Featured Articles
CNS DELIVERY - Bypassing the BBB: Drug Delivery From the Olfactory Mucosa to the CNS
T.R. Shantha, MD, PhD, FACA, explores and explains how therapeutic and non- therapeutic agents can reach the brain, bypassing through the formidable BBB based on the unique microanatomic and physiologic characteristics of the nasal olfactory mucosal route and its CNS connections that allow transportation directly into the CNS.
COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
EXECUTIVE INTERVIEW - Avista Pharma Solutions: Experience, Responsiveness & Expanded Capacity Driving Growth
Patrick Walsh, CEO of Avista Pharma Solutions, talks about his company’s range of capabilities and what is driving growth in this dynamic industry.
NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
INTRODUCTION GlobalData estimates that the value of the Non-Small Cell Lung Cancer (NSCLC) market in the 8 major markets (8MM) in 2015 was $6.21B. This…
ACS MARKET - Acute Coronary Syndrome Market 2015-2025
Michela J. McMullan, PhD, GlobalData Analyst, reports that although the ACS market is set to grow at a CAGR of 4.6%, reaching $12.1B by 2025, the potential for the market to be even more lucrative exists, especially in the sizable lipid-targeting arena.
DNA SEQUENCING MARKET - Emerging Technologies & Applications
Laurie L. Sullivan and John Bergin, MS, MBA, BCC Research Analysts, indicate that NGS has matured into an essential life science tool for genetic studies in a range of applications, and the industry is on the cusp of a second growth phase, powered by new applications in clinical diagnostics.
EXECUTIVE INTERVIEW - Insulet Corporation: Improving Adherence Through Wearable, Patient-Centric Drug Delivery
Michael Graffeo, Vice President of Business Development, Insulet Delivery Systems Group, discusses the importance of optimizing patient adherence to ensure improved clinical outcomes.
PLATFORM TECHNOLOGY - The 3DNA® Platform for Targeted Drug Delivery
Robert C. Getts, PhD, and Jessica Bowers review how the 3DNA platform is composed entirely of noncoding DNA assembled through the sequential hybridization of single strands of DNA into a network of double-stranded nucleic acid having a controlled architecture, and multiple attachment sites for drug and targeting molecules.
EXTERNAL DELIVERY - P.U.M.P. IT UP
John A. Bermingham, asks if you have ever been really hungry? He doesn’t mean the hunger you experience in the morning or just before dinner. He’s talking about major league hunger!
COMBINATION PRODUCTS - Device Development for Pharmaceutical & Biologic Combination Products
Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.
ADVANCED DELIVERY DEVICES - Sophisticated Connected Wearables: Boosting Biologics’ Compliance, Value & Patient Satisfaction
Michael D. Hooven, MSME, says the new, most advanced wearable large-volume injectors available now for clinical trials and commercial application are designed to address the challenges of formulating biologics, delivery complexity, patient compliance, and cost.
SPECIAL FEATURE - Platform Technologies: Not Just for Big Pharma
Contributor Cindy H. Dubin recently spoke with several companies that are debunking the theory that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating innovative platforms.
PACKAGING SYSTEMS - Container Closure Integrity in Cryogenic Storage Environments
Eugene T. Polini, MBA, reviews how cryogenics has proven to be especially useful in the pharmaceutical industry, where cryogenic storage is being utilized to ensure the efficacy of advanced therapeutics, such as biologics and stem cell therapies.
DEVICE STUDY - The Intuitiveness, Ergonomics & Usability of the Credence Companion® Safety Syringe: A Formative Study
John A. Merhige, MEM, and Lisa Caparra, RN, present an informative human factors study to evaluate and assess the intuitiveness, ergonomics, and usability of the Credence Companion® Staked Safety Syringe.
EXECUTIVE INTERVIEW - Catalent: Increasing Efficiency & Flexibility for the Clinical Supply Chain
Wetteny Joseph, President of Clinical Supply Services at Catalent Pharma Solutions, discusses the changing nature of clinical trials and the supply of materials for studies, and how Catalent is investing in new solutions, systems, and facilities to assist the biopharmaceutical industry.
EXECUTIVE INTERVIEW - PYRAMID: Prescription for Building Success Through Partnerships
Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc., discusses his success in building futures with his clients and more importantly, the lessons he’s learned along the way.
EXTERNAL DELIVERY - Social Responsibility
John A. Bermingham asks what all the ruckus is about with Mylan, maker of the EpiPen, which raised the cost for a pair of EpiPens over $600, and Turing Pharmaceuticals, maker of toxoplasmosis treatment Daraprim, which raised its price by over 5,000%?
TRAINING DEVICES - Best Practices & Considerations in Developing Effective Training Devices for Injectable Healthcare Markets
Joe Reynolds says training devices are often used to create consistent onboarding experiences for patients through the use of novel technologies and mechanisms that fully simulate the mechanical aspects of the injection experience. And while these devices appear to be fairly simple at first glance, numerous design and engineering challenges must be addressed.
COMPUTATIONAL METHODS - Formulation Development: An Innovative, Simulation-Based Approach
Tom Reynolds, PhD, Matt Wessel, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD, report that computational methods, such as QM and MD simulations, are playing an ever-expanding role in drug discovery and development, and transforming advances in drug development at all stages.
SOFTGEL FORMULATIONS - Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market
Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.
