ONdrugDelivery - ONdrugDelivery - drug delivery industry specialised b2b information

ESTABLISHING DATA-DRIVEN DESIGN AND MANUFACTURING FOR MEDICAL DEVICES

SHL's Frederick Gertz explores the benefits for medical device design and manufacturing organisations of adapting to the use of big data and analytics.

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.

SUPPORTING IMPROVED PATIENT ONBOARDING & ADHERENCE WITH TRAINING SOLUTIONS

Bill Guilliouma looks at the role of platform training solutions for patient onboarding and adherence to treatment regimens.

Chalmers University Pilot Project Developing Nasal spray to deliver vaccine against COVID-19

Chalmers University Pilot Project Developing Nasal spray to deliver vaccine against COVID-19

A unique concept for a nasal spray mRNA vaccine against COVID-19 is being investigated in a new pilot project. The Swedish group is exploring design principles for nasal immunisation, developing a biomimetic nanoparticle provided with both immune enhancers and a targeting protein.

INTERVIEW WITH STEVEN KAUFMAN, STEVANATO & URI BARUCH, CDP

Stevanato Group

INTERVIEW WITH STEVEN KAUFMAN, STEVANATO & URI BARUCH, CDP

Steven Kaufman and Uri Baruch discuss the recently announced collaboration between their two companies to accelerate the development of a new variable-dose, cartridge-based pen injector platform for diabetes.

A NOVEL PREFILLABLE SYRINGE WITH A GLASS PRIMARY CONTAINER BUT NO NEED FOR EXTREME THERMAL REFORMING

PREFILLED SYRINGES

Dr Stephen Shue

SaferMed Technologies

A NOVEL PREFILLABLE SYRINGE WITH A GLASS PRIMARY CONTAINER BUT NO NEED FOR EXTREME THERMAL REFORMING

Stephen Shue introduces a proprietary prefillable syringe, the SMPFS, whose novel glass-tube-plus-plastic-sheath design enables the use of a standard glass tube primary drug container, but avoids the need for the extreme thermal reforming process that conventional glass prefillable syringes must undergo.

UPDATE ON OXYCAPT MULTILAYER PLASTIC VIAL AND SYRINGE

PREFILLED SYRINGES

Tomohiro Suzuki

Mitsubishi Gas Chemical

UPDATE ON OXYCAPT MULTILAYER PLASTIC VIAL AND SYRINGE

Tomohiro Suzuki gives an update, including new oxygen barrier data, on the development of the OXYCAPT™ multilayer plastic vial and syringe.

Shorter Needles with Thinner Walls to Improve Injection Experience in Chronic Care

PREFILLED SYRINGES

BD (Becton Dickinson & Company)

Shorter Needles with Thinner Walls to Improve Injection Experience in Chronic Care

Aurélie Pager, Brigitte Duinat and Barbara Alves look at how new BD Neopak™ XtraFlow™ prefillable syringes with shorter, 8 mm needles and thinner-wall cannula technology are set to improve the injection experience for subcutaneous drug delivery in chronic care.

WHICH IS THE BETTER TOXICITY TESTING STRATEGY FOR COMBINATION DEVICES?

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?

DESIGN CONSIDERATIONS FOR IMPROVING TRAINING DEVICE SAFETY AND EFFECTIVENESS

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.

THE NEXT GENERATION OF COATED PLUNGERS

Carina Van Eester

Datwlyer Sealing Solutions

THE NEXT GENERATION OF COATED PLUNGERS

Carina Van Eester explores the benefits of fully coated plungers for prefilled syringes and cartridges.

APPLICATION OF CFD IN THE DEVELOPMENT OF A WEARABLE BOLUS INJECTOR

Validus Engineering

APPLICATION OF CFD IN THE DEVELOPMENT OF A WEARABLE BOLUS INJECTOR

Marcus Hall, Björn Ullbrand and Claus Schmidt Møller describe the use of computational fluid dynamics (CFD) as the primary design and analysis tool in the development of a wearable bolus injector.

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

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.

SILICA RE-EMERGES AS POTENTIAL NUCLEIC ACID DELIVERY VECTOR

SILICA RE-EMERGES AS POTENTIAL NUCLEIC ACID DELIVERY VECTOR

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

Senzer to Create Targeted Inhaled Antivirals for COVID-19

Senzer to Create Targeted Inhaled Antivirals for COVID-19

Senzer Pharmaceuticals has launched a Critical Care Division, which will utilise its expertise in respiratory pharmaceuticals to create targeted antiviral treatments for COVID-19.

