Featured Articles
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.
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 - Delivering Gastric-Resistant Functionality Via a Colorless Top Coat
Philip J. Butler and Thorsten Cech investigate the gastric-resistant functionality obtained by applying a clear, two-component MAE coating formulation onto a tablet sub-coated with a pigmented instant-release coating and investigate the impact of hydrophilic and lipophilic plasticizers on the film characteristics of MAE-based coating formulations.
EXECUTIVE INTERVIEW - SNBL, Ltd.: Innovation in Drug Delivery Enabled Through a Unique Business Model
Drug Development Executive: Dr. Shunji Haruta, Founder of NDS (Nasal Delivery Systems) Division and Executive Officer, SNBL, Ltd., discusses how NDS Division and its powder nasal delivery platform, µco System, fit into a new paradigm.
FORMULATION DEVELOPMENT - A Call for Collaboration to Meet the Bioavailability Challenge
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., begins his multiple-part series discussing today’s most challenging issues in solubility.
FORMULATION DEVELOPMENT - Trends & Opportunities in Particle Design Technologies - Life Sciences & Biopharma in the Spotlight
Frost & Sullivan Analyst, Cecilia Van Cauwenberghe, MS, examines the observed trends in particle design and engineering technologies, as well as the main factors and opportunities driving the principal technological advances in the biopharmaceutical industry.
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.
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.
