Mark Weinstein, Eduardo F. Motti, M.D., Dr. Nicholas Alp, E. David G. McIntosh, Ph.D., Laurence G. Poli, Ph.D.
Late phase clinical research has become a growing focus for regulators, CROs and biopharmaceutical and medical device companies. Increasing requirements for long-term safety and effectiveness of data collection during the peri-approval and post-marketing periods pose both challenges and opportunities. The challenge is to design global studies to collect the right kind of data while providing cost-effective strategies and utilizing appropriate methodologies for analysis and reporting.
Frances Grote
In any venue where clinical development outsourcing is being discussed, sooner or later someone always seems to wonder aloud if small companies can get the same attention from their providers that large companies do. What’s intriguing about this question is that if you put it to the people working in outsourced models you’re just as likely to hear a high level of satisfaction from those in small companies as from those at the largest sponsors. Interestingly, you may also hear from the largest sponsors that they’re not getting what they expected. For some of those large companies, the challenges in realizing their outsourcing goals have been so great that they’ve completely revamped their strategies in recent years. And whether an organization has made a strategic decision to outsource in a particular fashion such as functional service provider or full-service or has ended up with a patchwork of solutions, you’re likely to find both strong supporters and dissatisfaction even within that
Eric S. Langer
The significant differences in business models between contract manufacturing organizations (CMOs) and biotherapeutic developers translates to very divergent reasons for their increased use of disposable, single-use biomanufacturing devices, according to results from our 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production[1]. The CMO business model, which is built around a pipeline of multiple projects, needs smaller footprint requirements to generate higher revenue. Faster turnaround times and cleaning between campaigns are major factors in decision making for CMOs, as well.
Kenneth C. Waterman
Among the challenges involved in developing acceptable commercial dosage forms for active pharmaceutical ingredients (API’s) is demonstrating adequate chemical stability [1,2]. Expiration dating is generally determined based on the time a drug product remains within specification limits of potency or of individual or total degradation products. This review introduces a procedure for stability assessments of solid drug products and solid API’s that provides credible predictions for product expiration dating, improves product understanding, reduces uncertainty, and has the potential to change the way the pharmaceutical industry meets its stability commitments for clinical investigations, drug product registration and post-approval changes. This process also significantly reduces the time needed to make stability assessments without adding any risks to patients.
Michael Burdick
The proper classification, packaging, labeling, marking, and shipping of hazardous materials are an increasingly important aspect of remaining competitive in today’s business climate. This is especially the case with biological products and infectious substances used in testing, research, and the treatment of disease. It is often critical for these products to move in a timely and efficient process through the transportation system. In this highly competitive industry, delays that can result from the improper preparation of your shipment can become a ‘make or break’ issue. The correct classification of your existing products, the commodities you are developing, and the wares you are using daily in your production processes or at your facilities, can be the difference between timely delivery and substantial shipping delays and potential enforcement action.