COMBINATION CORNER – Keys to Avoiding Common Pitfalls in the Development of Product Requirements for Drug Combination Products
Jerzy Wojcik says it is more important than ever to bring the right team together early in a project to capture product requirements correctly. The cost of missing needs or requirements goes up exponentially as development proceeds, and many of these requirements can be identified early in the project if the right individuals are at the table.
ADVANCED DELIVERY DEVICES – Disruptive Delivery Technology Partnerships Are Key to Pharmaceutical Life Cycle Management
Michael D. Hooven, MSME, believes in the challenge to deliver innovative therapies that address unmet patient needs while delivering profitable growth, and the industry is responding by embracing disruptive technology that can concurrently help on both fronts and also speed time to market for pharmaceutical products and services.
BIODEGRADABLE FIBERS – Enabling Controlled Pharmaceutical & Biologic Delivery for Next-Generation Medical Applications
Kevin Nelson, PhD, discusses how wet-extruded fiber eliminates the traditional limitations of pharmaceuticals and biologics that may be incorporated into implantable medical devices with melt extrusion or electrospun fibers, microspheres, or nanoparticles.
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
EXECUTIVE INTERVIEW – Insulet Corporation: Improving Adherence Through Wearable, Patient-Centric Drug Delivery
Michael Graffeo, Vice President of Business Development, Insulet Delivery Systems Group, discusses the importance of optimizing patient adherence to ensure improved clinical outcomes.
Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.
ADVANCED DELIVERY DEVICES – Sophisticated Connected Wearables: Boosting Biologics’ Compliance, Value & Patient Satisfaction
Michael D. Hooven, MSME, says the new, most advanced wearable large-volume injectors available now for clinical trials and commercial application are designed to address the challenges of formulating biologics, delivery complexity, patient compliance, and cost.
DEVICE STUDY – The Intuitiveness, Ergonomics & Usability of the Credence Companion® Safety Syringe: A Formative Study
John A. Merhige, MEM, and Lisa Caparra, RN, present an informative human factors study to evaluate and assess the intuitiveness, ergonomics, and usability of the Credence Companion® Staked Safety Syringe.
TRAINING DEVICES – Best Practices & Considerations in Developing Effective Training Devices for Injectable Healthcare Markets
Joe Reynolds says training devices are often used to create consistent onboarding experiences for patients through the use of novel technologies and mechanisms that fully simulate the mechanical aspects of the injection experience. And while these devices appear to be fairly simple at first glance, numerous design and engineering challenges must be addressed.
Contributor Cindy H. Dubin spoke with some of the world’s leading device developers about their current injection technologies and how their devices are addressing the current trends and opportunities in the industry.
EXCLUSIVE ONLINE CONTENT
Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, recently announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB.
A team of industry experts awarded Nemera’s electronic add-on for ophthalmic droppers with a prestigious CPhI Award for Best Drug Delivery Device in its category.
By 2050, it is projected that the proportion of people aged 65 and older will be more than double that of children aged 5. This global phenomenon is also leading to an increasing number of people suffering from chronic diseases, such as diabetes and osteoporosis.
Aptar Pharma, a leading drug delivery systems provider, continues its commitment to meeting new market trends with the release of an industry first, PureHale, a new portable and ready-to-use drug delivery solution designed for upper respiratory care.
Nevakar Inc. recently announced it entered into an exclusive licensing agreement with Endo International plc’s subsidiary, Endo Ventures Limited, for the development of five differentiated, sterile injectable products in the US and Canada.