Covis Pharma’s Alvesco (ciclesonide) Inhaler Enters Phase III COVID-19 Trials

Covis Pharma’s Alvesco (ciclesonide) Inhaler Enters Phase III COVID-19 Trials

Covis Pharma's inhaled glucocorticoid, Alvesco (ciclesonide), has entered a US multicentre, randomised, double-blind, placebo-controlled Phase III safety and efficacy trial in 400 non-hospitalised patients 12 years of age and older with symptomatic COVID-19. The product is delivered twice daily via a pMDI.

Stabilitech Recognised by WHO, seeks £6m funding to make oral SARS-COV-2 vaccine available by end of 2020

Stabilitech Recognised by WHO, seeks £6m funding to make oral SARS-COV-2 vaccine available by end of 2020

Stabilitech Biopharma, which is developing OraPro-COVID-19, an oral coronavirus vaccine, has been formally recognised on the international stage by the WHO as a vaccine developer, and seeks £6 million to fund clinical trials and manufacturing required to make the vaccine available by the end of 2020.

Equashield<sup>®</sup> Pro from Equashield

Equashield^® Pro from Equashield

Closed System Transfer Device (CSTD) provider Equashield introduces Equashield^® Pro, the first CSTD-enabled automated drug compounding robot.

Telemedicine gains acceptance amid the COVID-19 pandemic

Telemedicine gains acceptance amid the COVID-19 pandemic

Noble highlights how telemedicine is poised to become a mainstream alternative to the traditional in-person methods of care delivery, with the COVID-19 pandemic easing barriers to acceptance and introducing patients to the safety and convenience of telehealth technology.

RedHill’s US IND Approved for Opaganib SARS-COV-2 trial; positive results from Israeli trial

RedHill’s US IND Approved for Opaganib SARS-COV-2 trial; positive results from Israeli trial

RedHill Biopharma has received US FDA of its IND for a Phase IIa clinical trial of opaganib (Yeliva^®, ABC294640) in 40 hospitalised SARS-COV-2 patients, and has reported positive preliminary results from a trial of the product in six patients in Israel.

BAVARIAN NORDIC ENTERS AGREEMENT WITH ADAPTVAC TO ADVANCE COVID-19 VACCINE

BAVARIAN NORDIC ENTERS AGREEMENT WITH ADAPTVAC TO ADVANCE COVID-19 VACCINE

Bavarian Nordic has entered into an exclusive head of terms agreement to license AdaptVac’s proprietary capsid virus like particle (VLP)-based SARS-CoV-2 subunit vaccine technology, to help a European consortium, PREVENT-nCoV, move towards clinical proof of concept. Bavarian Nordic takes responsibility for clinical development and global commercialisation of the vaccine.

WEBINAR: WORKING WITH POWDERS

Freeman Technology

WEBINAR: WORKING WITH POWDERS

In this on-demand webinar, the first in a series, Tim Freeman, Managing Director, Freeman Technology, introduces the challenges associated with understanding and predicting powder flowability and looks at how quantifying powder behaviour can aid process performance.

ARTES USING METAVAX<sup>®</sup> AND SplitCore VLP PLATFORM FOR SARS-CoV-2 vaccine

ARTES USING METAVAX^® AND SplitCore VLP PLATFORM FOR SARS-CoV-2 vaccine

ARTES Biotechnology has begun development of SARS-CoV-2 vaccine candidates based on its virus-like particle (VLP)-based platform technologies METAVAX^® and SplitCore.

MedPharm Develops Model to Support Coronavirus Pharmaceutical Development

MedPharm Develops Model to Support Coronavirus Pharmaceutical Development

A new testing model from MedPharm supports pharmaceutical development programmes targeting coronavirus treatments, meaning companies can assess the therapeutic effectiveness of their anti-COVID-19 candidate compounds in nasal, airway (bronchial), and deep lung (alveolar) epithelia against members of the Coronaviridae family.

Squalene-based nanoparticles for the treatment of uncontrolled inflammatory processes

Squalene-based nanoparticles for the treatment of uncontrolled inflammatory processes

Nanoparticles developed by researchers from Galien Institute at Paris-Saclay University and the Federal University of Rio de Janeiro, made by conjugating squalene to adenosine and then encapsulating α-tocopherol, a natural antioxidant, have shown potential against the uncontrolled inflammatory processes associated with severe SARS-COV-2 infection.

Chitosan nanoparticles suitable for aerosol treatment of Covid-19 patients

Chitosan nanoparticles suitable for aerosol treatment of Covid-19 patients

Bioavanta-Bosti has developed of a 48-hour manufacturing process, using its Novochizol chitosan polysaccharide nanotechnology to encapsulate APIs – small molecules or biologics – for localised delivery and sustained release, to generate intra-pulmonary drug delivery formulations suitable for treating COVID-19 patients.

