Featured Articles
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
EXECUTIVE INTERVIEW - Cardax Inc: Delivering Nature-Identical Astaxanthin to the Market
David G. Watumull, President and CEO of Cardax, Inc, discusses the company’s plans to create a new platform for products in the consumer health and pharmaceutical markets based on the delivery of nature-identical astaxanthin.
EXTERNAL DELIVERY - 5 Topics Your Board Needs to Discuss Immediately
Last week, this magazine’s Executive Director, Dan Marino, asked me to comment on an article titled 5 Topics Your Board Needs to Discuss Immediately by…
SPECIAL FEATURE - Analytical Testing: Using More Sophisticated Tools to Support Small & Large Molecule Projects
Contributor Cindy H. Dubin recently spoke with leading analytical testing providers to find out what services they offer and what equipment they use to handle both small and large molecules for their pharma clients.
EXECUTIVE INTERVIEW - Enable Injections: Revolutionizing Treatment With a New Class of Devices
Michael Hooven, CEO of Enable Injections, discusses his vision for the company and how it intends to create marketleading biologics delivery devices that meet the most pressing needs of pharmaceutical companies while enabling easy patient self-administration for significant cost-savings.
EXTERNAL DELIVERY - The New Marketing Paradigm
We are 60 days past the half-way mark for calendar 2015. For those on a calendar year fiscal basis, this means their business year is…
