Conflicts of interest in e-cigarette research: A public good and public interest perspective

The tobacco industry’s involvement in the electronic cigarette research that informs public health policy is controversial. On the one hand, some are concerned that their involvement presents conflicts of interest that bias research outputs and invalidate the policies that use them. On the other hand, some have argued that the tobacco industry may support valid research and contribute to the goals of public health, for instance, if the interests of the e-cigarette industry could be part of a tobacco smoking cessation policy. We approach this debate from the ethical perspective of the public interest and the public good, considering how legitimate researchers can square their expert opinion with validating tobacco industry-funded research, given the perfidy of the tobacco industry and paucity of robust, conclusive evidence on the public health impacts of liberalizing e-cigarette use.     

Developing oncolytic viruses for clinical use: A consortium approach

The use of oncolytic viruses forms an appealing approach for cancer treatment. On the one hand the viruses replicate in, and kill, tumor cells, leading to their intra-tumoral amplification. On the other hand the viral infection will activate virus-directed immune responses, and may trigger immune responses directed against tumor cells and tumor antigens. To date, a wide variety of oncolytic viruses is being developed for use in cancer treatment. While the development of oncolytic viruses has often been initiated by researchers in academia and other public institutions, a large majority of the final product development and the testing of these products in clinical trials is industry led. As a consequence relatively few pre-clinical and clinical studies evaluated different oncolytic viruses in competitive side-by-side preclinical or clinical studies. In this review we will summarize the steps and considerations essential in the development and characterization of oncolytic viruses, and describe our multidisciplinary academic consortium, which involves a dozen departments in three different Dutch universities, collaborating in the development of oncolytic viruses. This consortium has the ambition to develop a small series of oncolytic viruses and to evaluate these in various cancers.     

Bioengineered bugs, drugs and contentious issues in patenting

Bioengineered bugs, as is the scope of this journal, have great potential in various practical applications. A corollary to bringing useful products to the market is that such products need protection from copying by other people or businesses. Such government-sponsored protections are legally enforced through a patent, copyright or trademark/trade secret system commonly known as intellectual property rights. A condition for obtaining a patent is that the invention must not be disclosed to public either through seminars, informal public disclosures or publications in journals, although in the United States, there is a one year grace period that is allowed to obtain a patent after public disclosure. This article describes my personal experience in obtaining a patent in 1980 on a genetically manipulated bacterium designed for oil spill cleanup. This patent application went through a series of court cases that finally ended up in the Supreme Court of the United States. I also mention a similar contentious legal issue that is on the horizon and that the readers of Bioengineered Bugs should be aware of. Finally, I have taken the opportunity to describe my current efforts to bring to the market some unique potential multi-disease-targeting candidate drugs from Pseudomonas aeruginosa and gonococci/meningococci that, if found non-toxic and efficacious in humans, will revolutionize the drug industry. To ensure their marketability, we are trying to develop a patent portfolio that will ensure that they will be legally protected and such protections will be broad-based and enforceable.     

Global trends in research and commercialization of exogenous and endogenous RNAi technologies for crops

