SMi Group's 7th annual COPD 2015 conference returns to London this October

1. bENEfItS of AttENDING IN 2015:
• Discuss the advantages and disadvantages of combinational
therapeutics
• Gain insight into formulation developments and the
manufacturing of dry powder inhalation products
• Learn about "first in class" inhaled drugs for the treatment of
COPD and cystic fibrosis
• Ascertain the ACOS Definition and characteristics of a grey-zone
syndrome, excluded from current asthma and COPD trials
• Explore recent advances made in COPD biomarkers
• Analyse airway disease endotyping for personalized therapeutics
PLUS oNE INtERACtIvE hALf-DAY PoSt-CoNfERENCE WoRKShoP
Wednesday 21st october 2015, holiday Inn Regents Park, London UK
Improving probability of success in CoPD drug development
Workshop Leaders: Dr. Graham Clarke, Senior Director, Head of Respiratory & Inflammation
Early Clinical Development, Quintiles
Dr. Juan Gispert, European Head allergy, Respiratory, infectious Diseases, Vaccines, Medical
Science & Strategy, Quintiles
8.30am – 12.30pm
Dr frank thielmann,
Operational Lead Inhalation
New Solids, Novartis
Philip Silkoff,
Senior Medical Director,
Janssen Inc
Stefano Petruzzelli, Chief Medical Officer and Director
Global Clinical Development, Chiesi farmaceutici S.p.A
Sanjeeva Dissanayake, Head of Respirator Medical
Sciences, Mundipharma
Noel Snell, Director of Research,
british Lung foundation
Geoff Down, Chief Medical Officer,
Prosonix
Konstantinos Kostikas, Medical Director Respiratory (COPD),
Region Europe, Novartis Pharmaceuticals
thomas Schlange, Senior Biomarker Expert,
bayer
booK bY 30th JUNE 2015 AND SAvE £400 • booK bY 17th JULY 2015 AND SAvE £200
COPD
19 - 20
OCT
2015Holiday Inn Regents Park, London UK
Novel therapeutics and management strategies
SMI, the industry leaders in respiratory events present the
7th annual conference on…
www.copd-conference.co.uk
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GRoUP DISCoUNtS AvAILAbLE
@SMIPhARM
ChAIRS foR 2015:
KEY SPEAKERS INCLUDE:
Sponsored by

