Matthew CatleyTeam Leader, R&IAstraZeneca

Nestor MolfinoVice –President, ClinicalDevelopmentMedimmune

Edwin ChilversProfessor of Respiratory MedicineUniversity of Cambridge

Ewan WaltersMedical DirectorTeva UK

Liz HardakerSenior InvestigatorNovartis

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 conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Sebastian Johnston Professor of Respiratory MedicineImperial College School of Medicine(N.H.L.I)

Frank ThielmannOperational Lead, Inhalation NewSolidsNovartis

Dirk BredbroekerHead of Clinical Science RespiratoryTakeda

Wisia WedzichaProfessor of Respiratory MedicineUniversity College London

Louise DonnellyReader in Respiratory Cell BiologyImperial College London

KEY SPEAKERS INCLUDE:

WHY ATTEND THIS EVENT:• Consider developments in the modelling and management of exacerbations of COPD • Evaluate unique complexities of COPD pathophysiology - compare and contrast

COPD with Asthma to improve your understanding of what makes COPD unique andneeding of particular attention

• Develop combination and oxygen therapies within COPD - learn about tripletherapies and novel therapies within the treatment of COPD

• Hear from leading industry professionals on the current clinical trials process andrapid proof of concept studies

• Analyse all phases of the discovery process, from pre-clinical modelling, phase 2studies all the way through to modelling clincal outcomes.

• Network with and learn from key industry professionals and research leading academics • Discuss the latest in health economics for COPD drugs

SMi present their 4th annual conference on…

COPDNovel Therapeutics and Management Strategies

Monday 22nd and Tuesday 23rd October 2012, Copthorne Tara Hotel, London

Sponsored by

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 24th October 2012, Copthorne Tara Hotel, London

A: Developing Inhalation DevicesWorkshop Leader: Sabine Haeussermann, Senior Director, Scientific

Business Development, Inamed GmbH8.30am – 12.30pm

B: Biomarkers in Respiratory Diseases Workshop Leaders: Magnus Nord, Senior Translational Scientist,

AstraZeneca & Karin von Wachenfeldt, Co-Founder, Truly Translational AB1.00pm-5.30pm

Register online at www.copd-conference.co.uk • Alternatively fax

COPD: Novel Therapeutics & Management Strategies 2012Day One | Monday 22nd October 2012 www.copd-con

8.30 Registration and Coffee

9.00 Chairman’s Opening RemarksSebastian Johnston, Professor of Respiratory Medicine, ImperialCollege 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 developmentSebastian Johnston, Professor of Respiratory Medicine, ImperialCollege 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 regulationMatthew 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 fieldGeoff 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 trialsEdwin Chilvers, Professor of Respiratory Medicine, University of Cambridge

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 COPDEwan 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 studiesChristine Tiesler, Associate Director, Late Stage Research, PPD

16.50 From molecule to medicine; obstacles on the way from discovery tomarket• 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 productsFrank 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 Safetyand Efficacy, Pulmonary Function Testing including Spirometry, Peak Flow, Nitric Oxide,... and digital Medical Imaging forclinical trials, from classical imaging modalities as well as centralized EEG, Gait and Digital Pathology. www.biomedsys.com

Vitalograph has manufactured respiratory diagnostic equipment for the healthcare industry since 1963 and the nameVitalograph is synonymous with spirometry around the world. The name Vitalograph is also synonymous with quality, asmany of our spirometers in everyday use are more than 30 years old! As a consequence, our equipment is favoured byopinion leaders and clinical researchers who need reliable and accurate measurements. We provide a full range of serviceswithin respiratory clinical trials and this includes project management, centralized data management, over-reading and aglobal 24/7 support service. We also have a dedicated integrated solution via our Spirotrac® Centralized Spirometry Systemthat includes site based FeNO measurements, 6MWT, pulse oximetry, challenge testing, 12-lead ECG and our exciting newIn2itive™ e-Diary that complies with FDA‘s PRO guidance with validated questionnaires. All data is accessible via ourVIEWER™ web portal. Also ask about our unique new AIM inhaler trainer for pMDIs and DPIs. www.vitalograph.co.uk

Sponsored by

Supported by

x your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Day Two | Tuesday 23rd October 2012nference.co.uk

8.30 Re-registration and Coffee

9.00 Chairman's Opening RemarksWisia Wedzicha, Professor of Respiratory Medicine, University CollegeLondon

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 CollegeLondon

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 exacerbationsLiz Hardaker, Senior Investigator, Novartis