It has only been about 20 years since the first Nobel Prize-winning work on RNA interference (RNAi) in Caenorhabditis elegans was published in the journal Nature. Fast forward to today, and the use of RNA molecules as gene-silencing elements in crops has helped scientists to unveil possible solutions to the global problems of agricultural losses due to pests, viruses, pathogens, and to other abiotic and biotic stresses. The recent proliferation of publications suggests that the technology has gained significant attention and received ample funding support. In this article, an attempt has been made to visualize recent trends in Research & Development (R&D) investment in this field by analyzing top cited scholarly articles, patent trends, and commercialization activity. The publication and citation analysis identified that the development of RNAi-based crops conferring resistance against viruses, fungi, and pests are at the forefront of RNAi research and that Chinese and US institutions are the leaders in this field. The patent landscape analysis for RNAi technology over all aspects related to RNAi-derived crops provides an overview of patenting activity from a geographical, organizational, and legal perspective. Such an exercise is pivotal to industry players and public institutions aiming at creating intellectual property that is commercially appealing. An upswing in commercial interests in this technology in recent years is reflected by a consistent number of patent filings in US, European, and Chinese patent offices, with multinational giant firms as the most prolific patent filers. The expanding RNAi commercialization landscape is supported by a series of strategic partnerships, licensing agreements, and acquisitions created between agribusinesses, public research institutions, and startup companies. From key observations, we would like to highlight that such investments have very positive impacts on the development of RNAi technology. Nonetheless, the success of this technology is dependent on several factors, such as financial requirements, the complexity, and timeframe of the entire development process, as well as stringent regulations imposed by the relevant authorities. In most countries, RNAi-based transgenic crops are still considered as a genetically modified (GM) product, which necessitates the crops to undergo rigorous evaluation before approval is granted. Recent advancements in exogenous RNAi-derived biopesticides have provided a nontransgenic alternative to GM crops. However, challenges still remain in the form of technical hurdles and regulatory ambiguities surrounding this emerging technology. Its full potential remains to be realized.     

Intellectual property protection of plant biotechnology inventions

The intellectual property protection of biotechnology-related subject matter is undergoing significant change and several countries have revised their legislation and/or patent practice as a result of challenges from industry and members of the public. Plant-related subject matter can be protected using plant variety protection, utility patents or, in the USA, by plant patent. Although easier to obtain than a utility patent, plant variety protection does not provide the same scope of protection. Protecting a plant using a utility patent is permitted only in countries that allow the patenting of higher life forms and requires a higher degree of experimental support than is required for plant variety protection, although the scope of protection is being steadily reduced.     

Public policy and partnership in research on biological control in France

Most public institutions and companies of plant protection industry have a favourable opinion of biological control; they feel concerned by the issue, but weakly engaged in its solution. Biological plant protection is however poorly developed in agriculture, the success of biological control being insufficiently known due to severe competition with chemical pesticides that are reliable, efficient, specific and safer for the environment. In this context, and to improve the implementation of biological control, the following actions are proposed:

1. more interdisciplinarity in research between agronomists, economists and biologists who have to take better advantage of the various concepts of evolutionary biology and to carry out more field experiments on a large scale;
2. wider and more integrated objectives: the successful control of a pest using biological means is not a sufficient aim. We absolutely need to consider all aspects of IPM, in particular resistance to pesticides, cultural means, plant breeding and all alternative biotechnical means;
3. larger partnership: during too many years, only researchers of public institutions were involved in biological control. Today, many partners, including public institutions (Plant Protection Service, Technical Institutes) and private companies (large and small) are engaged in alternative plant protection. To facilitate cooperation between them, a specific committee has been set up in France in order to coordinate experimentations for registration and quality control of biopesticides.

With such improved relationships between all partners, specific arguments and lobbying pressure should be stronger on the distribution and retailers of agricultural goods with a view to promoting plant products obtained via biological or integrated control methods and to seeking public understanding and support.     

A Spatiotemporal Analysis of Brazilian Science from the Perspective of Researchers’ Career Trajectories

The growth of Brazilian scientific production in recent years is remarkable, which motivates an investigation on the factors, inside and outside the country, that helped shape this wealthy research environment. This article provides a thorough analysis of the education of researchers that constitute the main Brazilian research groups, using data on about 6,000 researchers involved in the country’s National Institutes of Science and Technology (INCT) initiative. Data on the steps taken by each researcher in her education, from the bachelor’s degree to doctorate, including a possible postdoctoral experience, and employment, are extracted from an official curriculum vitae repository. The location and the time at which each career step occurred define spatiotemporal career trajectories. We then analyze such trajectories considering additional data, including the area of knowledge of the INCTs to which each researcher is associated. We found an increasing prevalence of Brazilian institutions in the education of Brazilian scientists, as the number of doctorates earned abroad is decreasing over time. Postdoctoral stages, on the other hand, often take place in Europe or in the United States. Taking an international postdoctoral position after a full education in Brazil suggests a drive towards seeking higher-level exchange and cooperation with foreign groups in a more advanced career stage. Results also show that Brazilian researchers tend to seek employment in regions that are close to the institutions at which they received their bachelor’s degrees, suggesting low mobility within the country. This study can be instrumental in defining public policies for correcting distortions, and can help other developing countries that aim to improve their national science systems.     

