issues

October 2016

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COVER

SPECIAL FEATURE – Platform Technologies: Not Just for Big Pharma

Contributor Cindy H. Dubin recently spoke with several companies that are debunking the theory that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating innovative platforms.

FEATURES

COMBINATION PRODUCTS – Device Development for Pharmaceutical & Biologic Combination Products

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.

PACKAGING SYSTEMS – Container Closure Integrity in Cryogenic Storage Environments

Eugene T. Polini, MBA, reviews how cryogenics has proven to be especially useful in the pharmaceutical industry, where cryogenic storage is being utilized to ensure the efficacy of advanced therapeutics, such as biologics and stem cell therapies.

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.

EXECUTIVE INTERVIEW – Catalent: Increasing Efficiency & Flexibility for the Clinical Supply Chain

Wetteny Joseph, President of Clinical Supply Services at Catalent Pharma Solutions, discusses the changing nature of clinical trials and the supply of materials for studies, and how Catalent is investing in new solutions, systems, and facilities to assist the biopharmaceutical industry.

EXECUTIVE INTERVIEW – PYRAMID: Prescription for Building Success Through Partnerships

Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc., discusses his success in building futures with his clients and more importantly, the lessons he’s learned along the way.

EXTERNAL DELIVERY – Social Responsibility

John A. Bermingham asks what all the ruckus is about with Mylan, maker of the EpiPen, which raised the cost for a pair of EpiPens over $600, and Turing Pharmaceuticals, maker of toxoplasmosis treatment Daraprim, which raised its price by over 5,000%?

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.

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