issues

June 2014

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COVER

ADVANCED DELIVERY DEVICES – Incorporating Patient-Centric Design Into a Novel Anti-Needlestick Safety Device

Sarah Baer, MBA, says the market for biotechnology drugs continues to grow, and there is a need for pharmaceutical companies to offer injection devices that support both the complex properties of the biologic as well as the needs of the end-user who will be performing the injection.

FEATURES

COLON-SPECIFIC DELIVERY – Toward Reliable Colon-Specific Drug Delivery

Wilfried Andrä, PhD, Pieter Saupe, and Matthias E. Bellemann, PhD, indicate the greatest obstacle on the road to targeted drug delivery in the GI tract was, until now, the lack of a practicable method to localize the capsule.

MANAGEMENT INSIGHT – Antifragile: Nassim Taleb on the Evils of Modern Medicine

Derek Hennecke reviews the latest book by Black Swan author Nassim Taleb, indicating it is a thoroughly maddening book. And whether or not you enjoy this type of mental gymnastics, and if it gains anything like the notoriety of his previous books, you’re going to hear about it.

EXCIPIENT UPDATE – Elution of Dexamethasone Acetate Into Buffered Saline Solution Through a Silicone Elastomer Using Excipients

Brian Reilly, Mustafa Al-Azzam, and Robert Kivlin measure the elution rate of DMA from a cured silicone matrix into a physiological environment with the goal of understanding the influence of load level and the use of excipients in DMA delivery through a cured silicone matrix.

BIOAVAILABILITY ENHANCEMENT – Diffusion of Innovation & the Adoption of Solubilization Technologies: Observations of Trends & Catalysts

Marshall Crew, PhD, says that although diffusion processes of innovative products and services have been studied extensively for nearly 45 years, it seems reasonable that we might learn from others’ observations, and the frameworks they’ve developed to model diffusion of technology for the adoption of bioavailability platforms.

ADVANCED DELIVERY DEVICES – Incorporating Patient-Centric Design Into a Novel Anti-Needlestick Safety Device

Sarah Baer, MBA, says the market for biotechnology drugs continues to grow, and there is a need for pharmaceutical companies to offer injection devices that support both the complex properties of the biologic as well as the needs of the end-user who will be performing the injection.

EXECUTIVE INTERVIEW – The Integration of Bend Research With Capsugel Dosage Form Solutions (DFS)

Drug Development Executive: Rod Ray, former Bend Research CEO and now a member of Capsugel’s Scientific and Business Advisory Board, talks about the enhanced capabilities of Capsugel DFS and the advantages offered to companies developing new and/or enhanced medicines.

INJECTABLE MICROEMULSIONS – Prolonged-Release Injectable Microemulsions: Opportunities for Pain Treatment

Rajesh Dubey, PhD, and Luigi G. Martini, FRPharmS, MBA, indicate available technologies do not support development of certain formulations to treat pain; however, microemulsions with their unique features, can provide a viable alternative to develop such formulations.

CLINICAL TRIALS – Outsourcing Early-Stage Clinical Trials: How to Mitigate Costs & Risk

Roundtable Discussion: Contributor Cindy H. Dubin gathered leading CROs together to discuss the benefits of outsourcing early-stage clinical trials, how to mitigate the risks, and lower costs in the process.

REGULATORY MANAGEMENT – Renewed Focus on Reg IM as Commercial Takes Center Stage

Joel Finkle emphasizes that as companies start to shift their thinking toward their commercial needs, they’re coming to realize that the regulatory function plays a crucial role in securing and maintaining market access and that Reg IM is more than simply a useful submission tool - that it is essential to managing the big picture.

EXECUTIVE INTERVIEW – 4P Therapeutics: Developing New & Innovative Transdermal Products

Drug Development Executive: Steven Damon, Founder of 4P Therapeutics, discusses his vision for the company and how 4P intends to create new and innovative transdermal products that meet the needs of patients, physicians, and payers.

BUSINESS DEVELOPMENT – Successful Succession Planning

In a recent discussion I had with our Executive Director of this publication, Dan Marino, he suggested an article on succession planning. Why would anyone want to do succession planning? Why would you want to develop a person or persons below you in the company organizational chart who could take your job? What, are you crazy? Well, not so fast.