Injectable Drug Delivery

The essential conference for pharmaceutical and medical device professionals covering advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods – plus a regulatory update

22-23 Mar 2018

GBP 1,499
EUR 2,099
USD 2,339

Book now

Course Overview

The pharmaceutical industry and its main markets continue to change. Geopolitical changes influence healthcare industry funding models, demographic changes (in developed countries) increase the demand for healthcare and technology advancement opens up new opportunities. In drug delivery we have witnessed a very significant transition. For many years oral tablets held the leading market positions. For example, at one time oral H2 receptor blockers were the blockbusters. These were replaced by proton pump inhibitors and then cholesterol lowering drugs as the world’s biggest sellers. Today, depending upon which list you look at, around 9 of the world’s 12 best-selling drugs require a drug delivery device, as they are biologics for parental delivery or drugs for treatment of asthma, requiring an inhaler.

Injection devices to deliver the latest generation of drugs are evolving. First generation devices were typically mechanical and functioned only to get the drug into the body. Increasingly, in next generation parenteral devices, the drug delivery device is recognised as the interface between the drug and the patient. It can offer many features and functions which improve usability, safety, efficacy and compliance, plus many other functions beyond such as connectivity and diagnostics.

This conference looks at the latest trends, technologies and applications.

Please note we are also running:

Book both

This meeting runs back-to-back with Pre-filled Syringes on 21 March 2018 and there is a further £200/€280 discount when booked together with this programme.

To register on both events events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Exhibitors:

3PInnovation logo

Harro Hofliger logo

Owen Mumford logo

ODD logo

Advanex logo

Exhibition opportunities are available. Please contact Customer Services on +44 (0)20 7749 4730
or contact us through our contact form.

Benefits in attending

  • Hear the latest trends in injectable drug delivery
  • Know what’s in development for large volume and patch pump technology
  • Keep abreast of market opportunities
  • Understand the latest technologies using parenteral methods
  • Clarify the importance of human factor studies and compliance monitoring
  • Comply with the latest regulatory guidance and standards
  • Meet other medical device and pharmaceutical professionals in the parenteral market

Who should attend

This conference will be of particular interest to:
Scientists and management in medical devices, pharmaceutical and biotechnology companies working in parenteral delivery. Personnel responsible for device programmes, product development, regulatory affairs and product lifecycle management will find this event beneficial. Previous delegates include: Directors, Senior Executives in R&D, Head of Device Departments, Combination Products Specialists, Drug Delivery Managers, Business Development Executives, Product Development Managers and those in Project Co-ordination and Marketing roles.

Programme - Day one

Chairman’s welcome and introduction

Dr Greg Berman, Independent Consultant, UK

Trends in Injection Devices

  • Needs – the evolving patient, market, industry and regulatory expectations
  • Approaches: responding with appropriate solutions
  • Solutions: Some optimised, customised and novel technologies
  • Pathways: Navigating designations and the changing framework
  • Outcomes: Recent approvals, setbacks and regulator feedback

Mark Chipperfield, Company Director and Principal Consultant, Corvus Device, UK

Latest devices – connectivity with injectables

  • Improved patient health and adherence through new technologies

Markus Bauss, Managing Director, SHL Group, Germany

Ypsomed delivery systems for large volume self-injection and connectivity

  • Recent self-injection market trends with a focus on autoinjectors
  • SmartPilot reusable add-ons and their integration into the connected ecosystem • YpsoDose patch injector: making life simpler for patients and pharma companies

Ian Thompson, Vice President Business Development, Ypsomed

Connected health – getting to market with an electronic auto-injector, app and cloud services

  • Data
  • Analytics
  • Artificial intelligence

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

Pre-filled syringes over time

  • Evolution of processes and equipment
  • Evolution of components
  • Evolution of applications and application systems

Andreas Rothmund, Qualified Person, Vetter Pharma-Fertigung GmbH & Co KG Germany

Using polymeric PDC technology to improve auto-injector design

  • Polymeric primary drug container (PDC) technology unlocks the design freedom constraints of existing PDC systems, providing the ability to fully address both the needs of the user and drug
  • Increased design freedoms allow PDC components to be configured freely to resolve issues typically seen with glass-based systems
  • An integrated approach to device design reduces the impact on the user, whilst ensuring all required user interface features are present without compromise
    to overall device size or usability
  • Oval’s subcutaneous platform, Sumalen Ovali, embodies this integrated philosophy to device design
  • Combining both user and drug requirements into its development, the platform provides a patient-centric device for delivery of Sumatriptan to migraine and cluster headache sufferers
  • The subcutaneous auto-injector platform actively decouples the drug delivery requirements from those of the user interface providing both user and drug delivery benefit

