Thursday, March 6, 2014

Summary: Styhre (2008) "From the Laboratory to the Pipeline: New Drug Development in the Pharmaceutical Industry

Background: Alexander Styhre is a professor at the School of Business, Economics, and Law at the University of Gothenburg. He has studied product development in the pharmaceutical, telecom, and automotive industry.

After the first read through, I was confused by the different sections and how they developed into a cohesive chapter. Styhe says the purpose of this chapter was to “discuss how science-based innovation is organized in practice, and more specifically in the case of new drug development in pharmaceutical industry and in the British-Swedish major pharmaceutical company AstraZeneca.” After reading the sections again, I think the main thread that connects them is how the notion of objectivity in science limits our ability to research science-based innovation like that found at AstraZeneca.

The all-too-human nature of science
                Styhre begins the chapter by taking a sociological perspective on the “all-too-human characteristics” of science. Science’s value-neutral status is challenged by the following characteristics:
  • Scientists are highly emotional—concerned about whether they are pursuing important work. This leads scientists to place a lot of value on peer recognition.
  • Scientists create boundaries around their work declaring which methods, knowledge, values, etc are science and which are not. This boundary work helps scientists secure their authority and access to resources, but creates communities that regulate their own behavior and actions.
  •  Dual ideology: Scientists expect full funding from the state, but do not like their work to be questioned by outsiders.

New drug development
                Styhre uses new drug development as an example to discuss how science-based innovation is organized. He describes how drug discovery and development is made up of heterogeneous elements including human actors from different fields, non-human entities like drugs, materials, instruments, etc., and institutional and structural factors like strategies, human networks, funds, markets, and clinical trials.  Even something like a single drug molecule embodies “a texture of relations—be they chemical, biological, and pharmacological—between series of processes, events, and entities” (p. 103).
                He goes on to describe how all these elements can generate costs in the millions of dollars on drugs that may or may not make it in the market, and advances in virtual screening and genomic sciences do not necessary mean a higher success rate. To “maximize expected economic returns, minimize risk, maintain diversity in the product portfolio,” and become less reliant on blockbuster drugs, pharmaceutical firms have expanded their scientific networks to include biotech firms and universities in order to become ‘knowledge-brokers’ (p. 107).

New drug development process in AstraZeneca
Styhre shares the development process he observed at AstraZeneca.

Each stage of this process is described from pages 111-113.

Science-based innovation and knowledge management and innovation theory
                The subjective nature of science and messiness of scientific practice including the natural, social, and cultural elements that make up scientific work make knowledge management and science-based innovation difficult to study. Styhre begins this section by stating, “Knowledge management is making claims to provide theory that creates an understanding of and guide management practice in knowledge-intensive organizations. Yet, it has not showed sufficient interest in what is happening in scientific communities and under what conditions science is actually being produced” (p. 114-115). Styhre argues that while knowledge management literature makes statements about “the emergence of the knowledge society, the knowledge-based firm, or even knowledge capitalism” (p.116) this literature is limited in that research is not taking place where you find scientific work.
                Styhre then discusses the ontological and epistemological concerns regarding research methodology in organization theory and management studies including the debate between the realist and anti-realist schools of thought. He describes how these different schools of thought affect research including the theoretical frameworks used and the methods for data collection and analysis.
                 He states that his research methodology exists within the anti-realist domain and goes back to how the selection of a drug molecule is an example of the natural, social, and cultural resources that affect its selection. “For the synthesis chemist, a molecule is a chemical entity; for the biologist or pharmacologist, the molecule is what needs to affect the target of the selected indication; for the marketing manager, the molecule is one entity in a broader set of packages that may open up new markets…” (p. 120). To study new drug development or other science-based innovation, Styhre supports a methodology that accounts for these many perspectives.

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