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SMi's 2nd Annual Conference
Wearable Injectors and Connected Devices
18th-19th October, 2021 | London

SMi is proud to present Europe's only Wearable Injectors Conference, taking place on the 18th-19th October 2021, in London.


SMi’s 2nd annual Wearable Injectors and Connected Devices Conference will explore real world case studies of on-body device design and development for large volume delivery while engaging in the latest digital applications for wearable devices with industry case studies from pharma thought leaders. The conference will consider key developments in the wearable injectors field, including the enhanced demand for on-body injectors and digitalised health as the pandemic highlights the need for self-administered at-home care, managing sustainability in the field, and opportunities for development in oncology.


Key regulatory updates including guidance on MDR requirements and the impact of Brexit on data collection will be presented by regulatory experts for a comprehensive outlook of this exciting and ever-growing field, and the importance of considering human factors in order to enhance the user experience will be presented by industry experts.

 

This two-day agenda offers you peer-to-peer networking with Global Device Development Managers, Senior Connectivity Engineers, Leaders in Device Data Generation, Human Factors Directors and many more.


We look forward to welcoming you to the conference in October.

  • Gain insight into developments in wearable devices in clinical trials
  • Explore design strategies for connectivity and digital health
  • Hear key regulatory updates from regulatory and notified bodies
  • Discover advances in device design for large volume delivery via on-body injectors
  • Explore and benchmark against industry developments through case studies and real world examples in device development for on-body injectors

 

Who Should Attend
Executives, Directors, VPs, Heads, Principals, Managers of:

  • Drug-Delivery Developers
  • Autoinjectors
  • Device Engineering
  • Human Factors
  • Injectables
  • Packaging
  • Regulatory Affairs
  • Connectivity
  • Medical Device Data
  • Novel Product Technology
  • Smart Device Developers
  • Device Safety Solution Providers

or anyone who works with Wearable Devices/ On-Body Injectors within pharmaceuticals, biotech, device developers and solution providers.
 

AstraZeneca; Bayer AG; BD; Bristol-Myers Squibb Co; Cambridge Consultants; Cambridge Design Partnership; Cambridge Innovation Limited; City of Hope National Medical Center; Covestro Deutschland AG; DCA design international; DigitalHealth; GSK; Harro Hofliger Packaging Systems Ltd; IMCD/VELOX ; Janssen Pharmaceutica NV; Johnson & Johnson; LEO Pharma A/S; Merck; MHRA; Mikron S A Boudry; Mylan; Novartis; Novartis Pharma AG; Nypro Ireland; Nypro Medical; Owen Mumford; PA Consulting Group; Pfizer; Pfizer Devices Centre of Excellence; PharmaCircle LLC; Roche; Sagentia Ltd; Sanofi ; Sanofi-Aventis Deutschland Gmbh; SCHOTT Pharmceutical Systems; Schott Schweiz AG; St George's University Hospitals NHS Foundation Trust; Team Consulting; TTP Plc; ZwickRoell GmbH & Co.KG;

Conference programme

8:30 Registration & Coffee

9:00 Co-Chairs' Opening Remarks

Tiffany McIntire

Tiffany McIntire, Senior Human Factors Engineer, Roche
View Bio

Oliver Gazeley

Oliver Gazeley, Senior Device Engineer, Roche
View Bio

9:10 Impact of Medical Device Regulation on Drug Device Combination Products

Julia Frese

Julia Frese, Director, TÜV SÜD

  • Introduction of MDR requirements 
  • Impact of MDR requirements on Drug Device Combinations 
  • Notified Body Opinion and lessons learned from first assessments
  • 9:40 A regulatory outlook for wearable connected devices

    Samir Shah

    Samir Shah, Director, AstraZeneca

  • Is it a medical device or not in various regions
  • How to submit medical device software documentation to regulators
  • What regulators also expect: electrical safety and electromagnetic compatibility (e.g. IEC 60601)
  • 10:10 MDR Implementation for On-Body Injectors

    Andreas Brand

    Andreas Brand, Managing Director, Pro3 Management, Partnering with Congenius
    View Bio

  • Integral drug/device combination products and Article 117
  • Non-integral drug/device combination products and aspects to be considered for import, distribution, authorised representative, re-packaging & re-labelling
  • Considerations for pharma industry when implementing relevant MDR requirements
  • How will the MDR impact the future of the drug/device combination products industry
  • 10:40 Morning Coffee

