Working Paper, December 2013. Not to be cited without author’s permission. Comments welcome, to [email protected].

uk

Data storms and fishing trips: bioinformatics in the engine-room of genomic global health policy

Alex Faulkner, Centre for Global Health Policy, University of Sussex, UK

Abstract: Bioinformatics comprises a diffuse, hybrid and unstable field of technologies (e.g. biochips,
microarrays, supercomputers, ‘the cloud’), skills, knowledges, databases and software tools, which are
being brought together to transform biological materials into informatic forms useable for medical
innovation purposes. These purposes include notably the development of new drugs under the framing of
personalised or stratified medicine. The arrival of genetic and genomic analysis is producing unprecedented
volumes of person-level information, which is one of the dynamics producing the current increasing and
visionary movements around ‘big data’ in the life sciences. As national life science policies get ratcheted up
governments’ political agendas, it is clear that bioinformatics is becoming a clearer target of policymaking
for example through investment schemes, infrastructure-building and skills development at both national
and transnational levels. Alongside public and academic initiatives constituting the field, commercial
ventures including big pharma companies are employing bioinformatics for pharmacogenomic R&D, and a
range of companies are positioning themselves as providers of services for stakeholders inter-nationally
who are outsourcing parts of their bioinformatics processing needs, such as gene annotation. While
bioinformatics, or computational biology, is undoubtedly an essential engine for the development of
genome-based global health objectives, it appears beset by a range of conflicts that commercial and
governmental policies have to embrace. Drawing partly on political economy and recent theorisation of
‘bio-objectification’, this paper identifies the differential framings of bioinformatics in a range of policy
discourses, focusing especially on India, the UK, and transnational governance organisations such as the
WHO and Gates Foundation (drawing on initial exploratory research including document analysis and some
initial interviews from a UK ESRC-supported ‘Rising Powers’ project). India was one of the first countries in
the world to establish a national bioinformatics network, and the implementation of the UK’s national life
science strategy includes genome-related bioinformatics initiatives as part of its vision for the future health
service. Innovation studies and STS research has begun to examine this field; the focus has been mainly on
issues of standardisation, professional tensions, and public vs. private knowledge. The paper aims to
demonstrate the growing policy recognition of the importance of bioinformatics, and traces tensions in the
field relevant to global health politics and goals and their different manifestations in the states and
transnational governance sites of interest, including: patenting vs. open source/open access;
technonationalism vs. outsourcing; personal privacy vs. data linkage; data mining vs. disease targeting;
bioinformatics connections to health informatics i.e. combination of genomic data with patient medical
records; IT skills vs. biological skills; and communicable vs. noncommunicable disease targets.

_______________________________________________________________________________________

Introduction

The unravelling of the human genome is said to have stimulated a ‘gold rush’ in the field of bioinformatics
(Howard, 2000). Visions of the potential impact of genomics- based medicine on global public health
objectives have consequently mushroomed. A Toronto research group study identifying the ‘top 10’
biotechnologies that would further the UN Millennium Development Goals of 2000 (aimed at alleviating
conditions of the world’s poorest people, three of which are directly health-focused) included:

- bioinformatics to identify drug targets and to examine pathogen-host interactions; and

Bioinformatics changes the way scientific research is undertaken: ‘Laboratory life has changed to become
more virtual, and the experiment has become redefined to rely increasingly on the construction, curation
and mining of large scale databases, rather than using conventional ‘wet’ laboratories’ (McNally and
Glasner. 2006). In a celebration to dedicate the Gates Center for Computer Science at Carnegie Mellon
University in the US in September 2009, Bill Gates stated the following in his speech:

‘Today, we’re in the midst of a remarkable transformation that will see computing revolutionize
scientific discovery. Already, computing technology is the foundation for almost all scientific
research. The ability to collect massive amounts of data in digital form and share it across the
Internet has changed the way we drive progress in every field of science’... ‘In healthcare, data-
driven medicine and the ability to compute genomics and proteomics on a personal scale will
fundamentally change how medicine is practiced. Medical data will be available in real time to be
analyzed against each person’s individual characteristics, ensuring that medical care is truly
personal. Massive-scale data analytics will allow us to track disease so we can respond quickly to
potential pandemics. All of these advances will help medicine scale to meet the needs of the more
than 4 billion people who lack even basic care today’( http://www.gatesfoundation.org/Media-
Center/Speeches/2009/09/Bill-Gates-Carnegie-Mellon-University)

In this paper, the Gates Foundation, now a massive charitable funder of global health-related research, is
seen as an example of a transnational governance actor shaping the agenda of global health science and
policy, in particular ways. The type of techno-utopian vision shown by Gates is a familiar vision (in Science &
Technology Studies) , but the huge resources at the Foundation’s disposal means that the direction and
methods of its vision have to be taken seriously for their performative effects in the global health and
bioscience research and policy arena. Given Bill Gates’ own global biography it is of course unsurprising that
digital computation and massive data form the backbone of his vision – and practice - of health and medical
futures.

The bioinformatics field and its technologies

Unsurprisingly, commentators’ versions of what bioinformatics consists of vary greatly. Essentially it refers
to a combination of molecular biology and computer science, but can be seen as ‘covering anything from
epidemiology, the modeling of cell dynamics, to its now more common focus, the analysis of sequence data
of various kinds (genomic, transcriptomic, proteomic, metabolomic)’ (Harvey and McMeekin 2002, 10).
More specifically the techniques involved include sequencing of DNA base pairs; gene expression (when and
where genes are turned on), genetic differences among individuals (called single-nucleotide polymorphisms
(SNPs)), the structures of various proteins, and maps of how proteins interact with each other. One basic
operation involves searching for similarities, or homologies, between a newly sequenced piece of DNA and
previously sequenced DNA segments from various organisms - near -matches allow researchers to predict
the type of protein the new sequence encodes, producing leads for drug targets early in drug development
and discounting associations unlikely to be significant. A massive area of research globally is that of
genome-wide association studies (GWAS), which attempt the analysis of disease correlations by methods
by genotyping of thousands of cases and controls at hundreds of thousands of genetic marker sites.

