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SMi are pleased to announce the launch of  the Respiratory  Drug Delivery  conference as part of the newly branded Asthma and COPD series, which will be held in London on the 5th-6th December 2019.

With the rising prevalence of respiratory diseases such as Asthma, cystic fibrosis and COPD, this group of diseases are now amongst the leading cause death, affecting over 500 million adults and children worldwide. Lung cancer now accounts for over 50% of all respiratory disease related deaths in Europe, yet little work is being done to reduce this high mortality rate.

Opportunities for drug development has effectively resulted in the global pulmonary and respiratory drug delivery market expecting to reach 64 billion USD (6.7% CAGR) by 2025. However, the unmet medical needs of respiratory disease sufferers remain.

Join us this year as SMi aim to bring together clinical researchers, respiratory drug manufacturers and solution providers to discuss the current research and developments in providing appropriate long-term treatments that adhere to patient’s needs, analyzing the success of digital medical devices and connective health technology in aiding the diagnosis of severe asthma and COPD. This year will also investigate the developing issues surrounding pulmonary and nasal combination product design.

 

Topics for 2019 include:

• Assessing the product development and treatment landscape
• Evaluating respiratory device design development and novel technologies
• Exploring digital connective inhalation
• Pricing and reimbursement and the issues associated with pricing pressures of Asthma and COPD inhalers

 

Directors, principle scientists, senior scientists, associate directors, managing directors, medical directors, pharmaceutical experts, group leaders, inhalation toxicologists of the following departments:
 

• clinical pharmacology
• respiratory medicine/ science
• respiratory immunology
• pulmonary specialty
• respiratory physiology

Abon Pharmaceuticals LLC; Aerosol Therapeutics, LLC; Alkermes, Inc.; Amgen; Artificial Cell Technologies, Inc; Biogen Idec; BMS; Bristol Myers Squibb; Bristol-Myers Squibb; Bristol-Myers Squibb Company; Celgene; Ellab Inc; Gilead Sciences, Inc.; Hygieia Biological Laboratories; Illumina Singapore Pte Ltd; Janssen R&D JNJ; Merck; Merck & Co INC; Merck Research Laboratories; Optima Machinery Corporation; OPTIMA pharma GmbH; Pfizer Global SupplY (ADC); Pfizer Inc; Protherics UK Ltd; Purdue University; Regeneron Inc; Regeneron Pharmaceuticals Inc; Sanofi; Takeda; University Of Connecticut; University of Minnesota; Vertex Pharmaceuticals;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Tim Higenbottam

Tim Higenbottam, President of the Faculty of Pharmaceutical Medicine , Faculty of Pharmaceutical Medicine

9:10 Transforming disease management through inhaled and biologic treatments, drug combinations and devices

Richard Marsden

Richard Marsden, CEO , Synairgen Ltd

• Assessing how new, inhaled drug modalities could help us achieve early intervention and respiratory disease modification
• Exploring new technology and emerging modalities that play an increasing role in the drug modality toolbox
• Boosting collaboration with leading biotech companies around the world as an enable to uncover new potential drug targets and pathways but also assessing the challenges that can be faced in accessibility
 

9:50 Analysing the challenges of Quality-by-Design in novel respiratory development

Herbert Wachtel

Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

• Considering all aspects of the drive towards highly novel devices and the accelerated launch of clone devices
• Determining the relationship between risk-based and knowledge-based approaches in showing understanding and control of the device design
• Assessing key concepts of design understanding, design robustness, manufacturing understanding and manufacturing robustness
• How to transition from a systematic approach, systematic approach of design of experiments, quality risk management and knowledge management through to predictive modelling and physical testing
 

10:30 Morning Coffee

11:00 Regulatory updates in the respiratory field

Orla Ni  Ogain

Orla Ni Ogain, Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency (MHRA)

  • Addressing UK/EU regulatory concerns with inhaled drug delivery systems. How these impact development and approval of abridged applications (hybrid orally inhaled drug products)
  • Considering the device component and comparing international guidelines for orally inhaled products
  • The importance of regulatory and scientific collaboration
  • 11:40 Overview of the recent advances in dry powder inhaler technology

    Gunilla Petersson

    Gunilla Petersson, Science and Innovation Director, Astrazeneca

    • Evaluating the current drug delivery mechanism of dry powders inhalers (DPIs) and its effectiveness in delivery of fine drug particles deep into the lung airways
    • Exploring the role of technology in DPI devices, including the development of battery powered external assistance
    • Potentials to increase drug delivery to the lung and enabling regional lung targeting
     