    11:10 Regulatory Considerations for On-Body Delivery Systems

    Priti Baker

    Priti Baker, Manager Regulatory Affairs Combination Products and Devices, Biogen
    View Bio

  • Regulatory analysis of on-body delivery systems as complex delivery devices
  • FDA expectations for on-body delivery systems
  • Regulatory considerations for on-body delivery systems as a combination product
  • 11:40 Considerations for product development in Connected Health

    Daniel Latham

    Daniel Latham, Head Connected Health Product Development, Novartis
    View Bio

    Future trends in connected health
    • Outlook for connected devices
    • Exploring the ecosystem in healthcare
    User Experience
    • Improving the entire patient journey using digital technology
    Setting up a connected eco-system
    • Practical considerations for implementation
    • Exploring technical & regulatory aspects needed for success

    12:10 Human Factors Patch Pump Pipeline Planning

  • Forming a platform HF strategy
  • Gather inputs: Device competitive intelligence and analysis of known use problems
  • Assessing the potential users in your pipeline
  • Leveraging existing development activities to gain additional insights
     
  • Tiffany McIntire

    Tiffany McIntire, Senior Human Factors Engineer, Roche
    View Bio

    Flavia Pircher

    Flavia Pircher, Human Factors Engineer, Roche
    View Bio

    12:40 Networking Lunch

    13:40 Quantex Single-Use Micro-Pumps – Cutting Edge Tech Behind Drug Delivery IoT Devices of the Future

    Rachel An

    Rachel An, Medical Device Manager, Quantex Arc Ltd
    View Bio

  • Compact, low cost, disposable, accurate dosing without software calibration; can pumps viscous fluids against high back pressures with flowrates from 1ul up to 2.4L/hr
  • Pump forms part of the disposable pack and is primary container agnostic
  • Pump driver platform programmable by doctors, smartphone controlled and connected to the cloud for monitoring and analysis
  • Low power consumption and ability to communicate with sensors for closed feedback loop
  • 14:20 Considerations for early technology evaluation and selection of large-volume, on-body injectors

    Megan Heft

    Megan Heft, Senior Device Engineer, AstraZeneca
    View Bio

  • Patient-centric evaluation: incorporating early human factors evaluations to inform use case boundaries
  • Technical approaches to maximize characterization when drug product is scarce or unknown
  • Balancing use, technical, and manufacturing tradeoffs in technology selection
     
  • 14:50 The power of collaboration to deliver sustainable healthcare

    Fiona Adshead

    Fiona Adshead, Chair, Sustainable Healthcare Coalition
    View Bio

  • The presentation will outline how the Sustainable Healthcare Coalition, a partnership of leading companies and public sector agencies, addresses some of the most pressing sustainability issues in global healthcare.
  • Case studies of digital approaches and connected devices will demonstrate how healthcare sector industry partners can help the NHS achieve NetZero and bring together clinicians and industry to meet the challenges of improving sustainability through innovation.
  • 15:20 Afternoon Tea

    15:50 Overcoming the Divide Between Telemedicine and Clinic with High-fidelity Data and Low Impact Devices

    Christopher M Hartshorn

    Christopher M Hartshorn, Program Director, National Institutes of Health

  • Contemporary medicine has become increasingly reliant on cutting edge tools and treatments which are built out within large medical centers – requiring patients to come to the care they need
  • This care model is not adequate for those whom are disadvantaged by traditional health disparities, those whom are aging in place and, evidenced by the global pandemic, those whom we need to reduce the probability of acquiring a communicable disease 
  • The National Cancer Institute and, more broadly, the U.S. National Institutes of Health have been developing and funding initiatives aimed at moving the needle towards bringing care-to-patient
  • This session will focus on these efforts and the strategy behind them for the future of remote patient monitoring
  • 16:20 Digital Product Development – Connecting the team as well as the device

    Chris Hurlstone

    Chris Hurlstone, Director of Engineering, Team Consulting Limited
    View Bio

  • Case Study: Illustrating how the development process for digital medical devices requires effective collaboration across a wide range of technical disciplines
  • The challenges that this can present
  • Strategies to address these challenges
     
  • 16:50 Wearable injectors and digital applications

    Norbert Lauber

    Norbert Lauber, Team Head Packaging & Device Development, Novartis Deutschland Gmbh

