SMi Presents the 12th Annual Conference and Exhibition on...

11 - 12

APRIL2016Holiday Inn Kensington Forum, London, UK

Asthma & COPD

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 13th April 2016, Holiday Inn Kensington Forum, London, UK

www.asthma-copd.co.uk Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Leading strategies in the development of asthma and COPD drug treatments

@SMIPHARM#asthmacopdsmi

A: Human factors and inhaler handling studies

Workshop Leader: Stefan Leiner, Chemical - Pharmaceutical Expert, Boehringer Ingelheim

8.30am - 12.30pm

B: Pragmatic compliance remediation - how to get your marketed product into shape?

Workshop Leader: Mark Chipperfield, Principal Consultant, Corvus Device Limited,

1.30pm - 5.30pm

•BOOK BY 18TH DECEMBER AND SAVE £400•BOOK BY 29TH JANUARY AND SAVE £200•BOOK BY 29TH FEBRUARY AND SAVE £100

HIGHLIGHTS FOR 2016:• Discuss the challenges for generic inhalation

products for EU and US markets• Gain insight into scientific aspects of quality

regulations in respiratory drug development• Review innate lymphocytes (ILC) in COPD• Learn about "first in class" inhaled drugs for the

treatment of COPD and cystic fibrosis• Explore corticosteroid insensitivity in severe

asthma• Study formulation and process of inhaled

products• Analyse clinical development of generic

CHAIRMAN FOR 2016:Ewan Walters, Medical Director, Teva UK

KEYNOTE SPEAKERS INCLUDE:• Peter Daley-Yates, Director Clinical Pharmacology, GSK• Andy Kenwright, Senior Statistical Scientist, Roche Pharma• Jan Olof Svensson, Principal Scientist, AstraZeneca• Roland Kolbeck, Senior Director, MedImmune• Nayna Govind, Director for the Development of Generic

Inhalation Products, Dr. Reddy's Laboratories• Konstantinos Kostikas, Medical Director Respiratory, Novartis

“Awesome 2015 programme” – Novartis

Asthma & COPDDay One | Monday 11th April 2016

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Ewan Walters, Medical Director, Teva UK

APPROACHES AND DEVELOPMENT IN ASTHMA AND COPD

9.10 Recent advances in asthma and COPD management

•Management of chronic asthma including severe disease

•Pharmacological treatments for COPD

•Management of the asthma-COPD overlap syndrome

•Assessment of potential impact of drugs under

development for asthma and COPD

Professor Neil C Thomson, Institute of Infection, Immunity and

Inflammation, University of Glasgow

9.50 COPD: Unmet Need and Challenges in NHS Care

•Exploring the care needs of patients

•The challenge of patients' unmet palliative care

•Ten key challenges, representing unmet need, in NHS Care

for COPD

John Hurst, Consultant in Respiratory Medicine,

University College London

10.30 Morning Coffee

11.00 Developing and registering new inhalers to deliver clinical

benefits in asthma

•Approval process for inhalers in asthma

•Developing a new inhaler

•Real world data to assess performance for patients and

HCPs of new inhalers

•Characteristics of a new inhaler to provide benefit

•Assessment of training procedures in both HCP (doctors

and Nurses) and patients

•Clinical studies in real world and role of observational

studies in clinical practice

Ewan Walters, Medical Director, Teva UK

11.40 Development challenges for generic inhalation products for

EU and US markets

•Formulation and device considerations

•In-vitro bioequivalence

•EU and US regulatory requirements

Nayna Govind, Director for the Development of Generic

Inhalation Products, Dr. Reddy's Laboratories

12.20 Networking Lunch

1.30 Design implications and challenges in developing

treatments for Idiopathic Pulmonary Fibrosis: (IPF)

•Background to current state of play in treating IPF

•Clinical development challenges in IPF

•Combination therapy – is it the future?

•Attempting to predict pulmonary decline in IPF

Andy Kenwright, Senior Statistical Scientist, Roche Pharma

2.10 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

2.50 Afternoon Tea

LEADING A THERAPEUTIC APPROACH

3.20 Performance Characterisation of Inhalation Products

•Performance characterisation in general

•Different types of delivery systems – different challenges

•In-vivo relevant testing

Jan Olof Svensson, Principal Scientist, AstraZeneca

4.00 Innate Lymphocytes (ILC) in COPD

•Cigarette smoke and respiratory viral infections

regulate IL-33

•The role of IL-33 during acute exacerbations

•Effects of cigarette smoke and viral infections on ILC

biology in the lung

Roland Kolbeck, Senior Director, MedImmune

4.40 Chairman's Closing Remarks and Close of Day One

Supported by

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

Asthma & COPDDay Two | Tuesday 12th April 2016

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Ewan Walters, Medical Director, Teva UK

