CNS Clinical Trials
 Optimising development, management and recruitment for clinical trials in CNS


 16th - 17th Septembe...
Conference Introduction
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Day 1
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Day 2
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Registration Form
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Cns clinical trials (2010)

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Cns clinical trials (2010)

  1. 1. CNS Clinical Trials Optimising development, management and recruitment for clinical trials in CNS 16th - 17th September 2010, BSG Conference Centre, London, UK BOOK NOW! Key Speakers Dr Erik Buntinx, Managing Director and Chief Scientific Officer, 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, 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 Elaine Rankin, Medical Oncology, University of Dundee 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 Dr. Michael G. Palfreyman, Head, Translational R&D, ChemDiv, Executive Program Director, Senior Scientific Advisor, EnVivo Pharmaceuticals Associate Sponsors Driving the Industry Forward | www.futurepharmaus.com Organised By Media Partners To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/cns-trials
  2. 2. Conference Introduction CNS Clinical Trials 16th - 17th September 2010, London, UK CNS is one of the largest and fastest growing therapeutic areas of the Associate Sponsors: pharmaceutical market. The ageing of the baby-boom generation combined with new and emerging treatments for neurodegenerative disorders, ACR Image Metrix, an imaging contract research organization (CRO) including multiple sclerosis, Alzheimer’s disease and Parkinson’s disease, located in the American College of Radiology Clinical Research will lead to further expansion of the neurodegenerative therapies market. Center in Philadelphia, applies imaging techniques to improve (Source: Visiongain - World Neurodegenerative Diseases Market 2009 -2024) 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 Dear Colleague, 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 t Visiongain’s CNS Clinical Trials conference you will examine the strategies offering A experience utilizing state-of-the-art technologies to provide a complete line of imaging the greatest potential for success in CNS drug development, and understand the specific services from site qualification and training, study initiation, image management, reader challenges currently faced by developers in this market. In order to enhance productivity studies and much more. in this field, there has been an increased awareness of the need to align clinical and For further information please visit: www.acr-imagemetrix.net 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 ERT is a provider of technology and services to the pharmaceutical, in all phases of CNS trials, enabling CNS developers to make more timely decisions. biotechnology and medical device industries. The Company is a market leader in providing centralized core-diagnostic electrocardiographic s part of this 2-day event, leading industry and academic authorities will address how A (ECG) technology and services to evaluate cardiac safety in clinical development. Further, to balance risk and how attrition can be reduced to increase the chances of success in ERT’s ePRO Solutions™ provide a simple, immediate conduit to the Sponsor’s most valuable CNS clinical trials. Participants will look at overcoming some of the hurdles arising in asset – the patient. This phone based system captures throughout the Complete Patient designing, managing and recruiting for CNS clinical trials, and examine the tools and Experience – from Recruiting and Screening, Assessments and Diaries through to Safety and technologies to best enhance clinical development. Suicidality Monitoring. ERT harnesses internet and telecommunications technology and services to streamline the clinical trials process by enabling its customers to automate the collection, By attending this conference you will: analysis and distribution of clinical data in all phases of clinical development. • Examine novel approaches for assessing cognitive function For further information please visit: www.ERT.com • Explore the latest advances in neuroimaging Media Partners: • Develop effective methods for improved patient recruitment and retention PharmiWeb.com is the leading industry-sponsored portal for • Understand statistical thinking for designing adaptive trials the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, • Review Good Clinical Practice GCP guidelines events listings and international jobs to industry professionals across Europe and the US. • Address the regulatory challenges for CNS drug approval For further information please email: corporate@pharmiweb.com • Utilise biomarkers for Proof of Concept in CNS clinical trials BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. • mprove trial outcomes through increased communication, ethical consent and I It is based and located in Warsaw, Poland. Biotechnology World was patient care founded in 2007 to provide the world’s biotech and pharma information and market to • mplement translational methods to bridge the gap between pre-clinical and clinical I 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 CNS trials allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers • Be part of a major networking opportunity companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector I look forward to meeting you at the conference in Europe to global biotechnology, pharmaceutical and life science activities. Best regards For further information please visit: www.biotechnology-europe.com Driving the Industry Forward | www.futurepharmaus.com 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 Andrea Charles strategies based on the topics covered. Positioned to be an authoritative resource within top Head of Conferences 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 