ANSYS simulations to help provide insights in fight against COVID-19

ANSYS simulations to help provide insights in fight against COVID-19

ANSYS, Inc, has posted sample clips of various simulations on its webpage, for others to use to gain insights in the fight against COVID-19. The simulations, which can be viewed here, offer various insights on aspects.

NanoPass Sharing Microneedle Device with Pharma Partners for COVID-19 Vaccine

NanoPass Sharing Microneedle Device with Pharma Partners for COVID-19 Vaccine

NanoPass is sharing its proprietary MicronJet microneedle device with vaccine and immunotherapy companies to help in the efforts to develop a safe, effective and affordable vaccine against SARS-COV-2, novel coronavirus.

Pulmonary Delivery Could Make Niclosamide Effective Against COVID-19

Pulmonary Delivery Could Make Niclosamide Effective Against COVID-19

A novel inhaled formulation of the approved antihelminthic drug, niclosamide, is under development at the College of Pharmacy at The University of Texas at Austin for COVID-19. The compound was recently confirmed to exhibit antiviral efficacy in SARS-COV-2 infected cells and indeed was more potent compared with chloroquine, lopinavir and remdesivir, the group said.

IS NOW THE TIME TO SHAKE UP THE pMDI ENVIRONMENT?

IS NOW THE TIME TO SHAKE UP THE pMDI ENVIRONMENT?

Chris Baron explores how the use of propellants in pressurised metered dose inhalers has evolved – and how alternative propellants could be a catalyst for greater patient adherence.

NEW DRUG-NEBULISER COMBINATION PRODUCTS: CONSIDERATIONS BEYOND PERFORMANCE

Dr Nicolas Schwenck

NEW DRUG-NEBULISER COMBINATION PRODUCTS: CONSIDERATIONS BEYOND PERFORMANCE

Nicolas Schwenck and Michael Hahn summarise the critical success factors for bringing a new vibrating membrane nebuliser for a drug-device combination product to the market. They highlight opportunities and pitfalls – starting from the evaluation phase, through the development phase and finally during commercialisation.

OPTIMISING NASAL DRUG PRODUCTS FOR SYSTEMIC DELIVERY

Intertek Melbourn

OPTIMISING NASAL DRUG PRODUCTS FOR SYSTEMIC DELIVERY

David Ward discusses the benefits of systemic nasal delivery, describes a number of formulation strategies, and explains how to optimise absorption through properly informed formulation and device selection.

RETRONOSE: IMPROVING NASAL DELIVERY THROUGH A NEW AND IMPROVED DEVICE

Dr Laurent Vecellio

RETRONOSE: IMPROVING NASAL DELIVERY THROUGH A NEW AND IMPROVED DEVICE

Laurent Vecellio, Déborah Le Pennec, Guillaume Grevin and Alain Regard evaluate the performance of the RetroNose nasal drug delivery device.

THE IMPORTANCE OF TRAINING AND ONBOARDING FOR INTRANASAL RESCUE THERAPIES

THE IMPORTANCE OF TRAINING AND ONBOARDING FOR INTRANASAL RESCUE THERAPIES

With a recent resurgence in nasal drug repurposing, Joe Masci looks at the importance of training and onboarding for intranasal rescue therapies.

RESPIRATORY DRUG DELIVERY: THEN, NOW AND SOON

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.

PUBLIC INTEREST & INCENTIVES FOR INNOVATORS OF INHALED PRODUCTS

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.

ADVANCING ASPRIHALE<sup>®</sup> TO PIVOTAL PK/PD STUDY

Mark Stansfield

ADVANCING ASPRIHALE^® TO PIVOTAL PK/PD STUDY

Mark Stansfield and Kambiz Yadidi discuss results of their pilot Phase I clinical study of dry-powder inhalation of aspirin.

HOSOKAWA EXTENDS BLENDER RANGE FOR DPI FORMULATIONS

Hosokawa Micron

HOSOKAWA EXTENDS BLENDER RANGE FOR DPI FORMULATIONS

Bert Dekens announces the extension of the the company’s established Cyclomix modular blending technology range, to include small (R&D) scale, mid-range and large-scale systems.

THE OPTIONS FOR CREATING A MORE SUSTAINABLE INHALER

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.

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Li-Chun Tsou, PhD, MBA
Principal Engineer
Merck & Co

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Consultant
Plan Strategic

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President
Micro Engineering Solutions

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Corning Incorporated

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