Technologically, the growth of the field in the 1990s and 2000s has been facilitated by the development of
computer networking supporting possibilities of interconnectivity and of largescale data curation and
storage. ‘The key innovation in bioinformatics has been the invention of the microarray or ‘gene chip’. A

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microarray is a small glass slide which may be ordered as a series of slides, “...containing thousands of DNA
sequences in an ordered array, which allows simultaneous analysis of thousands of genetic markers or
sequences” (Oldham 2004).

Bioinformatics comprises a diffuse, hybrid and unstable field of technologies (e.g. biochips, microarrays,
supercomputers, ‘the cloud’), skills, knowledges, databases and software tools, which are being brought
together to transform biological materials into informatic forms useable for medical innovation purposes
(processes that can be summarised as ‘bio-objectification’, see below). These purposes include notably the
development of new drugs under the framing of ‘personalised’ or ‘stratified’ medicine. The arrival of
genetic and genomic analysis is producing unprecedented volumes of person-level information, which is one
of the dynamics producing the current increasing and visionary movements around ‘big data’ in the life
sciences. As national life science policies get ratcheted up governments’ political agendas, it is clear that
bioinformatics is becoming a clearer target of policymaking for example through investment schemes,
infrastructure-building and skills development at both national and transnational levels. The field is
developing rapidly and attracting major funding from public governments and the pharmaceutical industry.
The development of this computational form of biology is increasing the scales of international collaborative
activity and reconfiguring inter-disciplinary boundaries between biology, computer science, bio-engineering,
and statistics. Clusters and centres in Europe, Japan, and the USA are seen as the major locations for
genome and proteome projects (Harvey & McMeekin 2005). Both academic and commercial genomic
researchers in the advanced industrial states outsource significant processing requirements overseas,
including to China and India.

However, the national and transnational policy visions and actions driving this trend show wide geopolitical
variation. Also, while techno-hype is fascinated with the downward spiral of the cost of sequencing a
genome, less trumpeted is the cost of what has been called the ‘interpretome’ – the cost of making sense of
genome data, requiring bioinformatics techniques - which can run into millions of pounds/dollars/euros.

Bioinformatics has so far attracted only a little attention from scholars in science policy/political
economy/science & technology studies (STS)/sociology/anthropology. Most of the work to date can be
described as focused on ‘internalist’ accounts, describing and interpreting the epistemology, knowledges,
disciplines, field-shaping claims, data forms and processes internal to the field. For example Lewis and
Bartlett (2013) emphasize the lack of ‘disciplinary coherence’ in the field, its service status in relation to
biology within academia rather than as a primary innovative agenda-setting research area, and the
disciplinary identities of practitioners of bioinformatics as either developers of tools or service providers;
Mackenzie (2003) argues for what might be called a dis-embodiment perspective, which emphasizes the
potential for private property ownership in the field; Harvey and McMeekin (2009), from a perspective of
innovation pathway studies, similarly have discussed tensions between property issues and ‘the commons’
in the field.

The paper proceeds by outlining a conceptual approach to understanding the changing position of
bioinformatics in health policy as a sector or technological zone (Faulkner, 2009). In this discussion I show
how national state and transnational actors are framing, constructing and positioning bioinformatics in, and
how it is being enrolled into and constitutes visions of national or global bioeconomies, public health and
medical agendas. In analysing the developing position of innovative fields such as bioinformatics it is telling
to examine the way in which state policies frame the field in terms of particular national and international
ambitions, be they in health or other policy fields. I argue that the transformation of biological material into
manipulable forms of digital data that bioinformatics accomplishes (‘bio-objectification’) is accompanied by
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a range of tensions and opposing dynamics that currently shape and characterise the field. My (developing)
case material currently concerns primarily the UK, India and some transnational actors.

Conceptual approach

I combine an analytic approach that aligns the political economy of the action and interaction of
bioinformatics stakeholders, such as state agencies, academic centres, companies, with an approach that
views bioinformatics work as engaged in a range of medico-political domains whose classificatory
boundaries it may disturb or reinforce. The field of global health is a domain in which there is a conspicuous
politics of disease categories such as infectious disease, rare disease, neglected disease, communicable
disease and non-communicable disease, categories which become salient in the health policy debates of
organisations such as WHO and national governments.

In studies of global political economy in which the governance strategies and respective positions of nation
states are analysed, there is longstanding debate in terms of ‘competition states’ (the advanced industrial
states) and ‘developmental’ or more lately ‘adaptive’ (there are many related terms) states which may
attempt to ‘catch up’ and ‘keep up’ by governance strategies aimed at gaining market shares or through
stimulating and steering indigenous innovation (Salter and Faulkner, 2011). Harvey and McMeekin (2005)
have illustrated indigenous (and ‘competitive’) innovation in the case of Brazilian genomic innovation in
the agriculture sector, showing how particular local national scientific interests (e.g. sugar cane based
ethanol, and a plant pathogen that attacks grape vines amongst other crops) led to particular indigenous
expertise that ‘broke through’ to global status, including on to the front page of Nature, and in the case of
the plant pathogen development of genome annotation capacity which was then sought by commercial
interests in the US.

Alongside this conceptual lens, I bring in a focus on informatics as a mobiliser and enactor of health goals.
The digital age brings a broad and deep process of informaticisation of society, the economy and medicine
(Brown and Webster, 2004). Bowker and Star’s well known work (1999) has emphasized the importance of
information infrastructures in structuring the ‘built moral environment,’ in which we can include societies’
orientations to health and medicine. It is now commonplace to understand that ‘technical’ issues like how
to name things and how to store data constitute the taken-for-granted world. In the same vein:
‘bioinformatics, far from being neutral, entails values and specific enactments of specific human identities.’
(Baren-Nawrocka 2013). In bioscience and biotechnology, biological material is variously turned into
‘objects’, through ‘bio-objectification’ processes wherein life-forms or living entities are first made into
objects through scientific labor and its associated technologies, and then come to be attributed with specific
identities, often through contested processes (Holmberg et al 2011; Vermeulen et al 2011). As Mackenzie
(2003) has noted: ‘we should read the tools, interfaces and portals built around the sequence database as
artefacts that reflect (those) imagined bodies.’ Disruption of existing medical scientific and healthcare
boundaries is a key feature. Applying this concept to bioinformatics, we can propose that the boundaries
between the biological and the digital, the in-vivo and the in-silico, and the boundary between biomedical
research, health goals and healthcare systems will be challenged, possibly engendering new social, medical
and economic directions, and typically attracting the attention of governance actors (Hansen & Metzler
2012). We shall see clearly that national and global policy actors are engaged currently in efforts to mobilise
this set of knowledges and activity toward a range of health and medical goals, and that significant
differences in national orientations to valuing bioinformatics can be discerned. Bioinformatics heightens the
importance of classificatory issues in its implications for how it might shape the agendas of health

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policymakers and health entrepreneurs or be mobilised by them, as well as resulting in a wide range of
‘objects’, some of which are commercialisable products in the health sector.

