This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.
While implementing online water bioburden analyzer (OWBA) technology might seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.
Technology plays a critical role in drug development and the R&D value chain by revolutionizing clinical trials and decreasing the failure rate. Though the supply of technology has been increasing and regulation of innovative methods is easing, pharmaceutical companies have been slow to use the emerging technologies, due to the ambiguity prevailing around this space and a highly fragmented supply market. This article outlines the key technologies that have a high impact across trial phases.
This article explores some of the typical issues that may be encountered during recovery studies and show how the use of statistical tools for assessing the recovery data can provide greater insight into the results and enable data-driven decisions concerning recovery studies. To do so, we will look at three case studies.
With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.
The true effect of an intervention is often not seen until real-world usage takes place, but with such a delay between R&D and healthcare delivery, how can the industry close the gap? And what is needed to deliver more effective interventions that patients really want?
Progress in development of gene and cell therapies around the world has potential to transform standards of care for a range of diseases and address significant areas of unmet need in healthcare over the coming years. In the U.S. alone, almost 20 gene and cell therapy products have been approved thus far,1 with many other development programs reaching later clinical stages. The technology platforms of many of these drugs also offer the potential for curative efficacy and expansion for use in multiple indications.
The regenerative medicine sector is at a remarkable moment. Transformative products are now on the market and accessible to greater numbers of patients every day. Dozens of additional therapies are in late stage studies. The regulatory and policy environment has evolved rapidly alongside the science, enabling a surge of incoming innovation.
A range of factors — including small patient populations, complex manufacturing processes, and lack of specialized expertise — are positioned to both drive up costs and require new options for stakeholder engagement and risk sharing along the development pathway. New approaches in development are needed to support the next generation of novel drugs on the horizon.
Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.