Farah Huzair

H3Africa and the African Life Sciences Ecosystem: Building Sustainable Innovation

Interest in genomics research in African populations is experiencing exponential growth. This enthusiasm stems in part from the recognition that the genomic diversity of African populations is a window of opportunity for innovations in postgenomics medicine, ecology, and evolutionary biology. The recently launched H3Africa initiative, for example, captures the energy and momentum of this interest. This interdisciplinary socio-technical analysis highlights the challenges that have beset previous genomics research activities in Africa, and looking ahead, suggests constructive ways H3Africa and similar large scale science efforts could usefully chart a new era of genomics and life sciences research in Africa that is locally productive and globally competitive. As independent African scholars and social scientists, we propose that any serious global omics science effort, including H3Africa, aiming to build genomics research capacity and capability in Africa, needs to fund the establishment of biobanks and the genomic analyses platforms within Africa. Equally they need to prioritize community engagement and bioinformatics capability and the training of African scientists on these platforms. Historically, the financial, technological, and skills imbalance between Africa and developed countries has created exploitative frameworks of collaboration where African researchers have become merely facilitators of Western funded and conceived research agendas involving offshore expatriation of samples. Not surprisingly, very little funding was allocated to infrastructure and human capital development in the past. Moving forward, capacity building should materialize throughout the entire knowledge co-production trajectory: idea generation (e.g., brainstorming workshops for innovative hypotheses development by African scientists), data generation (e.g., genome sequencing), and high-throughput data analysis and contextualization. Additionally, building skills for political science scholarship that questions the unchecked assumptions of the innovation performers be they funders, scientists, and social scientists, would enable collective innovation that is truly sustainable, ethical, and robust.

Biosimilars and the long game

Despite greater certainty for biosimilar markets and regulation, the change that was seen in the small-molecule pharmaceuticals market with the rapid entrance of emerging-country generics suppliers will not be replicated exactly. The long game has yet to be played out, and recent changes in regulation, science, and production technology are likely to impact on future patterns of partnership and production.

A Global Health Diagnostic for Personalized Medicine in Resource-Constrained World Settings: A Simple PCR-RFLP Method for Genotyping CYP2B6 g.15582C>T and Science and Policy Relevance for Optimal Use of Antiretroviral Drug Efavirenz.

The use of pharmacogenomics (PGx) knowledge in treatment of individual patients is becoming a common phenomenon in the developed world. However, poorly resourced countries have thus far been constrained for three main reasons. First, the cost of whole genome sequencing is still considerably high in comparison to other (non-genomics) diagnostics in the developing world where both science and social dynamics create a dynamic and fragile healthcare ecosystem. Second, studies correlating genomic differences with drug pharmacokinetics and pharmacodynamics have not been consistent, and more importantly, often not indexed to impact on societal end-points, beyond clinical practice. Third, ethics regulatory frames over PGx testing require improvements based on nested accountability systems and in ways that address the user community needs. Thus, CYP2B6 is a crucial enzyme in the metabolism of antiretroviral drugs, efavirenz and nevirapine. More than 40 genetic variants have been reported, but only a few contribute to differences in plasma EFV and NVP concentrations. The most widely reported CYP2B6 variants affecting plasma drug levels include c.516G>T, c.983T>C, and to a lesser extent, g.15582C>T, which should be considered in future PGx tests. While the first two variants are easily characterized, the g.15582C>T detection has been performed primarily by sequencing, which is costly, labor intensive, and requires access to barely available expertise in the developing world. We report here on a simple, practical PCR-RFLP method with vast potentials for use in resource-constrained world regions to detect the g.15582C>T variation among South African and Cameroonian persons. The effects of CYP2B6 g.15582C>T on plasma EFV concentration were further evaluated among HIV/AIDS patients. We report no differences in the frequency of the g.15582T variant between the South African (0.08) and Cameroonian (0.06) groups, which are significantly lower than reported in Asians (0.39) and Caucasians (0.31). The g.15582C/T and T/T genotypes were associated with significantly reduced EFV levels (p=0.006). This article additionally presents the policy relevance of the PGX global health diagnostics and therefore, collectively makes an original interdisciplinary contribution to the field of integrative biology and personalized medicine in developing world. Such studies are, in fact, broadly important because resource-constrained regions exist not only in developing world but also in major geographical parts of the G20 nations and the developed countries.