  • How to reconcile the areas drug development, medical device and advanced digital applications 
  • Development, LCM and regulatory strategy, from data collection to medical devices
  • 17:20 Co-Chairs' Closing Remarks and Close of Day One

    Tiffany McIntire

    Tiffany McIntire, Senior Human Factors Engineer, Roche
    View Bio

    Oliver Gazeley

    Oliver Gazeley, Senior Device Engineer, Roche
    View Bio

    8:30 Registration & Coffee

    9:00 Co-Chairs' Opening Remarks

    Tiffany McIntire

    Tiffany McIntire, Senior Human Factors Engineer, Roche
    View Bio

    Oliver Gazeley

    Oliver Gazeley, Senior Device Engineer, Roche
    View Bio

    9:10 Digital data collection within observational studies

    Barbara Stollfuss

    Barbara Stollfuss, Team Lead Medical Affairs, Digital Strategy & Transformation, Bayer Vital GmbH
    View Bio

  • Challenges in digital data collection within observation studies
  • Establishing a digital study process allowing collection of medication usage data
  • An overview of case study and findings
  • 9:40 Remote patient monitoring - what have the last 18 months taught us?

    Gary McNamara

    Gary McNamara, Senior Delivery Manager, Aparito

  • I will discuss how decentralised trials can help overcome another pandemic like COVID-19 in relation to on going clinical trials
  • How empowering the patient and/or carer to get them recording their own health data can at least ensure that some results can come from a trial impacted by a pandemic
  • Future trials must have a contingency plan in place if trial sites are in lockdown
  • How regulators need to be willing to discuss changes to trials and protocols during a time of crisis so that a trial can continue
     
  • 10:10 Panel Discussion: Wearable Injectors and Connected Devices: Challenges from Design to Market

  • Considering feedback from clinical trials to incorporate human factors and usability in device design
  • Usability testing for effective/clear instructions for use (IFU)
  • Clinical trials for digital therapeutics: key considerations for regulatory approval
  • Post-market surveillance studies and considering the evolving regulatory landscape
  • Oliver Gazeley

    Oliver Gazeley, Senior Device Engineer, Roche
    View Bio

    Tiffany McIntire

    Tiffany McIntire, Senior Human Factors Engineer, Roche
    View Bio

    10:50 Morning Coffee

    11:20 Pharmaceutical company challenges with large volume wearable injectors

    Emmanuel Monnin

    Emmanuel Monnin, Device Development Lead, Merck KGAA
    View Bio

  • Wearable injector market overview
  • Existing technologies 
  • Therapy perspectives
  • User perspectives
  • 11:50 What does it take to design a good digital experience in healthcare products?

  • How to design a digital product while understanding behaviours
  • How important user-centric design is for digital solutions
  • Latest design tools and techniques used to develop digital products exploring best practice in screen layouts; prompts; language and more
  • Approaches to prototyping and user testing
     
  • Paul Greenhalgh

    Paul Greenhalgh, Director of Design, Team Consulting
    View Bio

    Ben Cox

    Ben Cox, Head of Digital Design, Team Consulting
    View Bio

    12:20 Patient centric design paradigms for wearable injectors and connected devices

    Olaf Lebau

    Olaf Lebau, Professional Design Engineer for Medical Devices and Combination Products, Boehringer Ingelheim GmbH
    View Bio

  • Why different PrimPacks and fill volumes are needed for different therapeutic areas
  • How to utilize the various wearable injector variants currently under development
  • What connectivity provides for user guidance and patient adherence
  • 12:50 Networking Lunch

    13:50 Digital Inhaler Case Study: New Variables and New Analyses

    Mark Milton-Edwards

    Mark Milton-Edwards, Head of Health Solutions, Teva
    View Bio

  • Framing the question (objective) is key
  • Design thinking is not about human error, it is a simply a tough design challenge
  • It is not always possible to work a priori
  • 14:20 Introduction to microneedle technology

    James  Birchall

    James Birchall, Professor of Pharmaceutical Sciences and Deputy Head of School, Cardiff University
    View Bio

  • Healthcare applications for microneedles
  • Microneedle design and state of the art
  • Human centred design of microneedle products
  • Considerations for regulatory and clinical adoption
  • 14:40 Emerging Technologies for Intelligent Delivery and Diagnostics