基于专利分析的3D生物打印产业发展态势研究

目的:揭示3D生物打印产业技术研发态势和专利布局,以期为相关机构提供竞争情报,为行业发展提供数据支撑。方法:基于3D生物打印领域产业调研和技术分解,构造检索式获取数据,多维度量化分析领域专利。结果:3D生物打印产业发展可分为孕育期、萌芽期和高速发展期;该产业集中度较低,处于分散竞争阶段;申请人多依据地缘因素选择合作对象,合作方之间多为不同类型的机构;中国申请人的专利申请量占全球的比重已接近50%,但美国申请人的专利篇均被引频次仍远超中国;美国申请人更关注海外市场。结论:3D生物打印产业尚未形成规模效应,有必要整合业内资源,打造产业集群;中、美两国在该产业都具有优势地位,中国亟待加强海外专利布局;综合权衡专利数量和质量,美国申请人的专利竞争力仍高于中国,中国需培育更多核心专利。     

Patenting for the research scientist: an update

Academic institutional research constantly produces results worthy of patent protection, but coping with the demands of patent law presents considerable challenges to bioscientists working in these institutions. Inventors need, however, to be aware of recent patent office guidelines and court decisions if they are to seek useful intellectual property as a basis for technology transfer to industry.     

Definitions and principles for bioindication and biomonitoring of trace metals in the environment

Clear-cut definitions are given for most terms used in monitoring studies. In these studies the observation or experimental investigation of living organisms give a qualitative or quantitative information on the state of the environment with special reference to trace metals. The focus and future goals of biogeochemical research must consider the direct effects on human health, by including modelling of active biogeochemical processes than they have done so far. Newly developed strategies as the multi-markered bioindication concept (MMBC) with its functional and integrated windows on prophylactic healthcare are essential tools for successfully observing the environment with respect to trace metals. An intensified training of students and a strong hand in hand work between industrial, educational and public institutions is necessary.     

Longitudinal Investigation of Public Trust in Institutions Relative to the 2009 H1N1 Pandemic in Switzerland

Background

The 2009 H1N1 pandemic left a legacy of mistrust in the public relative to how outbreaks of emerging infectious diseases are managed. To prepare for future outbreaks, it is crucial to explore the phenomenon of public trust in the institutions responsible for managing disease outbreaks. We investigated the evolution of public trust in institutions during and after the 2009 pandemic in Switzerland. We also explored respondents’ perceptions of the prevention campaign and the roles of the government and media.

Methodology/Principal Findings

A two-wave longitudinal survey was mailed to 2,400 members of the Swiss public. Wave 1 was in Spring 2009. Wave 2 was in Spring 2010. Six hundred and two participants responded in both waves. Participants indicated moderate to high levels of trust in medical organizations, the WHO, the Swiss government, the pharmaceutical industry, and the EU. On the other hand, trust in the media was low. Moreover, trust in almost all institutions decreased over time. Participants were satisfied with the amount of information received and indicated having followed official recommendations, but widespread concerns about the vaccine were evident. A large majority of participants agreed the vaccine might have unknown or undesirable side effects. Perceptions of the government’s and the media’s role in handling the outbreak were characterized by a substantial degree of skepticism and mistrust.

Conclusions/Significance

Results show clear patterns of skepticism and mistrust on the part of the public relative to various institutions and their actions. Results underscore the importance of systematically investigating trust of the public relative to epidemics. Moreover, studies investigating the evolution of the public’s memories of the pandemic over the coming years may be important to understand reactions to future pandemics. A systematic research program on trust can inform public health communication campaigns, enabling tailored communication initiatives.     