    12:20 Networking Lunch

    13:20 Establishing the progress and challenges of Lung epithelial Nanoparticle uptake and drug delivery at the molecular level

    Jorge Bernardino de le Sarna

    Jorge Bernardino de le Sarna, Senior Lecturer, Inhalation, Toxicology and Pharmacology, Imperial College London
    View Bio

    • Identifying how nanoparticles are taken up at the alveolar barrier at the molecular level to help designing more site-specific and controlled drug delivery
    • Assessing how nanoparticles can be the ideal delivery vehicle of therapeutic purposes to cells in vivo
     

    14:00 Establishing a new way to increase the penetration rate of nanoparticles through pulmonary mucus by investigating the nanoparticle mucus interaction

    Aljoscha Koenneke

    Aljoscha Koenneke, PhD Pharmacist, Institute of Biopharmaceutics and Pharmaceutical Technology, Saarland University

    • Rheology studies in human pulmonary mucus, what can we learn about the structure of mucus
    • Stimulated emission depletion (STED) microscopy as a new method to visualize mucus structure
    • Analyse the diffusion behaviour of nanoparticles in human pulmonary mucus at different temperatures
    • Establishing a particle system which allows the contactless heating of PLGA-Nanoparticles
     

    14:40 Calcilytics: a new, comprehensive, non-steroidal inhalable therapy for asthma

    Chris Corrigan

    Chris Corrigan , Professor of Asthma, Allergy and Immunology, Kings College London
    View Bio

    1. Over expression of the calcium sensing receptor on bronchial smooth muscle cells is responsible for the phenomenon of bronchial smooth muscle hyperresponsiveness in human asthma, a phenomenon which has never previously been explained mechanistically.
    2. Many cationic products of inflammatory cells implicated in the airways inflammation frequently observed in human asthma, such as eosinophilic cationic proteins, are agonists of the calcium sensing receptor, providing the first ever, clear mechanistic link between airways inflammation and chronic airways narrowing in human asthma.
    3. A variety of inhaled environmental agents urban particulate matter, allergens and respiratory viruses can activate epithelial and dendritic cells, causing local alarmin (IL-33, TSLP, IL-25) release and Th2 cytokine production by airways ILC2 and allergen=specific Th2 T cells. WE are accumulating evidence that the calcium sensing receptor antagonises these effects.
    4. We are developing the technology to deliver micronised, re-purposed calcium sensing receptor antagonists (calcilytics) to human asthmatics by dry powder inhalation. We are planning a first in human study addressing the hypothesis that inhaled calcilytics abolish both the early- and late-phase responses in the classical, allergen bronchial challenge model in atopic asthma.
    5. Calcilytics, by their effects in abolishing airways smooth muscle hyperresponsiveness and inflammation, are a clear candidate for the first non-steroidal replacement for both inhaled steroid and SABA/LABA therapy in the vast majority of asthmatics with mild/moderate disease.
     

    15:20 Afternoon Tea

    15:50 For more than three decades we’ve built more and apparently better inhalers – is it time for a new approach?

    Mark Milton-Edwards

    Mark Milton-Edwards, Head of Product & Health Solutions, Digital Health, Teva Pharmaceuticals

    • What is the challenge
    • Whose perspective is critical
    • What can we learn from user testing
    • Pointers for the future
     

    16:30 Assessing the future of respiratory drug devices at a digital age

    Alison  Moore

    Alison Moore, Clinical Development Manager , GSK

    • The burden of asthma and COPD remains high despite many new medicines.
    • Poor adherence to maintenance medications is an issue
    • Smart inhalers are being developed to monitor the way that patients use their inhalers.
    • Can the data from smart inhalers improve patient-clinician communication?
    • Can smart inhalers improve adherence?
    • Ultimately could this lead to better health outcomes?

     

    17:10 Chair’s Closing Remarks and Close of Day One

    Tim Higenbottam

    Tim Higenbottam, President of the Faculty of Pharmaceutical Medicine , Faculty of Pharmaceutical Medicine

    8:30 Registration & Coffee

    9:00 Novel Approaches to characterise Aerosol Dynamics

    Dave Lewis

    Dave Lewis, Aerosol Science Director, Chiesi Ltd
    View Bio

  • Setting the Scene: Introductory overview and case studies highlighting the reality of different characterisation approaches
  • Assessing Drug Delivery methods, discussing mechanisms and dynamic breakup
  • Reviewing the effects of the lung environment, including heat and relative humidity
  •  Why do dynamics matter in drug delivery?
  •  

    10:30 Morning tea

    11:00 Digital Enablement: could remote photoplethysmograpy be key to patient monitoring compliance?

