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Medical Devices

Wearable Drug Delivery

16-17 Oct 2017

GBP EUR USD
Standard 1499 2099 2338
Excluding VAT @ 20.00%

Venue: Cavendish Hotel, London

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Course Overview

The first “wearable” drug delivery device was developed in the early 1960s, a backpack which delivered insulin to the wearer. Smaller, more conveniently wearable, syringe-drivers were developed over the following decades for delivery of insulin. These type of devices are now universally known as insulin pumps and the latest versions are stuck directly onto the skin and controlled wirelessly. Ambulatory syringe drivers and bladder pumps are also used for chemotherapy and analgesia. From the 1980s onwards, wearable passive transdermal patches were developed for dosing a range of drugs such as hormones, analgesics, anti-hypertensives and nicotine to aid smoking cessation. Recently there has been emphasis on development of wearable pumps to deliver larger volumes of biologic drugs, which would be inconvenient to deliver by self-injection. This conference will review the current trends in the market and highlight the latest technology in this fast growing area.

Exhibitors

Who Should Attend

This inaugural conference will be beneficial to all those who are interested in learning about, developing or sourcing wearable drug delivery devices. This includes pharmaceutical, medical device and drug delivery companies both large and small. The conference will be of particular interest to R&D, technical, medical, clinical, operating and marketing functions at all levels of management within these organisations.

Programme Day One

Chairmen’s welcome
Dr Gregory Berman

An overview of regulations, technology and advances

  • Introduction to some of the different ‘wearable’ technology types in drug delivery
  • Some considerations for ‘wearables’ opportunities
  • Highlights from the landscape of relevant regulations, standards and guidance
    Mark Chipperfield

Enterprise connected health and wearable drug delivery

  • Clinical drivers
  • Commercial drivers for connectivity
  • Regulatory considerations for connected devices
  • Stakeholder focused solution design and delivery
    Neil Williams

The regulatory framework for pumps and delivery systems

  • Classification – getting it right from the start
  • Implications of the new EU Medical Device Regulations for drug delivery systems
  • Developing a global device regulatory dossier for supporting drug
    authoszations
    Stephen M Dew

Omnipod Delivery System

  • The POD (Personal Diabetes Manager) communicate wirelessly to deliver continuous insulin based on patients’ personal settings
    Dave Nazzaro

Accu Chek Technology

  • Accu Chek insulin pump systems portfolio
  • Clinically proven bolus advisor
    Nicola Birtwistle

3d Lithographic printing of microneedles onto flexible substrate

  • Exploring multiple-layered, geometrically optimised structures printed onto different materials that conform to the surface of the body
  • Using pre-existing materials already used in medical applications for a less complex route to market
  • Permeation analysis and additional techniques show the effectiveness of the technology
    Ken Jones and Ryan Barnsey

Low power wireless solutions for wearable drug delivery systems

  • Bluetooth low energy is changing healthcare
  • Addressing market requirements on power, cost and size
  • Proof-of-concept for a highly integrated low power and low cost solution • Low power cellular, the next evolution for wearable drug delivery systems
    Thomas Soderholm

Success factors for commercializing connected wearable drug delivery devices

  • Focus: Patient engagement vs. Professional sales?
  • Data: What is required for successful reimbursement as well as future
    next gen digitally integrated product/ service development?
  • Internet of Things/data driven future roadmaps: Medical grade end to
    end data sharing and integration
    Thomas Olesen

Programme Day Two

Review of day one
Dr Gregory Berman

Wearable devices for clinical trials

  • Is there an emerging need for wearable devices in the clinical research arena?
  • Wearable medical devices, mobile medical applications or Apps?
  • What are the benefits and disadvantages of such systems in clinical
    research?
    Tony Bedford

Considerations for the use of wearables in clinical trial

  • Clinical requirements • Patient impact
  • Device and vendor
  • Data transfer
  • Data management
  • Regulatory guidance
    Marie McCarthy

Demand for large volume Injectors – An introduction to YpsoDose for 2-10ml injection volumes

  • Current trends for large volume injectors above 1ml • Introduction to YpsoDose wearable injector
  • YpsoDose: Usability and technical aspects
    Ian Thompson

Wearable Large Volume Injectors: One device – Multiple solutions

  • Viscosity and volume challenges with biologics – Increase in promising new biologics and biosimilars to treat multiple disease states
  • Subcutaneous injection of biologics: Overcoming the volume challenge
  • Wearable Large Volume Injectors (LVIs): An Elegant solution
  • Wider implications of wearable LVIs: A hand-in-glove fit with the new
    healthcare paradigm
  • Considerations in choosing a wearable high volume subcutaneous
    delivery device
  • Pharma-device partnerships: Early clinical collaboration
    Mike Hooven