A note on method

This draft working paper is based on early-stage research being conducted as part of a UK Economic and
Research Council (ESRC) funded team research project, conducted at King’s College London and the
University of Sussex: ‘ State strategies of governance of biomedical innovation: the impact of China and
India’ (Salter et al, 2012; support of ESRC gratefully acknowledged). The project focuses on regenerative
medicine and ‘personalised’ medicine. A wide range of documents have been assembled including
government policies, stakeholders’ position papers, scientific articles, media reports and commentary,
market analysis, and so on. Fieldwork consists of interviews and conference/meeting observations and
‘policy workshops’. Apart from documentary data, this paper draws on an initial 6 interviews on
bioinformatics/pharmacogenomics, conducted mainly in academic science centres, 4 in the UK, one in the
US, and one in New Delhi.

Tensions in bioinformatics

The bioinformatics field can reasonably be divided into the different domains of drug discovery research,
provision of content and data integration in database form, provision of informatics processing tools
including those for ‘data mining’, and the production and use of microarray technology itself.

Bioinformatics presents economic business opportunities as well as the promise of eventual health benefits,
and this is one of the most controversial tensions in the field, encapsulated in the tension between open
access/open source principles and law and practices of intellectual property (IP) and patenting (cf. Gopalan,
2009). It is now conventional for academic journals to require researchers to deposit raw data online, a
position supported by powerful global funding organisation such as the Wellcome Trust. A commonly cited
convention here is that a ‘pre-competitive’ space should be based on these open source principles in order
to encourage data sharing and early-stage innovation, to be followed by a commercial, competitive phase
where IP can be claimed (US interview; the current extent and preservation of this open access convention
is a matter of debate and need for empirical research). A related argument is to distinguish between
primary (e.g. DNA sequence) and secondary databases, arguing that the former should be public domain
and suitably supported by government subsidy, and the latter open to patenting (Chang J, Zhu X., 2010). In
terms of technology, DNA microarray biochips are crucial to gene sequencing and other informatics
operations and this has been the subject of various patent disputes in the late 1990s and early 2000s
between companies seeking dominance in the field such as Affymetrix and Incyte (Abhilash, 2010). The lack
of standardization in arrays presents an interoperability problem that hinders the exchange of array data.
Various grass-roots open-source projects are attempting to facilitate the exchange and analysis of data
produced with non-proprietary chips.

In order to illustrate the different approaches to the framing and policy development of bioinformatics in
the UK and India, and the different emphases they therefore place on different disease areas, I now present
brief outlines of key features of the recent policy developments in each.

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UK shaping of bioinformatics: genomic medicine

In the UK, ownership and intellectual property issues related to bioinformatics have been dominated by
the Cambridge-based and Wellcome Trust supported insistence on open source and open access public
domain principles. The early-mover power and standardising influence on microarray technology of this
model, associated with the European Bioinformatics Institute (EBI) also based in Cambridge, has been
described by Rogers and Cambrosio (2011).

In the early 2000s, it was suggested, interestingly, in a Department of Trade & Industry report, that the main
strength of UK bioinformatics at that time lay in agrifood applications rather than health and medicine
(Harvey & McMeekin 2002). Be that as it may, medical and health applications have now been brought to
the fore in recent government policy development. Much of the policy development in UK bioinformatics is
now framed in terms of ‘genomic medicine’. The UK’s House of Lords conducted an inquiry into this topic in
the late 2000s, to which the government responded (Secretary of State for Health, 2009). Their response
included noting recent investments and a range of measures specific to bioinformatics, notably:

‘In 2009 more than £9 million… awarded by the MRC (Medical Research Council) to support the UK
research community’s access to high quality equipment for DNA sequencing via substantial
investment in the latest technology. Four regional hubs located across England and Scotland will
provide technical support and bioinformatics expertise’

‘We recommend that the Government show leadership on leveraging sustainable funding to the
European Bioinformatics Institute (EBI), through the European Research Infrastructure (ESFRI)
instrument and through the UK Research Councils. This would reduce the dependence of the EBI on
charitable and cyclical funding and allow further growth of the Institute commensurate with the
recent growth in genomic databases and the value of the EBI to the UK science base… The UK is
leading discussions at a pan-European level to help develop a more secure funding structure for the
EBI. Since 2008, Research Councils UK (RCUK) has made it a priority to provide capital expenditure
to renew computing facilities at the European Molecular Biology Laboratory – European
Bioinformatics Institute (EMBL-EBI)’.‘This forms a key part of the emerging pan‑European science
project, the European Life Science Infrastructure for Biological Information (ELIXIR), an initiative
involving 32 partners from 13 countries aimed at establishing an infrastructure for biological
information in Europe that attracts sustainable funding. The expansion in EMBL-EBI I data
management capacity is vital…’

Note the importance of ‘Europe’ as a strategic platform of collaboration in the above.

‘We recommend the establishment of a new (i.e. national) Institute of Biomedical Informatics to
address the challenges of handling the linking of medical and genetic information in order to
maximize the value of these two unique sources of information. Such an institute would bridge the
knowledge, culture and communications gap that currently exists between the expertise in NHS
(National Health Service) IT systems and bioinformaticians working on genome research. The
Institute would guide the NHS in the creation of NHS informatics platforms that will interface with
databases containing personal genetic data and with publicly available genome databases
(Paragraph 8.23). We recommend that the Department of Health should establish a centre for
national training in biomedical informatics (within the Institute of Biomedical Informatics) with the
aim of providing training that bridges the gap between health records information technology and
genome informatics, and ensuring the delivery of an expert workforce for the NHS (8.24). ‘
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And in the above we see how bioinformatics is being brought under the umbrella of genomic medicine, and
also strongly linked the public healthcare system of the NHS. The latter is a development more advanced in
certain research centres in the US.

