P 048 Copd
- 1. Matthew Catley Team Leader, R&I AstraZeneca Nestor Molfino Vice –President, Clinical Development Medimmune Edwin Chilvers Professor of Respiratory Medicine University of Cambridge Ewan Walters Medical Director Teva UK Liz Hardaker Senior Investigator Novartis REGISTER BY 29TH JUNE AND RECEIVE A £300 DISCOUNT www.copd-conference.co.uk Register online and receive full information on all of SMi’s conferences Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 Sebastian Johnston Professor of Respiratory Medicine Imperial College School of Medicine (N.H.L.I) Frank Thielmann Operational Lead, Inhalation New Solids Novartis Dirk Bredbroeker Head of Clinical Science Respiratory Takeda Wisia Wedzicha Professor of Respiratory Medicine University College London Louise Donnelly Reader in Respiratory Cell Biology Imperial College London KEY SPEAKERS INCLUDE: WHYATTENDTHISEVENT: • ConsiderdevelopmentsinthemodellingandmanagementofexacerbationsofCOPD • Evaluateunique complexities of COPD pathophysiology - compare and contrast COPD with Asthma to improve your understanding of what makes COPD unique and needing of particular attention • Developcombination and oxygen therapies within COPD - learn about triple therapies and novel therapies within the treatment of COPD • Hear from leading industry professionals on the current clinical trials process and rapid proof of concept studies • Analyseall phases of the discovery process, from pre-clinical modelling, phase 2 studies all the way through to modelling clincal outcomes. • Networkwithandlearnfromkeyindustryprofessionalsandresearchleadingacademics • Discussthe latest in health economics for COPD drugs SMipresenttheir4thannualconferenceon… COPD NovelTherapeuticsandManagementStrategies Monday22ndandTuesday23rdOctober2012, Copthorne Tara Hotel, London Sponsored by PLUSTWOINTERACTIVEHALF-DAYPOST-CONFERENCEWORKSHOPS Wednesday24thOctober2012,CopthorneTaraHotel,London A:DevelopingInhalationDevices Workshop Leader: SabineHaeussermann,Senior Director, Scientific Business Development,InamedGmbH 8.30am–12.30pm B:BiomarkersinRespiratoryDiseases Workshop Leaders: MagnusNord,Senior Translational Scientist, AstraZeneca&KarinvonWachenfeldt,Co-Founder,TrulyTranslationalAB 1.00pm-5.30pm
- 2. Register online at www.copd-conference.co.uk • Alternatively fax COPD:NovelTherapeutics&ManagementStrategies2012 Day One | Monday 22nd October 2012 www.copd-con 8.30 Registration and Coffee 9.00 Chairman’s Opening Remarks Sebastian Johnston, Professor of Respiratory Medicine, Imperial College School of Medicine (N.H.L.I.) CURRENT DEVELOPMENTS IN THE FIELD 9.10 Current overview of the COPD field • Mechanisms of exacerbations of COPD • Novel treatment strategies • What does the future hold in terms of drug development Sebastian Johnston, Professor of Respiratory Medicine, Imperial College School of Medicine (N.H.L.I.) 9.50 Anti-inflammatory drugs in COPD • Rationale and unmet needs • Potential benefits: from prevention to restructuring • Challenges in drug development: how to translate into clinical benefit? Daniel Bock, Chief Scientific Officer, Revotar 10.30 Morning Coffee 11.00 Immunology of COPD • Innate immune responses • Adaptive immune responses • Comparing and contrasting different responses • Loss of regulation Matthew Catley, Team Leader, R&I, AstraZeneca 11.40 Combination therapies in COPD • Unmet needs in the management of COPD patients • Scientific rationale for combination therapies • Delivering inhaled combination therapy • Discussion into future developments in the field Geoff Down, Chief Medical Officer, Prosonix 12.20 Measuring neutrophil kinetics in COPD • Use of radiolabelled neutrophils to quantify lung inflammation • Kinetics and fate of circulating neutrophils in man • Early studies of intravascular kinetics and fate of human eosinophils • Opportunity to use radiolabelled inflammatory cells to perform proof of principle therapeutic trials EdwinChilvers,ProfessorofRespiratoryMedicine,UniversityofCambridge 13.00 Networking LunchMANAGEMENT STRATEGIES MANAGEMENT STRATEGIES 14.20 Effective management of COPD • What are the burdens to society, the patient and to the economy? • What is the root of these problems? • Computer guided diagnosis and treatment algorithms • Lessons from Asthma that we can use in COPD Ewan Walters, Medical Director, Teva UK 15.00 COPD and co-morbidity • What are the associations between COPD and co-morbidity? • Why is this important? • What is the relevance in pharmaceutical studies? John Hurst, Senior Clinical Lecturer, University College London 15.40 Afternoon Tea 16.10 Clinical trial design considerations • Understanding current clinical trial guidelines