Target Audience: InPharm is the online platform for exclusive pharmaceutical news, • Pharmaceutical and biotech companies comment, contracts, services, jobs and events and is home to • Clinical research organisations InPharmjobs.com, Pharmafile and Pharmafocus. • Regulatory agencies/ associations For further information please visit: www.In-Pharm.com Who will be there? Pharma Connections Worldwide® is the leading professional Senior VPs, VPs, Chief Scientific Officers, Directors, Heads and business networking website focused in the Pharmaceutical, Managers of: Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for • CNS Trials delivery of premiere content coupled with the right clientele in order to facilitate business • Clinical Trials development opportunities among industry professionals responsible for making key • Clinical Research & Development decisions in a global marketplace. • Clinical Operations For further information please visit: www.pharmaconnections.com • CNS • CNS Clinical Biomarker Group • Clinical Pharmacology • Neurobiology • Neuromedical Oncology Sponsorship and exhibition opportunities: • Neurology/ Neuroscience Research This event offers a unique opportunity to meet and do business with some of the key • Psychiatry • Psychology players in the pharmaceutical and biotech industries. If you have a service or product to • CNS Ageing Research promote, you can do so at this event by: • Dementia • Imaging/ Neuroimaging • Hosting a networking drinks reception • Movement Disorders • Taking an exhibition space at the conference • CNS Global Marketing & Medicine • Preclinical R&D • Advertising in the delegate documentation pack • Translational Medicine • Providing branded bags, pens, gifts, etc. • Biostatistics • Experimental Therapeutics If you would like more information on the range of sponsorship or exhibition possibilities • Clinical Technology for visiongain's CNS Clinical Trials Conference, please contact us: • Outcomes Research • Regulatory Affairs Christopher Clegg, +44 (0)20 7549 9964 • Product Development christopher.clegg@visiongainglobal.com • Neurologists
  3. 3. Day 1 CNS Clinical Trials Thursday 16th September 2010 09:30 Registration and refreshments 14:30 mGluR5 Allosteric Antagonists: Preclinical profile and choice of therapeutic indication • haracterization of mGluR5 antagonist in preclinical paradigm C 10:00 Opening address from the chair • Validation of objective markers for monitoring drug action • se of preclinical profiling and proof-of-concept clinical trials to U 10:10 The discovery and development of CNS medicines select therapeutic indications for full development • rogress in CNS medicines research P Dr Fabrizio Gasparini • Market landscape Sr Research Investigator Novartis Institutes for BioMedical Research • The challenges for CNS R&D • Future prospects 15:10 Suicidality: Ensuring quality in mandated Professor Alan M Palmer Chief Scientific Officert prospective monitoring MS Therapeutics • verview of the Columbia-Suicide Severity Rating Scale (C-SSRS) O • otential pitfalls with collection of suicidality monitoring data P 10:50 Addressing specific challenges arising in the clinical • C-SSRS - electronically modeling and reproducing the optimal e human interview trials of neuroprotective agents • C-SSRS – meeting the goals of excellent science and clinical care e • C-SSRS – a clinical trial case study e 11:30 Morning refreshments Dr John Greist Distinguished Senior Scientist, Madison Institute of Medicine Clinical Professor of Psychiatry, University of Wisconsin 11:50 Clinical value of accelerated anti-depressant effect School of Medicine and Public Health • Lag time of antidepressants: an unmet medical need • arly and Sustained Full Response: A new FDA approved E efficacy paradigm 15:50 Afternoon refreshments • harmacological considerations to induce accelerated P antidepressant effect 16:10 CNS clinical trials beyond registration • reatment adherence in relation to an antidepressant with an T • rials beyond registration a tool for assessing a drug in real-life setting T accelerated effect • ypes of post-registration studies, goals, deliverables and methods T Dr Erik Buntinx Managing Director and Chief Scientific Officer • When should trials beyond registration begin? PharmaNeuroBoost • ife cycle management and drug safety- 2 sides for the same coin L • ho initiates investigator-initiated-trials and what is their purpose W 12:30 Considerations for design and statistical analysis Dr Samuel Agus of CNS trials Global Medical Affairs Director, Neurology Solvay Pharmaceuticals Marketing and Licensing • Analysis and design for disease modification • Missing data issues • Adaptive design issues when applied in CNS trials 16:50 Closing remarks from the chair Dr Stig Johan Wiklund Statistical Science Director AstraZeneca R&D 17:00 Networking drinks 13:10 Networking Lunch Take your discussions further and build new relationships in a relaxed and informal setting. Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010
  4. 4. Day 2 CNS Clinical Trials Friday 17th September 2010 09:30 Registration and refreshments 13:10 Networking Lunch 14.10 Use of biomarkers for demonstrating CNS effects of 10:00 Opening address from the chair drugs early in clinical development • Using animal PK/PD data to set dose range finding in Phase 1 10:10 Bridging the gap between pre-clinical and • Use of QEEG to demonstrate CNS activity clinical CNS trials • Computer measures of cognition • Translational assays of cognition • Evoked potentials to demonstrate clinical potential • Animal models of cognitive impairment Dr. Michael G. Palfreyman • Use of preclinical biomarkers to enhance assay translation Head, Translational R&D, ChemDiv Executive Program Director, Senior Scientific Advisor, EnVivo • linical testing of preclinical hypotheses C Pharmaceuticals Dr Mark Tricklebank Director, Lilly Centre for Cognitive Neuroscience 14:50 Recruiting strategies for Huntington’s Disease Eli Lilly and Co clinical trials • he