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UPDATE AND NEWS FROM ONDRUGDELIVERY’S PUBLISHER IN RESPONSE TO COVID-19

The world, and our industry with it, has entered an unfamiliar and difficult period. I would like to take this opportunity to update you on how ONdrugDelivery can and will continue to provide its services uninterrupted, and tell you about some specific initiatives we’re launching to help our readers, authors and clients across the global industry.

CALL FOR HELP IN THE FIGHT AGAINST COVID-19! BUSINESSES UNITE TO SUPPLY 15,000 FACE VISORS A DAY TO NHS

A growing group of businesses is urgently calling for more companies to join its initiative to put in place an end-to-end supply chain for desperately needed protective face visors for NHS and other workers in the fight against COVID-19. The group aims to achieve volumes of approx. 15,000 units/day.

PREFILLED SYRINGES

ADDRESSING COMPLEX BIOLOGICS WITH RATIONAL DRUG DEVICE DESIGN

Gene Rhode Fuensalida Pantig reviews drug development over the years, the discovery of biologics as therapeutic agents and the emergence of autoinjectors, in correspondence with Hans Lin, PhD, a Research Fellow from Academia Sinica, Taiwan.

8th Sep 2020 - 10th Sep 2020

San Diego, CA, USA

10th Injectables Summit 2020

10th Injectables Summit will return to San Diego on September 8 – 10 this year, uniting 120+ senior leaders in parenteral device design, development and engineers to share best practice and lessons learned from pre-filled syringes to autoinjectors. With the rise of emerging formulations and biologics, Injectable Device experts are tasked with new engineering challenges to ensure quality, computability and a human-centric approach to the device design. Join us to learn how your fellows are tackling these obstacles as well as leveraging strategic platforming to minimize development timeline.

Development of IMV’s DPX-COVID-19 Vaccine Progresses Apace

Canadian biotech company IMV has made impressively rapid, solid progress on the development of a vaccine candidate against the novel coronavirus, using its lipid-based vaccine delivery platform, DPX. New developments in just two weeks include, include: initiation of peptide candidate manufacturing, cGMP scale-up plans, preclinical models/assays; and Phase I clinical trial design completed, with discussions with Health Canada already underway also.

Aquavit Developing Microchannel Drug Delivery Device / Novel Compositions for Vaccine Against COVID-19

Aquavit Pharmaceuticals is applying its AQUAGOLD® microchannel drug delivery device in the development of a self-administered dermal vaccine against COVID-19 caused by the SARS-CoV-2 coronavirus.

Springboard offers medical device expertise to tackle COVID-19

Springboard is now offering: design reviews / risk assessments of COVID-19 related medical devices at no charge; answering ad hoc requests for advice on devices relevant to COVID-19 at no charge; device development expertise, including a willingness to tackle short term projects on a not-for profit basis; submission of services to the UK Gov call for businesses to help make NHS ventilators.

PREFILLED SYRINGES

ENHANCING THE PATIENT EXPERIENCE FOR SELF-INJECTION SYSTEMS

The complexity of injectable treatment regimens for chronic diseases means onboarding aids can be integral to disease management. Joe Reynolds discusses the role of demonstration devices in improving the patient experience and adherence.

Dr Andreas Schneider

HOW USERS DISTINGUISH BETWEEN SELF-INJECTION DEVICE PLATFORM VARIANTS

Andreas Schneider highlights how the ever-increasing interest in device platforms raises concerns around the broad availability of lookalike autoinjectors that may result in inappropriate medication usage. He summarises a recent empirical study¹ providing insights into which device attributes drive device distinguishability.

PREFILLED SYRINGES

Mitsubishi Gas Chemical

OXYCAPT MULTILAYER PLASTIC VIAL AND SYRINGE

Shota Arakawa and Tomohiro Suzuki, discuss the benefits of the OXYCAPT™ multilayer plastic vial and syringe for the rapidly growing field of biologics and regenerative medicines.

CHOOSING THE RIGHT LABEL MATERIAL FOR PREFILLED SYRINGES

Jos van Noort outlines some of the key factors that must be taken into consideration when selecting a label for prefillable syringes.

NEXT-GENERATION WEARABLE DELIVERY DEVICES FOR LARGE-VOLUME BIOLOGICS

Thomas Mayer discusses Sonceboz’s platform of wearable injection devices for large-volume biologics, which can follow drugs from clinical trials to commercial phase through lifecycle management, which reduces risk and speeds time to market.

