EXPERT VIEW

EXPERT VIEW

ROOM FOR INNOVATION?

Darren Mansell examines US FDA guidance on biosimilar interchangeability and asks whether there is room for innovation.

EXPERT VIEW

TOP FIVE DRUG DELIVERY TRENDS FOR 2021

Tom Oakley provides an overview of the top five trends to expect in drug delivery in 2021.

EXPERT VIEW

Robert Lee

CONSIDERATIONS FOR OPHTHALMIC DRUG DELIVERY AND DEVELOPMENT

Robert Lee discusses recent advances in ophthalmic dosage forms and how companies are meeting these challenges to better serve their customers.

EXPERT VIEW

Dr Suresh Gupta

DRUG DELIVERY TO THE EYE: OVERCOMING THE CHALLENGES OF INTRAVITREAL PREFILLED SYRINGES

Suresh Gupta discusses the challenges of developing a PFS product for intravitreal injection, highlighting how designing for the intravitreal space, rather than the standard parenteral, imposes a number of additional requirements on the design.

EXPERT VIEW

Mr John Ross

LINKING THE “D” & “M” IN CDMO

John Ross looks at the role of CDMOs in product development through to commercialisation and considers the benefits of consolidated “DM” models.

EXPERT VIEW

Jamie Clayton

ANALYTICAL TECHNIQUES FOR THE FORMULATION OF GASTRORETENTIVE TABLETS

Jamie Clayton, Phil Bone and Kyu Mok Hwang discuss the value of analyses such as mercury porosimetry and powder rheology in characterising excipients for gastroretentive tablet formulation, and go on to detail a case study investigating polymer excipients for a novel bilayer floating tablet.

EXPERT VIEW

Lars Skole

TACKLING PARENTERAL DRUG LABELLING’S SURGING COMPLEXITY

Lars Skole discusses emerging trends and challenges associated with growing parenteral packaging and labelling complexity – and how pharmaceutical developers and manufacturers can meet the challenges ahead.

EXPERT VIEW

George I’ons

CONNECTED DRUG DELIVERY: ACHIEVING OPTIMAL BENEFITS THROUGH SMART COLLABORATION

George I’ons discusses the challenges developing connected devices presents to key market stakeholders when it comes to successful rollout and implementation. Additionally, he considers the perspectives of these market players, as well as the patients themselves, with respect to how connected drug delivery devices can help them to better achieve their desired outcomes.

EXPERT VIEW

Beth Crandall

ECONOMIC OPERATORS UNDER THE EU MDR: THE NEW REQUIREMENTS

Beth Crandall spells out the new requirements for Economic Operators under the EU Medical Device Regulation.

EXPERT VIEW

Andy Fry

PREPARING FOR MASS VACCINATION

Andy Fry and Stephen Blatcher discuss the need for a mass vaccination device in response to the 2020 covid-19 pandemic. In particular, the authors discuss the benefits and challenges of turning to needle-free injection technology as a solution.

EXPERT VIEW

Allison Strochlic

CONDUCTING EFFECTIVE AND INFORMATIVE EVALUATIONS OF INJECTION DEVICE PACKAGING

Allison Strochlic and Andrea Dwyer discuss the often overlooked aspect of a combination product user interface: the packaging. With a specific look at injection devices, the authors cover how to perform proper human factors testing of a combination product’s packaging, and the advantages doing so can confer to a project.

EXPERT VIEW

Rina Chokshi

SUSTAINABLE PHARMACEUTICALS CAN OUTPERFORM THROUGH NATURALLY DERIVED INGREDIENTS & DEEP EXPERTISE

Rina Chokshi discusses the benefits of naturally derived, sustainable ingredients and their benefits to the environment and pharmaceutical industry.

EXPERT VIEW

Sergio Malorni

RETHINKING DRUG DELIVERY DEVICES FOR SUSTAINABILITY AND INNOVATION

Sergio Malorni and George Bostock discuss the issue of designing for sustainability, including going beyond “Reduce, Reuse, Recycle” to “Rethink” and looking to adjacent and consumer industries for inspiration on innovations the drug delivery industry can adopt with a view to reducing its environmental impact.

EXPERT VIEW

Rob Veasey

SUSTAINABILITY AND DRUG DELIVERY DEVICES

Rob Veasey explores the environmental challenges facing the drug delivery device industry – and the opportunities they bring.

EXPERT VIEW

Tom Oakley

WEARABLE INJECTORS: LATEST DEVICES & RECENT TRENDS

Wearable injection device expert Tom Oakley discusses recent trends in the space. He also takes a look at wearable injection devices currently on the market and considers the future of wearable injectors.

EXPERT VIEW

Frédérique Bordes-Picard

ADVANCED CAPSULE TECHNOLOGIES: DRY POWDER INHALERS TO TARGET DISEASE

Frédérique Bordes-Picard  and Julien Lamps discuss the value of capsule-based dry powder inhalers in the modern respiratory market, the factors driving development in this area and considerations for matching a capsule to a device and formulation.