importance of identifying unique barriers to participation in HD T clinical trials 10:50 Reducing the gap between preclinical PK/PD and • rass-roots social marketing for HD trials can speed enrollment: G CNS clinical trials a pilot study • dding value to the discovery of CNS active drugs through the application A • reating the HD trial participant as VIP is a cost-effective approach. T of mechanistic PK/PD principles Dr LaVonne Veatch Goodman • nderstanding the key drivers of in-vivo pharmacological effects and U Co-founder ensuring they are prominent in the lead optimisation paradigm Huntington’s Disease Drug Works (HDDW) • stablishing the link between blood concentration, receptor occupancy E and drug efficacy 15:30 Afternoon refreshments 11:30 Morning refreshments 15:50 Patient recruitment and retention strategies for CNS clinical trials • atient population insights that need to be considered in designing P 11:50 Novel imaging approaches in clinical trials and the recruitment and retention programs for CNS trials role of an imaging CRO • trategies for overcoming global CNS patient recruitment challenges S • ovel Imaging Approaches including Structural, Functional and Molecular N • pdates on evolving trends in patient recruitment and retention methodologies U in CNS Drug Discovery including PET, DTI, fMRI and vCT. • llustrative case studies of effective tactics I • maging Drug Actions Including Neuroreceptor Mapping I Gaynor Anders Vice President Global Operations • he role of an Imaging CRO in Managing an Imaging Clinical Trial T MMG Professor Mehdi Adineh Scientific Director Diagnostic Imaging Core Laboratory 16.30 Successful strategies for accelerating American College of Radiology patient recruitment • Preparing for successful enrolment 12:30 Utilising PET imaging biomarkers • The ideal set-up • Dementia: glucose metabolism, amyloid tracers, acetylcholine analogues • Avoiding the pitfalls for a pharma-driven trial • Parkinson’s disease: dopamine synthesis & storage capacity • Enlisting support from patients • Psychiatric disorders: dopamine & serotonin receptor occupancy Professor Elaine Rankin Medical Oncology • Brain tumours: progression and infiltration University of Dundee • Tracers and techniques for quantitative standardised analysis will be presented Dr Karl Herholz 17:10 Chair’s closing remarks Director, Wolfson Molecular Imaging Centre/ Professor of Clinical Neuroscience 17:20 End of conference University of Manchester
  5. 5. Registration Form CNS Clinical Trials 16th - 17th September 2010, London, UK Angel For multiple bookings Pentonville Road Photocopy this form Conf. code VG CNS Clinical Trials Ci ty Ro ad Standard Prices 16th - 17th September 2010 Conference only Fee: £1299 VAT: £227.33 Total: £1526.33 Location: SG Conference Centre B Old Street Address: Old Street 226-236 City Road London EC1V 2TT City Road Promotional Literature Distribution UK Distribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £174.83 Total: £1173.83 Details How to book Forename: Surname: Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/cns-trials Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain Ltd Address: BSG House 226-236 City Road London EC1V 2QY UK Country: Postcode: General information Venue: Directions: BSG Conference Centre 226 – 236 City Road, London, EC1V 2TT. United Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, Email: http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340 Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on Methods of payment or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable Payment must be made in sterling to transfer places between conferences and executive briefings. However, if you cannot attend the By Mail: Complete and return your signed registration form together with your cheque payable conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK organisation and are not transferable between countries. By Fax: Complete and fax your signed registration form with your credit card details Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the to +44 (0) 20 7549 9932 customer by credit card prior to the changes being made. By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or By Bank Transfer: expenses, which may be incurred by the customer as a consequence of the event being postponed or Visiongain Ltd A/C: visiongain Ltd cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses. Barclays Bank Sort Code: 20-71-64 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Piccadilly Branch Account No: 6038 7118 Protection Act 1988. Your personal information contained in this form may be used to update you on 48 Regent Street Swift Code: BARC GB22 visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you London, W1B 5RA IBAN: GB80 BARC 20716460387118 wish for your details to be amended, suppressed or not passed on to any external third party, please send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, Please debit my credit card: EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Access MasterCard Visa American Express Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from visiongain Ltd during the transitional period, whilst the changes are coming into effect. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. Card number: This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain). VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT Expiry Date: incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. Security number (last 3 digits on back of credit card): How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you. Signature: Unable to attend Cardholder’s name: Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive your copy of the event CD Rom two weeks after the event. Yes, please send me a copy of the CD for Price£550 VAT:£96.26 Total:£646.26 News updates Office use only Please tick if you do not want to receive email news updates in the future www.visiongain.com/cns-trials

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