    Conor O Mahony

    Conor O Mahony, Principal Researcher, Tyndall National Institute
    View Bio

  • Microneedle technologies for minimally invasive skin interface
  • Programmable micropumps and actuators for precise drug delivery on demand
  • Embedded sensors and communications will enable closed-loop diagnostics and increased patient adherence
  • Circular economy principles will play a key role in the design of next generation injector devices
  • 15:00 Afternoon Tea

    15:30 Smart Packaging to Improve Patient Adherence

    Ning Yu

    Ning Yu, Director, Head of Device Design and Process Development, Biogen
    View Bio

  • Adherence is Key to Therapeutic Success
  • Smart Packaging Landscaping 
  • Opportunities in Clinical Trials
  • Bringing Smart Packaging to Commercial Markets
  • 16:00 Innovations in Patient Medical Device Training

    Blaine Martin

    Blaine Martin, Director, Medical Device Customer Success & Training, Merck KGaA
    View Bio

  • Today, more than ever, it is possible to reinforce key device training messages found in the IFU by using engaging, interactive technologies that can be easily accessed on a patients’ smartphone or tablet.
  • The Merck Connected Health & Devices training team have had success exploring the potential for emerging technologies that will soon become commonly available, to enhance the overall patient experience at the start of their treatment.
  • Providing digital tools to support patients as they use their device at home may also help mitigate common device complaints.
     
  • 16:30 Co-Chairs' Closing Remarks and Close of Day Two

    Tiffany McIntire

    Tiffany McIntire, Senior Human Factors Engineer, Roche
    View Bio

    Oliver Gazeley

    Oliver Gazeley, Senior Device Engineer, Roche
    View Bio

    +

    FEATURED SPEAKERS

    Alex Gilbert

    Alex Gilbert

    Digital Medicine, Medopad HQ
    Andreas Brand

    Andreas Brand

    Managing Director, Pro3 Management, Partnering with Congenius
    Barbara Stollfuss

    Barbara Stollfuss

    Team Lead Medical Affairs, Digital Strategy & Transformation, Bayer Vital GmbH
    Chris Hurlstone

    Chris Hurlstone

    Director of Engineering, Team Consulting Limited
    Daniel Lewi

    Daniel Lewi

    Head of Business Development, Aparito
    Digby Harris

    Digby Harris

    Global Category Manager, Digital Therapeutics, AstraZeneca UK Ltd
    Julia Frese

    Julia Frese

    Director, TÜV SÜD
    Megan Heft

    Megan Heft

    Senior Device Engineer, AstraZeneca
    Oliver Gazeley

    Oliver Gazeley

    Senior Device Engineer, Roche
    Paul Greenhalgh

    Paul Greenhalgh

    Director of Design, Team Consulting
    Phil Tregunno

    Phil Tregunno

    Vigilance, Intelligence and Research Group, MHRA
    Tiffany McIntire

    Tiffany McIntire

    Senior Human Factors Engineer, Roche

    Alex Gilbert

    Digital Medicine, Medopad HQ
    Alex Gilbert

    Alex has worked within the Digital Health industry for a number of years alongside healthcare, pharmaceutical and tech organisations. He joined Huma as one of their first employees and currently manages some of their global Life Sciences Partnerships and Digital Medicine development. His passion is the use of technology to empower and engage the patient to take control of their care.

    Andreas Brand

    Managing Director, Pro3 Management, Partnering with Congenius
    Andreas Brand

    Since 2013 Managing Director Pro3 Management GmbH

    • Provides services for MD-, IVD- & Pharma Companies
    • Project management, design control MDR/IVDR, process development
    • Organization change processes, interim management

    1999 – 2013 Roche Diabetes Care AG

    • System Project Lead for Accu-Chek® Insight
    • Co-Lead for acquisition integration Israel to DE/CN and A
    • System Project Lead for Accu-Chek® Combo (Insulin Pump System)
    • Head of Pump Development (Mechanical-, Electronic-, Software engineers)
    • Development engineer OEM projects

    1995 – 1999 Precision Implants AG (today Smith & Nephew)

    • Development Mechanical engineer

    Education

    • EMBA in International Management at Kalaidos University of Applied Sciences, Switzerland
    • Mechanical Engineer at HTL, Switzerland
    • Mechanical- Design & Construction at WIFAG
       

    Barbara Stollfuss

    Team Lead Medical Affairs, Digital Strategy & Transformation, Bayer Vital GmbH
    Barbara Stollfuss

    Barbara Stollfuss is a highly result driven bilingual Biomedical, currently working as Head of Medical affairs, Digital Strategy & Transformation, with 9 years of professional experience within the pharmaceutical industry. Barbara has experience in strategy development and implementation for digitalization across Medical affairs, Management of international / global non-interventional/ observational studies incl. post authorization, risk management studies required by authorities, Investigator Initiated Research (IIR) projects and medical device studies.