The UK government produced a national Life Sciences Strategy (having earlier created an Office for Life
Sciences within its Department for Business, Innovation Skills (BIS)), which was launched by the Prime
Minister in November 2011. The terminology of this policy repays some attention, for example with the
extensive use of the notion of ‘bioresources’, which means not only biological material such as that stored
in biobanks, but also the population of the country and patients encountering the national healthcare
system. The policy makes some specific provisions for increasing bioinformatics capability in the UK,
notably:

‘Informatics – ELIXIR: We are moving at pace to deliver a robust informatics infrastructure via
ELIXIR. ELIXIR is a programme to assemble and manage biological and genetic information
generated by research. UK-funded research breakthroughs have recently led to a revolution in
commercially available high-throughput gene sequencing technology. This revolution has created
challenges in storing and analysing the huge volume of data generated. It is vital that this data is
collected, stored and curated in user-friendly ways that allow its efficient retrieval and rapid
exploitation. ELIXIR will allow us to do just this. ACTION: We will invest £75 million to: - expand the
existing European Bioinformatics Institute in Cambridge to provide a new facility for biological data-
storage to support life sciences research and its translation; and - deliver a new technical hub
(Hinxton, Cambridge) which will house 200 staff and will coordinate the network.

In 2012, Sir Mark Walport, director of the Wellcome Trust, which spends more than £100 million a year on
genomic research, endorsed the recommendations of the (Bell) report on genomic medicine:

“Our advancing ability to read and understand the genetic code is already beginning to spark
transformative improvements in healthcare, by refining diagnosis and revealing the processes of
disease…We particularly support the proposal to link genomic data to patients’ anonymised medical
records through a secure national centre, which would create an unparalleled resource for research
and diagnosis without compromising confidentiality or privacy. It is also important to develop
medical informatics services that can make sense of complex genomic data, and to update
professional training to meet the challenges of the genomic age…We are committed to working
with the Government to address these challenges, building on the world-class genomics and
bioinformatics expertise available in the UK at the Wellcome Trust Sanger Institute and the
European Bioinformatics Institute.”

Tensions in the innovation model to take forward this vision are conspicuous in UK debates currently. For
example a representative of the Medical Research Council (MRC) asserts that for the true potential of life
sciences in the UK to be realised, ‘industry and academia will have to engage in much more complicated
partnerships that in the past…The science must remain at the forefront, but each company will see the
science question in a different way, so a shared and very well-developed science agenda will be critical’ (Dr
(Declan Mulkeen, conference report at http://www.pharmatimes.com/Article/13-03-
26/UK_life_sciences_let_down_by_poor_informatics_skills_experts_warn.aspx).

Similarly, medical media headlines have included such as:

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UK life sciences let down by poor informatics skills, experts warn: ‘Health informatics is set to be a
major driver of success for UK life sciences, but the sector - and industry in particular - does not yet
have the necessary analytical skills, according to leading experts…"We need to build up a cadre of
people who can do this," (government life sciences champion) Professor Sir John Bell, and AMS
president Professor Sir John Tooke agreed that medical training should move towards including the
provision of skills in informatics and bioinformatics..’ (meeting at the Academy of Medical
Sciences)… Speakers agreed that the existing pattern of collaboration between the pharmaceutical
industry and academia has to change. Sir John Bell called for the whole process to begin again "with
a clean sheet," and to focus on ‘open and adjacent’ innovation. (UK News | March 26, 2013. Lynne
Taylor . Pharma Times)

Such opinions are supported by our research team’s interviews to date, with some skill gaps especially
mentioned such as in computational chemistry.

In 2012-2013 the UK government announced the formation of ‘Genome England’. Genome England will be a
company owned by the Department of Health that ‘will introduce high-tech DNA mapping for cancer
patients and those with rare or infectious diseases and link that new data to the patient’s medical records’.
It is the organisational form devised to implement the ‘100,000 genomes’ project announced in 2012. The
£100 million funding will also be used to train healthcare professionals in the clinical application of genomic
data, and new genetic scientists to develop novel treatments. Genome England will manage the contracts
for specialist UK-based companies, universities and hospitals to supply sequencing, data linkage and analysis
services. It will have responsibility for regulating issues of data storage and security and patient consent to
participation.

Thus overall we can see bioinformatics being strongly drawn into the agenda of a future vision for
healthcare and medical innovation based on the genomic revolution. The embedding of bioinformatics in
healthcare delivery organisations through integration of electronic patient record data is notable. Cancer
and rare diseases are high on the medicopolitical agenda, with strong emphasis on genomics-based drug
development and identification of new biomarkers and diagnostics, in other words ‘pharmacogenomics’.
However, much of the developmental trend appears aimed at developing ‘platform’ technology that can
have multiple disease-related applications. These features provide a striking contrast with developments in
India, to which I now turn.

India shaping bioinformatics: techno-nationalism, outsourcing and national disease

India’s well-acknowledged expertise in IT and its huge generics drug industry certainly shape the landscape
in which bioinformatics is developing in the nation.