10.30 Morning Coffee

11.00 COPD exacerbations, preventing and changing their natural historyusing the tools that we have• Use of ‘innovative endpoints’• Case Study: Current situation in the NHS• Learning from the past to develop the futureNabil Jarad, Consultant Respiratory Physician, Bristol Royal Infirmary

11.40 Novel strategies in exacerbation management• Exacerbation definitions• Impact of exacerbations• Exacerbation prevention• Treatment of exacerbationsWilliam MacNee, Professor of Respiratory and Environmental Medicine,University of Edinburgh

12.20 Session Reserved for VitalographSenior 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 infectionsNestor 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 CXCR2Louise Donnelly, Reader in Respiratory Cell Biolog, Imperial CollegeLondon (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 EXHIBITIONOPPORTUNITIES

SMi offer sponsorship, exhibition, advertising and brandingpackages, uniquely tailored to complement your company’smarketing strategy. Prime networking opportunities exist toentertain, enhance and expand your client base within thecontext of an independent discussion specific to yourindustry. Should you wish to join the increasing number ofcompanies benefiting from sponsoring our conferencesplease call: Alia Malick on +44 (0) 20 7827 6168 or email:amalick@smi-online.co.uk

Want to know how you can get involved? Interested inpromoting your pharmaceutical services to this market?

Contact Kellee Halliburton, SMi Marketing on +44 20 7827 6194 or email khalliburton@smi-online.co.uk

SMi's Pharmaceutical Forward Planner 2012JULY2-3 KOL Management and MSL

Best Practice in Europe(Switzerland)

9-10 ADMET 9-10 Social Media in the

Pharmaceutical Industry 11-12 BioBanking

SEPTEMBER17-18 Next Generation

Sequencing19-20 Cancer Vaccines

24-25 Biosimilars andBiobetters

26-27 KOL Management

OCTOBER3-4 Partnerships with CROs8-9 Pharmaceutical Orphan

Drugs22-23 COPD: Novel

TherapeuticsandManagement Strategies

24-25 Point of Care Diagnostics- Market Opportunitiesand Technology Trends

29-30 EuropeanPharmaceutical Pricing& Reimbursement

NOVEMBER5-6 Cell Based Assays5-6 Clinical Trials in CNS28-29 Diabetes

DECEMBER3-4 Cold Chain Distribution

All conferences take place in central London, UK – unless indicated otherwise in brackets

HALF-DAY POST-CONFERENCE AM WORKSHOP

8.30am – 12.30pmWednesday 24th October 2012Copthorne Tara Hotel, London

A: Developing Inhalation Devices

Workshop Leader: Sabine Häußermann, Director Business

Development, Inamed

In association with

Overview of workshopInhalation techniques and the inhalation device in use play animportant role in the success of inhaled drugs. Often drugs arenot effective and therefore not successful on the market – thereason for which is that the dose which reaches the target regionin the lungs is too small. This workshop will deal with inhalationdevices and inhalation techniques, as well as with the design ofclinical trials for successfully inhaled drugs.

Why you should attend:• 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

Programme8.30 Registration & Coffee

9.00 Welcome & Introductions

9.10 Overview of developing inhalation devices for COPD• Developing techniques in inhalation device design• Strategies to make the development process more

efficient• Overcoming common challenges in device

development

9.45 Case Study -Inhalation devices for generic productsin the EU and the US• Problems encountered• How were these obstacles overcome• What the future holds

10.45 Tea Break

11.00 Application / Inhalation devices in clinical trials andin practice• Clinical Trial design analysis• Information on the specifics of clinical trials for

inhaled drugs

12.10 Discussion Session

12.30 Close of workshop

About the workshop host Dr Sabine Häußermann, Director BusinessDevelopment, InamedDr. Häußermann has worked for Inamed in hercurrent role, since March 2010 and is responsiblefor scientific advice and regulatory services.

Dr. Häußermann is an engineer by training andstarted out her career in basic research on the inhalation ofaerosols in the Institute of Inhalation Biology at the HelmholzCenter in Neuherberg, Munich in Prof. Heyder's group.

After obtaining her PhD, she previously worked for Inamed from2000 to 2006, applying her research to the pharmaceutical fieldof respiratory aerosol medicine, initially as project manager.From 2002 she headed the clinical research group at Inamed inGauting, before moving to France. From 2006 to 2010 sheheaded the inhalation device development section in the medicalgases research group at Air Liquide.

Dr. Häußermann is an active member of the ISAM society, haschaired the ISAM Awards Committee and is now a member ofthe ISAM board.

