Weighing up the evidence used by direct-to-consumer stem cell businesses.

Hundreds of businesses across the United States offer direct-to-consumer stem-cell-based interventions that have not been approved by the Food and Drug Administration. Here, we characterize the types of evidence used on the websites of 59 stem cell businesses in the Southwest United States to market their services. We identify over a dozen forms of evidence, noting that businesses are less likely to rely on "gold-standard" scientific evidence, like randomized clinical trials, and instead draw substantially on forms of evidence that we identify as being "ambiguous." Ambiguous evidence has some scientific or medical basis, but its interpretation is highly context-dependent. These findings highlight the interpretive responsibility placed on prospective patients. We identify actions for regulators and professional societies to assist with evaluating evidence, but caution that focusing on the (in)validity of particular evidence types is unlikely to eliminate demand for stem-cell-based treatments in this complex marketplace.

Exploring presentations of sustainability by US synthetic biology companies.

The field of synthetic biology is increasingly being positioned as a key driver of a more sustainable, bio-based economy, and has seen rapid industry growth over the past 15 years. In this paper we undertake an exploratory investigation of the relationship between sustainability and synthetic biology, identifying and analyzing sustainability-related language on the public websites of 24, US-based synthetic biology companies. We observe that sustainability is a visible part of the self-presentation of the nascent synthetic biology industry, explicitly mentioned by 18 of the 24 companies. The dominant framing of sustainability on these company websites emphasizes environmental gains and "free-market" approaches to sustainability, with little explicit mention of social dimensions of sustainability such as access, justice or intergenerational equity. Furthermore, the model of sustainability presented focuses on incremental transition towards environmental sustainability through direct substitution of products and processes using bioengineered alternatives (n = 16 companies), with no change in societal consumption or policy frameworks required in order to see sustainability gains. One-third of the companies analyzed (n = 8) mention "nature" on their websites, variously framing it as a resource to be managed or as a source of inspiration; whether the latter signals a potentially more complex relationship with nature than advanced free-market models of sustainability remains to be seen. As the synthetic biology industry begins to grow in size and visibility, we suggest this is an opportune time for the community to engage in explicit deliberation about its approach to sustainability.

Building a biofoundry.

A biofoundry provides automation and analytics infrastructure to support the engineering of biological systems. It allows scientists to perform synthetic biology and aligned experimentation on a high-throughput scale, massively increasing the solution space that can be examined for any given problem or question. However, establishing a biofoundry is a challenging undertaking, with numerous technical and operational considerations that must be addressed. Using collated learnings, here we outline several considerations that should be addressed prior to and during establishment. These include drivers for establishment, institutional models, funding and revenue models, personnel, hardware and software, data management, interoperability, client engagement and biosecurity issues. The high cost of establishment and operation means that developing a long-term business model for biofoundry sustainability in the context of funding frameworks, actual and potential client base, and costing structure is critical. Moreover, since biofoundries are leading a conceptual shift in experimental design for bioengineering, sustained outreach and engagement with the research community are needed to grow the client base. Recognition of the significant, long-term financial investment required and an understanding of the complexities of operationalization is critical for a sustainable biofoundry venture. To ensure state-of-the-art technology is integrated into planning, extensive engagement with existing facilities and community groups, such as the Global Biofoundries Alliance, is recommended.

Characterizing Direct-to-Consumer Stem Cell Businesses in the Southwest United States.

There are currently hundreds of businesses across the United States offering direct-to-consumer stem cell treatments that have not been through regulatory approval by the Food and Drug Administration (FDA). Here, we provide a detailed characterization of nearly 170 stem cell businesses operating in the Southwest United States. We draw specific attention to two as-yet understudied facets of these businesses. First, we identify differences in the degree to which a given business focuses their practice on stem cell treatments. Second, we compare the stated expertise of the care providers in stem cell businesses with the range of conditions they purport to treat. These findings deepen our knowledge of the growing industry around unapproved stem cell treatments, and are used here to offer suggestions for how the FDA might target its resources with respect to regulatory oversight.

Tools for anti-inflammatory drug design: in vitro models of leukocyte migration.

Inhibiting leukocyte recruitment is now a major focus in the design of novel anti-inflammatory drugs. Following the identification of lead compounds from conventional high-throughput screens using appropriate receptors or enzymes, it is important to validate the action of the compounds in a suitable in vitro model of leukocyte migration. Here, we review a range of different experimental approaches to modelling leukocyte migration, and identify the multi-well filter migration assay as the best compromise between the amount of resources required to screen multiple compounds and the amount of information gained about the effects of the compounds on cell movement behavior. However, there are pitfalls in the interpretation of data obtained using the multi-well filter migration assay, which arise from the imperfect correlation between the number of cells undergoing migration and the inhibitory activity of the test substances. We examine a number of such pitfalls and provide practical approaches to mitigate these problems as far as possible. We recommend a general strategy for screening inhibitors of cell migration using in vitro functional assays. While being more resource intensive than surrogate measures such as calcium flux, functional approaches nevertheless provide superior correlations with anti-inflammatory activity in vivo.