Conference on CNS Clinical Trials  

Optimising development, management and recruitment for clinical trials in CNS
16th - 17th September 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 16th 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 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
15:50 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

Day2,Thursday 17th 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, Lilly Centre for Cognitive Neuroscience
Eli Lilly and Co
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
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
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 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
16.30 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
17:10 Chair’s closing remarks
17:20 End of conference

Related Reports:

Clinical Trials Market India 
Clinical Trials: World Market 2009-2024 
Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment 
Trends in Clinical Trials Strategies to enhance clinical trial design 
Medical Device Clinical Trials Destination India