Featured Articles
EXTERNAL DELIVERY – The Big Hack Attack
John A. Bermingham says it is not a matter of IF your business is going to be hacked but WHEN your business is going to be hacked, but the vast majority of businesses in the US do not have any plans in place for such an event.
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.
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…
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.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Using a Single Provider Reduces Costs & Risk
Contributor Cindy H. Dubin highlights several CDMOs that are evolving their models to become their clients’ single provider and to accommodate their more potent, challenging products.
IMMUNOTHERAPY RESEARCH - The Shift Toward Combination Therapies
Jean Pierre Wery, PhD, indicates immunotherapy in combination with traditional treatments has the potential for becoming a more effective alternative to the current standard of care. These types of combination therapies are currently under investigation and appear to have synergistic effects compared to the use of one therapy alone.
NANOPARTICLE CHARACTERIZATION - One Size Does Not Fit All: Nanoparticle Size Analysis for Nanomedicine Applications
Andrew N. Cleland, PhD, Jean-Luc Fraikin, PhD, Peter Meinhold, PhD, and Franklin Monzon, PhD, describe a new diagnostic instrument able to rapidly and accurately report detailed nanoparticle size distributions for a wide variety of nanoparticle types and concentrations in a range of different solutions.
DRUG DELIVERY - PLEX(TM) Local Drug Delivery Platform Enables Prolonged, Controlled-Release Medications
Noam Emanuel, PhD, reviews how PLEX is a unique local drug delivery platform that brings numerous innovative solutions to the market in various fields, such as infections, inflammations, and cancer.
MRI CONTRAST AGENTS - Could More Stable Soon Also Mean Safer?
Frost & Sullivan Analyst Nadim Michel Daher indicates radiology is going through interesting times. Under the coordinated care paradigm that is gradually emerging in the US, as well as all the changes forced on volume-based economic models, medical imaging enterprises are under a great deal of pressure to redefine their goals and reassess their value.
DRUG DEVELOPMENT - Don't Overlook Key Preclinical Research
Robert Wenslow, PhD, and Ann Newman, PhD, believe too often, drug discovery scientists, material scientists, and formulation specialists work in silos throughout the drug discovery process. Better integration of their efforts can reduce drug development schedules, risk, and overall costs that provide direct competitive business advantages.
EXTERNAL DELIVERY – It’s Never Too Late
“You’re going to do what?” was my wife’s reaction to my announcement. “Come on, you know it is something I’ve always wanted to do,” was…
LYOPHILIZATION - The Key to Creating Acceptable & Effective Fast-Dissolving Oral Formulations
Leon Grother says multiple products are on the market made using a controlled lyophilization process. The fast-dissolving characteristics it can impart have enabled the demands of several challenging patient populations to be met with formulations of important medicines that work well for them.
DISSOLUTION TESTING - Exploring the Link Between Particle Size & Dissolution Behavior for OINDPs
Paul Kippax, PhD; Deborah Huck-Jones, PhD; et al review current trends in dissolution testing within the context of understanding particle size, which impacts clinical studies and ultimately generic submissions.
MANAGEMENT INSIGHT - Why I Sold Xcelience: The Non-Linear Path of Decision-Making
Derek Hennecke explains that he sold his company to Capsugel, and some of you may be wondering did he sell out? He shares with you some of the thought process that brought him to this momentous and very emotional decision, as well as some of the lessons he learned.
PULMONARY DELIVERY - Afrezza – Another Lesson for Drug Delivery Professionals?
Josef Bossart, PhD, believes Mannkind’s recent announcement that Sanofi has decided to return the marketing rights for Afrezza may not exactly be history repeating itself, but it certainly feels as though it rhymes.
SPECIAL FEATURE - Advancements in Drug Delivery Technologies Tackle Solubility & Bioavailability Challenges
Contributor Cindy H. Dubin speaks with several innovator companies to learn more about the latest advances in drug delivery to address the challenging issues of solubility and bioavailability today