    Laurence  Pearce

    Laurence Pearce, CEO, Xim Ltd

    • Assess the ability for remote photoplethysmographic (rPPG) technologies to solve the challenges of compliance in patient self monitoring
    • Review the value of such technologies in predicting and preventing respiratory exacerbations
    • Consider the barriers to adoption of mass rPPG monitoring
    • Consider collaborations and partnerships for future delivery
     

    12:30 Networking Lunch

    13:30 Respiratory drug delivery: what may the future hold?

    Mayur Patel

    Mayur Patel, Leading innovative medical and combination product development, PA Consulting
    View Bio

  • Setting the scene for how intelligent drug delivery can transform the field of respiration
  • Assessing the emerging technologies landscape for improved respiratory drug delivery
  • Discussion on benefits and challenges of nasal route for drug administration 



     

  • 15:00 Afternoon Tea

    15:30 Device Discovery: How relevant is a device to the patient?

    Abid  Raza

    Abid Raza, Respiratory Medicine, Independent Medical Expert
    View Bio

  • Introduction to device discovery
  • Open Discussion on own real-world studies and feedback on hurdles
  • Understanding the significance of the conceptual elements in setting up a RWS
  • Reviewing the operational challenges of a RWS
  • Assessing what the data challenges are once a study is up and running

  •  

    17:00 Close of Day Two

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    FEATURED SPEAKERS

    Abid  Raza

    Abid Raza

    Respiratory Medicine, Independent Medical Expert
    Aljoscha Koenneke

    Aljoscha Koenneke

    PhD Pharmacist, Institute of Biopharmaceutics and Pharmaceutical Technology, Saarland University
    Dave Lewis

    Dave Lewis

    Aerosol Science Director, Chiesi Ltd
    Gunilla Petersson

    Gunilla Petersson

    Science and Innovation Director, Astrazeneca
    Herbert Wachtel

    Herbert Wachtel

    Senior Principal Scientist, Boehringer Ingelheim
    Jorge Bernardino de le Sarna

    Jorge Bernardino de le Sarna

    Senior Lecturer, Inhalation, Toxicology and Pharmacology, Imperial College London
    Laurence  Pearce

    Laurence Pearce

    CEO, Xim Ltd
    Mark Milton-Edwards

    Mark Milton-Edwards

    Head of Product & Health Solutions, Digital Health, Teva Pharmaceuticals
    Tim Higenbottam

    Tim Higenbottam

    President of the Faculty of Pharmaceutical Medicine , Faculty of Pharmaceutical Medicine

    Abid Raza

    Respiratory Medicine, Independent Medical Expert
    Abid  Raza

    Abid is a Pharmaceutical physician with a broad experience of healthcare research ranging from academia to industry and from developing to the developed world. Abid works as a consultant medical specialist providing clinical research support for phase II to IV clinical trials and observational studies. Having successfully participated in academic and industry clinical studies, Abid has dedicated experience that provides support for respiratory and cardiovascular studies.

    Alison Moore

    Clinical Development Manager , GSK
    Alison  Moore

    Aljoscha Koenneke

    PhD Pharmacist, Institute of Biopharmaceutics and Pharmaceutical Technology, Saarland University
    Aljoscha Koenneke

    Chris Corrigan

    Professor of Asthma, Allergy and Immunology, Kings College London
    Chris Corrigan

    Chris Corrigan

    Professor of Asthma, Allergy and Immunology, Kings College London
    Chris Corrigan

    Chris Corrigan is Professor of Asthma, Allergy & Respiratory Science at King’s College London School of Medicine, based at Guy’s Hospital. He has published over 160 original manuscripts on the cellular and molecular immunopathology of asthma, and particularly phenotypes of severe and resistant disease, including aspirin-sensitive and non-atopic asthma, and received more than £20 million in peer reviewed research funding. He created the large adult allergy service, particularly the allergen immunotherapy service, and the severe asthma service based at Guy’s Hospital, recently commissioned by NHS England as one of the three national providers for care for patients suffering with severe asthma in Greater London. He is also deeply committed to undergraduate and postgraduate medical education. He currently sits on the Royal College of Physicians Specialist Advisory Committee on Allergy and in the past formulated the content of the SpR training programme in Adult Allergy now approved by the JRCPTB and the GMC. He is also Training Programme Director for Allergy in the London Deanery and is or has been educational supervisor to 12 Allergy SpRs, 10 PhD students and hundreds of medical undergraduates.