for COPD • Are exacerbations the most relevant outcome parameters in COPD clinical trials • Long term observation • Short term studies Christine Tiesler, Associate Director, Late Stage Research, PPD 16.50 From molecule to medicine; obstacles on the way from discovery to market • Oral or inhaled? Developability assessment of new compounds in the treatment of COPD • Physical properties and stability – a good drug doesn´t always make a good product • DPI, MDI or nebuliser? Selection criteria from the products point of view • Manufacturing challenges for inhaled drug products • The future of development and manufacturing of inhaled products Frank Thielmann, Operational Lead Inhalation New Solids, Novartis 17.30 Chairman’s Closing Remarks 17.40 Close of Day One Biomedical Systems is a global leader in centralized diagnostic services offering a full suite of services for Cardiac Safety and Efficacy, Pulmonary Function Testing including Spirometry, Peak Flow, Nitric Oxide,... and digital Medical Imaging for clinicaltrials,fromclassicalimagingmodalitiesaswellascentralizedEEG,GaitandDigitalPathology. www.biomedsys.com Vitalograph has manufactured respiratory diagnostic equipment for the healthcare industry since 1963 and the name Vitalograph is synonymous with spirometry around the world. The name Vitalograph is also synonymous with quality, as many of our spirometers in everyday use are more than 30 years old! As a consequence, our equipment is favoured by opinion leaders and clinical researchers who need reliable and accurate measurements. We provide a full range of services within respiratory clinical trials and this includes project management, centralized data management, over-reading and a global 24/7 support service. We also have a dedicated integrated solution via our Spirotrac® Centralized Spirometry System that includes site based FeNO measurements, 6MWT, pulse oximetry, challenge testing, 12-lead ECG and our exciting new In2itive™ e-Diary that complies with FDA‘s PRO guidance with validated questionnaires. All data is accessible via our VIEWER™ web portal. Also ask about our unique new AIM inhaler trainer for pMDIs and DPIs. www.vitalograph.co.uk Sponsored by Supported by
- 3. x your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Day Two | Tuesday 23rd October 2012 nference.co.uk 8.30 Re-registration and Coffee 9.00 Chairman's Opening Remarks Wisia Wedzicha, Professor of Respiratory Medicine, University College London EXACERBATION PREVENTION 9.10 Managing COPD exacerbations • Guidelines for COPD exacerbation prevention • Novel bronchodilator approaches for exacerbation prevention • Combination therapy with ICS and exacerbation prevention • Phosphodiesterase inhibitors eg roflumilast and other anti- inflammatory therapy • Can managing the acute exacerbation affect exacerbation frequency? Wisia Wedzicha, Professor of Respiratory Medicine, University College London 9.50 Targeting exacerbations of COPD • Brief overview of exacerbations • Developing pre-clinical models of acute COPD exacerbations • Limitations of pre-clinical models • Looking to the future of treating exacerbations Liz Hardaker, Senior Investigator, Novartis 10.30 Morning Coffee 11.00 COPD exacerbations, preventing and changing their natural history using the tools that we have • Use of ‘innovative endpoints’ • Case Study: Current situation in the NHS • Learning from the past to develop the future Nabil Jarad, Consultant Respiratory Physician, Bristol Royal Infirmary 11.40 Novel strategies in exacerbation management • Exacerbation definitions • Impact of exacerbations • Exacerbation prevention • Treatment of exacerbations William MacNee, Professor of Respiratory and Environmental Medicine, University of Edinburgh 12.20 Session Reserved for Vitalograph Senior Representative, Vitalograph 13.00 Networking Lunch DRUG DEVELOPMENT AND NOVEL TARGETS 14.20 COPD as systemic disease – Implications for drug development • Role of co-morbidities in COPD • Cardiovascular Outcomes and COPD • New trial designs and endpoints needed for COPD to address a new paradigm? Dirk Bredenbröker, Senior Director, Head of Medical Strategy, R&D, Takeda 15.00 New strategies for bacterial infections in COPD • Effects of respiratory tract infections • New ways to prevent infections in COPD • Novel strategies to treat bacterical infections Nestor Molfino, Vice President, Clinical Development, Medimmune 15.40 Afternoon Tea 16.10 CXCR2 antagonists as treatment for COPD • Neutrophilic inflammation in COPD • Why target CXCR2? • Novel CXCR2 antagonists • Current trials of CXCR2 Louise Donnelly, Reader in Respiratory Cell Biolog, Imperial College London (N.H.L.I) 16.50 RC-Kinase; a