India was one of first countries in the world to establish a nationwide bioinformatics network, which
comprised 57 connected informatics centres set up in 1987. This was initially at least a technological
network allowing electronic network communications. The government Department of Biotechnology (DBT)
is the main responsible government department. DST (Science & Technology) is involved especially for
supporting biochip technology aspects. The Bioinformatics Institute of India (BII) was formed in 2002
registered as a professional society under Indian rules, for ‘academicians, scientists and engineers’. The
Indian Department for Biotechnology published a national bioinformatics policy in 2004, with an explicit
aim of making India a significant presence on the global stage. The Indian Council of Medical Research
(ICMR) has initiatives in the bioinformatics field, outlined below. Developments in India strikingly combine
attention to the field as a business sector and as a vehicle of (some) national health goals.
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The worldwide market for bioinformatics tools and services is estimated by Indian sources to exceed US$40
billion within the next five years. An ABLE/Biospectrum Biotech Survey 2013 reported: ‘Bioinformatics is
growing as an independent discipline and is fundamental to the growth of biotechnology. India has achieved
remarkable success in the software industry. BioInformatics sector grew by 11% (2003-13)... The
fragmented bioinformatics market will see a growth in the coming years because of government's spending
on R&D in addition to increase in private fundings.’ It is claimed that over 200 companies have some
involvement in bioinformatics in India, divided amongst three types of companies – pure research
bioinformatics, IT companies, and CRAMS (contract research and manufacturing services). A ‘huge
proportion’ of the sector is said to be focused on outsourced work (RNCOS, 2012). It is claimed that the
emergence of genomics is challenging the long-established devotion of multinational company business
models to protection of IP through patents, with a move toward forming alliances to ‘keep genomic data
free of any protection’ (Desai, personal communication).

The Indian Council for Medical Research (ICMR) has its own Biomedical Informatics Centre, formed in 1999
with support from WHO’s tropical diseases research fund. A number of disease targets can be identified in
their mission - nine centres were initially created. One of the original nine centres (now comprising
seventeen ‘projects’) is the Biomedical Informatics Centre (BMIC) at the Tuberculosis Research Centre
(Chennai). The aim of this centre, typical of the model, includes: ‘to enhance understanding of TB and
HIV/AIDS using computational approaches; to provide bioinformatics support for biomedical research; to
impart skills in bioinformatics through training programmes / workshops’
(http://bmi.icmr.org.in/DDTRP/[email protected]). The other BMIC centres include those with a focus on or being
part of: the National Institute of Cholera and Enteric Diseases, Kolkata, established 2006; National Institute
of Nutrition, Hyderabad; National Institute for Research in Reproductive Health, Mumbai; Rajendra
Memorial Research Institute of Medical Sciences, Patna (nano-informatics); All India Institute of Medical
Sciences (AIIMS), New Delhi (drug design, protein modelling); Institute of Cytology and Preventive Oncology,
Noida; Regional Medical Research Centre, Dibrugarh (malaria and mosquito-borne disease); Regional
Medical Research Centre, Bhubneshwar (filarial and dengue disease). Some of the centres undertake
unspecified generic work, eg. genotyping and genome-wide association studies (GWAS).

Also focused on a disease of major national importance, DBT sponsors TBNet India, a network of 13 centres
whose aims include attempting to understand different strains of drug-resistant TB and gathering and
curating published protein sequences, unpublished submitted sequences and cellular, molecular and
biochemical data publications on mycobacterial proteins in a Tuberculosis Reference Database.

The National Institute of Biomedical Genomics (NIBMG) was established near Kolkata as an autonomous
institution by the Government of India in 2010, under the aegis of the Department of Biotechnology. This is
said to be the first institution in India explicitly devoted to research, training, translation & service and
capacity-building in biomedical genomics. The main objective of the institute is to ‘promote better public
health in India by conducting large genetic epidemiological studies on Indian populations on diseases of
importance in India, including susceptibilities to infectious diseases and responses to vaccines against
infections’ (website). IGIB (the Institute of Genomics and Integrative Biology was established under the
central Council of Scientific and Industrial Research (CSIR), part of the Department for Biotechnology,
‘engaged in research of national importance in the areas of genomics, molecular medicine, bioinformatics,
proteomics and environmental biotechnology’ (website). IGIB has a basic mission of translating genomics
into commercialisable healthcare products . At the time of writing its website lists 148 patents held across
all fields of its activity. Founded in 2002, main research areas at IGIB include: major disease-related Indian
genomic variation, personal genome sequencing, Ayurgenomics, and genetic and epigenetic factors in
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obesity and metabolic disorder. The University of Columbia is partner in some of IGIB’s sequencing work.
Associated companies include Vyome Biosciences, specialising in dermatological products.

Thus we observe a range of different activity in the bioinformatics field in India, divided between
commercial outsourcing enterprise and public government supported informatics activity some of which is
targeted to ‘Indian’ disease issues, some of which not (the extent of which is yet to be assessed by the
present author). The arrival of biomedical genomics per se is clearly a very recent development.

Perhaps reflecting the diversity of activity in the bioinformatics field, there is notable criticism of the
innovation pathway of bioinformatics within the country:

‘The present Bioinformatics Policy lacks vision and fails to address the pertinent issues related to
research and development in this arena. Hence, to realise this vision, it is essential to form of a
stringent and functionary regulatory body, to systematise, control and facilitate projects related to
bioinformatics and synthetic biology research. ‘ (interview professor of bioinformatics, New Delhi,
2013)

So (compared to the UK for example), the extent of bioinformatics enrolment into the emergence of a
national policy discourse on pharmacogenomics in India is very recent. The Indian government has only in
the last three years started addressing the translational issue of pharmacogenomics as part of national
health strategy. The main action is to have issued guidance on the design of pharmacogenomics clinical
trials, which states that trial populations and the aims of trials must have relevance to diseases relevant to
the Indian population. Likewise, the ICMR has just set up a task force on pharmocogenomics to focus on
specific research topics in the field. The task force will focus on topics including identification of genes and
pathways involved in ‘pharmacokinetics and pharmacodynamics of common drugs, and validation of human
single nucleotide polymorphisms (SNP) haplotypes of short-listed genes in Indian population’. The task force
is also intending to conduct research on the development of an ‘Indian pharmacogenomics chip’ (which I
believe is being developed at least partly by Indian researchers based in US academia (this requires
confirmation).

