Featured Articles
M*A*S*H
John A. Bermingham explains how it is incumbent upon CEOs and their management teams to triage all functional areas of the company when in times of trouble and the investors are looking for a quick fix to stop the bleeding.
MANAGEMENT INSIGHT - Rook to D7: Game Theory in the Pharma Industry
Derek G. Hennecke continues with part 4 of 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 FORECASTING - Monte Carlo-Based Forecasting: How to Deal With Uncertainty
Jemma Lampkin and Gerard Loosschilder, PhD, show how Monte Carlo-based forecasts are better at handling uncertainties, turning them into valuable tools for product managers and marketers engaged in strategic business planning.
TRANSDERMAL DELIVERY - New Frontiers in Transdermal Drug Delivery
Kenneth B. Kirby and Chandan A.S. Alam, MD, are part of a team at Transdermal Delivery Solutions Corp. (TDSC) that has been leveraging its patented technology to develop a unique patchless, metered pump, spray-on drug delivery system and products.
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.
EXCIPIENT UPDATE - A Real Eye-Opener: Advances in Hyaluronic Acid for Ophthalmology
Hans Ole Klingenberg explains how Bacillus-derived HA offers new opportunities for ophthalmic applications by providing a safe and biocompatible source that can streamline manufacturing processes, while offering convenient application and increased patient comfort and compliance.
ADVANCED DELIVERY DEVICES - IntelliCap: An Intelligent, Electronic Capsule for Oral Drug Delivery & Development
Jeff Shimizu and Christoph Wanke, PhD, indicate electronic smart pills represent an emerging area with great potential for growth. Already established in the diagnostic area, the next move is into monitoring and drug delivery.
EXECUTIVE SUMMARY - Asmacure, Ltée: A New Mechanism for the Treatment for Asthma
Executive Summary: Martin Driscoll, CEO of Asmacure, talks about his company’s unique, yet practical approach to treating asthma and its core symptoms.
FORMULATION SELECTION - Amorphous Dispersions & Other Tools for Drug Discovery Formulation Support
Corey J. Bloom, PhD, and David K. Lyon, PhD, describe broadly applicable formulation approaches and biomodeling tools that have been successfully used to improve the solubility and in vivo performance of lowsolubility compounds.
IMPURITIES DETECTION - Impurities Detection in Pharmaceuticals
Kevin P. Menard, PhD, focuses on the detection of residual solvents from processing and small levels of contaminates leached from containers.
INNOVATION AWARDS - Drug Delivery Award Winners Move Innovation Needle; Formulation Takes Center Stage
Marc Dresner presents the three companies that were honored by their industry peers with prestigious awards for breakthrough drug delivery innovation at the Institute for International Research’s 17th annual Drug Delivery Partnerships conference.
MANAGEMENT INSIGHT - Listening to the Voice of Inexperience
Derek G. Hennecke continues with part 3 of 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.
SPECIAL REPORT - Outsourcing Formulation Development and Manufacturing: An Early Approach Saves Time and Money
In this Special Report, Contributor Cindy H. Dubin asks many of the leading companies in this sector what challenges pharma currently faces in formulation and manufacturing and how they, as third-party providers, are helping to alleviate those burdens.
THERAPEUTIC FOCUS: Sufentanil NanoTab Technology: Revolutionizing Patient-Controlled Analgesia
Pamela P. Palmer, MD, PhD; examines how AcelRx’s system can deliver the benefits of PCA in terms of patient pain relief and satisfaction while reducing both drug and device safety risks as well as the overall complexity of pain management, thus reducing both drug and device safety risks as well as the overall complexity of pain management, thus reducing the cost burden on the healthcare system.
EXECUTIVE INTERVIEW - Agere: Solubilization: Accessing Broader Chemistries by Integrating Fundamental Science With Automation for Greater Predictability
Drug Development Executive: Marshall Crew, President & CEO of Agere, discusses how the company is taking a different approach that leverages expertise, but relies heavily on the principles of physical chemistry to enable automation.
FORMULATION DEVELOPMENT - Bioavailability Enhancement Strategies & Opportunities
Frost & Sullivan Analyst Ruplekha Choudhurie reviews some BA approaches that are being developed by a number of companies that can mitigate the biological, physical, and chemical barriers for effective delivery of poorly soluble and permeable drugs.
SPECIAL FEATURE - Analytical Instrumentation Gets Faster, Smaller, and Easier to Use
Contributor Cindy H. Dubin learns that one doesn’t have to be a rocket scientist to use analytical instrumentation. Three leading players in the market showcase their products, all aimed at making analysis easier and faster.
EXECUTIVE INTERVIEW - AAIPharma: Making the CDMO a One-Stop-Shop for Manufacturing, Development & Analytical Services
Drug Development Executive: Patrick Walsh, CEO, and Board Director of AAIPharma Services Corp., talks about the role of a CDMO in today’s pharma and biotech space, why companies may choose to partner with a CDMO, and how the company has managed to maintain a leading position in the market.
