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CONNECTIVITY

ADDING CONNECTIVITY TO DRUG DELIVERY DEVICES

In this issue of ONdrugDelivery, Tsachi Shaked explores how – as the trend towards moving healthcare from the hospital to the home continues – connectivity in drug delivery devices may be changing from being the exception to the rule.

I SPY WITH MY LITTLE EYE: EYE TRACKING DRIVES PATIENT-CENTRED DEVELOPMENT OF CONNECTED SYSTEMS

The development of connected self-injection systems is driving industry to rethink its current approaches to patient-centred new product development. Andreas Schneider summarises a recent field study that used eye tracking for the formative usability testing of SmartPilot for YpsoMate.

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THE FUTURE OF CONNECTED ASTHMA AND COPD CARE: A NETWORK PERSPECTIVE

Benjamin Jung uses a network theory approach to look at the ongoing issue of adherence when it comes to the treatment of asthma and COPD, and the players involved in overcoming it.

10th Dec 2019 - 12th Dec 2019

San Francisco, CA, USA

Connected Medical Devices Cybersecurity Summit 2019

The 2nd annual Connected Medical Devices Cybersecurity Summit is a dedicated platform for device manufacturers, HDOs, regulatory bodies and drug developers to define a collaborative cybersecurity approach. With increased legacy products and take-home devices, it is prominent to bullet-proof legacy infrastructures and anticipate upcoming risks. Join 70+ senior leaders in cybersecurity, CIO, biomedical engineers to learn about their progresses so far!

CUSTOMISED INFUSION PUMPS: THE FUTURE OF SELF-ADMINISTRATION?

Shaul Eitan explores the challenges of home infusion and examines how customisation and connectivity could help provide a solution.

Dr Ramin Rafiei

MACRO TRENDS ACCELERATING THE ADOPTION OF CONNECTIVITY IN DRUG DELIVERY

Ramin Rafiei argues that connected therapeutics – the augmentation of drugs through sensors and connectivity – are now a clinical source for real-world data and provide an opportunity to bridge the efficacy-to-effectiveness gap. This next frontier in drug delivery, powered by connected therapeutics, will be data-driven, personalised, outcomes-based and accessible.

Eric Dessertenne

COMPLETING ITS TRANSITION FROM GENESIS TO MATURITY, BIOCORP OPENS NEW HORIZONS

As Biocorp prepares for the market launch of its connected injector pen add-on, Mallya, Eric Dessertenne and Arnaud Guillet share insights about key steps in the company’s development. The article discusses the many partnership Biocorp has entered in to, and includes a mini-interview with Sergio Monti, Plant Manager for one such partner, V.A.R.I.

CONNECTED DEVICES – MEDICATION DELIVERY JUST GOT PERSONAL

Thierry Decock and Hadrien Gremillet explore how the obstacles to the adoption of connectivity can be overcome and how connected devices can deliver truly patient-centric care that will clearly improve adherence rates, whilst demonstrating a clear cost benefit to the pharmaceutical partner.

Dr Mircea Despa

BD (Becton Dickinson & Company)

INTERVIEW: MIRCEA DESPA & DOUG McCLURE, BD

In this interview, Dr Despa and Mr McClure discuss BD’s approach to connecting devices in its portfolio to meet patient, pharma and other stakeholder requirements. Their discussion focuses in particular on safety and security, highlighting the connected wearable injector, BD Libertas™ with Smart Option, as an example.

Napoleon Monroe

CONNECTIVITY RESTORING TRUST IN PHARMA COMMUNICATIONS

Napoleon Monroe analyses connectivity coverage at recent drug delivery conferences and, more broadly, in various publications, to evaluate the current direction, and explore the scope for connectivity to effect changes benefiting multiple stakeholders across a range of treatment categories.

DON’T DEVELOP A CONNECTED DRUG DELIVERY DEVICE WITHOUT READING THIS

Matt Jones summarises some of the key challenges and opportunities in the development of connected drug delivery devices, focusing in detail on deciding what a connected drug delivery device should do, designing for a coin cell, direct cellular connection and antenna design.

USER-CENTERED DEVICE CONNECTIVITY

Mark Tunkel and Carolyn Rose discuss the benefits of taking a user-needs approach, and mapping the patient journey, in a connectivity strategy.

Phillips-Medisize

LOW-COST CONNECTIVITY MEETS PATIENT & PHARMA MEDICATION MANAGEMENT NEEDS

Neil Williams describes the potential connected drug delivery systems hold to address serious challenges in healthcare, including poor adherence, and also deliver substantial value, and outlines the company’s highly scalable enterprise platform, the Connected Health Platform.