Survey of commercial activity in the field shows a number of life science companies moving to work in the
pharmacogenomics field (Parveen 2010). However, there is strong perception that India, in
competitive/developmental state terms, is a latecomer to this field:

‘India’s pharmaceutical market, mostly deals with generic drugs, therefore, it further strengthens
the view that drug response monitoring program based on pharmacogenomic profiling of Indian
populations is ideal for having a safer response to medications’ India is far behind in addressing the
foreseeable challenge of drug response monitoring or even on biomarker discovery. It is indeed high
time that we realizes the potential of pharmacogenomic technologies or we end up paying SNP
Consortium Ltd. or Pfizer or AstraZeneca for accessing our own databases, as these companies are
already in the process of screening the Asian-Indian subgroups living in the United States…Scientific
journal, Nature, in 2010 indicated that India is way behind in the global map of genomic technology
landscape. It is an opportunity for India to tap its intellectual resources to initiate a mission mode
program in addressing the concerns of human health (Banerjee 2011).

Trade organisations such as an Indian Pharma Industry representative organisation likewise compares
India’s position to other ‘Rising Powers’: ‘India at this point is ahead of China in chemistry but the
impression in many countries is that India is weak on biology front. It is found that India’s strength in biology
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 Working Paper, December 2013. Not to be cited without author’s permission. Comments welcome, to [email protected]

sector is very limited especially in genetically modified animals, biochips and basic molecular biology. The
biology capabilities are mainly in government institutes with a handful of companies having skills in
molecular biology and protein expression’. Commentary on this position also alludes to a need to ‘bridge
the gap between bioinformaticians and experimental biologists’ (DBT, 2011).

Nevertheless, significant for the Indian genomics-based drug discovery/drug development sector, is a
remarkable initiative with symbolic significance for the Indian innovation pathway, namely the Open Source
Drug Discovery (OSDD) program, supported by the CSIR. OSDD is claimed as one of the world’s first
attempts to apply an open source/participative innovation model drawn from the IT world to
pharmaceutical innovation for soi-disant ‘neglected’ diseases. CSIR OSDD aims to discover novel therapies
for tuberculosis and other neglected tropical diseases. Its activities are stated to ‘spread throughout every
stage of the discovery process (from ‘drug target identification to lead optimization’). It has ‘initiated
discussions with pharmaceutical companies regarding pre-clinical and clinical trials’. Its main achievements
to date are: the re-annotation of the Mycobacterium tuberculosis genome and the generation of 11 models
for prediction of anti-tuberculosis activity’ (Årdal and Røttingen, 2012). The author of the book below has
won awards for his work at OSDD on M.tuberculosis :

The Director of CSIR is ‘mentor’ of OSDD.1 An independent Europe-based evaluation of OSDD states that
volunteers are attracted to the project by publicity in academic journals and utilizing social media and
networks. CSIR OSDD has also ‘effectively paired up with’ Indian universities and colleges, incentivizing
students to volunteer as parts of classroom assignments or positioning participation as valuable hands-on
experience. They have also ‘built in an element of patriotism’ linking finding cures for tuberculosis as an
Indian responsibility due to the high prevalence of the disease in India. This effect is reinforced through
project marketing efforts, like the project’s own music video and offer of prizes such as free holiday lets of
property ‘close to a bird sanctuary’. ‘Large number of students can participate and benefit from this activity.
1
Samir K. Brahmachari – Director of CSIR. ‘His current focus is on leveraging the angle of personalised medicine
towards pharmacogenomics with focus on affordable healthcare. He conceptualized and led the Indian Genome
Variation Consortium Project to provide the first comprehensive genetic map of the extremely diverse Indian
population and identify predictive markers for complex diseases and pharmacogenomics studies.He has also
conceptualized the Ayurgenomics project that aims to integrate the principles of personalized medicine from
Ayurveda, an ancient Indian medical system with modern genomics to bridge the gap from genotype to phentoype.
Prof. Brahmachari is the Chief Mentor of CSIR-Open Source Drug Discovery (OSDD) project, a CSIR-led Team India
Consortium with global partnership. Emerging as India’s first crowd sourcing initiative, OSDD is today a global
translational research platform with more than 7500 participants from 130 countries. He has championed Private-
Public Partnership conceptualizing ‘Genomed’, the first-of-its-kind knowledge alliance in India between a government
Institute and a private pharmaceutical company. He has also established The Centre for Genomic Application (TCGA)’.
http://en.wikipedia.org/wiki/Samir_K._Brahmachari . Accessed November 2013.

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 Working Paper, December 2013. Not to be cited without author’s permission. Comments welcome, to [email protected]

OSDD’s focus is in Drug discovery and Development in TB, Malaria and other neglected diseases. Chemistry,
Medicinal Chemistry, Biology and Informatic discipline plays a vital role in the early drug discovery.’ Actually
the innovation model is not open source per se because they use a protective license system and in effect a
‘gated community’ mode of access to the scheme. OSDD also aligns itself with the Indian generics drug
industry business model: ‘The drugs that come out of OSDD will be made available like a generic drug
without any IP encumbrances so that the generic drug industry can manufacture and sell it through their
channels anywhere’.. ‘(this) creates the environment of affordability’ (website). Independent assessment
concludes that ‘OSDD brings in the concept of open source, crowd source, open science, open innovation
and product development partnership concepts on the same platform and leaves delivery of drugs to
market forces’ (Årdal and Røttingen 2012). OSDD itself claims that the ‘OSDD community comprises over
7900 participants from more than 130 countries’ (OSDD website, December 2013).

In relation to non-communicable diseases, now endemic in developing states including India, India takes
part in the global International Cancer Genome Consortium. Its director, (Mike Stratton, based in the
Sanger Centre, Cambridge, UK) referring to the ambition to identify all the genes critical in the development
of cancer, has ‘hailed the role of the Kalyani-based Institute of Biomedical Genomics’…”It is playing an
important role in focusing on oral cancer which is quite prevalent in India. There are 17 countries in this
project who will eventually analyse over 25,000 cancer genomes. China is studying stomach cancer, and
Japan’s looking at liver cancer,” said Stratton’ (The Telegraph, Calcutta, 2011).