West’s SmartDose Platform: a Wearable engineered with both patient and pharma partner in mind

  • Trends in today’s drug delivery for biologics
  • SmartDose® technology platform
  • Improving the patient experience through integrated approach
    Robbie Mulligan

Patch Pump ‘small and large volume’

  • Pump and dose technology • Sensile medical devices
  • Typical applications
    Dr Paul Senn

SteadyMed Patch Pump technology

  • PatchPump technology overview
  • TrevyentTM (treprostinil PatchPump) – single-use drug-device
    combination product for the treatment of Pulmonary Arterial
    Hypertension
  • Next Generation infusion system – rapid subcutaneous delivery of
    large volume / high viscous drugs
    Assaf Shaked

Presenters

Gregory Berman

Gregory is Head of the Medical Group at Kinneir Dufort, an award-winning research, innovation, design and product development company, with over 30 years’ experience helping companies discover, create, develop and realise tangible new products, brands and experiences. He helps clients in the life-science, medical and healthcare sectors to develop products in complex situations, optimise life-science R&D and exploit technology strategically. Gregory has played a key role in developing a number of different devices including SmartJect™ and SmartStop™. He has worked extensively with start-up drug delivery companies to help commercialise the technology and he has also conducted a number of due diligence and technology assessments.

Ian Thompson

Ian has been Vice President Business Development, Delivery Systems with Ypsomed AG since 1995. He has had a number of roles in key account management and business development working with pharma companies to develop and bring to market innovative self-injection systems. He studied biochemistry and biotechnology in the UK from 1979-1983 and has worked in medical device companies since moving to Switzerland in 1990. Following the successful development and launch of a range of new pen and autoinjector custom products, Ypsomed Delivery Systems’ continues to focus on the development of next generation pen, autoinjector and bolus injector technologies.

Assaf Shaked

Assaf is the Head of Systems Integration at SteadyMed Theraputics Inc. and is responsible for SteadyMed’s PatchPump technology development. He has six years of experience in pumps technology development and holds B.S.E and M.E degrees from the Technion – Israel Institute of Technology.

Mark Chipperfield

Mark is Head of Device Development, EU Biologics, at F. Hoffmann-La Roche. He spent 20 years working within large Pharma (GSK, Sanofi-aventis, Novartis and F. Hoffmann-La Roche) in the field of drug delivery devices and special purpose packaging. He obtained his Bachelor degree in Mechanical Engineering from South Bank in London, UK and later his Master of Science in Engineering Management from Loughborough, UK. Through his career to date he has been heavily involved in development of medical devices for combination products in several forms: solutions/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, pen injectors, auto-injectors, dispensers and special purpose applicators. He has performed numerous due diligence and technical evaluations of novel delivery technologies developed products through the full design control phases to market and maintained marketed products. Mark has experienced many of the challenges associated with delivery device development and device product maintenance within large pharmaceutical companies and implemented Medical Device development guidance, quality systems and business processes. During 2013 Mark co-authored the PDA publication on Combination Products: Implementation of cGMP requirements.

Tony Bedford

Tony is Senior Account Director with Chiltern International, previously he was Head of Medical Business Development residing in Kinneir Dufort’s newly-formed Medical Device Design Centre of Excellence in Cambridge UK. He has extensive experience of medical device development, having designed and developed drug delivery, diagnostic and surgical devices on behalf of a range of international clients. In 2008, he took on a strategic role to help make sense of market opportunities in the medical space before joining Kinneir Dufort in a purely commercial role in early 2012. He has a number of patents to his name in the drug delivery and consumables space.

Thomas Olesen

Thomas is a Strategic Business Development Consultant at Connected Health. He was previously Commercial Director with Qualcomm Life, Europe, establishing 2Net as preferred platform for remote patient monitoring. He brings extensive global experience from the world of medical devices and in recent years specifically within mHealth and telemedicine. A native Dane, he contributed in making Denmark a leader in telemedicine working with the ministries of Science and Health. Due to his global background having lived and operated the majority of his life in major markets such as US, Brazil and today Germany, Thomas offers a global view on today’s challenges and opportunities in mHealth.

