May 2016

COVER

SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges

Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.

FEATURES

MANAGEMENT INSIGHT - The Wisdom of Bees: What the Honeybee Can Teach You & Your Company About Making Better Decisions

Derek Hennecke says once we understand what happens in our brains as we weigh our options, we can extrapolate this knowledge and look with fresh eyes at how CDMOs, large pharma, and the industry make decisions.

COMBINATION CORNER - How to Approach OTS Devices for Your Combination Product

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.

PROTEIN PHOSPHORYLATION - New Pathways, New Tools: Phosphohistidine Signaling in Mammalian Cells

Xiaoyi Xu, MS, Chandreyee Das, PhD, and Michael Sturges, PhD, indicate that the phosphorylation of histidine has not been widely studied in mammalian cells, despite its discovery in bovine liver mitochondria, and ask the question, could the phosphorylation of histidine emerge as a therapeutically important pathway in mammals?

PULMONARY DELIVERY - Pulmonary Delivery of Insulin to Treat Diabetes - A Debacle

T.R. Shantha, MD, PhD, FACA, says the market for new anti-diabetic therapeutic agents and their painless delivery is enormous and is sure drug companies and research scientists are in a race to develop a safer method other than the pulmonary and oral routes to deliver insulin.

EXECUTIVE INTERVIEW - Transdermal Specialties: A New Dimension in Transdermal Drug Delivery

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.

LYOPHILIZATION - A Lyophilization Scale-Up Model: Lessons Learned & Best Practices

Enrico Corona, indicates full scalability between laboratory and production lyophilization units allows for the development or optimization of freeze-drying cycle parameters that yield significant cost savings.

EXTERNAL DELIVERY - Lead Your Company, Don’t Over Manage It

For many years, I have witnessed a continuing discussion on the question of, “what’s the difference between leadership and management?” Or is there one? I believe that while there are..