A comparative assessment by optical coherence tomography of the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds

The first generation of the everolimus-eluting bioresorbable vascular scaffold (BVS 1.0) showed an angiographic late loss higher than the metallic everolimus-eluting stent Xience V due to scaffold shrinkage. The new generation (BVS 1.1) presents a different design and manufacturing process than the BVS 1.0. This study sought to evaluate the differences in late shrinkage, neointimal response, and bioresorption process between these two scaffold generations using optical coherence tomography (OCT).

Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes

The first generation of the bioresorbable everolimus drug-eluting vascular scaffold showed signs of shrinkage at 6 months, which largely contributed to late luminal loss. Nevertheless, late luminal loss was less than that observed with bare metal stents. To maintain the mechanical integrity of the device up to 6 months, the scaffold design and manufacturing process of its polymer were modified.

Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. LAY ABSTRACT: Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here explains how a biopharmaceutical process FMEA can be conducted. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. With the help of this guideline, different details of the manufacturing process can be ranked according to their potential risks, and this can help pharmaceutical companies to identify aspects with high potential risks and to react accordingly to improve the safety of medicines.

Making co-management work in protected areas with indigenous peoples in Bolivia and Peru

Sustainable and equitable management of biodiversity in protected areas inhabited by indigenous peoples is often a challenge. It requires an intercultural dialogue based on local norms of resource use and indigenous knowledge. Moreover, mechanisms that generate economic incentives must be able to compete with income from illegal activities such as logging, mining, and land trafficking. Finally, efforts are needed to ensure that regulations and policies on conservation and resource extraction do not overlap and contradict each other, as this hampers efforts both to conserve biodiversity and to promote development at the local level.

Segmentation and Segregation Patterns of Women-Owned High-Tech Firms in Four Metropolitan Regions in the United States

Mayer H. Segmentation and segregation patterns of women-owned high-tech firms in four metropolitan regions in the United States, Regional Studies. The number of women starting and owning a business has increased dramatically and female entrepreneurs are entering non-traditional sectors such as high technology, construction and manufacturing. This paper investigates the trends in high-tech entrepreneurship by women in four US metropolitan regions (Silicon Valley, California; Boston, Massachusetts; Washington, DC; and Portland, Oregon). The research examines the sectoral and spatial segmentation patterns of women-owned high-tech firms. Although women are entering non-traditional sectors, the research finds that women entrepreneurs tend to own businesses in female-typed high-tech sectors. In established high-tech regions like Silicon Valley and Boston, male-typed and female-typed women-owned high-tech firms differ significantly in terms of sectoral and spatial segmentation regardless of firm age. While differences between male-typed and female-typed firms are not significant at the regional level for Washington, DC, the analysis shows significant intra-metropolitan differences for the female-typed high-tech firms. The paper concludes that sectoral and spatial segmentation are powerful dynamics that shape business ownership by women in high technology.