Michael M. Hopkins

Putting pharmacogenetics into practice

Genetics is slowly explaining variations in drug response, but applying this knowledge depends on implementation of a host of policies that provide long-term support to the field, from translational research and regulation to professional education.

The current clinical practice of pharmacogenetic testing in Europe: TPMT and HER2 as case studies

The current clinical practice of pharmacogenetic testing in Europe: TPMT and HER2 as case studies

Big Pharma, Little Science? A Bibliometric Perspective on Big Pharma’s R&D Decline

There is a widespread perception that pharmaceutical R&D is facing a productivity crisis characterised by stagnation in the numbers of new drug approvals in the face of increasing R&D costs. This study explores pharmaceutical R&D dynamics by examining the publication activities of all R&D laboratories of the major European and US pharmaceutical firms (Big Pharma) during the period 1995–2009. The empirical findings present an industry in transformation. In the first place, we observe a decline of the total number of publications by large firms. Second, we show a relative increase of their external collaborations suggesting a tendency to outsource, and a diversification of the disciplinary base, in particular towards computation, health services and more clinical approaches. Also evident is a more pronounced decline in publications by both R&D laboratories located in Europe and by firms with European headquarters. Finally, while publications by Big Pharma in emerging economies sharply increase, they remain extremely low compared with those in developed countries. In summary, the trend in this transformation is one of a gradual decrease in internal research efforts and increasing reliance on external research. These empirical insights support the view that Big Pharma are increasingly becoming ‘network integrators’ rather than the prime locus of drug discovery.

DNA patenting: the end of an era?

Debates on patenting DNA must evolve to reflect the global decline in filings and regional disparities in patenting activity.

Towards a method for evaluating technological expectations: Revealing uncertainty in gene silencing technology discourse

Abstract This paper investigates the dynamics of expectations from a cognitive semantic perspective, specifically the relationship between epistemological asymmetry and uncertainty. Building on the work of several other authors since the 1980s, we propose a new framework based on frame semantics for discovering and organizing information related to expectations. When this framework is applied to two sets of expectations surrounding the applications of RNA interference, a recently discovered molecular genetic phenomenon with increasing notoriety, uncertainty seems to be correlated with what we call conceptual distance, the difference between past/present and future aspects of expectations. In essence, levelling of epistemological asymmetry through frame semantic analysis can decrease or increase uncertainty based on conceptual distance from previously fulfilled expectations.

The hidden research system: The evolution of cytogenetic testing in the national health service

There is growing public interest in the activities of medico-scientific communities in the provision of healthcare. This is particularly evident in the UK where a number of recent incidents have opened debates including: the use of organs in research following the hoarding of body parts by a pathologist at the Alder Hey Hospital (Jackson, 2001); the clinical validity of research following the politicization of the Measles, Mumps and Rubella triple vaccination (Dyer, 2004a); and the oversight of laboratory procedures after mixed race twins were born to a Caucasian couple following IVF treatment (Dyer, 2004b). As a result the public increasingly want to know how these communities operate and interact. Here we explore the important role such medico-scientific communities play in the shaping of a medical technology, through a case study of cytogenetics. We follow events from the birth of genetics in the early years of the twentieth century to the clinical debut of cytogenetics at the end of the 1950s and its subsequent rise to routine use in prenatal screening from the 1970s onwards. In this context we ask: which groups play a role in innovation? How do their views and context influence the nature and course of innovation? In what ways do such patterns of innovation differ from the forms we are more familiar with, such as the more visible commercial sector (i.e. the providers of highly marketed and regulated drugs and devices)? We conclude by examining the implications of the answers we provide for the governance of such technologies, such as the extent to which the medico-scientific communities that control them respond to pressures for greater accountability. We suggest that the shaping of cytogenetics reveals the central role that clinicians, research scientists, clinical scientists and their professional bodies play in laboratory-based healthcare innovations. We characterize their environment as informally regulated according to Science as Culture Vol. 15, No. 3, 253–276, September 2006

A molecular monopoly? HPV testing, the Pap smear and the molecularisation of cervical cancer screening in the USA.

DNA-based molecular testing for human papillomavirus has emerged as a novel approach to cervical cancer screening in the context of well-entrenched existing technology, the Pap smear. This article seeks to elucidate the process of molecularisation in the context of screening programmes. We illustrate how, although Pap has long been problematised and could be seen as a competing technological option, the existing networks and regime for Pap were important in supporting the entrenchment process for the artefacts, techniques and new diagnostics industry entrant, Digene, associated with the new test. The article provides insights into how the molecularisation of screening unfolds in a mainstream market. We reveal an incremental and accretive, rather than revolutionary, process led by new commercial interests in an era when diagnostic innovation is increasingly privatised. We show Digenes reliance on patents, an international scientific network and their position as an obligatory point of passage in the clinical research field with regard to the new technologys role, as well as on controversial new marketing practices. The article is based on a mixed method approach, drawing on a wide range of contemporary sources (including patents, statutory filings by companies, scientific literature and news sources) as well as interviews.

Generative and degenerative interactions: positive and negative dynamics of open, user-centric innovation in technology and engineering consultancies

The related concepts of open innovation and user-centric innovation are currently popular in the literature on technology and innovation management. In this paper, we attempt to address two shortcomings to their practical application. First, the precise mechanisms supporting open and user innovation in different industrial contexts are poorly specified. Second, it is not clear under what circumstances they might become dysfunctional. We identify how the interaction of meso- and micro-level mechanisms contribute to project-based user-centric innovation, based on a detailed characterization of the business activities of eight technology and engineering consultancies working across a range of sectors. We develop and illustrate the notion of generative interaction, which describes a series of mechanisms that produce a self-re-enforcing ecology, which favours innovation and profitability. At the same time, we observe the opposite dynamics of self-reinforcing degenerative interaction likely to produce a cycle of declining innovation and profitability. In the specific context of project-based firms, we show that user-centric, open innovation can affect performance negatively, and we discuss the consequences (positive and negative) of different patterns of interaction with clients.

The phantom menace of gene patents.

In this, the second of two Commentaries, Sibylle Gaisser, Michael M. Hopkins and colleagues discuss a survey demonstrating that European health-care systems are ill prepared for the commercial reality of gene patents.

Strategic intelligence on emerging technologies: Scientometric overlay mapping

This paper examines the use of scientometric overlay mapping as a tool of “strategic intelligence” to aid the governing of emerging technologies. We develop an integrative synthesis of different overlay mapping techniques and associated perspectives on technological emergence across geographical, social, and cognitive spaces. To do so, we longitudinally analyze (with publication and patent data) three case studies of emerging technologies in the medical domain. These are RNA interference (RNAi), human papillomavirus (HPV) testing technologies for cervical cancer, and thiopurine methyltransferase (TPMT) genetic testing. Given the flexibility (i.e., adaptability to different sources of data) and granularity (i.e., applicability across multiple levels of data aggregation) of overlay mapping techniques, we argue that these techniques can favor the integration and comparison of results from different contexts and cases, thus potentially functioning as a platform for “distributed” strategic intelligence for analysts and decision makers.