2. Register online at: www.copd-conference.co.uk • Alternatively fax
CoPD
Day one I Monday 19th october 2015 www.copd-co
8.30 Registration & Coffee
9.00 Chair’s opening Remarks
Dr frank thielmann, Operational Lead Inhalation New Solids,
Novartis
DRUG DEvELoPMENtS & CoMbINAtIoNAL thERAPIES
9.10 An immunological role for non-neuronal cholinergic
signalling via muscarinic receptors
• Tiotropium and muscarinic receptor 3 in COPD
• Non-neurological cholinergic signalling and muscarinic
receptor 3.
• Implications for treatment and drug targets
Corinna Schnoeller, Research Associate, Imperial College
London
9.50 from molecule to medicine - formulation development and
manufacturing of dry powder inhalation products
• Device and formulation systems and their selection
• Properties of drug substance and product and impact on
in-vitro/ vivo performance
• Challenges in the manufacturing of DPI systems
• Future trends in inhaled drug delivery
Dr frank thielmann, Operational Lead Inhalation New Solids,
Novartis
10.30 Morning Coffee
11.00 RPL554, a novel "first-in-class" inhaled drug for the treatment
of exacerbations of chronic obstructive pulmonary disease
(CoPD), and cystic fibrosis
• Treatment and prevention of COPD exacerbations
• Severe exacerbations of COPD and hospital re-admissions
shortly after discharge
• RPL554 – a novel dual PDE3 and PDE4 inhibitor with
bronchodilator and anti-inflammatory effects
Jan-Anders Karlsson, CEO, verona Pharma
11.40 optimising treatment for CoPD – new strategies for
combination therapy
• Are therapies that provide bronchodilation useful in COPD?
• Pros and cons of combination therapies
• Role of real Life Data
• Change in management strategies in UK
Ewan Walters, Medical Director, teva UK Ltd
12.20 Networking Lunch
1.30 triple fixed dose combination therapy in CoPD
• Therapeutic rationale
• Development challenges
• Potential future options
Geoff Down, Chief Medical Officer, Prosonix
2.10 p38 mitogen-activated protein kinase pathways in asthma
and CoPD
• Patients with severe asthma or COPD are resistant to the
beneficial therapeutics effects of corticosteroid therapy
• Heightened p38 MAPK activity is observed in alveolar
macrophages (AM), peripheral blood mononuclear cells
(PBMC) and airway smooth muscle cells of severe asthma
and COPD, and is associated with impaired steroid
suppression of cytokine release
• A p38 MAPK inhibitor and dexamethasone synergistically
suppress induced cytokine release in AM and PBMC of
severe asthma or COPD
• p38 MAPK inhibitors provide a potential new therapy for the
treatment of severe asthma or COPD where reversibility of
corticosteroid insensitivity could lead to better control of
disease symptoms.
Pankaj bhavsar, Research Lecturer, National heart & Lung
Institutee
2.50 Ceramide 1-phosphate, a novel therapeutic agent for
treatment of CoPD
• Ceramide 1-phosphate (C1P) reduces lung inflammation
• C1P stimulates cell growth, inhibits apoptosis, and promotes
cell migration
• The mechanisms by which C1P blocks inflammatory
responses involve inhibition of sphingomyelinase and serine
palmitoyl transferase activities, reduction of pro-
inflammatory cytokines, and inhibition of NF-kB expression
Antonio Gomez-Munoz, Professor of Biochemistry and
Molecular Biology, University of the basque Country
DEvELoPING CLINICAL tRIALS foR CoPD
3.20 Asthma-chronic obstructive pulmonary disease (CoPD)
overlap syndrome: ACoS or C(h)AoS?
• Definition and characteristics of a grey-zone syndrome,
excluded from current asthma and COPD trials
• Applying current knowledge to clinical practice
• Unmet needs and the future of ACOS
Konstantinos Kostikas, Medical Director Respiratory (COPD),
Region Europe, Novartis Pharmaceuticals
4.00 Afternoon tea
4.30 Endpoints in CoPD trials
•An overview of endpoints used in COPD trials: pitfalls,
limiting risk, and extracting additional value
•The focus will be on phase 3 registration studies
Sanjeeva Dissanayake, Head of Respiratory Medical
Sciences, Mundipharma
5.10 Developing Clinical trials in Pulmonary Rehabilitation
• Patient selection and recruitment
• Designing an effective rehabilitation programme
• Overcoming recruitment and adherence hurdles
• Prospects in the field
Chetna bhatia, Physical Therapist, University hospital Geneva
5.50 Asthma–chronic obstructive pulmonary disease (CoPD)
overlap syndrome (ACoS)
• Incidence of ACOS
• Clinical trials have consistently ignored this condition, as
evidenced by strict inclusion and exclusion criteria that
exclude either asthma patients from COPD studies or COPD
patients from asthma studies, how this is changing in drug
development programmes
• Explaining the phenotype
• Review of potential pharmacotherapeutic approaches
Jane Gunter, Advisor, Clinical Research, Respiratory Clinical
trials
6.30 Chairman’s Closing Remarks and Close of Day one
offICIAL MEDIA PARtNERS
Quintiles transnational (NYSE: Q), is a Fortune 500 company
and the world’s largest provider of biopharmaceutical
development and commercial outsourcing services with a
network of more than 32,000 employees conducting
business in approximately 100 countries.
www.www.quintiles.com
Sponsored by
KEYNotE
ADDRESS