    Ben Cox

    Head of Digital Design, Team Consulting
    Ben Cox

    Ben is Head of Digital Design at Team Consulting, working with a highly cross-functional group of designers, researchers and engineers to craft engaging and intuitive interfaces, and optimise the user experience of medical devices.

    With a background in human factors and user-centred design, Ben works at all project stages with a focus on UX/UI from product vision to implementation. Ben has worked on a broad range of drug delivery, surgical and diagnostic devices, several of which have been successfully launched in the US and Europe.
     

    Blaine Martin

    Director, Medical Device Customer Success & Training, Merck KGaA
    Blaine Martin

    Since December 2013, Blaine has been leading the Medical Device Customer Success & Training team within the Connected Health and Devices team business at Ares Trading, Merck KGaA in Switzerland. Blaine has over 30 years’ experience working with global, cross-functional teams to deliver digital communications and training programs in the pharmaceutical, consumer goods, and luxury brands industries.
    Blaine’s experience includes developing and managing training programs, implementing Learning Management and Content Management Systems, managing employee internal communications, implementing cross-functional digital marketing & IT governance, designing consumer-facing, and B2B Websites and mobile apps including e-commerce.

    Chris Hurlstone

    Director of Engineering, Team Consulting Limited
    Chris Hurlstone

    Chris has more than 25 years’ of experience with Team, developing technologies and devices for healthcare markets and with particular focus on drug delivery systems. He has successfully brought products to market in technical lead and project management roles, including a range of inhaler and injector drug delivery systems.
    A named inventor on numerous patents, Chris has a strong track-record in delivering innovative and robust engineering solutions. He is a regular attendee and contributor at key industry conferences and is also a member of the ISO TC84 standards committee covering devices for administration of medicinal products and catheters.
     

    Christopher M Hartshorn

    Program Director, National Institutes of Health
    Christopher M Hartshorn

    Conor O Mahony

    Principal Researcher, Tyndall National Institute
    Conor O Mahony

    Dr. Conor O’Mahony is a Principal Researcher with the Tyndall National Institute, and an Adjunct Professor at Chongqing Technology and Business University, China. He is currently leading a team focussed on the development of Micro Transdermal Interface Platforms (MicroTIPs) – high-value, wearable systems that combine elements of transdermal delivery, diagnostics, self-awareness and communications capabilities. These ‘smart patches’ interact with the outermost skin layers in a minimally invasive manner, and will blur the lines between implantable medical devices and the current generation of wearable electronics.

    Daniel Latham

    Head Connected Health Product Development, Novartis
    Daniel Latham

    Daniel Latham is the Head of Connected Health Product Development at Novartis, where he leads the organisation responsible for the development of connected health ecosystems comprising smart drug / device combinations, SaMD apps for web and mobile applications and tele-health solutions. Prior to this he was Head of Device Development and LCM for 5 years leading an organisation developing drug/device combinations for new biologic entities, biosimilars, and new chemical entities. Over the past 14 years at Novartis, he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and drug/device interaction within the organisation. Prior to Novartis, he worked in a variety of roles in consumer healthcare, focusing on the development of OTC medicines, transdermal patches, and medical devices. He has a Ph.D. in controlled drug delivery from Queen Mary, University of London and a bachelor’s degree and master’s degrees in Engineering from the University of Sheffield.

    Daniel Lewi

    Head of Business Development, Aparito
    Daniel Lewi

    Daniel has first-hand experience of caring for a family member with a rare disease after his daughter was diagnosed with Tay-Sachs in 2011. As the founder of the rare disease charity The Cure & Action for Tay-Sachs (CATS) Foundation, he is fully aware of the challenges that many families face when taking part in clinical trials whilst also juggling their day to day life.

    Digby Harris

    Global Category Manager, Digital Therapeutics, AstraZeneca UK Ltd
    Digby Harris

    Digby Harris is AstraZeneca’s Global Procurement lead for Digital Therapeutics and has been involved in developing Digital Therapeutics alliances for over 6 years (including connected device development). During that time Digby has also been AstraZeneca’s Global Procurement lead for drug delivery device development. Previously Digby has worked in technology licensing and research collaborations in the Oncology and Respiratory areas.

