LeRoy Walters's Legacy of Bioethics in Genetics and Biotechnology Policy.

LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades.

Recent Patents Applications in Red Biotechnology: A Mini-Review.

BACKGROUND: The different fields of biotechnology can be classified by colors, as a "rainbow" methodology. In this sense, the red biotechnology, focused on the preservation of health, has been outstanding in helping to solve this challenge through the provision of technologies, including diagnostic kits, molecular diagnostics, vaccines, innovations in cancer research, therapeutic antibodies and stem cells. OBJECTIVE: The main goal of this work is to highlight the different areas within the red Biotechnology. In this sense, we revised some patents regarding red biotechnology as examples to cover this subject. METHODS: A literature search of patents was performed from the followings Patents Database: INPI, USPTO, Esp@cenet, WIPO and Google Patents. RESULTS: Our analysis showed the following numbers from patents found: cancer research (8), diagnosis kit (9), vaccines (8), stem cells (9) and therapeutic antibodies (5), where the United States is the leader for most filled patents in Red Biotechnology. CONCLUSION: This mini-review has provided an update of some patents on Recent Patents in Red Biotechnology. As far as we know, this is the first mini-review report on Red Biotechnology based on patents.

[Monoclonal antibodies at the forefront of health care economic analyses]. / Les anticorps monoclonaux à l'aune de l'économie de la santé - Les accords de l'industrie pharmaceutique.

Therapeutic antibodies have been used for several decades and their associated market (project numbers, approvals…) continues to grow. Remarkably, a new threshold was crossed in the early 2010's to make this decade the decade of immunotherapy. Over the past 10 years, 62 antibodies have been approved, the number of annual transactions between stakeholders has increased to more than 300 (three times more in 2018 than in 2009). The revolution of immunotherapy in cancer treatment and the recent use of antibodies as first-line treatment are the major turning points in oncology. Thus, the last three years alone represent two thirds of the most important deals of the decade involving immunotherapies. Immunotherapy is currently experiencing a golden age that has resulted in many successes, especially in France where biotechnology companies and large pharmaceutical companies have achieved impressive therapeutic and financial results.

TITLE: Les anticorps monoclonaux à l'aune de l'économie de la santé - Les accords de l'industrie pharmaceutique. ABSTRACT: Bien que les anticorps thérapeutiques existent depuis maintenant plusieurs décennies et que le marché associé (nombre de projets en développement, nombre d'anticorps mis sur le marché…) soit en croissance, un palier a été franchi au début des années 2010 pour faire de cette décennie celle de l'immunothérapie. Pendant ces 10 dernières années, 62 anticorps ont obtenu une autorisation de mise sur le marché et le nombre d'accords (acquisitions, participations, partenariats) annuels entre les différents acteurs a dépassé la barre des 300 (avec trois fois plus d'accords en 2018 qu'en 2009). La révolution de l'immunothérapie dans le traitement des cancers et la récente utilisation d'anticorps en première ligne thérapeutique dans celui-ci sont les tournants majeurs de l'oncologie. Les trois dernières années (2016-2019) regroupent d'ailleurs à elles seules les deux tiers des plus importants accords de la décennie impliquant des immunothérapies. L'immunothérapie connaît donc actuellement un âge d'or qui se traduit par de nombreuses success stories, notamment en France, où sociétés de biotechnologie et big pharma présentent des résultats très positifs au plan tant thérapeutique que financier.

[In process.] / Die Genealogie eines Gens: Patente, HIV/AIDS und Rasse.

The story, which unfolds here, is a cultural history of science, one that closely analyzes the content of science. My story deals with an object, a gene. I use the CCR5 gene as a heuristic tool in order to probe the boundaries between science and society. Three important themes are discussed in this essay: genes as commodities (intellectual property and gene patents); alleles, natural selection, and the resistance to disease; and race and genomics. This is in part a story about neoliberalism, laissez-faire goverenments, free and open markets, the increase of privatization, and biotechnology. Many claim that the United States Patent and Trademake Office's (henceforth, USPTO) leniency in granting gene patenting led to the growth of biotechnology. I maintain the opposite: the growth of biotechnology led to decision to patent genes. My story is one of the present, a genealogy to borrow FOUCAULT'S and NIETZsCHE's terminology. How has it come about that genes are patentable entities, and that human classificatory schemes are usually based on race, although there are an infinite number of possibilities to characterize human variation? There are always alternatives, and historians are obliged to present those alternatives and explain why they were never chosen. I also use the concept of genealogy in the classical biological sense, i.e. to trace the passing of alleles from one generation to another. While this essay is similar to earlier studies dealing with the biography of objects, particularly scientific objects, the history told here is not a biography of the CCR5 gene, as that story is still ongoing. Rather, this essay concentrates upon a twenty-year period of the gene's life from the mid-1990s to the present. I am interested in understanding how it is we have reached the point we have today with respect to the relationship between science and society, and I use the CCR5 gene as a vehicle for that analysis.

Thirty years of European biotechnology programmes: from biomolecular engineering to the bioeconomy.

