With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.
The “cold chain” is simply a supply chain with temperature requirements factored in. Cold chain (or, in some contexts, “cool chain”) encompasses the container of the product being shipped, the storage facilities (from point of manufacture to point of dispensation), and the transportation modes (air, ground, ocean). By DDN
Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.
An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease.
While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.
Are you are getting your money’s worth from your clinical trials? As clinical trial costs expand and margins thin, this question becomes increasingly important. But it is currently hard to know if your clinical study team is performing well. It’s an ironic dilemma – even though life sciences is a data-intensive industry, measuring the performance of clinical trials is still an immature science.
Our on-going research, the Clinical Trials Outsourcing Performance (C-TOP) project is an academic-industry collaboration studying how to improve measurement of clinical trial performance. The goal is to develop scientific measures that will complement existing operational and financial metrics.
Current techniques used to separate adherent mammalian cells from microcarrier beads often use sophisticated equipment, requiring significant capital expenditure as well as routine maintenance, and cleaning and sterilization between uses.
This white paper, brought to you by Dassault Systèmes BIOVIA, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.
The ÄKTA™ pcc 75 chromatography system can be used for purification of target proteins in continuous downstream processes using periodic counter-current chromatography (PCC). PCC enables greater utilization of the chromatography medium (resin) capacity, allowing sample loading to much higher levels compared with what is possible in traditional batch chromatography.
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