Conference on CNS Clinical Trials

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Conference on CNS Clinical Trials

Optimising development, management and recruitment for clinical trials in CNS
15th - 16th March 2010, BSG Conference Centre, London, UK

Background Info

Key Speakers

Dr Erik Buntinx, Managing Director and Chief Scientifi c Offi cer, 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, Senior Research Fellow - Psychiatric Disorders Drug Hunting Team, Lilly
Dr Simone Braggio, Director Neurosciences CEDD DMPK, GlaxoSmithKline
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 Scientifi c Offi cer, MS Therapeutics
Nancy Mulligan, VP, CNS / Mental Health, MMG
Professor Mehdi Adineh, Scientifi c Director Diagnostic Imaging Core Laboratory, American College of
Radiology Imaging Network (ACRIN)

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.

CNS Clinical Trials conference you will examine the strategies offering
the greatest potential for success in CNS drug development, and understand the specifi c
challenges currently faced by developers in this market. In order to enhance productivity
in this fi eld, 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 effi cacy
in all phases of CNS trials, enabling CNS developers to make more timely decisions.

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 Scientifi c Offi cers, Directors, Heads and
Managers of:
• CNS Trials
• Clinical Trials
• 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

Day 1,Monday 15th March 2010, London, UK

09:30 Registration and refreshments

10:00 Opening address from the chair

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 Officert
MS Therapeutics

10:50 Addressing specific challenges arising in the clinical trials of neuroprotective agents

11:30 Morning refreshments

11:50 Clinical value of accelerated anti-depressant effect

• Lag time of antidepressants: an unmet medical need
• Early and Sustained Full Response: A new FDA approved
efficacy paradigm
• Pharmacological considerations to induce accelerated
antidepressant effect
• Treatment adherence in relation to an antidepressant with an
accelerated effect

Dr Erik Buntinx
Managing Director and Chief Scientific Officer
PharmaNeuroBoost

12:30 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

13:10 Networking Lunch

14:30 mGluR5 Allosteric Antagonists: Preclinical profile and choice of therapeutic indication

• Characterization of mGluR5 antagonist in preclinical paradigm
• Validation of objective markers for monitoring drug action
• Use of preclinical profiling and proof-of-concept clinical trials to
select therapeutic indications for full development

Dr Fabrizio Gasparini
Sr Research Investigator
Novartis Institutes for BioMedical Research

15:10 Avoiding trial failure by improving
study design

15:50 Afternoon refreshments

16:10 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
Solvay Pharmaceuticals Marketing and Licensing

16:50 Closing remarks from the chair

17:00 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.

Day2,Thursday 16th March 2010, London, UK

09:30 Registration and refreshments

10:00 Opening address from the chair

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, Senior Research Fellow - Psychiatric Disorders Drug Hunting Team
Lilly

10:50 Reducing the gap between preclinical PK/PD and CNS clinical trials

• Adding value to the discovery of CNS active drugs through the application of mechanistic PK/PD principles
• Understanding the key drivers of in-vivo pharmacological effects and ensuring they are prominent in the lead optimisation paradigm
• Establishing the link between blood concentration, receptor occupancy and drug efficacy

Simone Braggio
Director Neurosciences CEDD DMPK
GlaxoSmithKline

11:30 Morning refreshments

11:50 Presentation to be announced

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

14:30 Future trends in CNS clinical trials towards 2015
• Will adaptive clinical trial designs impact the effectiveness of Phase II/III trials?
• Can biomarkers or personalised medicine make an impact on trial outcomes in the next five years?
Paul Travis
Global Clinical Development Director
Huntingdon Life Sciences*

15:10 Patient recruitment and retention strategies for
CNS clinical trials

• Discuss strategies to overcome challenges and future trends in global patient enrollment with a focus on CNS
• Patient dynamics
Nancy Mulligan
VP, CNS / Mental Health
MMG

15:50 Afternoon refreshments

16.10 Successful strategies for accelerating patient recruitment

• Preparing for successful enrolment
• The ideal set-up
• Avoiding the pitfalls for a pharma-driven trial
• Enlisting support from patients
Professor Elaine Rankin
Medical Oncology
University of Dundee

16:50 Chair’s closing remarks

17:00 End of conference

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