Featured Articles
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.
MANAGEMENT INSIGHT - Digital Soup
Derek G. Hennecke continues with part 5 on a new 6-part series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
MARKET BRIEF - Controlled Release Technologies: Advancing Toward Targeting Therapeutics
Frost & Sullivan Analyst Cecilia Van Cauwenberghe, MS, reviews a few recent innovative approaches to controlled release technologies with a focus on some of the therapeutic areas most relevant to the current pharmaceuticals market.
ORALLY DISINTEGRATING TABLETS - Novel Controlled Release Formulation for Orally Disintegrating Tablets Using Ion Exchange Resins
Abhijit Gokhale, PhD, and Praba Sundararajan indicate that drugs not typically amenable to ODT formulations include those that present taste-masking difficulties or require controlled or sustained release. However, as the demand for ODTs continues to grow, formulation scientists are exploring ways to adapt ODT formulations for drugs that require controlled or sustained release for optimal therapeutic benefits.
THERAPEUTIC FOCUS - Evaluation of a Needleless Injection Technique for Treatment of Peyronie’s Disease: a Feasibility Case Study
Jeffrey Marotte, MD, FACS, presents a proof of concept that the Madajet may be a suitable instrument to inject medication into Peyronie’s plaques.
ADVANCED DELIVERY DEVICES - Tackling Traditional Usability Issues With Innovative Device Design
George Perkins believes that by addressing the stigma and usability issues of self-administered injections, it is possible to make them the more attractive method for the administration of drugs in various scenarios.
BIOAVAILABILITY ENHANCEMENT - Out of the Shadows: Excipients Take the Spotlight; Part 1 of 2
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
BUSINESS DEVELOPMENT- The Performance Report
John A. Bermingham says a performance report should be a document in which you and the person you are reviewing take the opportunity to talk about that person’s job performance not just from your perspective but from the reviewee’s perspective.
CELL CULTURE MEDIA - Addressing Variability in Dry Powder Mammalian Cell Culture Media
Jörg von Hagen, PhD, believes it is critical for media manufacturers to have a process in place that can consistently deliver raw material and process quality to be able to deliver batch-to-batch consistent dry powder cell culture media that are scalable from kilograms to tons.
EXECUTIVE INTERVIEW - Radius Health, Inc.: New Solutions for Healthy Aging
Drug Development Executive: Michael S. Wyzga, President & CEO of Radius Health, Inc., discusses what his company is bringing to the underserved market for women’s healthy aging solutions.
LIPOSOME PREPARATION TECHNOLOGY - Freeze Fracture Electron Microscopic (ff EM) Examination & Analysis of Liposomes Produced by Covaris AFA Technology
Srikanth Kakumanu, PhD, and Rajeev A. Jain, PhD, explain how an alternative ultrasonic processing technology allows manufacturing of liposomes of predetermined sizes and offers an efficient, isothermal, and non-contact process.
SPECIAL REPORT - Prefilled Syringes & Parenteral Contract Manufacturing: Improving for Flexibility & Customization
Special Feature: Contributor Cindy H. Dubin speaks with prefilled syringe manufacturers as well as contract parenteral manufacturers who share their thoughts about the delivery challenges associated with high-viscous, high-volume formulations.
ADVANCED DELIVERY DEVICES - Important Considerations in the Delivery of Large-Volume & Viscous Drugs
Kevin Cancelliere, MS, believes that as the trend toward self-administration continues, the need for careful consideration of primary container design, interaction with the drug product, method of administration, and end-user needs becomes even more critical.
AUTOLOGOUS CELL THERAPIES - Development of Autologous Cell Therapies: Keys to Clinical & Commercial Success
Ronnda L. Bartel, PhD, Tod Borton, and Brian S. Hampson review how Aastrom Biosciences has developed the innovative processes necessary to reduce risk throughout the manufacturing process. The company is now preparing for future commercialization for its investigational therapy derived from a patient’s own bone marrow stem cells.