EU MDR: ANCILLARY DELIVERY DEVICES FACE EQUAL SCRUTINY TO STANDALONE MEDICAL DEVICES

Elizma Parry offers her expertise and practical guidance to businesses hoping to achieve a CE mark for a medical device, with new EU regulations being implemented this year.

PREFILLED SYRINGES

Wolfgang Moersch

PRODUCT SHOWCASE: ZwickRoell Parenteral Device Testing Platform

ZwickRoell offers a wide variety of standardised test fixtures for parenteral devices including, described here: testing prefilled syringes to ISO 11040-4, -6 & -8; testing of Luer/Luer lock connections; serial, parallel and fully automatic syringe testing; and traceable, tamper-proof test results.

DEVELOPMENT OF A NEW HIGH-PERFORMANCE AUTOINJECTOR

Tom Oakley and Sigrid Saaler-Reinhardt discuss the development of the Midas Pharma’s NIS cartridge-based autoinjector.

PREFILLED SAFETY SYRINGE MARKET THRIVES AMID SELF-ADMINISTRATION TREND

George I’ons looks at how the growing trend of patient self-administration is driving demand for prefilled safety syringes.

Dr Paolo Fiorini

LARGE-VOLUME INJECTORS: RISE IN BIOLOGICS BRINGS CHALLENGES

Developing devices capable of delivering highly viscous biologic drug formulations at high volumes does not come without its challenges. Paolo Fiorini, Gerard Linnane, Michael Kiely, Maciej Grygorczuk and Joshua Coyne discuss these challenges and the merits of various drive solutions.

Séverine Duband

LEVERAGING THE PATIENT JOURNEY TO OPTIMISE DEVICE USE AT HOME

Séverine Duband and Mark Tunkel discuss the importance of device optimisation to increase patient safety during self-administration of medication.

Dr Temitope Sodunke

BD (Becton Dickinson & Company)

ADDRESSING THE EVOLVING NEEDS OF VARIABLE DRUG DELIVERY REGIMENS

Temitope Sodunke introduces the BD Evolve™ On-body Injector and describes how the device is designed specifically to address the rapidly evolving needs of the pharma industry and meet patient requirements.

Stephen Augustyn

HOW TO DESIGN A BODY-WORN INJECTOR

Body-worn injectors require you to understand your user, your drug and your technology – and there are numerous pitfalls for the unwary. Stephen Augustyn shares some insights.

THE NEED FOR CSTDS IN BOTH MANUAL AND AUTOMATED COMPOUNDING

Marino Kriheli discusses the benefits of using closed system transfer devices (CSTDs) in both manual and automated hazardous drugs compounding.

PREFILLED SYRINGES

Christian Helbig

FINDING THE RIGHT PACKAGING FOR BIOLOGIC DRUGS

Christian Helbig introduces a new 2.25 mL version of SCHOTT’s syriQ BioPure® prefillable syringes designed specifically for the biologics market and, developed in partnership with WL Gore, the world’s first silicone-free glass syringe system.

THE CHALLENGES OF A CHANGING MARKET & THE BENEFITS OF DEVELOPMENT FLEXIBILITY

David Fink and Sheila Trgovac describe how adopting a flexible development model in mid-to-late development brings benefits through to commercialisation, especially in the context of a changing market.

Credence MedSystems

VIDEO: Credence Connect from Credence MedSystems

Credence MedSystems takes us through the use steps of its new Credence Connect™ autosensing injection system, and smartphone app.

Dr Gautam N Shetty

Congruence Medical Solutions

INTERVIEW WITH DR SRI MUDUMBA, SANTEN & DR GAUTAM SHETTY, CONGRUENCE

In this interview, Dr Sri Mudumba, Santen, and Dr Gautam N Shetty, Congruence Medical Solutions, share insights from their experience of working together in developing the MDS for ophthalmic injections.

Dr Barbara Morgan

OPTIMISING OPHTHALMIC DRUG DELIVERY FOR THERAPEUTIC EFFECTIVENESS

Barbara Morgan discusses how eye physiology impacts product formulation and choice of dosage form, and how advanced delivery technologies are providing new options for formulators seeking to improve the bioavailability or stability of their ophthalmic treatments.

