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)

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Agenda:

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

For more information about this conference visit https://www.researchandmarkets.com/research/2l9rzs/injectable_drug?w=5

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]  

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Brad Bennett

Brad Bennett

Brad grew up in a small town in northern Iowa. He studied chemistry in college, graduated, and married his wife one month later. They were then blessed with two baby boys within the first four years of marriage. Having babies gave their family a desire to return to the old paths – to nourish their family with traditional, homegrown foods; rid their home of toxic chemicals and petroleum products; and give their boys a chance to know a simple, sustainable way of life. They are currently building a homestead from scratch on two little acres in central Texas. There’s a lot to be done to become somewhat self-sufficient, but they are debt-free and get to spend their days living this simple, good life together with their five young children.
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