In summary, these somewhat patchy examples of bioinformatics developments in India show an emerging
sector of very diverse activity and visions. On the one hand we see the well-known pattern of outsourcing of
clinical trials from the advanced states being reproduced in a developing bioinformatics service sector, and
on the other we see a more steered biomedical economy being shaped by government initiatives and
infrastructures, with some unique national elements and some notable international collaborations. The
noninvasive nature of genomics and massive human population resource may also bolster Indian
achievement in this sector (Desai, personal communication). In terms of disease target strategies, it seems
clear that infectious and neglected diseases are being addressed to some extent, and that the growing
incidence of noncommunicable diseases such as cancer is also impacting on the shaping of the
bioinformatics agenda. The published critiques by some commentators evidences a strong perception
perception of India’s current competitive lag on the global bioinformatics stage especially in aspects of
expertise in biology, even though this has long been one of the most supported sciences in India. However,
the latter is a conspicuous perception in the UK as well.

Transnational biomedical informatics actors: some examples

Transnational health policy has galvanised bioinformatics since the late 1990s unravelling of the human
genome.

In 1998, World Health Organization-Tropical Diseases Research convened a scientific working group on “The
utilization of genomic information for tropical disease drug and vaccine discovery”. This group
recommended that bioinformatics be considered a top priority, in light of opportunities this new field
provides for disease-endemic country researchers and institutions. The WHO-based Special Program on
Tropical Diseases Research and Training began running training programmes on bioinformatics for scientists
in the developing world’ (Hardy et al 2008). In 2001 WHO appointed four Regional Centers for Training in
Bioinformatics and Applied Genomics, establishing programs in Africa, Asia and Latin America
(www.who.int/tdr/grants/awards/bioinformatics-10-01.htm). The institutions

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Selected were: the South African National Bioinformatics Institute; the Departments of Parasitology and
Computing Sciences, Univ. São Paulo, Brazil, Mahidol University in Bangkok, Thailand; and the International
Center for Genetic Engineering and Biotechnology in Delhi (ICGEB).

In 2004, a UNICEF/UNDP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases
was established (WHO website). A ‘Working Group on Applied Genomics to Drugs and Diagnostics’ led to
support being provided to identify drug targets for parasites and vectors of a range of tropical diseases
including Chagas disease, leishmaniasis, malaria, and tuberculosis. It was noted that the availability of the
genome sequences of these produced ‘an unprecedented opportunity to use whole genome …
methodologies, computational biology, and functional genomics to identify new drug/insecticide targets
and diagnostic reagents’. Examples of invited proposals included ‘Use of computational bioinformatics
approaches to identify novel pathogenic mechanisms and potential insecticide targets’.

The Gates Foundation, as implied in the introduction to this paper, is also now active in sponsoring research
that mobilises bioinformatics. For example, the ‘Gates Grand Challenges - Explorations in Global Health’
includes ‘New Approaches for the Interrogation of Anti-malarial Compounds’ (February 2012). The initiative
notes that ‘The Medicines for Malaria Venture (MMV) has recently selected 400 compounds from the
chemical libraries of St. Jude Children's Research Hospital, Novartis and GlaxoSmithKline to form a “Malaria
Box” that is available for further study’. The ambition is to stimulate

‘the development of next generation malaria drugs. We wish to encourage researchers to develop
and apply innovative biological, chemical, computational, and systems-based approaches for the
interrogation of anti-malarial compounds to maximize knowledge gained from the publicly-available
anti-malarial compound set…’ (Gates Foundation Grand Challenges website).

(These brief examples will be expanded in later version of this paper).

Discussion

This working paper is based on early, partial data. Conspicuously absent, for example, are significant data
about the international pharmaceutical industry activity, further attention to civil society issues such as
privacy concerns and access to medicines, and further evidence of international collaborative activity. I have
also avoided at this stage reference to the other ‘omics apart from genomics.

With that caveat, in this discussion, I compare the picture assembled to date in the cases of India, UK and
transnational actors. I point to the various tensions in the dynamics of the bioinformatics sector that are
apparent (or hinted at), and conceptualise these in terms of the concepts introduced at the beginning of the
paper. I speculate about the significance of these developments for global health as a field and for specific
population health and disease agendas.

So how can we understand the emerging significance of bioinformatics for global health? First, is there
evidence that the genomic-related research agendas in India and the UK show evidence of having a national
character geared toward the perceived health needs of the respective populations? The answer is yes, to
varying extents and in different ways. The recent initiatives in the UK of Genome England are most
obviously geared toward introducing more personalised genetic/genomic testing directly into the
healthcare system, notably in the field of cancer drug therapies. It is also notable that the governance frame
into which bioinformatics is being drawn is that of ‘genomic medicine’. In India, the genomic medicine

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 Working Paper, December 2013. Not to be cited without author’s permission. Comments welcome, to [email protected]

framing is largely absent, as is the ambition to embed genomics and thus bioinformatics into the fabric of
healthcare delivery systems and clinical trialling.

The account focused primarily on India and the UK provides evidence in terms of national policy of both
inward and outward facing policies and actions. Technoscientific ‘nationalism’ can be seen in both cases. In
terms of the sectorisation of bioinformatics as a technological zone, India appears to have currently a mixed
bioinformatics economy model with a strong service element serving academic and commercial researchers
globally, while the UK appears to have a more public sector-based bioinformatics economy with strong
outsourcing and a globally important node in Cambridge, with new nodes being built currently with the new
investments being made.. There is clearly a very dynamic market for outsourced services where price is key
– for example a US interviewee suggested that companies in the Philippines are currently under-cutting
Indian companies in this field.

There are some commonalities in India and the UK in the problems perceived for bioinformatics as a sector,
notably the perceived need for more, and more advanced skill-building at the interface of biology and
computation. The policy discourse in both states has highlighted this issue. Likewise, both states appear to
identify issues in the sector that require regulatory policymaking. In the UK we see an attempt to how that
the NHS is ‘open for business’ (to use a phrase current amongst UK government politicians) – the business
of clinical trials. In India we see, in competition terms at least, a ‘late’ emergence of pharmacogenomics
discourse compared to UK, and relative lack of an attempt to engineer an integration of national healthcare
system, clinical trials and health informatics and bioinformatics in a genomics-driven vision of scientific
advance. Is India ‘less advanced’ than the UK or the European collaborations noted in this paper? Or, are
there signs of indigenous innovation like those mentioned for Brazilian genomics in the introduction here?
The self-perception by some critical commentators is indeed that India is ‘lagging’; however, this perception
may be one shaped by ideals of Indian genomic health ambitions that are not shared by those non-elite
actors active in providing bioinformatics services to customers in the global bioeconomic marketplace. It is
thus not easy to define it in simple terms as a competitive or adaptive state without considering the
different dimensions of its bioinformatics project in more detail.

