STANDARDIZATION TECHNOLOGY - Innovative Temperature Standardization Technology Supports Cell Therapy Clinical Trials
Rolf O. Ehrhardt, MD, PhD, and Maria Thompson, PhD, discuss a unique proprietary temperature standardization technology that is practical for all stages of cell processing and handling. It is currently supporting a Phase IIb clinical trial investigating the efficacy of an immunotherapy treatment for patients with moderate-to-severe refractory Crohn’s disease.
DISSOLUTION ENHANCEMENT - Dissolution Enhancement Through Factorally Designed Porous Solid Dispersions
Balwan Singh and Harish Dureja, PhD, use mathematical models developed in their present study to predict cumulative percentage of glimepiride from PSDs. These models can then be utilized to formulate PSDs with desired glimepiride release.
REGULATORY GUIDANCE - Staying on Top of FDA Guidance for Industry - Training Webinars Foster Transparency & Collaboration
Frost & Sullivan recently tuned into three webinars that were considered to be particularly relevant to current hot topics and therapy areas, and then reviews the current trends and needs behind each new or revised guidance document and key insights for potential sponsors.
EXTERNAL DELIVERY - Crisis Management
The saying, “when the going gets tough, the tough get going,” always comes to mind when I hear about the challenges facing many companies, particularly…
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.
TOPICAL DELIVERY - The Importance of the Right Formulation in Topical Drug Development
Vijendra Nalamothu, PhD, reports that the importance of the right formulation and delivery method in topical pharmaceuticals is critical. It can mean the success or failure of drug substance, and getting the preparation right from the outset saves money and time.
THERAPEUTIC FOCUS - Targeted Payload Therapies Radiate Potential to Attack Various Cancers
Kaushik J. Dave, PhD, MBA, and Dragan Cicic, MD, MBA, indicate that alpha-particle emitters, such as bismuth-213 or actinium-225, may be more effective and efficient at killing cancerous cells not currently treated with radiation while simultaneously decreasing nonspecific cytotoxic effects.
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.
ADVANCED DELIVERY DEVICES - Innovation Without Change: What is it & What Can it Mean for Pharmaceutical Manufacturers?
John A. Merhige, MEM, and Dan Thayer believe a rigorous, risky development and regulatory process forces pharmaceutical manufacturers into a bad compromise between advances in delivery systems and the time, cost, and risk associated with those advances.
THE SECOND QUADRANT - Outsourcing Solubilization: Making Bioavailability More Broadly Available
Marshall Crew, PhD, explores how the contract services and manufacturing market has responded to the opportunity presented by the rising numbers of BCS Type II/IV clinical compounds and solubilized commercial products.
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?
EXCIPIENT UPDATE - Soluplus®: An Understanding of Supersaturation From Amorphous Solid Dispersions
Oksana Tsinman, Konstantin Tsinman, PhD, and Shaukat Ali, PhD, describe the application of a hydrophilic polymeric solubilizer in solid dispersions of a model drug carbamazepine. The scope of this study is limited to understanding of hydrophilic polymers and their behaviors on amorphous dispersions.
EXECUTIVE INTERVIEW - Avomeen: A Unique Approach to the Traditional Analytical CRO
Shri Thanedar, PhD, CEO & Chief Chemist at Avomeen Analytical Services, discusses what sets his company’s analytical laboratory apart from other CROs that serve the pharmaceutical industry.
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.
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.
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.
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.
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.
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.
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.