    Dave Lewis

    Aerosol Science Director, Chiesi Ltd
    Dave Lewis

    Dr David A. Lewis is Director of Aerosol Research at Chiesi Limited, Chippenham UK. He holds a B.Sc. in Physics (1989) and M.Sc. and Ph.D. in Aerosol Science (1990 & 1994), from Essex University, England. He joined the Centre for Drug Formulation Studies at Bath University, England, in May 1996 to lead a start-up HFA programme sponsored by Chiesi Farmaceutici. The resultant successful development of HFA solution formulations lead to a rapid expansion of his group which transferred to Vectura in 1999 as a result of CDFS spin-out by the University of Bath. David joined Chiesi Limited in 2008 and established the UK Research Centre in Chippenham, UK which opened in July 2009.
    David has authored over 170 research publications within the fields of pharmaceutics, analytical chemistry, and aerosol science. He is co-inventor of over 30 patents relating to inhaler formulations and devices. These inventions led to the Chiesi Modulite technology which has seen formulations of beclomethasone dipropionate, budesonide, formoterol and a beclomethasone dipropionate-formoterol combination becoming commercialized in several European countries.
    Since establishing Chiesi’s UK Research Centre in 2008, David has allocated >£3M to support university collaborative research within the field of respiratory drug delivery. He is industrial supervisor for several PhD projects and is an Associate to Woolcock Medical Research Institute, University of Sydney, Australia
     

    Gunilla Petersson

    Science and Innovation Director, Astrazeneca
    Gunilla Petersson

    Herbert Wachtel

    Senior Principal Scientist, Boehringer Ingelheim
    Herbert Wachtel

    Jorge Bernardino de le Sarna

    Senior Lecturer, Inhalation, Toxicology and Pharmacology, Imperial College London
    Jorge Bernardino de le Sarna

    Dr. Jorge Bernardino de la Serna (JbdlS) is a Senior Lecturer at the National Heart and Lung Institute, Imperial College London, and Visiting Scientist at the United Kingdom Research and Innovation. JBdlS has a markedly multidisciplinary research track record; he has ~25 publications in the last 5 years. JBdlS’s research has been highlighted on 6 journal covers for his work on protein-lipid localisation and dynamics; Tcell lipid-protein interactions in atopic dermatitis; advanced quantitative fluorescence microscopy and spectroscopy; and peptide/peptoid-protein interactions with biological films. All these publications had in common the employment of highly-advanced microscopy techniques. JBdlS last publication in ACSnano were he bserved the theragnostic effect in Gram Negative Bacteria of a fluorescent molecule at the nanoscale. This article has been highlighted in The Telegraph and BBC Sheffield. JBdlS has a track record of microscopy method development and customisation to understand molecular mechanisms in cell biology and in respiratory biophysics. He did his PhD at the University Complutense of Madrid in Respiratory Biophysics; then, moved to the University of Southern Denmark to employ advance imaging techniques to understand how pulmonary surfactant was impaired in knocked out animal models and in COPD patients. Later, after a short stage as visiting scientist at Prof. S. Hell, Nobel Laureate in Chemistry (2014) for the development of STED superresolution microscopy, JBdlS joined the University of Oxford. At the MRC Human Immunology Unit he investigated the mechanisms of early activation and synapse in T cells, developing cell compatible protein/lipid fluorescent labelling strategies and using quasi-single molecule microscopy. Later on, before the joined Imperial College London, he was recruited by the United Kingdom Research and Innovation to develop methods and techniques for the UK-based Scientific Community at the National Laboratory for Bioimaging in the UK.

    Laurence Pearce

    CEO, Xim Ltd
    Laurence  Pearce

    Mark Milton-Edwards

    Head of Product & Health Solutions, Digital Health, Teva Pharmaceuticals
    Mark Milton-Edwards

    Mayur Patel

    Leading innovative medical and combination product development, PA Consulting
    Mayur Patel

    Mayur is a registered Clinical Scientist - a regulated professional qualification required to advise safety and effectiveness of medical devices/ physiological measurement techniques in the NHS, UK.
    His expertise lies in guiding Pharma and medical device companies to devise commercially focussed development plans for innovative devices and technologies by integrating regulatory aspects with the commercial and technical needs. He has led a number of turnkey development projects. His skills span across business, design, development, regulatory, quality, human factors and commercialisation.
    Mayur also lectures King’s College London postgraduate students and trainee clinical scientists on a range of medical device and healthcare management subjects.
     

    Orla Ni Ogain

    Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency (MHRA)
    Orla Ni  Ogain

    Tim Higenbottam

    President of the Faculty of Pharmaceutical Medicine , Faculty of Pharmaceutical Medicine
    Tim Higenbottam

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    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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