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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
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
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
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.
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.
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
Payment: If payment is not made at the time of booking, then an invoice will be issued and must be
paid immediately and prior to the start of the event. If payment has not been received then credit card
details will be requested and payment taken before entry to the event. Bookings within 7 days of
event require payment on booking. Access to the Document Portal will not be given until payment
has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send a
substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,
providing that cancellation is made in writing and received at least 28 days prior to the start of the
event. Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable to
attend for any reason. Due to the interactive nature of the Briefings we are not normally able to
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for Documentation or the Document Portal as these are reproduced specifically to order. If we have
to cancel the event for any reason, then we will make a full refund immediately, but disclaim any
further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection
Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other
products and services. Unless you tick here □ we may also share your data with third parties
offering complementary products or services. If you have any queries or want to update any of the
data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk
or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your
address on the attached letter.
Unique Reference Number
Our Reference LVP-048
Terms and Conditions of Booking
DELEGATE DETAILS
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
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Company VAT Number:
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Signature: Date:
I agree to be bound by SMi's Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Payment must be made to SMi Group Ltd, and received before the event, by one of the
following methods quoting reference P-048 and the delegate’s name. Bookings made within
7 days of the event require payment on booking, methods of payment are below. Please
indicate method of payment:
□ UK BACS Sort Code 300009, Account 00936418
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 00936418
IBAN GB48 LOYD 3000 0900 9364 18
□ Cheque We can only accept Sterling cheques drawn on a UK bank.
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Card Billing Address (If different from above):
DOCUMENTATION
I cannot attend but would like to purchase access to the following Document
Portal/paper copy documentation Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
PAYMENT
VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SR
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712
□ Book by 29th June 2012 to receive a £300 off the conference price
EARLYBIRD
DISCOUNT
CONFERENCE PRICES
I 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 £1437.60
Workshop 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.
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

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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.
  • 6. If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □ we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. Unique Reference Number Our Reference LVP-048 Terms and Conditions of Booking DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-048 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment: □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 □ Cheque We can only accept Sterling cheques drawn on a UK bank. □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. Card Billing Address (If different from above): DOCUMENTATION I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) PAYMENT VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SR □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712 □ Book by 29th June 2012 to receive a £300 off the conference price EARLYBIRD DISCOUNT CONFERENCE PRICES I 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 £1437.60 Workshop 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. 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