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CONFERENCE

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CNS Clinical Trials

Optimising development, management and recruitment for clinical trials in CNS

16th - 17th September 2010, Thistle Marble Arch, London, UK

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Background Info
Day 1
Day 2
Partners
Past Papers
Venue Info
Speakers

Associate Sponsors

Media Partners

Discussion Groups

Background Info

Key Speakers
• 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
• Professor Helen Dawes, Associate Research Fellow, Oxford Brookes University
• Dr. John Greist, Distinguished Senior Scientist, Madison Institute of Medicine, Clinical Professor of Psychiatry, University of Wisconsin School of Medicine and Public Health

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: Visiongain - World Neurodegenerative Diseases Market 2009 -2024)

At Visiongain’s 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

Venue:

Thistle Marble Arch
Bryanston Street
London
W1H 7EH
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_marble_arch/index.html

Day 1

Day One, 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

16:30 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day Two, 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

Partners

Associate Sponsors:

ACR Image Metrix
ACR Image Metrix, an imaging contract research organization (CRO) located in the American College of Radiology Clinical Research Center in Philadelphia, applies imaging techniques to improve 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 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 experience utilizing state-of-the-art technologies to provide a complete line of imaging services from site qualification and training, study initiation, image management, reader studies and much more. For further information, please visit www.acr-imagemetrix.net

ERT
ERT (www.ERT.com) is a provider of technology and services to the pharmaceutical, biotechnology and medical device industries. The Company is a market leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services to evaluate cardiac safety in clinical development. Further, ERT's ePRO Solutions™ provide a simple, immediate conduit to the Sponsor's most valuable asset - the patient. This phone based system captures throughout the Complete Patient Experience - from Recruiting and Screening, Assessments and Diaries through to Safety and Suicidality Monitoring. ERT harnesses internet and telecommunications technology and services to streamline the clinical trials process by enabling its customers to automate the collection, analysis and distribution of clinical data in all phases of clinical development.

Brainlab
Brainlab develops, manufactures and markets software-driven medical technology that enables procedures that are targeted, less invasive and also less expensive than traditional treatments. Among the core products are image-guided systems that provide real-time information used for navigation during surgical procedures. This utility has been further expanded to serve as a computer terminal for physicians to more effectively access and interpret diagnostic scans and other digital medical information for better informed decisions. Brainlab is pioneer in the field of convection-enhanced delivery and developed the first FDA cleared predictive planning software for direct drug delivery to the CNS. For further information, please visit www.brainlab.com

MediciGlobal
We are clinical trial recruitment-retention specialists. At Medici, patients are at the heart of everything we do, and since time is money, our Head Start to RecruitmentTM program allows us to fast-track patient centric recruitment, often starting to pre-identify patients in advance of study start.
As a global company, we work 'glocally'; planning globally while implementing locally. Using our ADaptTM system, we efficiently customize patient materials to the site level, ensuring local relevance and resonance.
Our online and traditional marketing and media buying expertise, in-house call center and lost-to-follow-up team positions us to achieve clinical trial success. For further information, please visit www.mediciglobal.com

Pharmidex
For further information, please visit www.pharmidex.com

Media Partners

PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to 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 allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Future Pharmaceuticals
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 strategies based on the topics covered. Positioned to be an authoritative resource within top 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

Pharma Connections Worldwide
Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical, Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. For further information please visit www.pharmaconnections.com

Enquiries

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's CNS Clinical Trials Conference, please contact:
Christopher Clegg, +44 (0)20 7549 9943
christopher.clegg@visiongainglobal.com

Past Papers

Speaker presentations are free to delegates. If you are unable to attend the event, the presentations are published two weeks after the event and are available to purchase.

Buy Now

Venue Info

Thistle Marble Arch
Bryanston Street
London
W1H 7EH
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_marble_arch/index.html

Please note: The information contained herein is intended for guidance purposes only. The responsibility to ensure accuracy of the details before visiting remains that of the individual. Visiongain can not be held responsible for any losses resulting from actions taken on the above information.

Speakers

Speaker bios:

Dr Karl Herholz

Director

Wolfson Molecular Imaging Centre

Karl Herholz moved to the University of Manchester, UK, in 2005 to become professor in clinical neuroscience and is leading the neuroscience imaging programme at the Wolfson Molecular Imaging Centre (www.manchester.ac.uk/wmic).
His research focuses on neuroimaging studies (PET and MRI) in dementia and brain tumours. He has been coordinating collaborations on Early Diagnosis of Neurodegenerative Diseases within the EU-funded Network on Diagnostic Molecular Imaging (www.dimi.eu) and was Chief investigator of the EU-funded "Network for Efficiency and Standardisation of Dementia Diagnosis" (NEST-DD) creating a comprehensive clinical and neuroimaging digital database of glucose and amyloid PET data.
Dr Samuel Agus

Global Medical Affairs Director, Neurology

Abbott
Elizabeth (Liz) Moench

President and CEO

MediciGlobal

Liz Moench is the President and founder of MediciGlobal, the global leader in marketing clinical trials directly to patients, caregivers and healthcare professionals. Liz founded the company in 1992, and has been dedicating her efforts to improving the patient recruitment and retention process in clinical trials worldwide, and leading the industry in creativity and systems for recruitment and retention on a global basis.
Utilising her extensive background in direct-to-patient marketing, Liz brought clinical research studies and patients together to help achieve important results. Through talent and applied knowledge gained from industry experience, she oversees programmes that help pharmaceutical and biotech companies achieve their patient recruitment and retention goals. She currently divides her time between the U.S. and Europe.
John H. Greist, M.D.

CEO

Healthcare Technology Systems, Inc.

From 1992 through 1998, Dr. Greist was a Distinguished Senior Scientist at the Dean Foundation for Health, Research and Education and in 1998 became a Distinguished Senior Scientist at the Madison Institute of Medicine, Inc. He is also Clinical Professor of Psychiatry at the University of Wisconsin School of Medicine and Public Health. In addition, he is co-founder and co-director of the Lithium, Bipolar and Obsessive Compulsive Information Centers and a Director of Healthcare Technology Systems, Inc. His major clinical and research interests are anxiety and mood disorders, psychopharmacology, behavior therapy and clinical applications of computing.
Stephan Mittermeyer

Business Development Manager

Brainlab AG

Stephan Mittermeyer is Business Development Manager at Brainlab AG, Germany. At BrainLAB, he is responsible for the identification of market and technology trends and opportunities, primarily focused on the interface to pharmaceutical/biotech companies. One of his main interests lies in interdisciplinary approaches including hardware, software and pharmaceutical products for direct delivery of therapeutic agents especially to the CNS, as well as the implementation of product service systems in the health care market, which is the topic of his PhD program at Cranfield University, UK. Stephan is industrial engineer by training and earned his diploma at TU Clausthal and TU Dresden. He is Secretary Treasurer of the Society for CNS Interstitial Delivery of Therapeutics and board member of the European Brain Council.