Featured Articles
MANAGEMENT INSIGHT - CDMOs Take Flight: Business Lessons From the Airline Industry
Derek Hennecke spends a lot of his time on an airplane and takes a moment to reflect on the similarities between the airline business and his own. In his opinion, there is no industry more similar to ours.
EXECUTIVE INTERVIEW - SGS Life Science Services: Getting Medicines to Market Quickly & Safely
Drug Development Executive: Mark Rogers, PhD, Senior Vice President Life Science Services at SGS, talks about his company’s evolutionary development and the trends it is witnessing in the analytical testing market.
EXECUTIVE INTERVIEW - BioSpectra: Trusted & Reliabe Source for Intermediates
Drug Development Executive: Richard Mutchler, President of BioSpectra, discusses the company’s unique ability to provide customers with validated, secure, and traceable intermediates that remain affordable.
BUSINESS DEVELOPMENT - Lead Me, Follow Me, or Get Out of My Way
The original quote, “lead, follow, or get out of the way” is attributed to Thomas Paine. The title of this article is a quote attributed…
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.
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.
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.
SPECIAL FEATURE - Patients & Physicians Desire Transdermal, Topical & Subcutaneous Delivery
Contributor Cindy H. Dubin recently interviewed several topical, transdermal, and subcutaneous product manufacturers to find out how they are working with patients and physicians to develop delivery systems that meet their needs for comfort, compliance, and more effective delivery.
BIOSIMILARS - The US Biosimilar Approval Pathway: Policy Precedes Science
David Shoemaker, PhD, says the origin of the BPCIA had its roots in the Drug Price Competition and Patent Restoration Act of 1984 championed by Senators Waxman and Hatch, which has provided low-cost generic alternatives to prescription brand-name drugs for the three subsequent decades. What Congress failed to appreciate at the time was the current state of protein characterization science and consequently whether interchangeability could in fact be obtained or what level of biosimilarity was acceptable.
REGULATORY REVIEW - Regulators Make Intentions Clear on Transparency & Harmonization
Erick Gaussens says that continued emphasis on data transparency and on streamlining of the submission process – to the benefit of both regulatory agencies and pharma companies – create both opportunities and challenges for companies.
MARKET BRIEF - Sequestration Haunts Life Science Research Tool Market Into 2014
Christi Bird, Senior Industry Analyst, Frost & Sullivan, believes the bleakest outlook provided for the life sciences industry is one without a clear light at the end of the tunnel, and successful companies will buckle down to determine long-term strategies for beating the lackluster numbers expected from a sustained austerity policy.
MANAGEMENT INSIGHT - The Secret to Successful Global Expansion is to Bring Your RATs & CATs Together
Derek Hennecke shares his strategy for getting ahead in the global race by following the RAT/CAT virtuous cycle approach to creating and sustaining global advantage developed by Donald Lessard, Rafael Lucea, and Luis Vives in “Building Your Company’s Capabilities Through Global Expansion,” MIT Sloan Management Review.
BIOAVAILABIITY ENHANCEMENT - Innovators & Corporate Cultures: Symbiotic Relationships
Marshall Crew, PhD, explores some of the key features of people and organizations that lead to the innovations and products, and hopes that by example, insights can be acquired that will be useful in his colleagues respective organizations and that might ultimately lead to more innovation in the industry.
PEPTIDES & ANTIBODIES - Peptides in Antibody & Peptide Drug Conjugates
Archana Gangakhedkar, MS, and Jyothi Thundimadathil, PhD, indicate peptide-based linkers are promising counterparts in ADCs, providing tumor-specific cleavable and stable circulating linkers, and a new emerging class of PDCs is proving to be useful toward a broad spectrum of indications when compared to ADCs.