PUSHING THE BOUNDARIES OF INFUSION PUMP INTEROPERABILITY

Interoperability is not a new concept for infusion pumps. But in many cases hospitals have been slow to embrace the full potential of connectivity. When is this likely to change? What will hospitals need when it does? And where should infusion pump manufacturers focus innovation efforts in the meantime? Tim Frearson considers the options.

ADHERENCE TO SELF-INJECTION REGIMENS CAN BE ENHANCED BY CONNECTED DEVICES

Craig Baker looks at the factors contributing to non-adherence and explores how connected devices can help patients follow their self-injection regimens.

#97 May 2019 - UL by Emergo_Featured

Allison Strochlic

SIMULATING STRESSFUL, EMERGENCY-USE SCENARIOS DURING USABILITY TESTS OF INJECTION DEVICES

Allison Strochlic highlights the importance of simulating environments that are as realistic as possible when conducting usability tests of emergency-use injection devices, and provides case studies with examples of how to create more realistic tests.

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A PATIENT CENTRIC AND PHARMA COMPANY CENTRIC PREFILLED WEARABLE BOLUS INJECTOR

Jesper Roested explains why the pharma/biotech drug development process often means device selection occurs after Phase II despite the advantages of earlier selection being well understood, and how this then precludes the selection of novel primary packaging and delivery systems.

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Dr Cristianne Rijcken

Cristal Therapeutics

COMPANY SHOWCASE: Cristal Therapeutics

Over the past year, Cristal Therapeutics has transitioned from a research-stage start-up to a fully fledged, clinical-stage business with a promising pipeline of proprietary drug candidates. This diverse pipeline together with the proprietary nanoparticle platform, CriPec^®, presents a broad range of promising late- and early-stage partnering opportunities for companies active in the oncology space.

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CONFERENCE REVIEW

10TH GLOBAL DRUG DELIVERY & FORMULATION (DDF) SUMMIT, Berlin, Germany, March 11–13, 2019

The second week of March is a key date in the delivery and formulation event calendar. This is when the good and the great of Europe’s pharmaceutical development community gather in Berlin, Germany, for the DDF Summit – a high-level scientific event for industry and academia.

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Dr Elham Blouet

A NEW MULTI-COMPENDIA MODIFIED BETA-CYCLODEXTRIN, KLEPTOSE^® HPB-LB PARENTERAL GRADE

Elham Blouet introduces the latest addition to the company’s range of beta-cyclodextrins, and outlines the benefits it brings.

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Credence MedSystems

TECHNOLOGY SHOWCASE: Credence MedSystems Multi-Site™ Injection System

Credence MedSystems introduces the Multi-Site™ Injection System – a product that addresses specific needs in the high-growth dermal filler market.

Feature image

BD (Becton Dickinson & Company)

SELECTING THE RIGHT PRIMARY CONTAINER FOR INJECTABLES IN ACUTE CARE

Alfred Harvey explains why it’s important to select the right primary container presentation – and what can happen if you get it wrong.

Figure 3: West’s on-body injector platform, SmartDose®.

Victoria Morgan

West Pharmaceutical Services

ALTERING PATIENT TREATMENT: HOW SC DELIVERY CAN HELP PATIENTS MANAGE CHRONIC CONDITIONS

Victoria Morgan looks at the benefits of combining an active pharmaceutical product with a novel subcutaneous delivery device, and highlights some of the partnerships West has with biopharmaceutical and other companies, which have led to market launches of products incorporating its on-body delivery system.

Dr Gautam N Shetty

MICROLITRE DOSING WITH PREFILLABLE SYRINGES – WHEN DOES A DEVICE MAKE SENSE?

Gautam Shetty and Bernd Zeiss outline factors that need to be weighed when considering a device-based approach to microlitre injections.

Figure 1: OXYCAPT™ Vials and Syringes.

Takuya Minezaki

Mitsubishi Gas Chemical

MULTILAYER PLASTIC VIALS & SYRINGES FOR BIOLOGICS

Dr Takuya Minezaki and Tomohiro Suzuki, provide an overview of the company’s OXYCAPT™ Vials and Syringes, explaining how their multi-layered polymer material delivers the advantages of both COP and glass, and is especially suitable for biotherapeutics.

