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807 ISSN 1473-7159 © 2012 Expert Reviews Ltd 10.1586/ERM.12.123 www.expert-reviews.com Interview Theranostics, the 21st century bioeconomy and ‘one health’ Expert Rev. Mol. Diagn. 12(8), 807–809 (2012) Interview with Vural Özdemir (McGill University, QC, Canada) and Edward S Dove (Columbia University, NY, USA) Tikki Pang was previously the Director of Research Policy & Cooperation and Senior Policy Adviser, Innovation, Information, Evidence & Research for the WHO in Geneva, Switzerland (1999–2012). He has published more than 200 scientific publications and has coordinated the publication of several high-impact WHO reports (e.g., [1–3] ). Pang was the lead writer of the World Health Report 2012, the Founding Editor of both the Asia–Pacific Journal of Molecular Biology & Biotechnology and the journal Health Research Policy and Systems. As a nascent field of postgenomics R&D, theranostics is broadening the scope of sci- ence and technology investments for per- sonalized medicine and global health. The envisioned theranostics applications are embedded in vast expectations for the ‘bio- economy’ by governments and stakeholders who aim to develop customized health interventions with drugs (e.g., pharmaco- genomics), nutrition (nutrigenomics) and vaccines (vaccinomics), as well as diagnos- tics for human diseases. However, theranos- tics science is not situated in a vacuum. It is developing in the broader postgenomics R&D landscape, with projects such as the Human Microbiome Project demonstrat- ing that microbial communities and their genes (the microbiome) inextricably coexist throughout the human body, with funda- mental roles in both human and ecosystem health [4] . This convergence of human, animal and environmental (e.g., microbial) health invites us to reconsider theranostics innovations under the rubric of ‘one health’. One health is an emerging frame on human and ecosystem health where inseparable ties between human, animal and environ- mental (e.g., microorganism) health are underscored so as to eliminate the artificial boundaries among them [101] . Our readership in diagnostic medicine is familiar with the science of personalized medicine, but theranostics is broadening the extant frames on personalized medicine for applications to personalized drug therapy (the science of pharmacogenomics), personalized nutrition (nutrigenomics), personalized vaccines (vaccinomics), not to mention diagnostics for rare and common human diseases. A pressing question is how do we ‘make sense’ out of theranostics in terms of its anticipated promise and challenges for global health? In your view as an expert on global health, how does such broadening of the scope of postgenomics diagnostics R&D impact the boundaries between health and disease, and also between developed and developing countries? Theranostics certainly has the potential to blur boundaries between health and dis- ease, particularly in the context of nutrition and vaccines, often considered preventive rather than therapeutic. At the same time, this ‘blurring’ can be taken as a positive in that it can promote the development of a common platform for a more holistic and integrated approach to human well being that takes into account therapeutic, preven- tive and even predictive aspects of health- care delivery (referred to as the one health approach). In the same vein, the broaden- ing of the scope and range of diagnostics can reduce the existing divide between developed and developing countries; tech- nological advances that are cost effective can actually allow developing countries to ‘leapfrog’ some of the expensive invest- ments that used to characterize diagnostics in the past. Tikki Pang Lee Kuan Yew School of Public Policy, National University of Singapore, 469C Bukit Timah Road 259772, Singapore [email protected] MINI FOCUS y Theranostics for Innovation in 21st Century Healthcare www.expert-reviews.com/toc/erm/12/8 Expert Review of Molecular Diagnostics Downloaded from informahealthcare.com by SUNY State University of New York at Stony Brook on 10/25/14 For personal use only.

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Page 1: Theranostics, the 21st century bioeconomy and ‘one health’

807ISSN 1473-7159© 2012 Expert Reviews Ltd10.1586/ERM.12.123www.expert-reviews.com

InterviewExpert Review of Molecular Diagnostics

© 2012 Expert Reviews Ltd

10.1586/ERM.12.123

1473-7159

1744-8352

Interview

Theranostics, the 21st century bioeconomy and ‘one health’Expert Rev. Mol. Diagn. 12(8), 807–809 (2012)

Interview with Vural Özdemir (McGill University, QC, Canada) and Edward S Dove (Columbia University, NY, USA)

Tikki Pang was previously the Director of Research Policy & Cooperation and Senior Policy Adviser, Innovation, Information, Evidence & Research for the WHO in Geneva, Switzerland (1999–2012). He has published more than 200 scientific publications and has coordinated the publication of several high-impact WHO reports (e.g., [1–3]). Pang was the lead writer of the World Health Report 2012, the Founding Editor of both the Asia–Pacific Journal of Molecular Biology & Biotechnology and the journal Health Research Policy and Systems.

