March 2015

COVER

SPECIAL FEATURE - Bioavailability & Solubility: A Demand for Enhanced Technologies & Materials is Spurring Innovation

Contributor Cindy H. Dubin spoke with several contract research/manufacturing organizations on how they are successfully overcoming solubility/bioavailability challenges, such as matching APIs to formulations and choosing the best excipients.

FEATURES

MARKET BRIEF - Miniaturizing Healthcare - From Microelectronics to Nanobiosensing

Cecilia Van Cauwenberghe, MS, Technical Insights Senior Research Analyst, Frost & Sullivan, reports that the proliferation of lower cost microfluidics-based genomics tools offering improved capabilities and allowing more access to end-users is expected to drive this technology for pharmaceutical and biomedical research throughout the next 5 years.

SPECIAL FEATURE - Bioavailability & Solubility: A Demand for Enhanced Technologies & Materials is Spurring Innovation

Contributor Cindy H. Dubin spoke with several contract research/manufacturing organizations on how they are successfully overcoming solubility/bioavailability challenges, such as matching APIs to formulations and choosing the best excipients.

DYNAMIC LIGHT SCATTERING - Colloidal Gold: The Gold Standard for Drug Delivery?

Stephen Ball explores the importance of particle size in biomedical nanotechnology. Experimental data are presented to illustrate how advanced DLS techniques deliver these measurements for colloidal gold in the nanosized and sub-nanosized ranges.

COMBINATION PRODUCTS - Human Factors & Combination Products

Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.

MANAGEMENT INSIGHT - The Specific Peck Response & How Express Scripts Has Changed the Future Course of Drug Pricing

In the book, The Bird, author Colin Tudge describes how his favorite pub once ran out of peanuts and lamely proffered a medley of Japanese biscuits in their place. The..

EXECUTIVE INTERVIEW - Ascendia Pharmaceuticals: Sophisticated Formulations for Poorly Soluble Drugs

Jingjun (Jim) Huang, PhD, CEO, and Founder of Ascendia, discusses his company’s unique vision and strategy to provide pharmaceutical companies with a contract research partner that can provide technologies in order to efficiently determine which approach is most suitable for a given molecule.

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 when the issue a company..