    Emmanuel Monnin

    Device Development Lead, Merck KGAA
    Emmanuel Monnin

    Polymer engineer by education, I am a technical lead with 15 years’ experience in various aspects of the healthcare and medical device industries. My experience covers New Product Development, Product Lifecycle Management and General Engineering Leadership. This experience has been acquired in several countries, in multicultural and pluridisciplinary team. It is demonstrated by a proven track record of leading drug-device combination products and medical device products from concept to commercialization in a highly competitive business environment.

    Fiona Adshead

    Chair, Sustainable Healthcare Coalition
    Fiona Adshead

    Fiona chairs the Sustainable Healthcare Coalition that inspires partnerships and action on sustainable healthcare. She also works as an independent expert advisor and board member for national and global organisations on wellbeing and sustainability. She is a high-profile wellbeing and public health leader with a track record of reframing thinking and developing innovative strategy and programmes at the heart of business and government. Her previous roles include Deputy Chief Medical Officer and Director General in the UK Government, Director of Chronic Disease and Health Promotion at the World Health Organisation and Bupa’s Chief Wellbeing Officer.

    Fiona is a visiting Professor at UCL and teaches at Cambridge Institute for Sustainability Leadership. Fiona’s recent board roles include British Land’s Sustainability Advisory Panel, Marks and Spencer’s Sustainable Retail Advisory Board, and Business in the Community’s Wellbeing Leadership Team.
     

    Flavia Pircher

    Human Factors Engineer, Roche
    Flavia Pircher

    Flavia Pircher is a Human Factors Engineer at Roche, where she manages the entire design process according to health authorities requirements including early user research, formative and summative study design, risk management, and design validation for medical devices. Flavia also manages usability activities for an innovative technology digital endpoint in ophthalmology.

    Gary McNamara

    Senior Delivery Manager, Aparito
    Gary McNamara

    James Birchall

    Professor of Pharmaceutical Sciences and Deputy Head of School, Cardiff University
    James  Birchall

    James Birchall is Professor of Pharmaceutical Sciences and Deputy Head of the School of Pharmacy and Pharmaceutical Sciences, Cardiff University. Professor Birchall graduated from Bath University in 1993 and completed his PhD researching drug and DNA delivery systems in 1998 (Cardiff University). Current research includes pulmonary drug delivery and microneedle delivery of molecules, macromolecules, vaccines, auto-antigens and cells into skin for therapeutic, immunisation or immunotherapy applications.

    Professor Birchall has acted as Associate Editor of Critical Reviews in Therapeutic Drug Carrier Systems, a member of the Editorial Board of Expert Review of Medical Devices, a temporary advisor to the WHO and an expert advisor to the British Pharmacopoeia and conducted research funded by the EU, DFID, Bill and Melinda Gates Foundation, NIH, Wellcome Trust, EPSRC, MRC, Welsh Government, Royal Society, Innovate UK and various charities and pharmaceutical companies.

    Julia Frese

    Director, TÜV SÜD
    Julia Frese

    Mark Milton-Edwards

    Head of Health Solutions, Teva
    Mark Milton-Edwards

    Mark is responsible for the Health Solutions within Digital Health at TEVA Pharmaceuticals. Over ten years with TEVA and prior to that sixteen with AstraZeneca. Mark has held various positions including R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead. Graduated in Aeronautical Sciences and completed his MBA at Durham University, UK. During his career he has led technology & especially inhaler development teams through engineering, CMC characterisation, clinical evidence generation, registration within US, EU and International Markets and ultimately to successful global launch. Total Brand Leadership value >$2.5bn. Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®, the first FDA approved digital inhaler with built-in sensors.

    Megan Heft

    Senior Device Engineer, AstraZeneca
    Megan Heft

    Megan Heft is a Senior Device Engineer at AstraZeneca, where she leads device teams in the development of parenteral combination products, including early technology selection and feasibility. Megan has over ten years’ experience, with prior roles as device team lead in Combination Products R&D at Teva Pharmaceuticals and technical lead in Primary Container R&D at West Pharmaceutical Services. Megan holds a Master of Engineering in Biomedical Engineering from Cornell University and a Bachelor of Science in Biomedical Engineering from Bucknell University.