EXPERT VIEW

María Fernández-Martos Balson

THE RISE OF COMPLEX ORAL DELIVERY SYSTEMS

María Fernández-Martos Balson and Bastiaan De Leeuw explore the oral delivery of biologics and the challenges that must be overcome in order to enhance bioavailability. The authors also take a look at some recently developed drug-device combinations.

EXPERT VIEW

Napoleon Monroe

COVID-19: A CATALYST FOR IMPLEMENTING CONNECTED HEALTHCARE PRODUCTS?

Napoleon Monroe analyses how covid-19 is catalysing a wide range of reactions in healthcare, explaining how drug and device connectivity are essential to improving patient access to treatment – and patient outcomes – as well as reducing overall cost. 

EXPERT VIEW

Tom Oakley

RISKS AND REAL-WORLD SOLUTIONS FOR CONNECTED MEDICAL DEVICES

Tom Oakley discusses the risks surrounding the use of connected drug delivery devices – and the real-world solutions that have either been proved or are being trialled.

EXPERT VIEW

Dr Andrei Yosef

CONNECTED DEVICE DATA NEEDED TO MAKE HOME CARE THE STANDARD

With home care on the increase as a result of the coronavirus pandemic, Andrei Yosef looks at the crucial role played by connected home care medical devices and the data they generate.

EXPERT VIEW

Salvatore Forte

SENSOR ADVANCEMENTS IN DRUG DELIVERY IMPROVE COMPLIANCE

Salvatore Forte discusses various advancements in sensors that are transforming drug delivery systems, making complex devices more automated, easier to use, and improving patient compliance as a result.

EXPERT VIEW

Mark Turner

WHICH IS THE BETTER TOXICITY TESTING STRATEGY FOR COMBINATION DEVICES?

Mark Turner explores the issue of toxicity testing for combination devices and asks which is the better testing strategy – ISO 10993 or extractables and leachables?

EXPERT VIEW

Yvonne Limpens

DESIGN CONSIDERATIONS FOR IMPROVING TRAINING DEVICE SAFETY AND EFFECTIVENESS

Yvonne Limpens and Brenda van Geel, explore the design considerations that need to be taken into account when developing training devices that are safe and effective – and support patients in learning how to administer an injection correctly.

EXPERT VIEW

Beth Crandall

EU MDR DEADLINE DELAY: WHAT DOES IT MEAN FOR THE MEDICAL DEVICE INDUSTRY?

With the compliance deadline for the EU Medical Device Regulation recently delayed by a year due to the novel coronavirus pandemic, Beth Crandall looks at what it means for the medical device industry.

EXPERT VIEW

Nigel Theobald

SILICA RE-EMERGES AS POTENTIAL NUCLEIC ACID DELIVERY VECTOR

Nigel Theobald looks at the challenges of oligonucleotide delivery and explores approaches to overcome them.

EXPERT VIEW

Brennan Miles

RESPIRATORY DRUG DELIVERY: THEN, NOW AND SOON

Brennan Miles takes a look back at respiratory drug delivery over the last few decades to see what we can learn from the past – and looks ahead to what the future might look like, covering sustainability, device regulation, and formulation milestones.

EXPERT VIEW

Dr Igor Gonda

PUBLIC INTEREST & INCENTIVES FOR INNOVATORS OF INHALED PRODUCTS

Igor Gonda, David Cipolla and Philippe Rogueda discuss the changes needed to increase the number of approved generic orally inhaled drug products (OIDPs) whilst providing additional incentives to innovators to meet the needs of the general public.

EXPERT VIEW

Phil Seeney

THE OPTIONS FOR CREATING A MORE SUSTAINABLE INHALER

With growing pressure to tackle climate change, Phil Seeney looks at the arguments in favour of creating more sustainable inhalers, and examines potential strategies to accomplish it.

EXPERT VIEW

Jos van Noort

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.

EXPERT VIEW

Elizma Parry

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.

EXPERT VIEW

George I’ons

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.

EXPERT VIEW

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.

EXPERT VIEW

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.

EXPERT VIEW

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.

EXPERT VIEW

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. 

EXPERT VIEW

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.

EXPERT VIEW

Dr Matt Ash

HOW A DIGITAL APPROACH CAN UNPICK CLINICAL TRIAL CHALLENGES AND IMPROVE OUTCOMES

Matt Ash, Tom Lawrie-Fussey and Bastiaan De Leeuw look at the role digital technology can play in the development of drug-device combination products.

EXPERT VIEW

Dr Jeffrey Philippson

THE INTERFACE BETWEEN PREFILLED SYRINGE AND AUTOINJECTOR – A DEVELOPMENT FRAMEWORK

Jeffrey Philippson and Tom Kemp outline the challenges for autoinjector developers at the interface between the device and the prefilled syringe – and describe a framework to formalise analysis of the interface.