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.
Robert C. Getts, PhD, and Jessica Bowers review how the 3DNA platform is composed entirely of noncoding DNA assembled through the sequential hybridization of single strands of DNA into a network of double-stranded nucleic acid having a controlled architecture, and multiple attachment sites for drug and targeting molecules.
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.
ORALLY DISINTEGRATING TABLETS – Designed With Patients in Mind: The Art of Patient-Centric Drug Formulation
Anthony Recupero, PhD, believes by partnering with an expert in drug delivery technology, whose portfolio features a broad range of proprietary technologies, pharmaceutical companies have the potential to add further value to their products and extend market exclusivity.
Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.
EXCLUSIVE ONLINE CONTENT
Enable Injections, Inc. recently announced it has entered into a multi-product development agreement with Sanofi S.A.
AptarGroup, Inc. recently announced it has acquired two leading pharmaceutical services companies, Nanopharm Ltd. and Gateway Analytical LLC, for a combined enterprise value of approximately $50 million.
Sol-Gel Technologies, Ltd. recently announced it has entered into a seventh collaborative agreement with Perrigo Israel, an affiliate of Perrigo Company plc for the development, manufacturing, and commercialization of two new generic formulations of antibiotic foams.
Medherant Limited, the clinical-stage developer of innovative transdermal delivery products for pain and CNS diseases using its unique TEPI Patch technology, recently announced a new $2.5-million investment.
Bone Sci Bio introduces PeptOss, a novel solution for bone treatment. The new product promotes formation and repair of bone tissue and enables controlled delivery of drugs, such as antibiotics or chemotherapy, directly to the bone, for various orthopedic and dental applications.