novel target implicated in COPD • Effects of small molecule inhibitors in mouse models of smoke-induced inflammation and fibrosis • Identification and characterization of a novel COPD-relevant kinase • Immune mechanisms • Generation of small molecule inhibitors and characterization in smoking, fibrosis and oncology models relevant to COPD and its co-morbidities Kevin Bacon, CSO, Axikin Pharmaceuticals 17.30 Chairman’s Closing Remarks 17.40 Close of Day Two SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketingstrategy. Primenetworkingopportunitiesexistto entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk Wanttoknowhowyoucangetinvolved?Interestedin promotingyourpharmaceuticalservicestothismarket? Contact Kellee Halliburton, SMi Marketing on +44 20 7827 6194 or email khalliburton@smi-online.co.uk SMi's Pharmaceutical Forward Planner 2012 JULY 2-3 KOLManagementandMSL BestPracticeinEurope (Switzerland) 9-10 ADMET 9-10 SocialMediainthe PharmaceuticalIndustry 11-12 BioBanking SEPTEMBER 17-18 NextGeneration Sequencing 19-20 CancerVaccines 24-25 Biosimilarsand Biobetters 26-27 KOLManagement OCTOBER 3-4 PartnershipswithCROs 8-9 PharmaceuticalOrphan Drugs 22-23 COPD:Novel Therapeuticsand ManagementStrategies 24-25 PointofCareDiagnostics -MarketOpportunities andTechnologyTrends 29-30 European PharmaceuticalPricing &Reimbursement NOVEMBER 5-6 CellBasedAssays 5-6 ClinicalTrialsinCNS 28-29 Diabetes DECEMBER 3-4 ColdChainDistribution Allconferencestakeplacein centralLondon,UK–unless indicatedotherwiseinbrackets
- 4. HALF-DAY POST-CONFERENCE AM WORKSHOP 8.30am – 12.30pm Wednesday 24th October 2012 Copthorne Tara Hotel, London A:DevelopingInhalationDevices Workshop Leader: Sabine Häußermann, Director Business Development, Inamed In association with Overviewofworkshop Inhalation techniques and the inhalation device in use play an important role in the success of inhaled drugs. Often drugs are not effective and therefore not successful on the market – the reasonforwhichisthatthedosewhichreachesthetargetregion in the lungs is too small. This workshop will deal with inhalation devices and inhalation techniques, as well as with the design of clinical trials for successfully inhaled drugs. Whyyoushouldattend: • Learn how best to develop and apply inhalation techniques • Discover the challenges within device development • Utilize the experience of an expert in the field • Develop strategies to improve success of clinical trials • Evaluate current European guidelines and what they mean for the industry • Network with key industry professionals Programme 8.30 Registration&Coffee 9.00 Welcome&Introductions 9.10 OverviewofdevelopinginhalationdevicesforCOPD • Developing techniques in inhalation device design • Strategies to make the development process more efficient • Overcoming common challenges in device development 9.45 CaseStudy-Inhalationdevicesforgenericproducts intheEUandtheUS • Problems encountered • How were these obstacles overcome • What the future holds 10.45 TeaBreak 11.00 Application/Inhalationdevicesinclinicaltrialsand inpractice • Clinical Trial design analysis • Information on the specifics of clinical trials for inhaled drugs 12.10 DiscussionSession 12.30 Closeofworkshop Abouttheworkshophost DrSabineHäußermann,Director Business Development, Inamed Dr. Häußermann has worked for Inamed in her currentrole,sinceMarch2010andisresponsible for scientific advice and regulatory services. Dr. Häußermann is an engineer by training and started out her career in basic research on the inhalation of aerosols in the Institute of Inhalation Biology at the Helmholz Center in Neuherberg, Munich in Prof. Heyder's group. After obtaining her PhD, she previously worked for Inamed from 2000 to 2006, applying her research to the pharmaceutical field of respiratory aerosol medicine, initially as project manager. From 2002 she headed the clinical research group at Inamed in Gauting, before moving to France. From 2006 to 2010 she headedtheinhalationdevicedevelopmentsectioninthemedical gases research group at Air Liquide. Dr. Häußermann is an active member of the ISAM society, has chaired the ISAM Awards Committee and is now a member of the ISAM board. AboutINAMED Complementingoursolidexperienceinconductingclinicaltrials and our staffed, in-house Phase I unit, Inamed performs in-vitro studies in our own labs and performs radio-labeling studies. With over two decades of clinical research experience, our clients benefit from our state-of-the-art infrastructure, long- term experience and network of competent partners. Inamed enable its sponsors to reach better go" or "no-go” decisions to launch and market their products successfully.
