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
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:
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 find out more call Customer Services on +44 (0)20 7749 4730 or e-mail email@example.com
Exhibition opportunities are available. Please contact Customer Services on +44 (0)20 7749 4730
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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.
Chairman’s welcome and introduction
Dr Greg Berman, Independent Consultant, UK
Trends in Injection Devices
Mark Chipperfield, Company Director and Principal Consultant, Corvus Device, UK
Latest devices – connectivity with injectables
Markus Bauss, Managing Director, SHL Group, Germany
Ypsomed delivery systems for large volume self-injection and connectivity
Ian Thompson, Vice President Business Development, Ypsomed
Connected health – getting to market with an electronic auto-injector, app and cloud services
Neil Williams, Director, Front-End Innovation, Head of Connected Health, Medicom Innovation Partner, UK
Pre-filled syringes over time
Andreas Rothmund, Qualified Person, Vetter Pharma-Fertigung GmbH & Co KG Germany
Using polymeric PDC technology to improve auto-injector design
Jonathan Bradshaw, Device Development Engineer, Oval Medical Technologies, UK
Polymers for better injection devices
Ian Wands, Market Development Specialist, DuPont Performance Materials, UK
Large volume injectors: one device – multiple solutions
Mike Hooven, CEO, Enable Injections, USA
Networking drinks reception
Review of day one
Dr Greg Berman, Independent Consultant, UK
What do pharma companies want from devices?
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
Stephen Dew, Associate Director RA (CMC) Combination Products, Biogen, UK
US regulatory considerations for injectable delivery systems
Suzette Roan, Senior Director, Global Regulatory Affairs, Sanofi, USA
Advances in Needle Free Drug Delivery
Andrew Coats, Director of Engineering, Portal Instruments, USA
Enhance existing devices or move to brand new integrated solutions? Two approaches for smart pen injectors
Arnaud Guillet, Business Development Associate, Bicorp, France
Human factors in injectable drug delivery
Greg Thay, Human Factors Director, Medical Devices,Thay Medical, UK
Key training device considerations for injection based therapies
Joe Reynolds, Research Manager at Noble, UK
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.
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 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 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 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 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 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 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 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 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 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 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 ReynoldsJoe 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, 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 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.”
Adrew Coats, Director of Engineering, Portal Instruments, USA