September 2014

COVER

SPECIAL FEATURE - Injectable Drug Delivery: Safer, Simpler, Smarter Devices

Contributor Cindy H. Dubin speaks with some of the leading companies operating in the injectables arena, and discovers this ever-evolving sector is witnessing some very specific and eye-opening trends that are affecting the market’s growth.

FEATURES

SPECIAL FEATURE - Injectable Drug Delivery: Safer, Simpler, Smarter Devices

Contributor Cindy H. Dubin speaks with some of the leading companies operating in the injectables arena, and discovers this ever-evolving sector is witnessing some very specific and eye-opening trends that are affecting the market’s growth.

CLINICAL TRIALS - Recruitment Challenges for Proof-of-Concept Viral Challenge Trials

Robert Lins, MD, says contrary to most perceptions, patient recruitment is a difficult process, and finding adequate numbers of suitable subjects is frequently the biggest barrier to trial success, and the most common reason why most clinical trials face delays.

PARENTERAL CONTAINERS - A Novel Approach to Mitigating Oxygen Permeation in Prefilled Syringes

Peter Sagona, MS, Rómulo Romero, MS, and Adam Breeland report that biological systems are entering the market place at an increased rate, and thus focus on the importance of designing a primary container system (prefilled syringe) for the minimization of oxygen exposure to the drug product.

LEACHABLES STUDIES - Investigating Leachables in Oral Solid Dosage Forms

Chris Connolly and Niculae Miron indicate that with increasingly potent drug products and lower acceptable levels of contaminants today, more-sensitive analytical methods must be used to detect and analyze leachables and determine drug product safety.

BIOAVAILABILITY ENHANCEMENT - Potential for Expanding Chemical Space

Marshall Crew, PhD, focuses on considering what might be achieved if we borrow best practices and processes that have assisted other industries facing growing complexity, in fact, much of the advances in accelerating our solubilization processes are already borrowed from other industries, in many cases even the technologies.

EXECUTIVE INTERVIEW - Cronos: Innovation in Clinical Trial Services Through Focus on Quality Data

Drug Development Executive: Guillermo DiClemente, Founder & President of Cronos Clinical Consulting Service, discusses the company’s unique approach, its relationship with customers, industry trends, and the importance of focusing on quality clinical data.

EXECUTIVE INTERVIEW - Foster Delivery Science: Unmatched History & Uncompromising Focus in Hot-Melt Extrusion

Drug Development Executive: Larry Acquarulo, CEO of Foster Corporation, talks about the history of Foster Delivery Science, their highly focused strategy in melt extrusion, and future plans for the business.

MANAGEMENT INSIGHT - The Davids of Drug Development

Derek Hennecke believes every one of us is a little guy, facing insurmountable odds, scouring the countless compounds of the universe in search of a cure. Most of them sizzle and die out. And yet we move on, like addicts in search of a buzz, pursuing that moment again; that one incredible high that is drug discovery.

BUSINESS DEVELOPMENT - Founder's Syndrome

John Bermingham says Founder’s Syndrome is defined as a situation that occurs when an organization operates according to the personality of a dominate person within the organization, usually the founder. This syndrome normally occurs when an organization begins to achieve revenue growth at a level that requires a change in management style and how things get done, and this type of problem can be very difficult to deal with.