Injectable drug delivery is considered to be one of the most effective routes of administration due to the speed and effectiveness of delivery to the target, and recent developments have improved the 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 to provide all those working in the industry with the latest information on the next generation of injectable drugs and devices and an update on recent trends, technologies and applications. It will also be a great opportunity to meet industry leaders, as well as like-minded professionals, and share common experience and best practice.
Attending this two-day seminar, presented by experts in the field, will:
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This is a key seminar for all those working in the parenteral delivery area, including:
Latest developments for injectable drug delivery solutions
Recent advances in large-volume injection
Developments in technology with injectables – digitalisation and smart technology
Digital design in development of injectable systems
Case study: Connected needle-free technology
Assessing injection site pain
Betwixt and between – managing the interface between PFS and autoinjector
Interactive panel discussion: Next generation innovations in drug delivery
Moderator: Dr Gregory Berman
Panellists: Ian Thompson, Neil Williams, Markus Bauss, Dr Thomas Schoenknecht
The EU regulatory framework for injectable delivery systems
Human factors validation – when is usability testing not required?
Sustainability – its impact on self-care drug delivery
Extractables and leachables (E&L) in injectable drug products
Pre-filled syringes in a nutshell
The relationship between the ICH guidelines for impurities and E&L thresholds
Interactive panel discussion: The future with smart injection devices
Moderator: Dr Gregory Berman
Panellists: Ian Thompson and Dr Thomas Schoenknecht
Chair’s closing remarks
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.
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 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.
Dr. Patrick Anquetil is Portal Instrument’s Chief Executive Officer. He brings more than 18 years of experience in nanotechnology, including extensive knowledge in the areas of cleantech, material science, and instrumentation.
From 2009 to 2012, he was co-founder and director of strategic and process planning for SynapDx Corporation, where he had responsibility for development of the company’s business and operational plans as well as securing $9 million in Series A funding. He began his career as a science and nanotechnology equity research analyst at Susquehanna International Group, authoring and marketing nanotechnology industry and equity research reports to hedge funds and portfolio managers. He holds a doctorate in bio-instrumentation from MIT, an MBA from Harvard University, and a master’s degree from the ETH in Zurich and the University of Tokyo. His work has appeared in numerous peer-reviewed publications as well as mainstream media, including MIT Technology Review, Wired Magazine, PBS, and CNBC among others.
Neil is the Head of Connected Health and Director of Front-End Innovation for Phillips-Medisize, 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.
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.
Jeffrey Philippson is a specialist in testing and evaluation of parenteral drug delivery devices with PA Consulting in Cambridge, UK and leads the PA Injection Science team. Jeffrey applies statistics and data analysis to the development and evaluation of drug delivery devices, with a particular focus on autoinjectors, pen-injectors and infusion pumps. He is an expert in design input creation, test method development and validation, and design verification processes. He holds a PhD in Experimental Physics from Queen’s University (Kingston, ON, Canada).
Lee Wood is Co-founder and CEO of medHF and specialises in the application of Human Factors Engineering to the medical device development process. medHF support manufacturers to develop safe, usable and approvable devices by delivering high quality Human Factors services. Lee is an expert in supporting manufacturers to effectively navigate and successfully meet regulatory expectation. Previously he was Head of Human Factors Engineering with Roche and before that Human Factors/Principal Scientist with Novartis.
Greg Anderson set up Pharmacentric Solutions in late 2017 offering consultancy services specialising in packaging and device strategies and solutions for the Pharma industry. He advises both small and large Life Science companies on topics such as sustainability, human factors, design for manufacture and leveraging new technologies. Prior to this he spent 30 years working at GSK with his last role there being Senior Device and Packaging Director.
His career started at Smiths Industries Medical Systems as a device designer where he focused on surgical equipment development working closely with healthcare professionals. He then joined the R&D Device Development Unit at Glaxo and worked on the conceptualisation, design and scale-up of various injectors and key inhaler device platforms and the ongoing lifecycle for these novel inhalers. In 2009 Greg moved to GSK Manufacturing as Head of Global Technical Packaging. More recently he has focused on supporting the launches of the Ellipta inhaler, respiratory training devices and also researching and preparing GSK’s respiratory and packaging strategy for Emerging Markets. In 2016 he joined the Medicines Manufacturing Industry Partnership and wrote and published the UK Pharma roadmap for Innovation and Technology. He holds over 40 patents and has expertise in ideation and conceptualization, integration of sustainable technologies and patient centric design and has presented papers on these topics globally. Greg sits on the UK Institute of Materials Packaging Board representing Pharma. He has a B.Sc. in Industrial Design, a M.Sc. in Polymer Science & Engineering and a Postgraduate Diploma in Marketing.
Raphael Nudelman,is Director, Chemical & Computational Toxicolog, Teva Pharmaceutical Industries Ltd. Raphael has a M.Sc. degree in Pharmaceutical Sciences from the Hebrew University in Jerusalem, and a Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel. He held postdoctoral positions in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, and in Duke University Medical Center, North Carolina. In 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals and in 2010 he established the Chemical & Computational Toxicology group which he currently heads.
From 2011 to 2016, Raphael was the President of the Medicinal Chemistry Section of the Israel Chemical Society, and was as a Council member of the European Federation of Medicinal Chemistry (EFMC). He is a member of the Advisory Council of High School Chemistry Education in the Israel Ministry of Education and a member of the Advisory Editorial Boards of Elsevier’s journal Drug Discovery Today: Technologies, and of Trends in Medicine and Health (TMH).