    Ning Yu

    Director, Head of Device Design and Process Development, Biogen
    Ning Yu

    Ning Yu is Director, Head of Device Design and Process Development at Biogen’s Product and Technology department. Ning has been working in the field of drug delivery device for the past ten years, with broad experience on syringes, auto injectors, pen injectors, needle safety, wearable pumps, IV kit, intrathecal delivery device, ophthalmology, smart packaging and connected device etc. Ning has worked on combination products from both the medical device and biopharma sides. Prior to entering the drug delivery device world, Ning worked on orthopedic implants and computer hard drives. Ning has a BS in Mechanical and Electrical Engineering, MS and PhD in Mechanical Engineering from University of Illinois at Urbana-Champaign, and MBA from Boston University.

    Norbert Lauber

    Team Head Packaging & Device Development, Novartis Deutschland Gmbh
    Norbert Lauber

    Olaf Lebau

    Professional Design Engineer for Medical Devices and Combination Products, Boehringer Ingelheim GmbH
    Olaf Lebau

    Olaf is an applied physicist by training with a broad knowledge in interdisciplinary fields like nanotechnology and biomimetics, married with an interest in design and human psychology. Over the years, he has worked on extracorporeal circuits, in vitro diagnostic, predictive algorithms and complex drug delivery systems. After joining Boehringer Ingelheim, he is currently working on combination products for new pharmaceuticals as well as innovation projects for smart-, large volume and connected drug delivery devices.
     

    Oliver Gazeley

    Senior Device Engineer, Roche
    Oliver Gazeley

    Oliver has been working in medical devices for over 10 years, enthusiastically involved in technical innovation and leading cross-functional teams through the design process for a number of award-winning devices. After reading Engineering at the University of Cambridge, he began his career at DCA, a product development agency in the UK. He has worked on a range of medical devices such as injection pens, wearable injectors and connected devices in collaboration with such clients as Sanofi, BD and others. More recently, he has joined the Device Development team at Roche, based in Switzerland. His interests lie in the space where innovation and ingenuity meet with real patient needs.

    Paul Greenhalgh

    Director of Design, Team Consulting
    Paul Greenhalgh

    Paul Greenhalgh heads up Team’s design group, working closely with clients and colleagues to improve the user experience of medical devices through design. Paul is a passionate advocate of the importance of ‘good design’ and is involved in all stages of product development from front-end innovation to detailed design for manufacture.
    During his time at Team, Paul has led the design & project management of many innovative products including inhalers, injectors, surgical instruments, diagnostic platforms, child resistant packaging and consumer medical products. He is particularly focused on ensuring the right direction is set from the outset, that user needs are thoroughly understood and represented throughout.
    Before joining Team in 2002, Paul earned his stripes working as an in-house designer for several manufacturing companies, gaining a deep knowledge of design for injection moulding and volume manufacture and an ability to ‘see it from the other side’. He has a degree in Product Design from Central St. Martin’s College in London.
     

    Phil Tregunno

    Vigilance, Intelligence and Research Group, MHRA
    Phil Tregunno

    Priti Baker

    Manager Regulatory Affairs Combination Products and Devices, Biogen
    Priti Baker

    Priti Baker is a Manager, Regulatory Affairs Medical Devices and Combination Products at Biogen. She has responsibility for developing regulatory strategies related to Biogen drug delivery devices and combination products. Priti has over 20 years of experience in research & development, quality, and regulatory affairs from GSK and Amgen. Priti has an undergraduate degree in biochemistry and a Master’s degree in Regulatory Science from John’s Hopkins University.

    Rachel An

    Medical Device Manager, Quantex Arc Ltd
    Rachel An

    Rachel An is the Medical Device Manager at Quantex Arc, where she leads the development and medical applications of the CS-series micropumps. Ms An holds a BSE in Bioengineering from the University of Pennsylvania (USA) and a MSE in Bioengineering Innovation and Design from Johns Hopkins University (MD, USA). During her time at Hopkins, she managed a surgical device project from needs finding in the operating room, and technical design in collaboration with surgeons to developing a regulatory strategy and business plan. She also led a neonatal monitoring global health project that won many grants including the Gates Foundation Grand Challenges Exploration Award.

