EXECUTIVE INTERVIEW - Capsugel DFS: Integrating Technology for Innovative Finished Dosage Forms
Drug Development Executive: Amit Patel, President of Capsugel’s Dosage Form Solutions business unit, speaks about the formulation challenges facing the industry and the increasing pressure on companies to remain competitive in today’s dynamic marketplace.
EXCIPIENT UPDATE - Maximizing the Stability of Therapeutic Proteins Using Recombinant Human Albumin
Mark Perkins, PhD, reviews some of the important factors involved, and highlights the advantages of including recombinant human albumin to stabilize protein therapeutics with reference to a recent case study.
BIOAVAILABILITY ENHANCEMENT - Navigating a Broad Spectrum of Solubilization Technologies: Part I of III
In the past two columns, The Second Quadrant focused on excipients and the roles they play in the quest to overcome bioavailability challenges of poorly…
EXECUTIVE INTERVIEW - Vetter: Successfully Bridging the Innovation Gap in Drug Development & Manufacturing
BIOGRAPHY Claudia Roth, PhD President, Vetter Development Service Chicago “We are noticing that CDMOs are acting more and more as the interface between small biotech…
TOPICAL TRENDS - Trends in Skin Medication Dispensing
Stefan Hellbardt, PhD, and Degenhard Marx, PhD, focus their review on the trends in topical skin medication, the impact on primary packaging, and possible dispensing solutions.
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.…
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.
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.
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.
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.
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.