Public Health Pharmacogenomics and the Design Principles for Global Public Goods - Moving Genomics to Responsible Innovation

1Research Group on Complex Collaboration, Faculty of Management, McGill University 2Centre of Genomics and Policy, Department of Human Genetics, Faculty of Medicine, McGill University, Montreal, QC, Canada 3Data-Enabled Life Sciences Alliance International (DELSA Global), Seattle, WA, USA 4Development Policy and Practice, The Open University, Walton Hall, Milton Keynes, UK 5The ESRC Centre for Social and Economic Research on Innovation in Genomics (Innogen Centre), Milton Keynes, UK 6Columbia Law School – LL.M. Program, New York, NY, USA 7Auckland Cancer Society Research Centre, Faculty of Medical and Health Sciences (FM&HS), The University of Auckland, Auckland, New Zealand 8Discipline of Nutrition, FM&HS, The University of Auckland, Auckland, New Zealand 9Nutrigenomics New Zealand, New Zealand 10Laboratory of Pharmacology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece 11Clinical Pharmacology Unit, Academic General Hospital of Alexandroupolis, Alexandroupolis, Greece 12European Society of Pharmacogenomics and Theranostics 13L.C. Campbell Cognitive Neurology Research Unit, Sunnybrook Research Institute, Department of Medicine (Neurology), Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada 14Faculty of Private Law, University of Cape Town, Cape Town, South Africa 15Department of Genetics, Stellenbosch University, Stellenbosch, South Africa 16Wadhwani Research Center for Biosciences and Bioengineering, Department of Biosciences and Bioengineering, Indian Institute of Technology Bombay, Powai, Mumbai, India

Biotechnology and the transformation of vaccine innovation: The case of the hepatitis B vaccines 1968–2000

The approval, from 1986, of a series of recombinant hepatitis B vaccines was a landmark both in the growth of biotechnology and in the development of the vaccine innovation system. In this paper, we show how the early development of the hepatitis B vaccines was shaped by a political and economic context that newly favoured commercialisation of academic research, including the appropriation and management of intellectual property; we elucidate the contingent interests and motivations that led new biotechnology companies and established pharmaceutical businesses to invest in developing recombinant vaccines specifically against hepatitis B; and we show how these and other factors combined to make those vaccines an unexpected commercial success. Broadening the scope of our analysis to include not just North America and Europe but also low- and middle-income countries, we show how the development of the hepatitis B vaccines facilitated the emergence of a two-tier innovation system structured by tensions between the demands for commercial profitability on the one hand, and the expectation of public health benefit for low- and middle-income countries on the other.

Revisiting the Paris Declaration: Pharmacogenomics and Personalized Medicine as Accelerators for Development Aid and Effectiveness

From novel H1N1 vaccines to improved retroviral treatments for persons with HIV/AIDS, novel health technologies have substantially improved health care in developed countries. Whereas in developing countries, major infectious diseases such as malaria, tuberculosis and HIV/AIDS as well as noncommunicable diseases (NCDs) remain prevalent, are the leading causes of death, and stand to benefit from postgenomics diagnostics enabled by data intensive Omics technologies [1-3]. Historically, aid to developing countries has been provided by governments and aid organizations for over 50 years in a number of forms that included the provision of health technologies, medicines, and training for health campaigns (e.g., immunization programs). However, despite decades of aid and the global health funding that keeps flowing, people are still dying. Indeed, little progress has been made towards eradicating poverty and improving healthcare access for the poor. In this editorial analysis, we argue that the benefits of pharmacogenomics and personalized medicine should be considered beyond a narrow focus on clinical medicine and in particular, in strategies of international development aid delivery in order to achieve greater effectiveness of global development aid.

