Injectable Drug Delivery: The Essential Annual Conference for Pharmaceutical and Medical Device Professionals in the Parenteral Drug Delivery Industry (London, United Kingdom - March 22-23, 2018)
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)
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