Featured Articles
SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development
Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.
FORMULATION DEVELOPMENT - Interactive Web Tool Helps Innovators Match Formulations to Drug Delivery Technologies
Kurt Nielsen, PhD, explains how an interactive web tool designed to help innovators match formulations to drug delivery challenges allows users to assess multiple oral drug delivery technologies in order to establish which may be the most appropriate for their molecule.
MANAGEMENT INSIGHT - Pharmaceutical Innovation in the Second Machine Age
Derek Hennecke says on one side, we have those who argue that technology is advancing so fast we have achieved a second-derivative rate of change. On the other side are those who claim we haven’t seen true innovation since the 1970s. Which is it?
LAB DEVELOPED TESTS - FDA Working on LDT Guideline: Implications & Questions
Aish Vivekanandan, Industry Analyst at Frost & Sullivan, reports that in the past several years, it seemed that a cry for regulation of LDTs was falling on deaf years at the FDA. However, after a thorough and intricate letter from the Senate and public outcry for regulations, it seems the FDA is finally taking action.
GLOBAL DELIVERY MARKET - Advanced Drug Delivery Systems: mAb, RNAi, & Breaking the Blood-Brain Barrier
Kevin James, Shalini Dewan, MS, Kim Lawson, and Usha Nagavarapu believe advances in understanding human biology and diseases are opening new and exciting possibilities in the biotechnology industry. R&D spending, along with increasing competition, patent expiries, and new and emerging technologies will continue to shape growth in this market for the foreseeable future.
NANOTECHNOLOGY MARKET - Nanotechnology Markets in Healthcare & Medicine
Kevin James, Jackson Highsmith, and Paul Evers report the global market for nanoparticles in the life sciences is estimated at over $29.6 billion for 2014. This market is forecast to grow to more than $79.8 billion by 2019, to register a healthy compound annual growth rate of 22%. The biggest increase will come in the area of drug delivery systems.
EXECUTIVE INTERVIEW - Exostar: Speeding the Drug Development & Delivery Process Through Secure Communities of Industry Partners
Drug Development Executive: Tom Johnson, Exostar’s Senior Director of Pharma and Life Science Solutions, discusses how Exostar’s Life Sciences Identity Hub efficiently and cost effectively brings organizations, individuals, applications, and information together to promote the external collaboration initiatives imperative to today’s drug research and development processes.
ABUSE-DETERRENT MARKET - What’s in the Pipeline? Abuse-Deterrent Products
Tugrul Kararli, PhD, MBA, Kurt Sedo, and Josef Bossart, PhD, decided it would be interesting to interrogate the PharmaCircle database and see what successes have been achieved with respect to abuse-deterrent formulations in terms of approved and pipeline products.
IMMUNOCHEMISTRY ANALYZER MARKET - Mutiplexing Technologies for Infectious Disease, Cancer, Cardiac & Autoimmune Testing Rise Above the Horizon
Divyaa Ravishankar, MS, Senior Industry Analyst at Frost & Sullivan, indicates the market has undergone a massive change from just a few vendors offering only enzyme-linked immunosorbent assay, chemiluminescent immunoassay, radioactive immunoassay, and flourescent immunoassay to also multiplex assays, such as microarrays, flow cytometry-based platforms, recombinant immunoassays, and indirect immunofluorescence assays.
ORPHAN DRUG MARKET - Drug Developers Drawn to Orphan Drugs Market: Financial Incentives Create Rich, Competitive Pipelines
As drug developers abandon the “blockbuster model” in favor of greater focus on drug development for rare conditions, the global orphan drugs market is becoming increasingly competitive. It is imperative that drug developers continually keep a tab of competitors’ pipelines as approval and reimbursement of new orphan drugs are highly dependent on the availability of alternative therapies.
IVD TRENDS - In Vitro Diagnostics Players Go Global as US & Europe Markets Slow Down
Despite economic and industry challenges, the global in vitro diagnostics (IVD) market is growing robustly – at double the rate of the global pharmaceutical industry…
INVESTMENT TRENDS - A Rise in IPOs Revive Investments for the Global Pharma & Biotech Industry
Dr. E. Saneesh, Financial Analyst at Frost & Sullivan, reports that new analysis reveals that PEVC investors in the global pharmaceutical and biotechnology industry have demonstrated maximum interest in oncology drugs, followed by anti-infective drugs and pharmaceutical contract laboratories. They also conclude the maximum pharmaceutical- and biotechnology-related PEVC deals in the US, and are expected to continue to do so in the forthcoming years.
MARKET ANALYSIS - Unprecedented Uptake of Sovaldi & Tecfidera Paves the Way for New Optimism in Pharma
Joshua Owide, GlobalData’s Director of Healthcare Industry Dynamics, believes a successful drug launch is pivotal in the corporate evolution of most innovative drug companies, allowing them to sustain growth momentum, or, as is more commonplace in the age of the blockbuster patent expiration, replenish existing revenues at risk from lower-cost equivalents.
DNA VACCINES MARKET - DNA Vaccines: Strategic Markets & Emerging Technologies
Kevin James, Shalini Dewan, MS, and Jon Evans, MBA, say the global market for DNA vaccines is estimated at $305.3 million for 2014 and is forecast to grow at a stellar 54.8% compound annual growth rate (CAGR) to reach $2.7 billion by 2019.
PERSONALIZED MEDICINE - Targeted, Personalized Therapy is the Future of Chronic Disease Therapeutics
The global life sciences sector is employing new research and development (R&D) and business models to cost effectively deliver innovation, value, and improved patient outcomes.…
PREFILLED SYRINGE STERILIZATION - NO2 Sterilization: A Flexible Solution for Prefilled Syringes
Evan Goulet, PhD, and Elizabeth Robbins report on the Noxilizer RTS 360 Industrial NO2 Sterilizer that provides surface sterilization of prefilled syringes with a range of material compatibility and low levels of residuals using its rapid, room-temperature process.
VACCINE TECHNOLOGY - Vaccine Technologies & the Rationale for New Nanoparticle Formulations
Robert S. Becker, PhD, MBA, and Mark A. Mitchnick, MD, explain how SATx technology provides a new flexible formulation platform for the generation of nanoparticulate vaccine formulations without the limitations of previous formulation technologies that have inhibited the optimization of vaccine potencies and safety profiles.
FORMULATION DEVELOPMENT - Solumerized(TM) Trans-Resveratrol, Bridging the Bioenhancement Gap to Drug Delivery Between Pharmaceuticals & Dietary Supplements
Amir Zalcenstein, PhD, Galia Temtsin Krayz, PhD, and Sabina Glozman, PhD, discuss the example of Resveratrol, a supplement with a solid body of scientific data attesting to its efficacy in enhancing lifespan and treating a variety of medical conditions, which yet remains short of its true market potential due to stability, bioavailability, and cost issues.
QUALITY-BY-DESIGN - Quality-by-Design: The Good, The Bad, The Inevitable
Michael Lowenborg believes in essence, QbD can be interpreted as a way to maximize time and cost savings by better understanding the components and processes necessary to optimize a drug product’s safety, efficacy, and quality at every stage in development.
NANOEMULSION FORMULATIONS - Nanoemulsion Formulations for Injection & Oral Administration
Troy M. Harmon, MS, MBA, and Jingjun Huang, PhD, use Ascendia’s EmulSol technology to develop a novel oil-in-water nanoemulsion formulation of clopidogrel whereby the free-base form of clopidogrel has acceptable solubility in the oil phase, and is protected from chemical degradation.