The structure of the policy centres attempting to shape and guide bioinformatics in these nation states also
appears very different. While India’s initiatives appear strongly driven by the government Department of
Biotechnology, the UK’s governance ecology appears much more diverse with key actors including the
government itself (Office of Life Sciences), but also notably the research councils, and specially configured
Technology Strategy Board, and the charitable Wellcome Trust. With the advent of Genome England, ethics
actors and industry actors will also play significant steering roles.

The relative lack of reference to disease targets, drug development and other translational issues in the
national bioinformatics policy discourse, especially in the UK, is notable. One can only speculate as to the
extent to which this is due to the ‘social distance’, or perhaps sociotechnical distance, between informatics
work and health goals, or whether this can be explained more by the ‘platform’ status of bioinformatics – as
a director of a major academic biomedical informatics centre in the US told me, ‘we are agnostic regarding
different diseases’. This appears particularly strong in the case of the UK/EU developments, and is perhaps
characteristic of genomic research effort focused more on a ‘basic science’ model of developing platform
technologies. Nevertheless, as has been shown above, there are policy priorities and disease target agendas
to be discerned in the health visions and bioinformatics shaping activity described above. In the UK, the
clear primary focus is on cancers, and the aim of developing of cancer biomarkers with the ability to better
target drug therapies for different types of cancer at different disease stages. In India by contrast, and in the
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 Working Paper, December 2013. Not to be cited without author’s permission. Comments welcome, to [email protected]

transnational domain, there is some, though not exclusive, focus on communicable and ‘neglected’ tropical
diseases.

The example of OSDD from India, though it is only one developing initiative, is symbolically resonant. It
shows an alignment of emerging, novel genomic-based and disease-targeted science with the existing
economic interest and market strength of India in generic drug manufacture. The discursive, ideological link
forged between a commitment to crowdsourcing participatory science involving bioinformatics, the
generics industry, and the infectious disease targets is particularly striking as an example of communitarian
medico-technonationalism. In contrast, the UK, which has historically prided itself on the socialist roots of
the publicy-funded National Health Service, continues to court controversy by embarking on the Genome
England project which will inevitably require major commercial investments in operations that will require
the intimate genomic and clinical healthcare data of tens of thousands of citizens2.

Bio-objectification has been an implicit concept in much of this paper. Bioinformatics work can be regarded
as a bio-objectification process par excellence. Biomedical research that aims at impacting medical practice
is often dubbed ‘translational’ research, a metaphor that highlight the objectification process while at the
same time skating over the computational work involved, e.g. in centres for ‘translational genomics’. Bio-
objectification here can be regarded as a sociotechnical process of transformation of genomic biology into
biodata; and it can also be regarded as a more diffuse process of transformation of genomic matter into
‘value’ in a variety of forms, which may achieve an acknowledged status of a bioeconomic sector. This paper
has shown some of the different stakeholders involved in attempting to create new drug objects by
supporting bioinformatics work, and those involved in providing and capitalising on bioinformatics objects
such as complex multi-dimensional databases. I have touched on trends and controversies in intellectual
property aspects of these various value-building objectifications, and pointed out the global marketplace for
outsourcing technical bioinformatics work.

What might be called the ‘bio-objectification thesis’ implies a challenging of sociomedically important
boundaries, and entails Baren-Nawrocka ‘s (2013) claim, noted above, that bioinformatics is value-laden and
not ‘neutral’. Are these characteristics evident in the accounts that I have assembled in this paper? It is
difficult to be clear about this. Bioinformatics is treated as a functional black box in (especially UK) policy
discourse, at the service of genomic health goals. In this sense, it does serve as a vehicle ‘disrupting’
established medical science and healthcare practice, arguably in a depoliticised form. However, the US
bioinformatics director’s comment that they are ‘agnostic’ regarding disease is a scientific position (the
centre in question undertakes work on breast and colorectal cancer, for example), because clearly
bioinformatics work is enrolled into a variety of different stakeholders’ health agendas and priorities. Thus,
at this point and in this research, it remains an open question as to whether bioinformatics tools and
databases themselves encode and embed particular health or social values, beyond a general conveyance of
a genomic style of medical futures.

Finally, regarding matters that are commonly framed as ‘ethical issues’, I note that the media reporting of
genomic medicine (in the UK at least) is preoccupied with civil liberty issues of privacy, almost to the
exclusion of what might be considered by some the far more worrying issue of the asymptomatic
genetic/genomic risk profiling of millions of non-patient citizens. Where is the public discussion of this in
India, the UK or elsewhere? Is there a genomic imperative that is irresistible? In India, there is a vocal

2
The November 2013 recent announcement of a parallel or competitor, commercial, US-based 100,000 genome
initiative in the UK is even more controversial: http://www.personalgenomes.org/network
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 Working Paper, December 2013. Not to be cited without author’s permission. Comments welcome, to [email protected]

protest movement targeting the government aimed at extending affordability and access to Herceptin
drawing on India’s generic drug innovation industry model. Herceptin is a monoclonal antibody drug that
acts genetically, produced by multinational Roche for treatment of advanced breast cancer. It is notable
that Roche relinquished its patent on Herceptin in India in August 2013, responding to the strong current
social and political movements on pharmaceutical innovation and access in India. Bioinformatics is likely to
become implicated in similar sociomedical, ethically important and complex movements around genetic and
genomic medicine, which bioinformatics governance will have to take into account.

Acknowledgement

A version of this paper was presented at a workshop on ‘Global Health and Science & Technology Studies’,
12-13 November 2013, Maastricht University - Department of Health, Ethics and Society, Faculty of Health,
Medicine and Life Sciences. I am grateful to participants for their comments. I also thank Professor Pranav
Desai of JNU, New Delhi, for comments on a previous version.

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Acknowledgment

This working paper was first presented at the Global Health and STS Workshop, 12-13 November 2013,
Maastricht University, The Netherlands. I am grateful for comments made by the participants.

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