Conference on CNS Clinical Trials

Conference on CNS Clinical Trials Bharatbook

Conference on CNS Clinical Trials Bharatbook.com announces the inclusion of latest conference on "Conference on CNS Clinical Trials " To be held on 16th - 17th September 2010, BSG Conference Centre, London, UK 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. (http://www.bharatbook.com/detail.asp?id=128073&rt=Conference-on-CNS-Clinical-Trials.html) 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.

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Conference on CNS Clinical Trials Bharatbook

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 file:///C|/Documents%20and%20Settings/user29/Desktop/Conference%20on%20CNS%20Clinical%20Trial.htm (2 of 6)7/26/2010 4:37:09 PM

Conference on CNS Clinical Trials Bharatbook

• 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 file:///C|/Documents%20and%20Settings/user29/Desktop/Conference%20on%20CNS%20Clinical%20Trial.htm (3 of 6)7/26/2010 4:37:09 PM

Conference on CNS Clinical Trials Bharatbook

• 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

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Conference on CNS Clinical Trials Bharatbook

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 file:///C|/Documents%20and%20Settings/user29/Desktop/Conference%20on%20CNS%20Clinical%20Trial.htm (5 of 6)7/26/2010 4:37:09 PM

Conference on CNS Clinical Trials Bharatbook

• 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

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