May 2014

COVER

SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing - Product Differentiation Is Critical

Contributor Cindy H. Dubin speaks with several of these suppliers and manufacturers about the importance of customization and differentiation as the key to pharma companies staying competitive in the prefilled syringe space.

FEATURES

METAL-COORDINATED PHARMACEUTICALS - Reducing Inter-Subject Variability With Metal-Coordinated Pharmaceuticals: A Case Study With Furosemide

John D. Price, PhD, and Thomas Piccariello, PhD, use metal coordination chemistry to create a novel coordination complex of furosemide and magnesium that is absorbed more efficiently and consistently than furosemide itself.

CLINICAL DEVELOPMENT STRATEGIES - Optimizing a Full-Package Strategic Alliance for Clinical Development Services

INTRODUCTION Pharmaceutical and biopharmaceutical companies are confronting a fundamental productivity challenge. In the past two decades, R&D cost has increased significantly, yet the rate of innovation is diminishing and so..

CLOUD COMPUTING - Enabling Better Collaboration in the Cloud

Peter Shaw and Yury Rozenman believe the pharmaceutical industry has reached a crucial inflection point, requiring access to new working methods and tools. But where should the pharmaceutical industry look for answers to these real-world challenges?

FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products - What’s in the Clinic? (Part 3 – Pipeline)

Tugrul T. Kararli, PhD, MBA; Kurt Sedo; and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and conclude this series of three articles, examining the past, present, and future of these products with the intent of understanding their whats and whys.

CONTAINER CLOSURE SYSTEMS - Application & Effectiveness of Daikyo Crystal Zenith® Container Closure Systems for Radiopharmaceuticals

Lloyd Waxman, PhD, and Vinod Vilivalam, PhD, believe a more promising application has been to label mAbs with a positron emitter for use in understanding the in vivo behavior and efficacy of targeted drugs in individual patients and for more effective drug development.

FORMULATION DESIGN - Formulation of Poorly Soluble Drugs: A Modern Simulation-Based Approach

Sanjay Konagurthu, PhD, and Alexander McVey, MS, present a case study in which a model BCS Class II compound, dipyridamole, was evaluated as an amorphous dispersion using molecular modeling combined with experimental data.

ADVANCED DELIVERY DEVICES - Wearable Bolus Injectors - A New Class of Patient-Friendly Drug Delivery Systems

Michael D. Hooven, MSME, indicates bolus injectors represent one of the most exciting new opportunities in the field of medical devices, and his company’s focus on developing innovative technology in combination with an intense emphasis on Human Factors has resulted in a system that is unique in a number of ways.

MANAGEMENT INSIGHT - The Biotech Bubble: What Goes Up Must Come Down

Physicists know it. Coffee drinkers live it. Roller coasters capitalize on it. Yet stock market investors - even coffee-drinking physicist-investors strapped into roller coasters - routinely deny it. What goes..

EXECUTIVE INTERVIEW - Norwich Pharma Services: Synchronized Outsourced Solutions for Contract Development & Manufacturing

Drug Development Executive: Kristin Arnold, PhD, Norwich’s VP of Product Development and Technical Services, talks about the company’s long history in pharmaceutical manufacturing, its evolution as a CDMO, the “perfect” client, and its role as a service provider from start to finish.

BUSINESS DEVELOPMENT - If You Are Not At Risk of Losing Your Job, Then You Are Probably Not Doing It Right!

John A. Bermingham believes too many companies today, and the people who run them, have developed a negative culture on responsible risk and believes with proper due diligence, success can be achieved.