• CNS
• CNS Clinical Biomarker Group
• Clinical Pharmacology
• Neurobiology
• Neuromedical Oncology
• Neurology/ Neuroscience Research
• Psychiatry
• Psychology
• CNS Ageing Research
• Dementia
• Imaging/ Neuroimaging
• Movement Disorders
• CNS Global Marketing & Medicine
• Preclinical R&D
• Translational Medicine
• Biostatistics
• Experimental Therapeutics
• Clinical Technology
• Outcomes Research
• Regulatory Affairs
• Product Development
• Neurologists
Terms and Conditions
NB - Due to high demand, we do not 'reserve' or 'hold' places - a request for an invoice to be raised will be treated
as an official booking and will be subject to the cancellation policy as outlined below. Cancellations/substitutions
and name changes: All bookings carry a 50% liability after the booking has been made, by post fax, email or web.
There will be no refunds for cancellations received on or after one month before the start of the conference (e.g.
cancellation on or after 20th January for a conference starting on 20th February). If you decide to cancel after this
date the full invoice remains payable. Discounted delegate places at our events are non refundable. Conference
notes, which are available on the day, will be sent to you.
Unfortunately we are not able to transfer places between conferences and executive briefings. However if you are
unable to attend the event you may make a substitution/name change at any time as long as we are informed in
writing by e-mail, fax or post. Name changes and substitutions must be from the same company and are not
transferable between companies or countries.
Indemnity: our company reserve the right to change the conference/executive briefing content, timing, speakers or
venue without notice. The event may be postponed or cancelled due to acts of terrorism, war, extreme weather
conditions, industrial action, acts of God or any event beyond the control of our company. If such a situation arises
we will endeavour to reschedule the event. However, our company cannot be held responsible for any cost,
damage or expenses, which may be incurred by the customer as a consequence of the event being postponed or
cancelled. We therefore strongly advise all customers to take out insurance to cover the cost of the registration,
travel and expenses.
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Contact Information:
Bijal Patel
Tel: +44 (0)20 7549 9946
bijal.patel@vgpharma.com
Registered Office:
226-236 City Road , London ,
EC1V 2QY
United Kingdom
SPONSORS
Associate Sponsor:
MEDIA PARTNERS
PharmiWeb.com
Biotechnology Europe
Future Pharmaceuticals
InPharm.com
Pharma Connections Worldwild
UPCOMING EVENTS
1. 4th Lyophilisation Conference
7th - 9th September 2010, BSG House, London, UK
2. 4th Annual Pharmaceutical PLM
14th - 15th September 2010, BSG Conference Centre, London, UK
3. CNS Clinical Trials
16th - 17th September 2010, BSG House, London, UK
4. Cell-Based Assays
20th - 22nd September 2010, BSG House, London, UK
5. 9th Annual Pricing and Reimbursement
27th - 29th September 2010, BSG House, London, UK
6. 7th Annual Pain Management
18th - 19th October 2010, BSG House, London, UK
7. Phase I Clinical Trials Summit
28th - 29th October 2010, BSG House, London, UK
8. 5th Annual Pharmaceutical Anti-Counterfeiting Strategies
8th - 9th November 2010, Philadelphia, USA