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.
Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.
Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.
Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
EXCLUSIVE ONLINE CONTENT
As we come to learn more about the human body, the dynamics of the industry must react accordingly. A primary example of this is the fact that the dominating blockbuster drug model that was paramount in the industry until a couple of years ago is no longer valid……
Pfenex Inc. recently announced the receipt of a milestone payment from Merck associated with the initiation of the first Phase 3 clinical study of (V114), an investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease.
Immatics Biotechnologies GmbH recently announced it has entered into a research collaboration and license agreement with Genmab A/S to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancer indications.
With the acquisition of Sensile Medical AG, Switzerland under a recent share purchase agreement, Gerresheimer is extending its business model in the direction of an Original Equipment Manufacturer (OEM) for drug delivery platforms with digital and electronic capabilities for pharmaceutical and biopharmaceutical customers.
Future Market Insights (FMI) delivers key insights on the global biologic excipients market in its upcoming report titled Biologic Excipients Market: Global Industry Analysis 2013–2017 and Opportunity Assessment…