3. x your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
CoPD
Day two I tuesday 20th october 2015nference.co.uk
8.30 Registration & Coffee
9.00 Chairman's opening Remarks
Philip Silkoff, Senior Medical Director,
Janssen Inc
DEfINING CoPD PULMoNARY INDICAtIoNS thRoUGh bIoMARKERS
oPENING ADDRESS
9.10 Analysis of CoPD biomarkers in sputum at the point-of-care
• Use of infra-red spectroscopy in respiratory clinical
diagnostics
• Determination of sputum biomarkers for COPD and
exacerbation
• Development of a simple hand-held device for biomarker
detection
• Determination of sensitivity and specificity to predict
exacerbation using device and biomarkers
• Evaluation of device in the SPEDIC clinical trial
• Potential for use of device in primary care to aid COPD
management
Paul Lewis, Chief Scientific Officer, Glyconics Limited
9.50 the ADEPt study "Airways Disease Endotyping for
Personalized therapeutics": Study design, populations and
initial learnings
• COPD is a heterogeneous disease; surprised?
• When assessing biomarkers in COPD, there may be
profound impacts of current smoking and also inhaled
steroid use
• A deeper level of disease understanding may assist in
discovering novel therapies for COPD based on a
personalized medicine approach
Philip Silkoff, Senior Medical Director, Janssen Inc
10.30 Morning Coffee
11.00 Explaining the importance of biomarker discovery in CoPD
• The status of biomarker research in COPD will be presented
and put in context of their relevance for drug development
programs, companion diagnostics development and
clinical utility. Lessons learned from other lung disorders will
be discussed.
• COPD biomarkers data from recent studies
• Importance of biomarkers in disease management, drug
development and personalised medicine
thomas Schlange, Senior Biomarker Scientist, bayer
CoPD Co-MoRbIDItIES
KEYNotE ADDRESS
11.40 Understanding CoPD and Comorbidities
• What is the link between comorbidities and disease
• Current issues with treatments for COPD
• The use of corticosteroids, do they cause more harm than
good?
John hurst, Senior Clinical Lecturer, Honorary Consultant,
University College London
12.20 Networking Lunch
MANAGING ExACERbAtIoNS
1.30 Managing Exacerbations in CoPD: Role of Pulmonary
Rehabilitation
• When does Rehabilitation start
• Can Non Invasive Ventilation be used for early
rehabilitation and muscle building
• Case Study in HUG
• From ICU to the rehabilitation room
Chetna bhatia, Physical Therapist, University hospital Geneva
2.10 Update on the clinical management of exacerbations
• The course of COPD exacerbations. What are we
measuring?
• Similarities and differences between healthcare resource
utilisation definition and EXACT
• How do exacerbations relate to a range of health
outcomes
Stefano Petruzzelli, Chief Medical Officer and Director Global
Clinical Development, Chiesi farmaceutici S.p.A.
2.50 Afternoon tea
3.20 Investigating the role of ectopic lymphoid follicles in
respiratory disease
• Exploring the role of lung damage and injury in formation
of ectopic follicles
• Evaluation of follicle formation in models of COPD
• Review the key pathways and mechanisms that contribute
to lymphoid follicle formation in COPD and related
interstitial lung diseases
Matthew Sleeman, Senior Director of Biology, Respiratory,
Inflammation and Autoimmunity, MedImmune
4.00 Respiratory research in the UK - the role of the british Lung
foundation
• The current state of UK respiratory research: why is it grossly
underfunded compared with therapeutic areas of similar
disease burden?
• Development of a revised research strategy for the BLF in
partnership with patients
• What is the future outlook for respiratory research in the UK?
Noel Snell, Director of Research, british Lung foundation
4.40 Chairman’s Closing Remarks and Close of Day two
Supported by

4. overview of workshop:
The workshop will be an interactive session where we will
review major topics of development of drugs for COPD.
• Early studies special characteristics
• Study design, challenge models, adaptive designs
• COPD biomarkers
• Selection of proper sites and patients
• How to ensure compliance in long term studies
• Major operational issues in COPD studies
• Tools & tips to collaborate with site networks
• Patient centric studies
benefits of attending:
This workshop will offer a global view on the design, setup
and management of clinical trials in COPD patients;
based on the wide experience and lessons learned of
Quintiles team members
Programme:
8.30 Registration and Coffee
9.00 opening remarks and introductions
9.15 Session 1: Smarter approaches in early clinical
development in CoPD
• Adaptive designs and POC studies in COPD
• Incorporation of challenge models to
determine POM – LPS and Ozone Challenge
• Functional markers of COPD in adaptive
designs
• Sputum methodologies to enhance key
Biomarkers in COPD
10.00 Coffee
10.15 Session 2: full development of CoPD
compounds smart transition from ECD to Late
phase
• Regulatory perspective
• Current landscape of compounds under
development
• Real world data as strategy driver
11.00 Coffee
11.15 Session 3: Maximizing efficiency of CoPD trials
• Recruitment strategies to ensure proper study
completion
• Patient centric studies
• Compliance in long term studies
1200 End of Workshop
About the workshop leaders:
Dr. Graham Clarke is the senior director and head
of the respiratory and inflammation unit in Early
Clinical Development at Quintiles, London. He
leads the development and execution of inhaler
generics and inhaler characterization studies. He also
leads Quintiles’ biomarker identification efforts and the
development of challenge models of inflammation. Dr.
Clarke has served in a variety of respiratory clinical
research environments and he is an honorary senior
research fellow in cardiothoracic pharmacology at
Imperial College London’s National Heart and Lung
Institute.
Dr. Juan Gispert is member of EAACI and ERS.
Since he joined pharmaceutical industry in 1992,
he has got wide experience in all aspects of
clinical trials, from protocol development to
conduct, and regulatory submissions, both in FDA and
EMA. After joining Quintiles in 2005, currently serves as
Senior Medical Director, and leads the medical Allergy
and Respiratory teams.
About the organisation:
Quintiles will be hosting this years workshop. For further
details about the organisation please go to:
www.quintiles.com
Improving probability of success in
CoPD drug development
hALf-DAY PoSt-CoNfERENCE WoRKShoP
Wednesday 21st october 2015 I 8.30am – 12.30pm
holiday Inn Regents Park, London UK
In association with

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email tarri@smi-online.co.uk
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and branding packages, uniquely tailored to
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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, Director
on+44 (0) 20 7827 6168 or email: amalick@smi-
online.co.uk
SMi Pharmaceutical
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CoPD
Conference: 19th -20th october 2015, holiday Inn Regents Park, London UK I Workshops: 21st october 2015, London
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