Marie McCarthy

Marie is Director of Product Innovation, Information Technology at ICON plc, Ireland

Mike Hooven

Mike has over 30 years of experience in the medical device industry in a broad variety of technical and clinical areas. He is the founder of five medical device companies and holds over 100 issued and pending US patents. He earned a BS in Physics and a Master of Science in Mechanical Engineering from the University of Michigan

Nicola Birtwistle

Nicola has worked at Roche Diabetes care for 4 years as an infusion specialist, recently taking on a new role as the Continuous Glucose Monitoring Specialist. She completed nurse training in 1990 at Great Ormond Street and Hammersmith hospitals, obtaining her degree and non-medical prescribing qualifications some years later. Soon after qualifying Nicola joined the diabetes team at the Macclesfield District General Hospital as a diabetes specialist nurse where she worked for 20 years, initiating and developing the paediatric insulin pump service. She shares Roche Diabetes Care’s belief that all people with diabetes deserve the best healthcare and their purpose to support people at every step of the journey with diabetes, helping the to live a less restricted life.

Paul Senn

Dr Paul Senn, Head Business Development, Sensile Medical AG, Switzerland.

Ken Jones

Ken Jones joined Innoture Ltd in June 2016 as Chief Executive Officer to take the company to the next major level of growth. His focus has been on implementing a strategy to deliver next generation microneedle technology products initially for pain management and dermatology. Innoture has the first and only commercially available microneedle patch, Radara, launched in the medical aesthetic sector. Innoture’s patented microneedle platform technology provides an opportunity for pharmaceutical industry partners to develop new therapeutic options and opens the door for medicines that could not previously be effectively applied topically.

With 30 years of pharmaceutical and medical device industry experience operating at global, regional and national levels Ken is a strategic thinker. He also has strong marketing, sales, market access and commercial capabilities, successfully bringing to market ‘first in class’ and ‘best in class’ products across European and Japan markets. Through astute leadership and insightful new product development, Ken has a proven record in achieving sustained growth and profitability targets.

Ken has additional expertise in corporate strategy and successfully negotiating and integrating into organisations, business development licensing and acquisition deals. He has set up organisations from scratch and grown and developed companies internationally across four continents.

Most recently, Ken worked for Astellas from 2005 to 2016, the last 5 years as President and CEO, EMEA Operations. He had full P&L responsibility for €2.6 billion revenue, generating 15% growth in 2015, as well as responsibility for 4,500 employees in 21 affiliates covering over 50 countries. He was involved in the developing the pricing strategy for four market leading products across Europe in Immunology, Oncology and Urology. He also spent 17 years at Allergan in various senior positions working in the US, UK, Europe and Japan and launching a variety of new products in the Pharmaceutical, Medical Device and OTC segments.

Ryan Bamsey

Ryan is Project Director involved with the design/development of core IP, scale up to mass manufacture and regulatory compliance. Has worked for Innoture for five years. His background is in cosmetics, biotechnology and directing early stage companies through the product life-cycle.

Robbie Mulligan

Robert is responsible for market development of West’s self-injection portfolio in Europe and Asia-Pacific. In this role, he is working closely with customers to understand their delivery device needs and to develop these opportunities together with West’s device/container R&D and commercial organization. Robert has fifteen years’ experience in medical device design and development, high volume manufacturing and global product launches. In his most recent role in market development he was responsible for West’s proprietary COP container European portfolio made from Daikyo Crystal Zenith®, working hand in hand with our strategic partner Daikyo Seiko in Japan. He has studied management and leadership in both European School of Management and Technology, Berlin and INSEAD, The Business School for the World, France.

Stephen Dew

Stephen is Associate Director Regulatory Affairs (CMC), Combination Products & Medical Devices at Biogen, with responsibility for EMEA, CEE and AP regions and the development, review and approval of required processes and documentation for international drug and medical device strategy and submissions. He is a regulatory and quality professional with more than 25 years of applied strategic and tactical delivery of knowledge and experience in international medical technology regulatory affairs, quality assurance and project management working in various medical technologies including drug/device combination delivery systems, borderline drug/devices, In-Vitro Diagnostics/companion diagnostics, general medical devices, medical electrical equipment, software medical devices, digital health including ‘Apps’, cosmetics, consumer health products and food supplements.

Neil Williams

Neil Williams, Director, Front-End Innovation, Head of Connected Health, Medicom Innovation Partner, UK

Thomas Soderholm

Thomas Soederholm is currently Business Development Manager for Medical and Drug Delivery Devices with Nordic Semiconductor ASA in Oslo, Norway. He has a background from digital microelectronics design and has been in the microelectronics business for 18 years. Building on experience as a Region Sales Manager in Europe, to a worldwide responsibility as Business Development Manager for sport, wearable and toy applications. Thomas has helped to establish 2.4 GHz connectivity (proprietary, ANT+ and Bluetooth Low Energy) in the sport and fitness market. Today his focus is centred on applications in the medical and drug delivery space.

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This course qualifies for the following CPD programmes:

  • Certificate