CONDUCTING PREVENTIVE STRATEGIES

9.10 Formulation and process challenges in the development of

inhaled 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

Frank Thielmann, Operational Lead Inhalation New Solids,

Novartis

9.50 Is global harmonisation of OIP requirements possible?

•Provide specific anti-inflammatory or inhibitory proteins

•Evaluating the clinical trial situation and how pre-approved

develops are focussed

•Evaluating PK/PD modelling, design and analysis applied to

respiratory studies

Michelle Lee-Bourner, Head of Regulatory,

Mylan Global Respiratory Group

10.30 Morning Coffee

11.00 Corticosteroid insensitivity in severe asthma: Mechanisms

and new targets

•Relative corticosteroid (CS) insensitivity is displayed in both

inflammatory and structural cells of patients with severe

asthma compared to non-severe asthma

•Decreased glucocorticoid receptor (GR) expression with

impaired nuclear translocation in airway smooth muscle

cells (ASMC)

•Therapies to overcome corticoid insensitivity

Pankaj Bhavsar, Research Lecturer, Imperial College London

11.40 Clinical development of “generic” DPIs

•EMA regulations about the clinical development of OIP

•Regulatory obstacles on the development

•Is the term “generic” applicable to DPIs?

Katerina Athanassiou, CR Director, Elpen Pharmaceutical Co Inc

12.20 Networking Lunch

FUTURE DEVELOPMENTS IN ASTHMA AND COPD

1.30 Improving inhaled therapies

•Challenge of nonadherence in COPD

•Determinants of adherence

•Patient-clinician communication

Peter Daley-Yates, Director Clinical Pharmacology, GSK

2.10 Identification and prevention of COPD exacerbations

•Types of COPD exacerbations

•Timely identification as a predictor of treatment response

•Preventing exacerbations: a diachronic hot topic in COPD

management

Konstantinos Kostikas, Medical Director Respiratory, Novartis

2.50 Afternoon Tea

3.20 Scientific aspects of quality regulations in respiratory drug

development

•What are the current philosophical differences between US

and EU quality regulations for inhalation products?

•How do they translate into current hot topics, e.g. generic

approvals

•What would be quality requirements for future therapies

(lung cancer, sustained release)?

Stephan Leiner, Chemical-Pharmaceutical Expert,

Boehringer Ingelheim

4.00 Challenges of developing drug-device Combination Products

•Inhaler technology - typical product formats

•Key regulations and Quality System requirements

•Integrating the drug and device worlds

•Application of cGMPs in the clinical phase

•Design Control, Risk Management and Human Factors

Mark A. Chipperfield, Principal Consultant & Company

Director, Corvus Device Limited

4.40 Chairman’s Closing Remarks and Close of Day Two

Want to know how you can get involved?

Interested in promoting your services to this market?

Contact Anna Serazetdinova, SMi Marketing on

+44 (0) 207 827 6180 or email:aserazetdinova@smi-online.co.uk

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

Sponsorship And Exhibition Opportunities

SMi 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 independentdiscussion 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

INTERACTIVE HALF-DAY POST-CONFERENCEWORKSHOP A

Wednesday 13th April 20168.30am – 12.30pm

Holiday Inn Kensington Forum, London, UK

Human factors and inhalerhandling studies

Leader: Stefan Leiner, Chemical - Pharmaceutical Expert,Boehringer Ingelheim

Overview of the workshop: Dry Powder Inhalers (DPIs) and Pressurized Metered-doseInhaler (pMDIs) are the most common inhalers. While allpMDIs follow the same handling principles, thedevelopment of DPIs offers new challenges: Theoperations to use the inhaler correctly get more complexand vary from product to product. Even with training,there is the intellectual challenge that prescribers andpatients may forget and mix-up essential handling steps.

The workshop aims to identify ways to prove that patientsuse their inhalers correctly.

Key Benefits of Attending: The workshop aims at identifying ways to prove thatpatients use their inhalers correctly. Stefan Leiner will givean overview on operating principles of inhalers, followedby an overview on human factor studies and oninvestigations on used inhalers. Attendees areencouraged to provide own examples.

Programme

8.30 Registration and coffee

9.00 The importance of correct inhaler handling• Do patients and developers speak the same

language? Complexity of inhalers• Different inhaler operational steps• Are we provoking medication errors? Is this

Quality by Design?

9.30 Laying the ground for correct use and patientsatisfaction during development of an inhalationproduct• What are human factor studies, and why are

they useful?• How can I prepare for foreseeable

mis-use? How can I see if my inhaler is usedcorrectly? Investigations on returned inhalers

• Patient satisfaction• After approval: Lifecycle management

10.30 Coffee break

11.35 Experiences of the participants• Each participant is asked to provide his/her

experiences. They should be willing to presentthem. This may include human factor studies,complaints, mis-use, questionnaires

• Can we identify the optimal route to make agood inhaler?

• Is there interest in a publication?