As a nascent field of postgenomics R&D, theranostics is broadening the scope of sci-ence and technology investments for per-sonalized medicine and global health. The envisioned theranostics applications are embedded in vast expectations for the ‘bio-economy’ by governments and stake holders who aim to develop customized health interventions with drugs (e.g., pharmaco-genomics), nutrition (nutrigenomics) and vaccines (vaccinomics), as well as diagnos-tics for human diseases. However, theranos-tics science is not situated in a vacuum. It is developing in the broader postgenomics R&D landscape, with projects such as the Human Microbiome Project demonstrat-ing that microbial communities and their genes (the microbiome) inextricably coexist throughout the human body, with funda-mental roles in both human and ecosystem health [4]. This convergence of human, animal and environmental (e.g., microbial) health invites us to reconsider theranostics innovations under the rubric of ‘one health’. One health is an emerging frame on human and ecosystem health where inseparable ties between human, animal and environ-mental (e.g., microorganism) health are underscored so as to eliminate the artificial boundaries among them [101].

❚❚ Our readership in diagnostic medicine is familiar with the science of personalized medicine, but theranostics is broadening the extant frames on personalized medicine for applications to

personalized drug therapy (the science of pharmacogenomics), personalized nutrition (nutrigenomics), personalized vaccines (vaccinomics), not to mention diagnostics for rare and common human diseases. A pressing question is how do we ‘make sense’ out of theranostics in terms of its anticipated promise and challenges for global health? In your view as an expert on global health, how does such broadening of the scope of postgenomics diagnostics R&D impact the boundaries between health and disease, and also between developed and developing countries?Theranostics certainly has the potential to blur boundaries between health and dis-ease, particularly in the context of nutrition and vaccines, often considered preventive rather than therapeutic. At the same time, this ‘blurring’ can be taken as a positive in that it can promote the development of a common platform for a more holistic and integrated approach to human well being that takes into account therapeutic, preven-tive and even predictive aspects of health-care delivery (referred to as the one health approach). In the same vein, the broaden-ing of the scope and range of diagnostics can reduce the existing divide between developed and developing countries; tech-nological advances that are cost effective can actually allow developing countries to ‘leapfrog’ some of the expensive invest-ments that used to characterize diagnostics in the past.

Tikki PangLee Kuan Yew School of Public Policy, National University of Singapore, 469C Bukit Timah Road 259772, Singapore [email protected]

MINI FOCUS y Theranostics for Innovation in 21st Century Healthcare

www.expert-reviews.com/toc/erm/12/8

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Interview

❚❚ Theranostics and postgenomics personalized medicine R&D are often touted as veritable catalysts for a global bioeconomy. Are there unchecked assumptions in current discourses on the alleged convergence of data-intensive theranostics technologies (e.g., genomics, proteomics, nanoproteomics) and the bioeconomy? Conversely, are there hitherto neglected pathways to realize a bioeconomy under the rubric of theranostics that can benefit global health and particularly citizens in developing countries?The primary unchecked assumption is in the ‘knowledge transla-tion’ and ‘implementation’ areas. How do you convert the ‘big data’ repositories (e.g., biobanks) to applications that have practi-cal utility, are feasible for scaling-up, and hence have commercial value for the economy and those who might invest in the devel-opment of such technologies? In terms of neglected pathways, perhaps a ‘reverse flow’ involving judicial screening of relevant information, which could reduce the deluge of unmanageable data, could be worth developing (see next question). Can the ‘experts’ learn something from the ‘users’?

❚❚ Scholars in the field of social study of science and technology have in the past underscored the need for early engagement with the public, particularly at the design stage of emerging technologies and innovations [4–9]. However, postgenomics science is still conducted to a large extent by technology experts. If the general public is engaged at all, this appears to take place during the downstream product uptake phase (e.g., for adoption of genomics tests for personalized medicine). Please tell us a few points to bear in mind for sound early engagement between scientists and the public in reference to emerging theranostics innovations.There are a few points worth bearing in mind in this respect: the potential benefits and pitfalls should be explained clearly and in a manner that is understandable to an educated lay person; they should be actively assisted in formulating the right questions to help them link their needs with study hypotheses and designs; and provide feedback as to how their inputs have been used.

