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.
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?
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.
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.
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.
Comparative Human In Vivo Study of an Immediate-Release Tablet Over-Encapsulated by Gelatin & Hydroxypropyl Methyl Cellulose Capsules – Impact of Dissolution Rate on Bioequivalence
Introduction Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties…
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…
LIPID NANOPARTICLES - EnCore(TM): Facilitating Delivery of RNAi Therapeutics to Treat Cancer
Marc T. Abrams, PhD, and Bob D. Brown, PhD, explain how nanoparticle technology has the potential to enable tumor bioavailability even in the absence of a targeting ligand.
EXECUTIVE INTERVIEW - Gerresheimer in the US - Fully Focused on Core Business
Roger Kurinsky, Senior Vice President of Tubular Glass Americas talks about recent strategy shifts, the importance of the US pharma market, and how Gerresheimer’s investments in the US can benefit pharma companies.
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.
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.
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.