Jonathan Bradshaw, Device Development Engineer, Oval Medical Technologies, UK

Polymers for better injection devices

  • Functional Integration of parts with Engineering Polymers
  • Designing for low and consistent frictional performance
  • Predicting long term performance under load

Ian Wands, Market Development Specialist, DuPont Performance Materials, UK

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, CEO, Enable Injections, USA

Networking drinks reception

Programme - Day two

Review of day one

Dr Greg Berman, Independent Consultant, UK

What do pharma companies want from devices?

  • Key considerations- improving the benefit risk profile, enhancing patient compliance
  • Contribution to successful life cycle management
  • Implications from Brexit and the new implementation of the new legislation
  • How to avoid disappointment

Dr David Jefferys, Senior Vice President Global Regulatory, Government Relations and European Product Safety, Eisai Europe Ltd, UK

The EU regulatory framework for injectable delivery systems

  • Classification – getting it right from the start
  • Implications of the new EU Medical Device Regulations for drug delivery systems
  • Device essential requirements for Injectable Medicinal Products

Stephen Dew, Associate Director RA (CMC) Combination Products, Biogen, UK

US regulatory considerations for injectable delivery systems

  • Implementing 21 CFR 4: Integrated development and product maintenance
  • Integrating essential performance into control strategy
  • Approaches for bridging changes made during development
  • Regulatory submission strategies for initial registration, post-approval changes, platform technologies and master files

Suzette Roan, Senior Director, Global Regulatory Affairs, Sanofi, USA

Advances in Needle Free Drug Delivery

  • Portal Instruments is developing a next generation needle-free drug injection platform to transform the drug delivery experience for patients suffering from chronic diseases such as ulcerative colitis, multiple sclerosis, rheumatoid arthritis, and psoriasis
  • Our approach, which is issued from MIT research, uses a computer-controlled linear actuator that pressurizes the medication and injects it in a very fine jet
  • It can administer up to 1 mL of medication, is relatively quiet, fast, and automatically adapts to both the viscosity and temperature of the medication
  • Clinical studies we’ve conducted have shown that patients perceive less pain and prefer the Portal Needle-free injector versus needle and syringe injections

Andrew Coats, Director of Engineering, Portal Instruments, USA

Enhance existing devices or move to brand new integrated solutions? Two approaches for smart pen injectors

  • Moving towards connected devices in the field of injection seems inevitable: two approaches are possible to achieve this goal
  • Some benefits of connectivity: automatic collection of treatment information (dose, time and date), reminders, alerts, treatment calendar on the smartphone, advice, engagement…
  • The advantages of Add-On approach: seamless for the patients (do not change patient’s habits, same device, same use), painless for the pharma (regulatory and industrial processes remain unchanged)
  • The advantages of integrated solutions: enhance accuracy, comfort, and security
  • Elements to consider in order to make a choice: time to market, regulatory environment, specific needs (dosage, comfort), maturity of the market

Arnaud Guillet, Business Development Associate, Bicorp, France

Human factors in injectable drug delivery

  • Current climate
  • Understanding anthropometrics and ergonomics to meet patient needs • Use safety in performing injections and infusions
  • Human Factors testing injection and infusion systems
  • Case Study: An injection aid

Greg Thay, Human Factors Director, Medical Devices,Thay Medical, UK

Key training device considerations for injection based therapies

  • Market needs and trends
  • User needs and characteristics
  • Training device considerations (AI, PFS, Onbody, etc.) • Best practices (Process, systems, innovation)
  • Case study/Research findings (TBD)

Joe Reynolds, Research Manager at Noble, UK

Presenters

David Jefferys

Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine he worked in clinical and academic medicine, before spending 20 years as a senior regulator for both medicines and medical devices. He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.

Andreas Rothmund

Dr. Andreas Rothmund is Qualified Person at Vetter Pharma-Fertigung in Ravensburg, Germany, an independent contract manufacturer specialised in the aseptic production of pre-filled application systems. He started his industrial career in 1985 as a lab manager. After two years he took over production responsibility for a German company specialised in eye drops and eye ointments, a position he held for nearly eight years. He joined Vetter in 1994, where he has held several positions, including Head of Production for one of Vetter’s aseptic production units. He holds a degree in organic chemistry from the University of Constance, Germany.

Gregory Berman

Gregory Berman is an Independent Consultant and Director of Cantab Innovations Ltd. Previously he was 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. For example he:
Led the design and development of SmartJect™; an autoinjector which automatically retracts the needle and was launched by J&J in 2010 with an important next-generation drug.
Worked with Chrono Therapeutics, helping to develop their SmartStop™ based device, the world’s first programmable, wearable transdermal smoking cessation therapy.
Participated in a detailed design review of an autoinjector being developed by a leading pharmaceutical company for a new drug.
Undertook the Voice of Customer study for a leading biopharmaceutical company, as the starting point for developing high volume parenteral delivery devices for lifesaving immunotherapies.
Undertook a technology survey for a company interested in needle-free, transdermal, micro-needle, electroporation and iontophoresis drug delivery devices.

Markus Bauss

Markus Bauss has over 10 years’ experience in the area of pharmaceutical packaging in various leading roles such as global key account management, research & innovation and business development. Looking at upcoming new technologies such as smart phones, mobile apps and connectivity, he started his technology Start-Up company ConnectMeSmart GmbH in 2013.
In 2015 SHL Group and ConnectMeSmart partnered up in the Joint Venture SHL Connect to investigate the market for connectivity, emerging technologies and explore their potential application within each of SHL Group’s companies. SHLGroup is the world’s largest privately-owned designer, developer and manufacturer of advanced drug delivery devices such as auto injectors and pen injectors. In addition the company provides contract manufacturing and engineering services for the production of medtech and industrial products and final assembly, labeling and packaging services of drug delivery devices to the biotech and biopharma industries.

From 2004 to 2014 he has been working for Schreiner MediPharm, a leading supplier of advanced labeling solutions. Working in the U.S. and Europe, he contributed with innovative products, such as Needle-Trap, a label integrated needle stick prevention solution. He studied process engineering at the Technical University of Clausthal and started his career in environmental & recycling technology at RWE in Germany in 1997 prior to moving to the pharmaceutical area.

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.

Greg Thay

Greg Thay is the founder and principle human factors consultant at THAY Medical, and has over twenty years’ experience in the medical and pharmaceutical industries. He has worked in many therapy areas (orthopaedics, infusion therapy, wound-care) before finding a vocation in human factors and usability engineering nearly a decade ago. He now leads the human factors engineering team at THAY Medical to assist large and small pharmaceutical and medical organisations to develop usable, safe and effective technologies. Recently, THAY Medical CE-Marked their first wearable drug delivery device, which Greg project managed and tested, to ensure its first-rate usability and timely completion. Greg also has been involved in the human factors and usability engineering of many drug delivery technologies, and loves nothing more than to present on this subject!

Mark Chipperfield

Mark serves as an independent consultant to the Pharma and Medical Device industries via his company Corvus Device Ltd. He has over twenty years of experience in Medical Device, Drug Delivery Device and Combination Product Development, Operations and Regulatory/Quality Compliance – from a range of roles with GSK, sanofi-aventis, Novartis and F. Hoffmann-La Roche.Through his career to date he has been heavily involved in development of medical devices for combination products in several forms: syringes, pen injectors, auto-injectors, patch injectors, solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, 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 is a veteran of several successful IND/CTA/NDA/BLA/MAA submissions and approvals that have included drug delivery devices.He 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.

Suzette Roan

Suzette Roan is Senior Director, Global Regulatory Affairs with Sanofi, USA. She was previously Associate Director in Regulatory CMC – Device Regulatory, with Biogen. Prior to Biogen, Suzette was with Pfizer for 19 years, with roles in Analytical Development, Outsourcing and Regulatory CMC. She has experience with pulmonary inhaler, prefilled syringe, autoinjector and on body delivery systems.

Suzette holds a BS in Chemistry from the University of Connecticut, a MS in Management from Albertus Magnus College and a JD from the University of Connecticut School of Law. She is an active member of ISO/TC 84 working groups, PDA and is currently chair of the Combination Products Coalition Marketing Submissions working group.

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.

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.

Arnaud Guillet

Arnaud is currently business development associate at BIOCORP, in charge of finding partnerships and license opportunities for BIOCORP’s range of connected devices. Previously, he worked for a healthcare consulting firm with a strong focus on connected health strategies for pharma and insurance companies. Other past experiences in the pharmaceutical industry (Sanofi) and the insurance industry (AXA). Graduated from HEC Paris, a major European business school. For 20 years, BIOCORP has been designing, developing and manufacturing medical devices for the pharmaceutical industry, enhancing drug reconstitution, safety, packaging and delivery.

Neil Williams

Neil is the Head of Connected Health and Director of Front-End Innovation for Medicom Innovation Partner, a Phillips-Medisize Company, based in Cambridge UK. Neil consults for BioPharma clients, innovating and executing strategies to enhance stakeholder engagement through connected devices and service design. He has over 22 years’ commercial experience covering medical devices, telemetry, digital imaging, clinical decision support, secure mobile working, patient engagement and health analytics for businesses including Philips Healthcare, Microsoft, Elsevier Health Sciences, Hospira, Map of Medicine and ZOLL. Prior to Neil’s commercial career he trained at Leicester University Hospitals in Operating Department Practice and was Faculty for numerous Advanced Life Support programs having qualified in the UK and United States.

Joe Reynolds

Joe Reynolds is Research Manager at Noble, where he leverages his knowledge and experience to develop and implement strategies that improve the patient experience and maximize value for stakeholders. His experiences include commercial, managed care and product development initiatives with leading medical device, pharmaceutical and biopharmaceutical manufacturers. Mr. Reynolds holds a Bachelor of Science in Business Administration from the University of Central Florida, a Master of Science in Marketing from the University of South Florida and a Master of Science in Pharmacy and Master Certificate in Drug Regulatory Affairs from the University of Florida.

Ian Wands

Ian Wands, Market Development Specialist, DuPont Performance Materials, UK. Ian has over 10 years’ experience working with engineering polymers in a broad range of application areas. He joined DuPont in 2005 having graduated with a Masters in Materials Science (MRes). While operating across various industry segments, Ian specialises in the medical device market and predominantly drug delivery systems. Working with customers to optimise part performance through careful material selection, assisted by DuPont’s wealth of design, technical and R&D resources.

Jonathan Bradshaw

Jonathan Bradshaw is a Design Engineer with a background in Industrial Design and a Masters in Medical Device Engineering. Jonathan has experience in the design, development and commercialisation of fluidic dilution and dosing systems, cardiac catheterisation devices and more recently drug delivery technologies. Currently Jonathan works as a Device Development Engineer within Oval Medical Technologies where he focuses on furthering the development of their novel PDC and autoinjector technology to ensure their devices offer reliability and consistently high performance in combination with usability benefits.”

Andrew Coats

Adrew Coats, Director of Engineering, Portal Instruments, USA

Book now

22-23 Mar 2018
22-23 Mar 2018 Le Meridien Piccadilly Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,339.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

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  • ABBOTT GmbH & Co KG
  • Aptar France SAS
  • Artsana S.p.A.
  • Bang & Olufsen Medicom A/S
  • Becton Dickinson
  • Bespak UK
  • Biogen Idec
  • Biogen Idec Ltd
  • Clamason Industries Limited
  • Coalesce Product Development Ltd
  • Crospon Limited
  • Daicel Corporation
  • Enable Injections LLC
  • Genentech
  • Gerresheimer Regensburg GmbH
  • Halozyme Therapeutics Inc
  • Harro Höfliger Verpackungsmaschinen GmbH
  • Interface International Consultancy Ltd
  • Oval Medical Technologies Ltd
  • Roche
  • Rothschild & Compagnie Gestion
  • Rovi Contract Manufacturing S.L.
  • Sandoz GmbH
  • SHL Group AB
  • TECH GROUP
  • Terumo Europe NV
  • Texchem-Pack (M) Bhd
  • Tip-top.com Limited
  • Veterinary Medicines Directorate