DEVELOPING AN EFFICIENT OPHTHALMIC DEVICE COMBINATION PRODUCT

Zoë Davidson looks at how understanding the patient journey can help develop an efficient ophthalmic device combination product.

Matthias Birkhoff

DELIVERING ON THE GROWING NEED FOR TOPICAL PRESERVATIVE-FREE OPHTHALMIC TREATMENTS

Matthias Birkhoff provides an overview of existing ophthalmic delivery technologies and progress made within topically applied medications – and introduces a new market standard for testing microbial integrity in preservative-free formulation.

ADVANCED DRUG DELIVERY FOR DRY EYE TREATMENT

Rouven Kraus and Wilfried Woesthuis discuss Aero Pump and Medspray's new open-eye spray for the treatment of dry eyes.

HOW TO DEVELOP A CUSTOMISED IOT PLATFORM WITH A RUNNING START

Do you need a drug delivery Internet of Things (IoT) platform across your entire portfolio of drugs that is agnostic to the type of source container, drug viscosity and the volume to be dispensed? Rachel An and Gillian Harding-Moore discuss how to develop such a platform with a running start.

THE TRUSTED TABLET: A NEW LEVEL OF SUPPLY CHAIN SECURITY FROM MASS DIGITALISATION OF MEDICINES

Kelly Boyer, Trent Lund and Barry McDough describe a means of mass digitalising medicines to address the problem of illegal and unauthorised production of pharmaceutical products in a meaningful way.

BiologIC Technologies

A FLEXIBLE, MODULAR PLATFORM TO DISRUPT THE BLOCKBUSTER MANUFACTURING MODEL

Nick Rollings, Colin Barker and Richard Vellacott discuss the drug delivery scenario in the advanced therapy (AT) era, examining how the current slow-moving blockbuster treatment model is making way for a fast-moving, patient-focused era of personalised medicine

Phillips-Medisize

NEXT-GENERATION CONNECTED DRUG DELIVERY SUPPORTS DATA LIQUIDITY & COST SAVINGS

Neil Williams discusses medication non-adherence, the toll it takes on the healthcare system and how integration, analytics and more affordable connectivity in drug delivery devices as part of a connected health ecosystem improves patient care and lowers costs.

Portal Instruments

AN INJECTION OF CONNECTED NEEDLE-FREE INNOVATION

Barb Taylor discusses the next generation of needle-free injection devices, which incorporate connectivity.

Dr Ulrica Sehlstedt

TRANSFORMING HEALTHCARE – HOW CURATIVE THERAPIES WILL DISRUPT THE MARKET

Ulrica Sehlstedt, Craig Wylie, Thomas Unger, Rebecka Axelsson Wadman, Vikas Kharbanda, and Satoshi Ohara, all members of Arthur D. Little’s Healthcare and Life Sciences Practice, explain how the shift to curative treatments promises to transform the entire healthcare ecosystem.

THE CURRENT STATE OF PLAY IN CONNECTED DEVICES

Marcus Bates; Joachim Koerner and Jerôme Prraquin discuss the current state of play, what connected device advocates are doing to enable faster implementation, and how we can optimise connected technology while reducing the cost and improving human factors.

Dr Juan Nogueira

CHOOSING THE RIGHT CONNECTIVITY FOR DRUG DELIVERY AND MEDICAL PRODUCTS

Juan Nogueira; Tommaso Borghi and Marco Vergani discuss the factors that need to be taken into account in the selection of connectivity technology for a drug delivery device or other medical product.

PRODUCT SHOWCASE: Injay – Connected Prefilled Syringe

Biocorp presents Injay, the first prefilled syringe with built-in connectivity, providing a cost-effective and easy-to-implement solution that improves treatment adherence, upholds quality of reporting, and provides a secure treatment protocol and traceability.

Dr João Ventura Fernandes

Hovione Technology Ltd

DRY POWDER INHALERS: TOWARDS EFFECTIVE, AFFORDABLE, SUSTAINABLE RESPIRATORY HEALTHCARE

João Ventura Fernandes and Peter Villax look at the trends shaping the development of dry powder inhalers, highlighting the need for a shift in industrial strategy towards effective, globally affordable, sustainable devices.

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Merck & Co

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Plan Strategic

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