12.30 End of workshop

About the Workshop Leader:Stefan Leiner is a pharmacist by training. Hehas responsibility for the standards ofBoehringer Ingelheim’s inhalation products.He is the representative of BoehringerIngelheim in several scientific aerosolorganisations.

About the Organisation: The pharmaceutical company Boehringer Ingelheim wasfounded in 1885 by Albert Boehringer (1861-1939) inIngelheim am Rhein. From its beginnings in 1885 when itemployed just 28 people in Nieder-Ingelheim, thecompany has since become a global enterprise. As partof research and development activities for innovativedrugs, the company focuses primarily on the therapeuticareas of cardiovascular disease, respiratory diseases,diseases of the central nervous system, metabolicdiseases, virological diseases and oncology.

For further information visit us at www.smi-online.co.uk/pharmaceuticals

INTERACTIVE HALF-DAY POST-CONFERENCEWORKSHOP B

Wednesday 13th April 20161.30pm – 5.30pm

Holiday Inn Kensington Forum, London, UK

Pragmatic compliance remediation - how to get your marketed product

into shape?

Leader: Mark Chipperfield, Principal Consultant, Corvus Device Limited

Overview of the workshop: Many marketed products were approved within a periodwhereby the Pharma company did not recognise the needto comply with 21CFR820, the regulatory agency did notactively ‘police’ such regulation and 21CFR4 was not inexistence.

However, such products remain on the market and are nowsubject to such regulations.

Key Benefits of Attending: This workshop will provide practical guidance on how toresolve compliance gaps quickly and efficiently, and how toprepare your organisation for upcoming inspections relatedto such products.

Programme

1.30 Registration and coffee

2.00 Session 1• Review of regulation changes that are

significant to marketed products. • The impact of evolving regulation on your

marketed products

3.00 Session 2• How to find your gaps• Defining a plan for remediation

3.30 Coffee Break

4.00 Session 3• The value-added remediation activities• Preparation for the upcoming inspection

5.00 Discussion

5.30 Close of workshop

About the Workshop Leader:Mark serves as an Independent Consultant tothe Pharma and Medical Device industries. Hehas spent 20 years working within large Pharma(GSK, sanofi-aventis, Novartis and F. Hoffmann-La Roche) in the field of drug delivery devicesand special purpose packaging.

Through his career to date he has been heavily involved indevelopment of medical devices for combination productsin several forms: solution/suspension inhalers, multi-dosedisposable and reusable dry powder inhalers, conveniencekits, pen injectors, auto-injectors, dispensers and specialpurpose applicators. He has performed numerous duediligence and technical evaluations of novel deliverytechnologies, developed products through the full designcontrol phases to market and maintained marketedproducts. He has experienced many of the challengesassociated with delivery device development and deviceproduct maintenance within large pharmaceuticalcompanies and implemented Medical Device developmentguidance, quality systems and business processes.

About the Organisation: The Corvus Device Consultancy was formed as a result of aclear vision;

To support pharma companies, device developers andmanufacturers in achieving high-quality, well-engineered,usable and approvable medical device/combinationproducts for the benefit of users and patients.

The company takes its operating name from the Latin:Corvus, describing the broad genus of birds in the familyCorvidae. The species is known to demonstrate self-awareness, devise ingenious ways to succeed, whilst alsohaving the ability to recognise, remember and use individualexperience in prediction.

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

ASTHMA & COPD Conference: Monday 11th & Tuesday 12th April 2016, Holiday Inn Kensington Forum, London, UK Workshops: Wednesday 13th April 2016, London, UK

4 WAYS TO REGISTERwww.asthma-copd.co.uk

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk

Payment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then creditcard details will be requested and payment taken before entry to the event. Bookings within 7 daysof event require payment on booking. Access to the Document Portal will not be given until paymenthas been received.Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘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 asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providingthat 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 theconferences documentation via the Document Portal to any delegate who has paid but is unableto attend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther 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 ProtectionAct 1998 and we may use this to contact you by telephone, fax, post or email to tell you about otherproducts and services. Unless you tick here □ we may also share your data with third parties offeringcomplementary products or services. If you have any queries or want to update any of the data thatwe hold then please contact our Database Manager databasemanager@smi-online.co.uk or visitour website www.smi-online.co.uk/updates quoting the URN as detailed above your address on theattached letter.

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Payment must be made to SMi Group Ltd, and received before the event, by one ofthe following methods quoting reference P-165 and the delegate’s name. Bookingsmade within 7 days of the event require payment on booking, methods of paymentare below. Please indicate method of payment:

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DOCUMENTATIONI cannot attend but would like to purchase access to the following DocumentPortal/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

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PAYMENT

VATVAT at 20% is charged on the attendance fees for all delegates. VAT is also charged onDocument portal and literature distribution for all UK customers and for those EU Customersnot supplying a registration number for their own country here.______________________________________________________________________________________________

CONFERENCE PRICES

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

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