Exploring Central and Eastern Europe’s Biotechnology Landscape

At a time when the human genome has been sequenced advances in the life sciences seem to have great potential for human health, industry and the environment throughout Central and Eastern Europe (CEE). Still, for some, potential risks and ethical dilemmas remain, surrounding issues such as the appropriate use of GM crops, stem cells, genetic information, the nature of intellectual property and other challenges that come with EU accession. This book is the first of its kind to bring together experts from across Europe to explore the landscape of current life science policy and industrial development in CEE, including implications for economies, regulatory and legal frameworks, health care, ethics and human rights. It will be essential reading for researchers and students in science and technology studies, development, sociology, politics and law, and those interested in life science development in transition economies.

Heterogeneity in learning processes and the evolution of dynamic managerial capabilities as a response of emergence of biosimilar market: evidence from the Indian pharmaceutical industry

ABSTRACT This paper examines heterogeneity in the response of Indian firms to the emergence of a new segment in the pharmaceutical generics market – biosimilars. The necessary diversity of the knowledge base and regulatory requirements underlying biosmilar products have created significant technological capability and market access challenges for Indian firms. This is but the latest development which adds to an existing catalogue of challenges including the decline of the traditional generics markets, regulatory hurdles in advanced country markets and failures in managing new drug development. Using case studies of three Indian firms we show that dynamic managerial capability is a key driver of heterogeneity in learning processes involved in acquisition of technological capabilities for biosimilars and market access strategies. It further highlights the important role of pre-existing capabilities in enabling and constraining the development of new biosimilar capabilities.

Capacity Building in Genomics Medicine and Molecular Diagnostics: The Case of Sri Lanka

In this paper, we advance the extant health technology innovation frames on global personalized medicine by highlighting the need to rethink genomics medicine in real-life settings – including situations where populations are frequently faced with natural disasters or man-made conflicts. We identify the steps towards building sufficient capacity to effectively harness and integrate genomic medicine and molecular diagnostics in order to benefit global society including those in resource-limited settings and post-war capacity building contexts. Surprisingly, despite a great number of populations currently living in developing countries, including in a state of post-war or conflict resolution context, the public health pharmacogenomics community has largely neglected this crucial dimension in biomedical literature. By exploring the particular case of Sri-Lanka in this paper, we are able to investigate the obstacles commonly faced by low and middle income countries similarly afflicted by crises, natural disasters, conflict and the need for improved, more cost effective health care. Sri Lanka has a relatively strong platform for launching molecular diagnostic technology, including a well networked set of primary, secondary and tertiary care institutions, a small but burgeoning private health and research sector and a strong science base in its universities. Despite this, there has been slow uptake and exploitation of novel molecular diagnostics due to various factors such as a weak regulatory framework and high costs associated with the import of molecular reagents and import and maintenance of equipment. In summary, as a way forward for health technology assessment in resource-limited countries, this paper brings to the fore an integrated discourse on real-life experiences and putative solutions on genomics and molecular diagnostic medicine. For a comprehensive discussion in the nascent field of public health pharmacogenomics, post-war and post-conflict capacity building on biotechnologies such as genomics is essential.

Life Sciences Innovation in Central and Eastern Europe: Conceptual Frameworks and Contributions

This article outlines analytical frameworks for studying life sciences innovation in Central and Eastern Europe (CEE), based on national systems of innovation and the triple helix. The reflexive and evolutionary models of triple helix 1-3 help us in evaluating life sciences innovation in the shift from pre- to post-transition, and are useful in providing a systemic approach that emphasises social institutions over the role of the firm. While pre-transition CEE embodied a linear innovation model rooted in state ownership, after the transition we see the importance of the state as a network organiser, and the productive inputs of multinational corporations. Life sciences innovation in CEE is challenged by path dependency and institutional lock-in established through years of state control, from which it can be difficult to break out. Articles in this special issue highlight the benefits and constraints of new forms of private investment. While there is evidence for cautious optimism in the CEE pharmaceutical industry, quango-run state genome projects have been less successful. Findings on knowledge cultures in Hungarian agbiotech innovation communities help to flesh out the triple helix model. This issue also provides foresight in examining challenges of the central European pharmaceutical industry and open intellectual property regimes being trialed in Canada, which may have relevance for the region as post-transition innovation systems deepen.