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www.asthma-copd.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 #asthmacopdsmi SMi proudly present their 13th annual conference on… Asthma & COPD Leading strategies to novel treatments and solutions Holiday Inn Kensington Forum, London, UK HIGHLIGHTS IN 2017: Updates from the MHRA on the regulatory challenges to developing inhalation devices Overcome hurdles to the success of new devices with Boehringer Ingelheim Janssen’s innovative approaches to COPD interception Track the emerging trends in targeted treatment with biomarkers and biologics with MedImmune ‘Real time data collection’ – an exclusive case study presentation on GSK’s pioneering ‘Salford Lung study’ PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS Tuesday 28th March 2017, Holiday Inn Kensington Forum, London, UK CHAIRS: Day 1 - Wisia Wedzicha, Professor of Respiratory Medicine, Imperial College London Day 2 - Stephen Beckman, Head of Global Respiratory and Allergy, Mylan FEATURED SPEAKERS: Quan Yang, Pharmaceutical Assessor, MHRA David Leather, Global Medical Affairs Leader, GlaxoSmithKline Stefan Leiner, Chemical-Pharmaceutical Expert, Boehringer Ingelheim Neelima Khairatkar Joshi, Senior Vice President & Head of Drug Discovery, Glenmark Pharmaceuticals Christopher Stevenson, Venture Leader COPD Interception, Janssen Frank Thielmann, Operational Lead Inhalation New Solids, Novartis Ewan Walters, Medical Director, Teva UK Outi Vaarala, Head of Translational Biology, AstraZeneca REGISTER BY 30TH NOVEMBER FOR A £400 DISCOUNT REGISTER BY 16TH DECEMBER FOR A £200 DISCOUNT REGISTER BY 31ST JANUARY FOR A £100 DISCOUNT WORKSHOP A The future of Asthma & COPD management; from connected inhalers to therapy management 08.30 – 12.30 Workshop Leader: Vaishali Kamat, Director of Digital Health, Cambridge Consultants WORKSHOP B Innovative approaches to COPD – Proactive, not reactive, strategies 13.30 – 17.30 Workshop Leader: Christopher Stevenson, Venture Leader COPD Interception, Janssen CONFERENCE: 29TH - 30TH WORKSHOPS: 28TH MAR 2017

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Page 1: P-200 - FINAL

www.asthma-copd.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 #asthmacopdsmi

SMi proudly present their 13th annual conference on…

Asthma & COPD Leading strategies to novel treatments and solutions

Holiday Inn Kensington Forum, London, UK

HIGHLIGHTS IN 2017: • Updates from the MHRA on the regulatory challenges

to developing inhalation devices

• Overcome hurdles to the success of new devices with Boehringer Ingelheim

• Janssen’s innovative approaches to COPD interception

• Track the emerging trends in targeted treatment with biomarkers and biologics with MedImmune

• ‘Real time data collection’ – an exclusive case study presentation on GSK’s pioneering ‘Salford Lung study’

PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPSTuesday 28th March 2017, Holiday Inn Kensington Forum, London, UK

CHAIRS: Day 1 - Wisia Wedzicha, Professor of Respiratory Medicine, Imperial College London

Day 2 - Stephen Beckman, Head of Global Respiratory and Allergy, Mylan

FEATURED SPEAKERS: • Quan Yang, Pharmaceutical Assessor, MHRA • David Leather, Global Medical Affairs Leader,

GlaxoSmithKline • Stefan Leiner, Chemical-Pharmaceutical Expert,

Boehringer Ingelheim • Neelima Khairatkar Joshi, Senior Vice President & Head of

Drug Discovery, Glenmark Pharmaceuticals • Christopher Stevenson, Venture Leader COPD Interception,

Janssen • Frank Thielmann, Operational Lead Inhalation New Solids,

Novartis • Ewan Walters, Medical Director, Teva UK • Outi Vaarala, Head of Translational Biology, AstraZeneca

REGISTER BY 30TH NOVEMBER FOR A £400 DISCOUNTREGISTER BY 16TH DECEMBER FOR A £200 DISCOUNT REGISTER BY 31ST JANUARY FOR A £100 DISCOUNT

WORKSHOP AThe future of Asthma & COPD management; from

connected inhalers to therapy management 08.30 – 12.30

Workshop Leader: Vaishali Kamat, Director of Digital Health, Cambridge Consultants

WORKSHOP BInnovative approaches to COPD – Proactive, not reactive, strategies

13.30 – 17.30 Workshop Leader:

Christopher Stevenson, Venture Leader COPD Interception, Janssen

CONFERENCE: 29TH - 30THWORKSHOPS: 28TH

MAR 2017

Page 2: P-200 - FINAL

Asthma & COPD Day One | Wednesday 29th March 2017

08.30 Registration & Coffee

09.00 Chairman’s Opening Remarks Wisia Wedzicha, Professor of Respiratory Medicine,

Imperial College London

OPENING ADDRESS 09.10 EU and UK regulatory considerations for the development

of inhaled products • EU and UK regulatory hurdles to developing and

registering a generic inhalation product • Regulations for inhalation drug development, including

combination considerations • Regulatory updates on the device component of a

medicinal product • How does device type affect the development and

approval process? Quan Yang, Pharmaceutical Assessor, MHRA

09.50 Overcoming challenges to industry in the device development process

• Moving away from generic development • Taking age group into consideration when developing a

device; considerations for paediatric and elderly patients • Incorporating clinical trials as a key step in obtaining

device approval • USP regulatory update on spacers in new devices Stefan Leiner, Chemical-Pharmaceutical Expert,

Boehringer Ingelheim

10.30 Morning Coffee

11.00 From molecule to medicine – formulation development and manufacturing of dry powder inhalation products

• Device and formulation systems and their selection • Drug substance – product relationship. How does

performance in vitro relate to performance in vivo? • Challenges in the manufacturing of DPI systems • Future trends in inhaled drug delivery Frank Thielmann, Operational Lead Inhalation New Solids,

Novartis

11.40 Matching device and treatment to disease stage; considerations for the treatment of asthma

• Clinical development of novel inhalers – trends with case study examples

• Challenges to the development of novel inhalers; increased cost of development vs. improved performance and decreased cost to NHS

• Targeting severe exacerbation with novel monoclonal antibodies

- Mechanism for targeting and exacerbation reduction - Knock on effects to NHS and pricing strategies Ewan Walters, Medical Director, Teva UK

12.20 Networking Lunch

13.30 Case study; Inhaled calcilytics for infl ammatory lung disease

• The calcium-sensing receptor as a novel drug target for

asthma and COPD

• Calcilytics prevent asthma-associated airways hyper-

responsiveness and infl ammation

• Calcilytics in eosinophilic and neutrophilic models of

infl ammatory lung disease

• Targeting a potential root of infl ammatory lung disease

Daniela Riccardi, Professor of Physiology, Cardiff University 14.10 Application of biomarkers and patients characteristics to

personalise treatment of Asthma & COPD • Current clinical unmet needs in Asthma and COPD

• How useful are biomarkers in identifying disease

phenotype and disease course?

• Multidimensional approach to deliver the right treatment

to the right patient

• Using biomarkers to develop targeted therapeutics for

Asthma and COPD

Marianna Alacqua, Senior Global Medical Affairs Leader of

Respiratory Biologics, AstraZeneca

14.50 Afternoon Tea

15.20 Biologics; targeted treatment to targeted cases • Case study

• Current patient selection strategies for identifying best

treatment

• Moving towards personalised treatments for asthma and

COPD

Donna Finch, Principle Scientist, MedImmune

16.00 Identifying eosinophil biomarkers for targeted therpeutic treatment of COPD

• Blood eosinophils as biomarkers in COPD

• How blood eosinophils can be used to adjust treatment

approach

• Implications for future treatment strategies

Wisia Wedzicha, Professor of Respiratory Medicine, Imperial College London

16.40 Chairman’s Closing Remarks and Close of Day One

REGULATORY UPDATE FOR INHALATION DEVICE DEVELOPMENT

THERAPEUTIC DEVELOPMENTS - PART 1

Supported byOffi cial Publications

Register online at www.asthma-copd.co.uk

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy.

Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences please call:

Alia Malick on +44 (0) 20 7827 6168 or email: [email protected]

MARKETING OPPORTUNITIESWant to know how you can get involved? Interested in promoting your services to this market?

Contact – Zoe Gale SMi Marketing on +44 (0) 20 7827 6132 or email: [email protected]

Page 3: P-200 - FINAL

Asthma & COPD Day Two | Thursday 30th March 2017

08.30 Registration & Coffee

09.00 Chairman’s Opening Remarks Stephen Beckman, Head of Global Respiratory and

Allergy, Mylan

09.10 Integration of innovation and opportunity in COPD • Innovation serving new ways to treat and manage

unique sub populations in COPD • Impact of RX and GX solutions in COPD and Asthma • How advanced delivery solutions will impact the market • Changes in payer and provider care impacts innovation • What trends will most affect the next ten years in Asthma

and COPD Stephen Beckman, Head of Global Respiratory and

Allergy, Mylan 09.50 Early interception of COPD • Focussing on early identifi cation of COPD using targeted

biomarkers and identifying related disease pathways • Impact of early interception to later disease course,

progression and treatment strategies • Integrating novel therapeutics and diagnostics to

address patient susceptibility to COPD Christopher Stevenson, Venture Leader COPD Interception,

Janssen

10.30 Morning Coffee

11.00 Novel anti-infl ammatory approaches in the treatment of COPD

• Lung infl ammation orchestrations in COPD • Past and present approaches to anti-infl ammatory

approaches • Breaking down infl ammation; from animals to man to

patients: mind the gap • Will novel targets deliver novel therapeutics in COPD Neelima Khairatkar Joshi, Senior Vice President & Head of

Drug Discovery, Glenmark Pharmaceuticals

11.40 Phenotyping Asthma and COPD disease types • Rethinking diagnosis criteria for asthma and COPD

based on genetic phenotyping • Impacts of phenotyping on treatment type, and

individuality of treatment • Patient stratifi cation using phenotypic patient subsets Neil Barnes, Global Medical Head, GlaxoSmithKline

12.20 Networking Lunch

SPOTLIGHT SESSION

13.30 ‘Real time’ data collection

– The Salford Lung study

• A fi rst of its kind study to demonstrate the

effectiveness of Relvar Ellipta in COPD

and asthma patients

• Study overview, aims and background

• Benefi ts of real time data collection – setting future

trends?

- Comparing the representativeness of effectiveness

studies vs randomised double blind controlled studies

- Drivers of effectiveness; for example adherence, co-

morbidity and age

• Implications of integrated health systems

- Changing patient ~ clinician relationships

David Leather, Global Medical Affairs Leader,

GlaxoSmithKline

14.10 Recent advances in drug development and treatments for

Asthma and COPD

• Current treatment options for asthma and COPD

• Moving forward: Insilico, PK and PD modelling and

simulation methods for evaluating respiratory drugs

• Assessing drug performance and dose response

relationships using a PKPD approach

• Increasing weight of evidence for the evaluation of the

safety and effi cacy of respiratory drugs

Beverley Patterson, Associate Director of Inhalation Clinical

R&D, Actavis

14.50 Afternoon Tea

15.30 Identifying novel biomarkers to determine patient

response disease types

• Development of novel biomarkers for eosinophilic

respiratory disease and mixed T-cell asthma

• Identifying epigenetic drivers in respiratory disease

• Towards more targeted treatment strategies for

respiratory diseases

Outi Vaarala, Head of Translational Biology, AstraZeneca

16.10 Chairman’s Closing Remarks and Close of Day Two

THERAPEUTIC DEVELOPMENTS - PART 2

COPD UPDATES

Supported by

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

MARKETING OPPORTUNITIESWant to know how you can get involved? Interested in promoting your services to this market?

Contact – Zoe Gale SMi Marketing on +44 (0) 20 7827 6132 or email: [email protected]

SPOTLIGHT CASE STUDY

Page 4: P-200 - FINAL

The future of Asthma & COPD management; from connected inhalers

to therapy management

Workshop Leaders: Vaishali Kamat, Director of Digital Health,

Cambridge Consultants

HALF-DAY POST-CONFERENCE WORKSHOPTuesday 28th March 2017

08.30 – 12.30Holiday Inn Kensington Forum, London, UK

Overview of Workshop:This half day workshop will explore how the treatment of Asthma and COPD is evolving. The discussion will focus on how personalised medicine and enhanced user experience can improve patient outcome. The workshop will provide insights on emerging technology trends relevant to the future of respiratory drug delivery devices and highlight the manufacturing and development challenges one might face. Specifi cally, the workshop will examine the impact that wireless technologies, sensors, wearables and data analytics will have in a future which will undoubtedly require pharmaceutical companies to develop more holistic treatment solutions that support 1) patients to take control of their disease state and 2) healthcare professionals provide more effi cient care.

Reasons for attending• Discuss challenges and opportunities in COPD and

Asthma treatment • Hear about emerging trends in digital health and

their relevance to respiratory drug delivery• Review lessons learned and obtain top tips on

development connected drug delivery solutions

Programme:

08.30 Registration & Coffee

09.00 Workshop leader introduction

09.10 Current gaps in the treatment of COPD and Asthma • Compliance • Patient outcomes • Reimbursement/ competiveness

09.50 Emerging trends in digital health • Delivering better user experience • Role of sensors, wearables and digital

biomarkers • Data analytics and digital services

10.30 Morning Coffee

11.00 The future of COPD and Asthma • Evolution of connected drug delivery devices • Development and manufacturing

considerations • Regulatory considerations

12.20 Discussion

12.30 Close of Workshop

About the Workshop Leader:Vaishali Kamat is a director and Head of Digital health at Cambridge Consultants, a leading technology and product development fi rm. Over the past 6 years she has helped clients develop ecosystem solutions comprising of wireless medical devices, mobile applications and services to improve health outcomes and increase revenues. She brings signifi cant domain and technical expertise in the rapidly evolving digital health space including an understanding of the regulations and insight into fi nancial models and market players. Vaishali is an engineer by training and has over 18 years’ experience in medical device design and has several published articles to her credit. Prior to joining Cambridge Consultants, she worked in diagnostic imaging for GE Healthcare.

About the Organisation:Cambridge Consultants develops breakthrough products, creates and licenses IP, and provides business consultancy in technology-critical issues for clients worldwide. For more than 50 years, we have been helping clients turn business opportunities into commercial successes, whether they are launching fi rst-to-market products, entering new markets or expanding existing markets through new technologies. Our auto-injector, inhaler and injection device development programmes extend from concept creation though to industrialisation, with a ‘quality by design’ approach and full compliance with international regulatory standards.

Page 5: P-200 - FINAL

Innovative approaches to COPD – Proactive, not reactive, strategies

Workshop Leader: Christopher Stevenson,

Venture Leader COPD Interception, Janssen

HALF-DAY POST-CONFERENCE WORKSHOPTuesday 28th March 2017

13.30 – 17.30Holiday Inn Kensington Forum, London, UK

Overview of Workshop:COPD is the 3rd leading cause of death worldwide. It is also a growing burden to healthcare services, in terms of number of unscheduled visits, comorbidities and disease prevalence. It is clear that fresh, proactive approaches to tackling COPD are necessary. This workshop affords exploration and insight into the emerging efforts to catch and treat COPD in the early stages of the disease. Janssen’s Christopher Stevenson leads a pioneering team focussed on interception of COPD. This workshop will comprehensively address the emerging trends, benefi ts and ideal outcomes of COPD interception. This trend could be a pivotal development in tackling COPD.

Reasons for attending • Map emerging trends and new approaches to tackling

COPD• Discuss best methods for earlier identifi cation of COPD • See the benefi ts of intervening at earlier stages of COPD• COPD prevention – a feasible possibility for the near

future? • Identify key areas of future development and future

trends in addressing COPD

Programme:

14.00 Session 1 – Shifting towards early diagnosis and interception of COPD

• Emerging trends in COPD • Approaches to earlier identifi cation, intervention

and monitoring COPD

14.15 Discussion

14.20 Session 2 – Defi ning the early molecular events in the pathogenesis of COPD

• Molecular biomarkers for earlier diagnosis of COPD - Is a molecular screening test possible? • Insights into molecular causes of COPD

14.50 Discussion

15.10 Afternoon Tea

15.40 Session 3 – Current state-of-the-art overview of COPD imaging biomarker efforts

• CT biomarkers for earlier diagnosis of COPD - Considerations for diagnostic tests: Predictive

value, cost, test complexity • Imaging insights for stratifi cation of COPD

sub-types

16.10 Discussion

16.30 Session 3 – Implementing change in approaching COPD

• Biomarkers for monitoring disease progression – Lessons from current COPD cohorts

• Regulatory considerations of reclassifying COPD endpoints

• Next steps towards interception and prevention of COPD

17.00 Discussion

17.30 Workshop leaders’ comments and close of Workshop

About the Workshop Leader:Dr. Christopher Stevenson is the the COPD Venture Leader for the Janssen Disease Interception Accelerator (DIA). Chris is a health care innovator with nearly 20 years of experience spanning both industry and academia. He has previous respiratory discovery experience at GlaxoSmithKline, Hoffmann-La Roche and Novartis. Chris also held a faculty position at Imperial College London and is currently an honorary professor at the University of Southern Denmark. In his current role, Chris is leading efforts to identify the root cause(s) of COPD with the aim of intervening earlier than today’s clinically-accepted point of diagnosis and stop disease before it starts.

About the Janssen Pharmaceutical Companies At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by fi nding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

Page 6: P-200 - FINAL

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VENUE Holiday Inn Kensington Forum,, 97 Cromwell Rd, London SW7 4DN, UK

ASTHMA & COPD Conference: Wednesday 29th & Thursday 30th March 2017, Holiday Inn Kensington Forum, London, UK

Workshops: Tuesday 28th March 2017, London, UK

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