- 5. HALF-DAY POST-CONFERENCE PM WORKSHOP 1.00pm – 5.30pm Wednesday 24th October 2012 Copthorne Tara Hotel, London BiomarkersinRespiratoryDiseases- Whatcantheydeliver,andforwhodowe generatetheresults? Workshop Leaders: Magnus Nord, Senior Translational Scientist, AstraZeneca & Karin von Wachenfeldt, Co-Founder, Truly Translational AB In association with AstraZeneca & Truly Translational Overviewofworkshop This unique workshop will allow attendees to discuss the latest developments within translational biomarkers and how they can be used in COPD drug development. This case-study led session will present attendees with success stories to learn from and adapt into their own drug development programs. With biomarkers playing a larger and more important role in COPD drugdevelopment,thisworkshopisnottobemissed. Whyyoushouldattend: •Learnhowbesttodeveloppre-clinicalbiomarkerdiscovery •Considerthelatestobstaclesinbiomarkerdiscoveryandhow toovercomethem •Developimagingtechnologiestoimprovebiomarker developmentinCOPD •Networkwithkeyindustryprofessionals Programme 1.00 Registration&Coffee 1.30 Welcome&Introductions 1.45 OverviewofBiomarkersforEfficacy 2.15 OverviewofBiomarkersforSafety 2.45 AfternoonTea 3.00 ChallengesinBiomarkerdevelopmentinthe respiratoryfield-COPD. •Circulatingbiomarkers •Imagingasbiomarker? •Validationchallenges,andreasonstocollaborate. 4.00 ChallengesinBiomarkerdevelopmentinthe respiratoryfield-Drug-inducedInterstitialLung Disease •Strategiesfordiscovery •Imagingvscirculatingbiomarkers •Challengesinclinicalqualification 5.00 DiscussionSession 5.30 CloseofWorkshop Abouttheworkshophosts: DrMagnusNord,MD, PhD, Assoc Prof, holds a position in Safety Science, a Global Enabling Science Function in AstraZeneca Patient Safety. It is a focused group of scientists, physicians, statisticians and informaticians working to shape clinical safety and support decision-making in drug projects. Magnus is also chairman and clinical lead of the AstraZeneca Pulmonary Safety KnowledgeGroupandhastodatepublished40+scientificarticles. Dr Karin von Wachenfeldt, CEO and Co-founder of Truly Translational Sweden, an Immunologist by training, and with a strong scientific interest in understanding why people develop disease, and how diseases can be treated or prevented. For 12 years she held different leading biology positions at AstraZeneca, alwayswithafocusonincreasingtheunderstandingofunderlying disease mechanisms, and how to translate these to drug targets. At AZ she pioneered the use of biomarkers in early clinical trials, and how these can be used for decision making. Since 2011 she heads up Truly Translational Sweden AB a company focusing entirely on translational sciences, offering senior consultancy services. AboutAstraZeneca: AstraZeneca is a global, innovation-driven, integrated biopharmaceuticalcompany.Theydiscover,developmanufacture and market prescription medicines for six important areas of healthcare, which include some of the world’s most serious illnesses: cancer, cardiovascular, gastrointestinal infection, neuroscience,andrespiratoryandinflammation. AboutTrulyTranslational: Truly Translational Sweden AB provides life science and drug development consultancy with an emphasis on biology and translationalscience.Ourmissionistotranslatepreclinicalproject ideas into efficient development plans delivering successful clinical trials. Truly Translational is founded on solid scientific expertise and more than 50 years experience with drug research and development in both large pharma and biotech. We focus on bringing biologicals and small molecule projects from preclinical in vitro studies and animal models via common biomarker strategies,intoconcepttestinginpatients.
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VAT VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on Document Portal and Literature Distribution for all UK customers and for those EU customers not supplying a registration number for their own country here: ______________________________________ COPD: NOVEL THERAPEUTICS AND MANAGEMENT STRATEGIES Conference: Monday 22nd and Tuesday 23rd October 2012, Copthorne Tara Hotel, London, UK Workshops:Wednesday 24th October 2012,London,UK 4 WAYS TO REGISTER FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 www.copd-conference.co.uk POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK