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The chapter analyses the re-emergence of gene editing as an object of policy attention at the European Union (EU) level. Editing the genome of plants and/or animals has been a rather controversial component of all EU policies on agricultural biotechnology since the late 1980s. The chapter examines in detail the various initiatives that have been assumed for the regulation of gene editing at the EU level. Since the first political and legislative attempts, the field has been revolutionized with the development of the CRISPR-Cas9 system, which is comparatively much easier to design, produce, and use. Beyond the pure, safety-driven scientific questions, gene editing, in its contemporary form, raises a series of ethical and regulatory questions that are discussed in the context of the legal options and competences of the EU legislators. Special attention is paid to questions about the legal status of gene editing in Europe and the adequacy of the current GMO framework to deal with all the challenges associated with the latest scientific developments in the field of gene editing with a special focus on gene drive. Given the ongoing discussions regarding the ethical tenets of gene editing, the chapter investigates the question on whether there is a need to shape an EU-wide “intervention” that will address the complex and dynamic socio-ethical challenges of gene editing and puts forward a series of proposals for the framing of an inclusive framework that will be based on the need to re-enforce public trust in the EU governance of emerging technologies.

For more than 20 years, genome editing has been one of the numerous technologies developed for the study and manipulation of the genome. However, since the relatively recent appearance of the so-called precision approaches, and especially through the “CRISPR revolution,” the modification of the genome of any living beings on our planet has become possible, despite recent results showing some unexpected and undesirable effects of this technology. The objective of this chapter is to illustrate how a mobilization of the scientific community through the setting-up of an association should allow a responsible and ethical use of these technologies with considerable impacts for our society.

This teaching case describes a born-global Indian enterprise in R&D that developed and leveraged knowledge-intensive business services in speciality chemicals, custom synthesis of genes and contract research co-evolving dynamic capabilities in partnership with multinationals from Europe and North America. The purpose of this case to explore how emerging market multinationals can leverage factor market strengths for niche positioning in industries generally populated by large players, in this case, the big Pharma companies.

The case describes how the international strategy of the company was rooted in the “Make in India” national policy. The risks and opportunities involved a “springboard” approach of gaining customer confidence in North America, Europe and Japan in incremental steps. Challenges concerned fostering a credible talent management eco-system where scientific spirit and business pathways were pursued around unknown and unfamiliar projects challenging resource-based views of the firm.

An interesting facet of this case is how the nexus of treaties with stakeholding constituents were configured and sustained for strategic management of intellectual capital and organizational knowledge.

The novelty of the case is in demonstrating how small EMNCs can leverage factor market advantages to become world leaders in niche segments. Another interesting feature is how such firms are organized around sustainability of shareholder value without profitability in their initial years.

By taking conventionalist view of the evolution of biotechnology, we suggest that the process by which entrepreneurs determined what made biotechnology valuable and figured out how to organize around such an economic logic was contested. The shape that biotechnology has ultimately taken emerged from the resolution of these contests. Convention theory – as elaborated in Boltanski and Thévenot's (2006) On Justification ¹ – argues that our economy is shaped by participants affecting the rules of economic action. Whereas most economists would argue that the assignment of value underpins any system of exchange, conventionalists suggest that this value is not only given by the principles of optimization but instead can be derived from many possible spheres such as civic duty, attainment of fame, proof of technologic performance, and demonstration of creativity. More specifically, Boltanski and Thévenot (2006, p. 43) claim that the establishment of a particular logic “comes about as a part of a coordinated process that relies on two supports: a common identification of market goods, whose exchange defines the course of action, and a common evaluation of these objects in terms of prices that make it possible to adjust various actions.” Simply put, economic logics embody principles of economic coordination or conventions that guide interpretation of the technology and its value.

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

Neuroscientific technologies have begun to change the ways in which we understand, respond to, and treat drug addiction. According to addiction researchers, neuroscience marks a new era because of its potential to locate the causes of addiction within the brain and to treat addiction through altering neurochemistry. However, little is known about how addiction neuroscience and new neurochemical treatments shape individuals' experience of addiction and constitute new arrangements of knowledge and power that shape subjectivity and governance. This chapter addresses these domains by drawing on an analysis of scientific literature about addiction neuroscience and qualitative interviews with people being treated for addiction with buprenorphine, a pharmaceutical treatment for opioid dependence. The chapter charts four major themes in the addiction neuroscience literature (pleasure and the limbic system, rationality and the role of the prefrontal cortex, theories of plasticity, and the role of volition) and explores how each of these is incorporated, adapted, or rejected by individuals being treated for addiction with a pharmaceutical. This analysis demonstrates how neuroscientific ideas are mediated by the lived experiences of those being treated under a neuroscientific model. It also suggests that while neuroscientific interventions, like pharmaceuticals, shape the experience of those being treated for addiction, so too do many other forces, including social circumstances, moral frameworks, the drive for autonomy, and the quest to be “normal.”