This article traces back thirty years of biotechnology research sponsored by the European Union (EU). It outlines the crucial role played by De Nettancourt, Goffeau and Van Hoeck to promote and prepare the first European programme on biotechnology (1982-1986) run by the European Commission. Following this first biotechnology programme, others followed until the current one, part of the seventh Framework Programme for Research, Technological Development and Demonstration (2007-2013) (FP7). Particular attention is given to the statutory role of the European institutions in the design and orientation of the successive biotechnology programmes, compared to the more informal-yet visionary-role of key individuals upstream to any legislative decision. Examples of success stories and of the role of the biotechnology programmes in addressing societal issues and industrial competitiveness are also presented. Finally, an outline of Horizon 2020, the successor of FP7, is described, together with the role of biotechnology in building the bioeconomy.

The biopharmaceutical industry in China: history and future perspectives.

Biopharmaceuticals reflect the rapid progress achieved in modern biomedical research. This area has also become one of the main criteria for assessing the development level of biotechnology for a particular country. Although it has been only three decades since the first biopharmaceutical, recombinant human insulin, was licensed by the US Food and Drug Administration, the biopharmaceutical industry has become the fastest growing, most dynamic and technology-intensive sector in the biomedical field. Since the licensing of recombinant human interferon α1b in 1989, the biopharmaceutical industry in China has gone through initial developments and gradually entered a period of rapid growth. This paper provides an overview of the status and development trends of biopharmaceuticals in China, and compares them with those observed in developed countries.

Plant diversity and conservation in China: planning a strategic bioresource for a sustainable future.

China is one of the richest countries for plant diversity with approximately 33 000 vascular plant species, ranking second in the world. However, the plant diversity in China is increasingly threatened, with an estimated 4000­5000 plant species being threatened or on the verge of extinction, making China, proportionally, one of the highest priorities for global plant biodiversity conservation. Coming in the face of the current ecological crisis, it is timely that China has launched China's Strategy for Plant Conservation (CSPC). China has increasingly recognized the importance of plant diversity in efforts to conserve and sustainably use its plant diversity. More than 3000 nature reserves have been established, covering approximately 16% of the land surface of China. These natural reserves play important roles in plant conservation, covering more than 85% of types of terrestrial natural ecosystems, 40% of types of natural wetlands, 20% of native forests and 65% of natural communities of vascular plants. Meanwhile, the flora conserved in botanical gardens is also extensive. A recent survey shows that the 10 largest botanical gardens have living collections of 43 502 taxa, with a total of 24 667 species in ex situ conservation. These provide an important reserve of plant resources for sustainable economic and social development in China. Plant diversity is the basis for bioresources and sustainable utilization. The 21st century is predicted to be an era of bio-economy driven by advances of bioscience and biotechnology. Bio-economy may become the fourth economy form after agricultural, industrial, and information and information technology economies, having far-reaching impacts on sustainable development in agriculture, forestry, environmental protection, light industry, food supply and health care and other micro-economy aspects. Thus, a strategic and forward vision for conservation of plant diversity and sustainable use of plant resources in the 21st century is of far-reaching significance for sustainable development of Chinese economy and society.

Application of GM crops in Sub-Saharan Africa: lessons learned from Green Revolution.

While the Green Revolution has been successful in some regions like South and East Asia, it could hardly address any achievement in Sub-Saharan Africa (SSA). This paper tries to draw a picture on lessons learned from the failures of this revolution that should be taken into account before implementing the so-called Gene Revolution in the SSA region. After scrutinizing the failures and the pros and cons of GM crops in the region, the paper introduces some potentials for improving the malnutrition situation in SSA through launching a successful GM technology. However, it remains doubtful whether this technology can improve the situation of small-scale farmers as long as they receive no financial support from their national governments. Therefore, before any intervention, the socio-economic and environmental impacts of GM technology need to be carefully addressed in the framework of a series of risk assessment studies. Besides, some sort of multi-stakeholder dialog (from small-scale farmers to consumers) involving public-private sector and non-governmental organizations should be heated up at both national and regional levels with regard to the myths and truths of this technology.

The making of an entrepreneurial science: biotechnology in Britain, 1975-1995.

Monoclonal antibodies played a key role in the development of the biotechnology industry of the 1980s and 1990s. Investments in the sector and commercial returns have rivaled those of recombinant DNA technologies. Although the monoclonal antibody technology was first developed in Britain, the first patents were taken out by American scientists. During the first Thatcher government in Britain, blame for the missed opportunity fell on the scientists involved as well as on the National Research and Development Corporation, which had been put in place after World War II to avoid a repeat of the penicillin story, when patent rights were not sought. Instead of apportioning the blame, this essay suggests that despite past experiences and despite the new channels that were in place, Britain was not in a "patent culture" in the 1970s. It traces the long and painful process that made a commercial attitude among publicly funded British research scientists and in a civil service institution like the Medical Research Council both possible and desirable. In this process the meaning of the term "public science" also changed dramatically.