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.
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.
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.
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.
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.
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.
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…
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?
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.
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.
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 -…
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.
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.
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.