About INAMEDComplementing our solid experience in conducting clinical trialsand our staffed, in-house Phase I unit, Inamed performs in-vitrostudies in our own labs and performs radio-labeling studies.

With over two decades of clinical research experience, ourclients benefit from our state-of-the-art infrastructure, long-term experience and network of competent partners. Inamedenable its sponsors to reach better go" or "no-go” decisions tolaunch and market their products successfully.

HALF-DAY POST-CONFERENCE PM WORKSHOP

1.00pm – 5.30pmWednesday 24th October 2012Copthorne Tara Hotel, London

Biomarkers in Respiratory Diseases -What can they deliver, and for who do we

generate the results ?

Workshop Leaders: Magnus Nord, Senior Translational Scientist,

AstraZeneca & Karin von Wachenfeldt, Co-Founder, Truly Translational AB

In association with

AstraZeneca & Truly Translational

Overview of workshopThis unique workshop will allow attendees to discuss the latestdevelopments within translational biomarkers and how they canbe used in COPD drug development. This case-study led sessionwill present attendees with success stories to learn from andadapt into their own drug development programs. Withbiomarkers playing a larger and more important role in COPDdrug development, this workshop is not to be missed.

Why you should attend:• Learn how best to develop pre-clinical biomarker discovery• Consider the latest obstacles in biomarker discovery and how

to overcome them• Develop imaging technologies to improve biomarker

development in COPD• Network with key industry professionals

Programme1.00 Registration & Coffee1.30 Welcome & Introductions1.45 Overview of Biomarkers for Efficacy2.15 Overview of Biomarkers for Safety2.45 Afternoon Tea 3.00 Challenges in Biomarker development in the

respiratory field - COPD. • Circulating biomarkers• Imaging as biomarker?• Validation challenges, and reasons to collaborate.

4.00 Challenges in Biomarker development in therespiratory field - Drug-induced Interstitial LungDisease • Strategies for discovery• Imaging vs circulating biomarkers• Challenges in clinical qualification

5.00 Discussion Session5.30 Close of Workshop

About the workshop hosts:Dr Magnus Nord, MD, PhD, Assoc Prof, holds a position in SafetyScience, a Global Enabling Science Function in AstraZenecaPatient Safety. It is a focused group of scientists, physicians,statisticians and informaticians working to shape clinical safetyand support decision-making in drug projects. Magnus is alsochairman and clinical lead of the AstraZeneca Pulmonary SafetyKnowledge Group and has to date published 40+ scientific articles.

Dr Karin von Wachenfeldt, CEO and Co-founder of TrulyTranslational Sweden, an Immunologist by training, and with astrong scientific interest in understanding why people developdisease, and how diseases can be treated or prevented. For 12years she held different leading biology positions at AstraZeneca,always with a focus on increasing the understanding of underlyingdisease 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 sheheads up Truly Translational Sweden AB a company focusingentirely on translational sciences, offering senior consultancyservices.

About AstraZeneca:AstraZeneca is a global, innovation-driven, integratedbiopharmaceutical company. They discover, develop manufactureand market prescription medicines for six important areas ofhealthcare, which include some of the world’s most seriousillnesses: cancer, cardiovascular, gastrointestinal infection,neuroscience, and respiratory and inflammation.

About Truly Translational:Truly Translational Sweden AB provides life science and drugdevelopment consultancy with an emphasis on biology andtranslational science. Our mission is to translate preclinical projectideas into efficient development plans delivering successfulclinical trials. Truly Translational is founded on solid scientificexpertise and more than 50 years experience with drug researchand development in both large pharma and biotech. We focus onbringing biologicals and small molecule projects from preclinicalin vitro studies and animal models via common biomarkerstrategies, into concept testing in patients.

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VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SR

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□ Book by 29th June 2012 to receive a £300 off the conference priceEARLY BIRDDISCOUNT

CONFERENCE PRICESI would like to attend: (Please tick as appropriate) Fee Total□ Conference & 2 Workshops £2697.00 + VAT £3236.40□ Conference & 1 Workshop £2098.00 + VAT £2517.60□ Conference only £1499.00 + VAT £1798.80□ 1 Workshop only £599.00 + VAT £718.80□ 2 Workshops £1198.00 + VAT £1437.60Workshop A □ Workshop B □

PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional

literature to all conference attendees £999.00 + VAT £1198.80

GROUP DISCOUNTS AVAILABLE

The conference fee includes refreshments, lunch, conference papers and access to the Document Portal containing all of the presentations.

VATVAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on DocumentPortal 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 712PHONE on +44 (0) 870 9090 711

www.copd-conference.co.ukPOST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK