Injectable drug delivery is considered one of the most effective routes of administration due to the speed and effectiveness of delivery to the target, as well as the improved patient experience. The global injectable drug delivery market continues to grow and technology is advancing. This, coupled with the ever-changing regulatory requirements, means that it is imperative for companies to stay abreast of the latest developments and challenges within the industry in order to remain compliant, as well as gaining a competitive edge.
This seminar has been designed for all those working in the industry to discover the next generation of injectable drugs and devices and get an update on the latest trends, technologies and applications. Attending this event will provide a great opportunity to network with industry leaders, as well as like-minded professionals, to share common experience and best practice.
Attending this two-day seminar, presented by key industry experts, will:
This meeting runs back-to-back with Pre-filled Syringes and there is a further £200/€280 discount when booked together with this programme.
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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.
Chair’s welcome and introduction
Dr Gregory Berman
The evolving market for self-injection devices, differentiation through patient-friendly drug delivery devices
Assessing injection site pain
Challenges with high-volume and high-viscous drug formulations
Approaches to combination product control
Pre-filled syringes over time
Using polymeric PDC technology to improve auto-injector design
Connected needle-free drug delivery: innovative technology to differentiate your brand
Interactive panel discussion: opportunities for connectivity with hand-held injection devices
Moderator: Dr Gregory Berman
Panellists: Dr Thomas Schönknecht, Chris Muenzer and Barb Taylor
Networking drinks reception
Review of day one Dr Gregory Berman
Demand for large volume injectors for 2-10 ml injection volumes
Challenges of medical delivery in acute and chronic care settings – implications for delivery design
From the treatment chair to the sofa – innovative concept for wearable injection
Update on the Ominpod device
The EU regulatory framework for injectable delivery systems
Planned changes to the 11608 series of ISO standards and their implications on device design
Interactive panel discussion: opportunities with wearable and large volume injectors
Moderator: Dr Gregory Berman
Panellists: Ian Thompson and Stephen Augustyn
Chair’s closing remarks
End of seminar and refreshments
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.
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.
Dr Thomas Schoenknecht, is Head of Research and Development Drug Product Services, Lonza, Switzerland, previously he was Executive Director, Business Development at SHL Group, with responsibility for global Business Development, Key Account Management and new Technology Evaluation within SHL’s Medical division.
He has over 20 years’ experience in pharmaceutical industry in various leading roles in project management, research & development and business development. Prior to joining SHL in 2013, Thomas worked at Schott Pharmaceutical Packing Division where he was heading the global Key Account Organization with a specific focus on new product developments addressing the customer needs.
Thomas previously worked at Amgen Inc in California as Director Drug Product and Device Development overseeing and managing Amgen’s global drug delivery container projects and interfacing Amgen’s drug delivery device platforms. Prior to being engaged with Amgen he was heading the Research & Development activities at Gerresheimer’s Pharmaceutical Packing Division and was leading the Product Management and Business Development activities of this division for sterile drug delivery solutions.
Thomas has a Ph.D. in Biophysical Chemistry from the Max-Planck-Society and the University Goettingen, Germany and a Master’s degree in Chemistry from the University Goettingen. He is a frequent speaker, moderator and committee member at conferences regarding drug delivery and packing material science; Thomas was heading the PDA interest group for prefilled syringes and being active as member in various DIN ISO committees regarding primary packaging materials and drug delivery devices.
Ian Thompson 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.
Bruce Davis, Senior Consultant, Engineering, QbD and Qualification, Bruce Davis Global Consulting. Bruce is a professional engineer with 20 years’international experience of projects for drug substance and drug product manufacturing facilities. When he was with AstraZeneca, he led major changes to qualification processes globally as well as leading Quality by Design (QbD)cross-functional workshops for newproducts. He is ISPE’s former Chairman and Secretary to ASTM E55.03. For ISPE, he led the QbD case study, now published.
Uri Baruch heads up the drug delivery sector within CDP, leading a variety of design projects including an award-winning needle safety device, an emergency auto-injector, a pen injector packaging design for delivery devices and inhalation products. These projects included compiling design history files and led to successful submissions to both the FDA and the EMA. Uri has worked in industries including aerospace and defence, medical devices, automotive and inkjet. He has extensive knowledge of design for manufacturing and process design, and was involved in setting up several production lines around the world in the automotive inkjet and medical devices sectors.
Tsachi Shaked, MBA, Chief Marketing and Business Development Officer at E3D (Elcam Drug Delivery Devices) a subsidiary of Elcam Medical. Tsachi graduated with a Master in Business Administration (MBA) with experterise in Marketing from Bar-Ilan University in Ramat-Gan, Israel. As part of the company’s portfolio, Tsachi is deeply involved with the development of the new version of drug delivery devices that includes connectivity and electronic applications. Tsachi has been with the company from 2006.
Steve is head of mechanical engineering for Team Consulting; an award-winning, specialist medical device design consultancy based in Cambridge. Before joining Team nine years ago, Steve worked as a freelance designer for multinational companies including five years working for Glaxo Smith Kline. Most of Steve’s technical work is focussed on drug delivery devices and through this experience he has worked as a member of ISO TC-84 developing the 11608 series of standards over the past five years. A graduate of Loughborough University, Steve also lectures undergraduates on the medical device development process.
Chris Muenzer is a Senior Device Technology Manager at Novartis in Basel, Switzerland. He has almost 20 years of development experience with a focus on drug delivery devices and has filed several patents in the field. At Novartis, Mr. Muenzer leads a team supporting injectable delivery systems for Novartis’ diverse portfolio of drugs. In addition to his work at Novartis, he is active on the ISO working group for injection devices. Mr. Muenzer holds a BSME from Carnegie Mellon University in Pittsburgh, Pennsylvania in the US.
Sukie Whitehall, Device Development Engineer with Oval Medical Technologies. She is a young Mechanical Design engineer with a background in Physics, who tailored her education and career to specialise in Medical devices. She has worked on IVD’s, point-of-care diagnostics, home diagnostics and more recently drug delivery. Sukie is focused on providing user friendly devices that not only work perfectly every time – but fit seamlessly into people’s lifestyles. She believes that with good design, a shift can be facilitated in healthcare from surgeries into the home – and hopes this will help to alleviate the pressures on the public health services.
Shruthi Vidyasagar, Device Development Lead, GSK. Shruthi is a Device Lead at GSK, UK managing late stage parenteral projects. Prior to GSK, she worked at Pfizer in North Chicago on differentiated drug delivery systems. She has device development and regulatory experience across multiple platforms – combination products, electromechanical devices and consumable products.
Her recent focus has been on development of combination products- syringes, injectors, closed transfer devices, etc supporting all activities from development to launch. Shruthi holds a BE in Electrical Engineering (VTU, India) and an MS in Biomedical Engineering (University of Michigan).
Barbara Taylor leads the marketing team at Portal Instruments. With over 20 years experience in health tech strategy and marketing, she brings to Portal expertise in healthcare software development, new product introduction, lifecycle and service strategy, and business model innovation. Prior to Portal Instruments, Barbara was at a number of large and small firms including Philips Healthcare and Mercer Management Consulting. Barbara holds an MBA from the Kellogg Graduate School in Evanston, IL and a BS in biology from the University of Michigan in Ann Arbor, MI.