❚❚ What are your thoughts on how to prevent moving candidate theranostic applications to the marketplace too soon without sufficient evidence while ensuring truly innovative discoveries supported by evidence are not ‘lost in translation’ or hindered by regulations insufficiently informed by the nuances and materiality of postgenomics data-intensive technology? This appears important particularly because the envisioned theranostic tests are intended to customize health interventions as diverse as drugs, nutrition and vaccines?A pragmatic approach is needed here, which can be characterized as ‘learning by doing’ or ‘building a ship as you sail it’. Phased implementation and pilot projects that enable early identifica-tion of barriers and which include an iterative/feedback compo-nent, should be encouraged. At the same time, some flexibility in regulatory frameworks, without reducing standards of quality and safety, should also be considered for accelerating approval of promising innovations.

❚❚ On 14 June 2012, we and others interested in the social study of postgenomics innovations read the initial outcome of the Human Microbiome Project, which seems to lend support to considering theranostics under the rubric of ‘one health’ [10]. Do you foresee that theranostics at this early phase of its R&D might stand a chance to advance under the ethos of one health, rather than a narrow focus on personalized human medicine?This will take time as the tendency to think narrowly and in silos is still very prevalent in medicine, even between therapy and prevention, let alone cutting across to other disciplines. It is also important not to underestimate the regulatory challenges of combining different interventions with different end points into a single platform.

❚❚ Theranostics, along with one health and the bioeconomy, are very much transdisciplinary concepts that span many disciplines, professions, and epistemologies. You were trained as a biologist before switching to policy research and global health. Do you have any advice to individuals who might want to pursue transdisciplinary careers in theranostics and global personalized medicine to understand the coproduction of postgenomics scientific knowledge in the 21st century?This is a central challenge for the future. In the absence of formal courses that explicitly attempt to address the barriers that inhibit transdisciplinary learning and cooperation we are, unfortunately, dependent on ‘accidental’ career paths that tend to develop ser-endipitously and usually without any conscious planning. My only advice for future practitioners would be to keep an open mind and perhaps keep an eye on some of the design princi-ples for global public goods (GPGs), of which theranostics is a good example. These principles were outlined by Elinor Ostrom, Nobel Laureate in Economic Sciences in 2009, and include the following tenets:

• Defined beneficiary of success;

• Convergence between success and environmental conditions is necessary;

• Individuals affected by the GPG should have a voice in modifying the developmental pathways;

• Contributions necessary to develop and use common resources should be monitored by individuals who developed and use GPGs;

• Dialog and discourse mechanisms should be available;

• Individuals producing GPGs should have the ability to devise their own ways of achieving ends;

• Governance systems are organized in nested enterprises and each organization must conform to larger systems.

Financial & competing interests disclosureThe author (Pang) and interviewees (Özdemir and Dove) have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies,

Pang

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honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

References1 Advisory Committee on Health Research,

WHO. Genomics and world health. WHO, Geneva, Switzerland (2002).

2 WHO. World report on knowledge for better health: strengthening health systems. WHO, Geneva, Switzerland (2004).

3 WHO. Research and the WHO: a history of the advisory committee on health research, 1959–1999. WHO, Geneva, Switzerland (2010).

4 Cho I, Blaser MJ. The human microbiome: at the interface of health and disease. Nat. Rev. Genet. 13(4), 260–270 (2012).

5 Collingridge D. The Social Control of Technology. St. Martin’s Press, New York, USA (1980).

6 Wynne B. Public engagement as a means of restoring public trust in science – hitting the notes, but missing the music? Community Genet. 9(3), 211–220 (2006).

7 Dove ES. The genetic privacy carousel: a discourse on proposed genetic privacy bills and the co-evolution of law and science. Curr. Pharmacogenomics Person. Med. 9(4), 252–263 (2011).

8 Fisher E. Editorial overview: public science and technology scholars: engaging whom? Sci. Eng. Ethics 17(4), 607–620 (2011).

9 Ozdemir V, Fisher E, Dove ES et al. End of the beginning and public health pharmacogenomics: knowledge in ‘mode 2’ and P5 medicine. Curr. Pharmacogenomics Person. Med. 10(1), 1–6 (2012).

10 Human Microbiome Project Consortium. A framework for human microbiome research. Nature 486(7402), 215–221 (2012).

Website

101 One Health Initiative Task Force. ‘One Health: A New Professional Imperative’. www.avma.org/onehealth/onehealth_final.pdf (Accessed 15 July 2008)

Theranostics, the 21st Century bioeconomy & ‘one health’

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