January/February 2012

TABLE OF CONTENTS

COVER

BIOAVAILABILITY ENHANCEMENT – A Novel Spray-Drying Technology to Improve the Bioavailability of Biopharmaceutical Classification System Class II Molecules

David Shi, PhD; Andrew Loxley, PhD; Robert W. Lee, PhD; and David Fairhurst, PhD; briefly discuss a proven and scalable solid dispersion approach based on spray-drying that is suitable for BCS Class II APIs and NCEs.

FEATURES

CONTRACT MANAGEMENT – ROI Optimization Through Contract Management

Laszlo Fabriczi says contract management system implementations typically cause significant shifts from the manual processes in place to a more automated contracting culture; thus, an integrated approach must be taken that includes the technology and business process transformation and associated change management to fully derive significant benefits for the business.

DISSOLUTION ENHANCEMENT – Nanonization: A Dissolution Enhancement Approach for BCS Class II Drugs

Anand Shah, MPharm; Sunny Shah, MPharm; Vipul Patel, MPharm, PhD; and Arti Potdar, MPharm; review the various approaches adapted to nanonize the drug, the characterization of the prepared drug nanoparticles, and their applications.

DRUG DEVELOPMENT – Advancing Personalized Medicine: A Seamless Solution to Discover & Deliver Novel Diagnostic Tests

The use of companion diagnostics in conjunction with custom pharmaceuticals is expected to expand as the promise of personalized medicine continues to be realized. However, a concurrent development cycle of both diagnostic and therapeutic requires a complex synergy of both diagnostic and drug development, and represents a significant deviation from the current pharmaceutical model.

EXECUTIVE INTERVIEW – Immunovaccine, Inc: Developing More Effective Cancer Vaccines

Dr. Marc Mansour, Chief Operating Officer & Chief Science Officer of Immunovaccine, discusses the DepoVax platform and the company’s clinical trials for DPX-0907 and DPX-Survivac.

EXECUTIVE INTERVIEW – NanoSmart Pharmaceuticals: Patented Delivery Platform Using Human Autoimmune Antibodies to Target Cancers & Other Debilitating Diseases

Dr. James Smith, President of NanoSmart Pharmaceuticals, discusses his company’s innovative approach to drug delivery using immunoliposomes and their unique targeting ability.

FORMULATION DEVELOPMENT – Oral Administration of an Insulin-Soybean Suspension in Streptozocin Rats: Effect of Aqueous Soybean Extract Vehicle

Antoine Al-Achi, PhD; Brijesh Patel, MS; and Sejal Patel, MS; investigate in this study the hypoglycemic activity of an insulin suspension given orally in a vehicle of soybean extract to streptozocin diabetic rats.

CLINICAL TRIALS – Overview of Challenges in Oncology Studies

David Underwood provides an overview of some of the significant challenges (and associated recommendations) in setting up, conducting, and reporting oncology studies.

MARKET BRIEF – Stakeholders Portrait in the Pharmaceutical Industry

Frost & Sullivan Analyst Cecilia E. Van Cauwenberghe says that even though pharmaceutical and biotechnology companies, as with healthcare industry representatives, will continue to play a leading role, many players characterize the current industry landscape with many disciplines and technologies.

BIOAVAILABILITY ENHANCEMENT – A Novel Spray-Drying Technology to Improve the Bioavailability of Biopharmaceutical Classification System Class II Molecules

David Shi, PhD; Andrew Loxley, PhD; Robert W. Lee, PhD; and David Fairhurst, PhD; briefly discuss a proven and scalable solid dispersion approach based on spray-drying that is suitable for BCS Class II APIs and NCEs.

COVER

FEATURES