July/August 2013

COVER

SPECIAL FEATURE - Transdermal, Topical & Subcutaneous Drug Delivery: Extending Pipelines & Improving Self-Administration

Contributor Cindy H. Dubin explores how the movement of home care and self- administration is pushing the development of this growing sector in drug delivery.

FEATURES

SPECIAL FEATURE - Transdermal, Topical & Subcutaneous Drug Delivery: Extending Pipelines & Improving Self-Administration

Contributor Cindy H. Dubin explores how the movement of home care and self- administration is pushing the development of this growing sector in drug delivery.

MARKETING MATTERS - 3E Trilogy: Entertain, Educate & Engage...Become an Infotainer

David F. Scelba continues his multiple part series on effective messaging and communications in the life science industry.

BIOAVAILABILITY ENHANCEMENT - Out of the Shadows: Excipients Take the Spotlight; Part 2 of 2

In June’s edition of The Second Quadrant, we heard from leading excipient providers about challenges faced directly related to formulating with excipients for greater bioavailability. They also made suggestions for..

BUSINESS DEVELOPMENT- Big Brother/Little Brother

John A. Bermingham believes the word anonymous may soon disappear from our language, that is if Little Brother has anything to do with it.

EXECUTIVE INTERVIEW - West Pharmaceutical Services: Celebrating 90 Years of Healthcare Innovation

Drug Development Executive: Donald E. Morel, Jr., PhD, Chairman and CEO, West, discusses how the company works closely with pharmaceutical and biotechnology companies to deliver life-changing therapies safely and effectively to patients.

FORMULATION DEVELOPMENT - Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability & Dosage Form

John Baumann, Dan Dobry, and Rod Ray, PhD, review the development and use of amorphous SDDs and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and incorporation into final dosage forms.

GENOMIC BIOMARKERS - EGFR Mutations, Apoptosis & Gefitinib Response: A Model for Integrating Genomic Biomarkers Into Successful Precision Medicine

Sirosh Bokhari, PhD, says by not recognizing the importance of integrating biomarkers early in drug development and not considering companion diagnostics as an ultimate goal, companies would not be ready to select a companion diagnostic partner and negotiate agreements with long-term implications.

MANAGEMENT INSIGHT - Lessons From the Auto Industry

Derek G. Hennecke concludes his 6-part series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.

MASS SPECTROMETRY - Access for All - A New Solution to the Age Old Challenge of a Multi-Vendor Open Access Laboratory

Hayley Crowe reviews AxION(R) eDoor(TM), a web-based, multi-vendor, open-access software platform that addresses all the complexities associated with analytical mass spectrometry analysis.

PAIN MANAGEMENT - Rapid Action Therapy in Pain Relief: Potential for Nasal Delivery Systems

Shunji Haruta, PhD, examines a dry-powder carrier technology and line of delivery devices that help formulations meet the criteria for rapid action and successful delivery of pain therapies.

PREDICTIVE MODELING - Predicting Price Changes of Oncology Drugs in the US: Can Proportional Hazard Models Predict the Timing & Percentage of Changes?

Bruce Wang, PhD, MA, suggests that Cox Proportional Hazard Models can be used to predict price change percentages and timing of prescription drugs in the market, which is extremely valuable as it enables more informed insights through predictive modeling and analytics on the lifecycle of a drug.