Wolfgang Moersch

PRODUCT SHOWCASE: Zwickroell Autoinjector Testing Platform

ZwickRoell introduces RoboTest, its automated autoinjector testing platform, which works together with the AutoEdition 3 automation software ad testXpert III testing software.

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PATIENT TOLERABILITY WITH HIGH-VISCOSITY, LARGE-VOLUME SUBCUTANEOUS INFUSIONS

Jennifer King and Matthew J Huddleston discuss the advantages of subcutaneous drug delivery and how these have yet to be fully harnessed in currently marketed therapeutics.

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Dr Chi Hwan Lee

Weldon School of Biomedical Engineering

SKIN-MOUNTABLE FLEXIBLE NEEDLE PATCH FOR MINIMALLY INVASIVE CONTROLLED DRUG DELIVERY

Chi Hwan Lee and Eun Kwang Lee introduce a skin-mountable flexible needle patch and discuss its applications in non-invasive drug delivery applications.

Zahoransky_featured

Berthold Schopferer

NEXT-LEVEL FUTURE MANUFACTURING FOR MEDICAL TECHNOLOGY

Berthold Schopferer explains the lengths the production equipment company goes to in its efforts to ensure the customer is always king.

ENABLING SUBCUTANEOUS DELIVERY OF BIOLOGICS

Elektrofi introduces Elektroject™, a gentle process for the production of ultra-high concentration protein formulations, that maintains a syringeable format and excellent protein stability, making the switch from intravenous to subcutaneous delivery viable for numerous biotherapeutics, including monoclonal antibodies.

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BEST PRACTICES FOR DEVELOPING EFFECTIVE TRAINING DEVICES FOR PULMONARY HEALTHCARE

Joe Reynolds discusses the current state of pulmonary drug delivery device trainers, including their value to patients, the complexities of modern design and the stringent quality requirements.

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AUTOMATING UNDER UNCERTAINTY – GOOD PRACTICES

Simon Drexler discusses lessons learned and good practices when dealing with uncertainty at the various stages of automation development for drug delivery device manufacturing.

Guillaume Brouet

GUILLAUME BROUET, APTAR PHARMA

Guillaume Brouet talks with ONdrugDelivery Magazine about how Aptar Pharma uses its device development expertise and infrastructure to provide its pharmaceutical company customers a comprehensive services offering around device development, global regulatory approval and commercialisation.

THE CHALLENGES OF DELIVERING QBD IN NOVEL RESPIRATORY DEVELOPMENT

David Belton discusses the meaning of quality by design in novel respiratory drug delivery device development. He covers how, with more novel devices, prior knowledge may be insufficient for a standard FMEA-style risk analysis, and alternate science-based methods, such as functional mapping and knowledge scoring, can help in achieving QbD.

CONFERENCE SHOWCASE

RDD ASIA 2018 CONFERENCE REVIEW AND UPCOMING RDD EVENTS

RDD showcases its three biennial conferences – RDD (the North American event), RDD Europe and RDD Asia, which have become a series of must-attend events for researchers, product developers and vendors concerned with all aspects of nasal and inhaled pharmaceuticals.

Consort Medical

PAUL ALLSOP, MILES KOTTMAN, HANNAH PRIESTLY & JON REED, CONSORT GROUP

Consort Medical's Paul Allsop, Miles Kottman, Hannah Priestly and Jon Reed talk with ONdrugDelivery Magazine about the company’s integrated formulation and device offering, and focus on its simple, low-cost, single unit-dose, spring powered nasal device, Unidose Xtra.

CounterAct_featured

130 A DAY AND GROWING: ANSWERING THE US OPIOID OVERDOSE EPIDEMIC

Todd Pizitz and Donald Mealing discuss the ongoing opioid crisis in the US and the current use of the opioid reversal medication naxalone, and introduce the CounterAct device for naxalone home use.

IS THERE A FUTURE FOR THE RESPIRATORY DELIVERY OF BIOLOGICS?

Igor Gonda covers the field of nasal and pulmonary delivery of biologics, considers past failures and successes, and proposes answers to the challenges faced, from biological, biopharmaceutical and commercial standpoints.

Figure 2: RetroNose prototype device examples.

Dr Laurent Vecellio

University of Tours

DEPOSITION IN THREE NASAL CAST MODELS USING RETRONOSE CONCEPT

Laurent Vecellio, Déborah Le Pennec, Guillaume Grevin and Alain Regard discuss a study conducted to test particle deposition characteristics of the RetroNose device prototype for nasal drug delivery.

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