Challenges for proteomics core facilities

Many analytical techniques have been executed by core facilities established within academic, pharmaceutical and other industrial institutions. The centralization of such facilities ensures a level of expertise and hardware which often cannot be supported by individual laboratories. The establishment of a core facility thus makes the technology available for multiple researchers in the same institution. Often, the services within the core facility are also opened out to researchers from other institutions, frequently with a fee being levied for the service provided. In the 1990s, with the onset of the age of genomics, there was an abundance of DNA analysis facilities, many of which have since disappeared from institutions and are now available through commercial sources. Ten years on, as proteomics was beginning to be utilized by many researchers, this technology found itself an ideal candidate for being placed within a core facility. We discuss what in our view are the daily challenges of proteomics core facilities. We also examine the potential unmet needs of the proteomics core facility that may also be applicable to proteomics laboratories which do not function as core facilities.     

The commercialization of genome-editing technologies

The emergence of new gene-editing technologies is profoundly transforming human therapeutics, agriculture, and industrial biotechnology. Advances in clustered regularly interspaced short palindromic repeats (CRISPR) have created a fertile environment for mass-scale manufacturing of cost-effective products ranging from basic research to translational medicine. In our analyses, we evaluated the patent landscape of gene-editing technologies and found that in comparison to earlier gene-editing techniques, CRISPR has gained significant traction and this has established dominance. Although most of the gene-editing technologies originated from the industry, CRISPR has been pioneered by academic research institutions. The spinout of CRISPR biotechnology companies from academic institutions demonstrates a shift in entrepreneurship strategies that were previously led by the industry. These academic institutions, and their subsequent companies, are competing to generate comprehensive intellectual property portfolios to rapidly commercialize CRISPR products. Our analysis shows that the emergence of CRISPR has resulted in a fivefold increase in genome-editing bioenterprise investment over the last year. This entrepreneurial movement has spurred a global biotechnology revolution in the realization of novel gene-editing technologies. This global shift in bioenterprise will continue to grow as the demand for personalized medicine, genetically modified crops and environmentally sustainable biofuels increases. However, the monopolization of intellectual property, negative public perception of genetic engineering and ambiguous regulatory policies may limit the growth of these market segments.     

埃博拉病毒检测与防治技术在中国的专利申请状况分析

近年来,埃博拉病毒(EBOV)因其在非洲造成的严峻疫情而引起了广泛关注。本文对涉及埃博拉病毒检测与防治技术方面的在中国申请的国内外专利申请数量、年代分布、技术发展状况等信息进行分析,对国内埃博拉病毒检测、免疫、治疗相关专利技术进行简要总结,并对目前热点关注药物(jk-05,ZMapp,VSV-EBOV)专利申请信息进行比较概括,结果表明,我国申请人在提出的相关专利申请数量以及技术多样性上与国外申请人存在差距,为国内科研人员提供了相关技术领域参考。     

Microarrays: handling the deluge of data and extracting reliable information

Application of powerful, high-throughput genomics technologies is becoming more common and these technologies are evolving at a rapid pace. Genomics facilities are being established in major research institutions to produce inexpensive, customized cDNA microarrays that are accessible to researchers in a broad range of fields. These high-throughput platforms have generated a massive onslaught of data, which threatens to overwhelm researchers. Although microarrays show great promise, the technology has not matured to the point of consistently generating robust and reliable data when used in the average laboratory. This article addresses several aspects related to the handling of the deluge of microarray data and extracting reliable information from these data. We review the essential elements of data acquisition, data processing and data analysis, and briefly discuss issues related to the quality, validation and storage of data. Our goal is to point out some of the problems that must be overcome before this promising technology can achieve its full potential.     

The emergence of the genetically engineered animal models in carcinogenic risk assessment of pharmaceuticals: a case study of process innovation

In this article, we explain the emergence of new short-term tests for carcinogenicity involving genetically engineered animals for the purposes of pharmaceutical regulation. Drawing on some long-standing theories of technological innovation, we argue that the alteration of carcinogenic risk assessment of pharmaceuticals, which occurred from 1998, did not result solely, or perhaps even mainly, from internal logical and technical developments in the experimental sciences of toxicology or genetics. Rather, this process innovation in regulatory science resulted from a complex interaction between scientist activism around molecularization of toxicology in powerful US government institutions, on the one hand, and a powerful research-based trans-national pharmaceutical industry committed to deregulatory mobilization, on the other, seeking to reduce carcinogenicity testing of its products and capable of marshalling significant support from governments and regulators, especially in Europe and Japan, to achieve that goal. The new techno-scientific basis for regulatory decisions about whether pharmaceuticals are carcinogenic risks to the public was, in effect, an accommodation in “bio-political” trading between two power-blocks of expert scientists. Those from industry and their regulatory allies in Europe and Japan, who sought reductions in “the burden” of drug testing, on the one hand, and FDA scientists, who did not accept the simple “reduction” agenda, but were interested in shifting the paradigm of carcinogenicity testing toward geneticization, on the other.     

Annuario della societa botanica italiana 1934

Apple research has undergone great improvements in the last years, in both quantitative and qualitative terms. Huge amount of data are now available, especially as far as the early development and the ripening phase are concerned. Moreover, the recent release of the apple genome sequence is significantly speeding up research, allowing on one hand to shed light on the most critical aspects of fruit development with almost immediate practical implications and, on the other hand, to identify new molecular markers that will improve the future breeding programs. In this context, apple is being increasingly considered as a model for fruit development studies, although many gaps still exist in apple research. These gaps are being filled by coupling the next generation high-throughput technologies with new physiological approaches, aimed at achieving both new basic knowledge and innovative tools to improve the final quality of the fruit. In this review, the available information on the regulatory aspects of apple fruit development will be reported and discussed in the light of the future perspectives of apple research.     

The Patentability of Biomolecules – Does Online Bioinformatics Compromise Novelty?

Researchers are becoming increasingly concerned that the confidentiality of their novel biomolecule sequences is being jeopardised, particularly when these sequences are either submitted to sequence databases or uploaded as query terms onto internet-based bioinformatic software suites. The researcher's fears stem from the fact that the actual uploading of their sequences acts as a novelty destroying prior disclosure or publication, and that this may subsequently preclude valid patent protection for the sequences. This article addresses the key issues involved in the analyses of biomolecules, highlighting potential risks taken by many researchers in regard to patent protection and suggests possible ways in which these risks may be mitigated.     

Bacteriocins from lactic acid bacteria and their potential in the preservation of fruit products

Bacteriocins produced by lactic acid bacteria (LAB) are well-recognized for their potential as natural food preservatives. These antimicrobial peptides usually do not change the sensorial properties of food products and can be used in combination with traditional preservation methods to ensure microbial stability. In recent years, fruit products are increasingly being associated with food-borne pathogens and spoilage microorganisms, and bacteriocins are important candidates to preserve these products. Bacteriocins have been extensively studied to preserve foods of animal origin. However, little information is available for their use in vegetable products, especially in minimally processed ready-to-eat fruits. Although, many bacteriocins possess useful characteristics that can be used to preserve fruit products, to date, only nisin, enterocin AS-48, bovicin HC5, enterocin 416K1, pediocin and bificin C6165 have been tested for their activity against spoilage and pathogenic microorganisms in these products. Among these, only nisin and pediocin are approved to be commercially used as food additives, and their use in fruit products is still limited to certain countries. Considering the increasing demand for fresh-tasting fruit products and concern for public safety, the study of other bacteriocins with biochemical characteristics that make them candidates for the preservation of these products are of great interest. Efforts for their approval as food additives are also important. In this review, we discuss why the study of bacteriocins as an alternative method to preserve fruit products is important; we detail the biotechnological approaches for the use of bacteriocins in fruit products; and describe some bacteriocins that have been tested and have potential to be tested for the preservation of fruit products.