    Samir Shah

    Director, AstraZeneca
    Samir Shah

    Tiffany McIntire

    Senior Human Factors Engineer, Roche
    Tiffany McIntire

    Tiffany McIntire has been working as a Human Factors Engineer in the pharmaceutical industry for 6 years developing delivery systems, labeling strategies, co-packed products, and new solutions. After her studies in Industrial/Organizational Psychology, she started her career at Lilly where she worked on a range of combination products including dial-and-dose insulin injectors, autoinjectors, pre-filled syringes, digital products, and nasal glucagon. While working at Lilly, she began taking Human-Computer Interaction night courses to deepen her knowledge of digital product development. After, she jumped across the pond to Germany to join a recently established device group within Boehringer Ingelheim (BI). Her core contributions in this position were deepening the team's knowledge of HF and advocating for QMS improvements. While there she worked on an AI and a PFS program, a transfer system, and an occular injection system. After her time at BI, she briefly freelanced before joining the Roche team in Basel where she is currently working.

    Sponsors and Exhibitors

    Exhibitors

    Official Media Partner

    Key Media Partners

    Supporting Media Partners

    Workshops

    Cross company collaboration to develop digital therapeutic solutions using connected devices
    Workshop

    Cross company collaboration to develop digital therapeutic solutions using connected devices

    Holiday Inn Kensington Forum
    20th October 2021
    London, United Kingdom

    Optimising Patient Engagement & Creating Novel Company Value through Digital Technologies
    Workshop

    Optimising Patient Engagement & Creating Novel Company Value through Digital Technologies

    Holiday Inn Kensington Forum
    20th October 2021
    London, United Kingdom

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Speaker interview with Oliver Gazeley, Senior Device Engineer, Roche

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    Speaker Bios 2021

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    Past Attendees 2021

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    Workshop A

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    Workshop B

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    Short programme 2021

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    Full Programme 2021

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    Chair letter

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    SPEAKER INTERVIEW - Andreas Brand, Managing Director, Pro3 Management

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    Injectable Drug Delivery – Paul Greenhalgh Speaker Interview

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    Infographic

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    Oliver Shergold, Novartis, Past presentation

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    Niall MacLoughlin,Congenius AG, Past presentation

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    Michael Song, AstraZeneca, Past presentation

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    Min Wei, AstraZeneca, Past presentation

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    Maxime Gaillot & Andrew Warrington, Novartis, Past presentation

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    Digby Harris, AstraZeneca, Past Presentation

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    Bjorg K. Hunter, GSK Past presentation

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    Sponsors and Exhibitors


    Quantex

    Sponsors and Exhibitors
    https://www.quantex-arc.com/

    Quantex is the global leader in single-use pump technology enabling big-impact, game-changing fluid delivery solutions across sectors. Privately owned, Quantex holds 74 global patents commercially deployed for customised-catalogue pumps, bespoke-designed pumps and entire system designs. The pumps provide precision dosing with low power consumption enabling equipment to be more compact, less expensive and requiring zero cleaning/calibration. www.quantex-arc.com

    Exhibitors


    Avery Dennison Medical

    Exhibitors
    https://medical.averydennison.com

    Avery Dennison Medical, part of Avery Dennison Corporation (NYSE: AVY), brings more than four decades of expertise in adhesive chemistries, performance characteristics and production technologies focused on pressure-sensitive adhesives for medical applications. Our work aims to meet the current demands and future needs of medical device providers, helping them find ways to improve patient care while keeping costs in check.

    Our vast portfolio of proven products is in daily use at medical facilities throughout the world. Through long-term relationships with original equipment manufacturers, industry-specific converters and leading universities, we continually find new ways to meet evolving market requirements.

    Our approach revolves around four key attributes: We are research-driven, customer-focused, technologically advanced and globally integrated.


    Media Partners


    Pharma Journalist

    Official Media Partner
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.

    Media Partners


    pharmaphorum

    Key Media Partners
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    pharmanews hq

    Key Media Partners
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    World Pharma News

    Key Media Partners
    http://www.worldpharmanews.com/


    Media Partners


    Farmavita

    Supporting Media Partners
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    Pharmavision

    Supporting Media Partners
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Pharmalicensing

    Supporting Media Partners
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc


    Pharmaceutical Technology

    Supporting Media Partners
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Drug Discovery Today

    Supporting Media Partners
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Pharmacircle

    Supporting Media Partners
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Technology Networks

    Supporting Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Mednous

    Supporting Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

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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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