Farah Huzair | University of Edinburgh (original) (raw)
Papers by Farah Huzair
The approval, from 1986, of a series of recombinant hepatitis B vaccines was a landmark both in t... more 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 recombi-nant 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.
About the book: Recent decades have witnessed the transition from the government of rural areas t... more About the book: Recent decades have witnessed the transition from the government of rural areas towards processes of governance in which the boundaries between the state and civil society are blurred. As a result, governance is commonly linked to ‘bottom-up’ or community-based approaches to planning and development, which are said to ‘empower’ rural citizens and liberate them from the disabling structures of top-down government control. At the same time, however, a range of other actors beyond the local level have also become increasingly influential in determining the future of rural spaces, thereby embedding rural citizens within new configurations of power relations. This book critically explores the social causes and consequences of these emerging governance arrangements. In particular, the book seeks to move beyond questions of empowerment in governance debates and to consider how new kinds of power relations arise between the various actors involved. The book addresses questio...
OMICS: A Journal of Integrative Biology, 2015
The use of pharmacogenomics (PGx) knowledge in treatment of individual patients is becoming a com... more 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.
Current Pharmacogenomics and Personalized Medicine, 2012
Abstract Biobanks as collections of population level genetic and health data will be central to t... more Abstract Biobanks as collections of population level genetic and health data will be central to the innovation of new drugs and drug targets. The UK Biobank, funded by massive public and charitable investment, was created to store and manage the genetic and health data of over 500,000 people in the UK. The UK Biobank will be available to researchers from both private and public sectors, and is intended to support innovation and serve the public good. We argue that the UK Biobank faces a dilemma in that the knowledge generated is ...
Abstract Biobanks as collections of population level genetic and health data will be central to t... more Abstract Biobanks as collections of population level genetic and health data will be central to the innovation of new drugs and drug targets. The UK Biobank, funded by massive public and charitable investment, was created to store and manage the genetic and health data of over 500,000 people in the UK. The UK Biobank will be available to researchers from both private and public sectors, and is intended to support innovation and serve the public good.
Current Pharmacogenomics and Personalized Medicine, Mar 2013
Keywords: Genomics and development, genomics without borders, global governance of biotechnology ... more Keywords: Genomics and development, genomics without borders, global governance of biotechnology innovation and uncertainty, P5 medicine, public health pharmacogenomics, responsible innovation, STS and organizations, theranostic medicine.
OMICS: A Journal of Integrative Biology, 2015
Diagnostics spanning a wide range of new biotechnologies, including proteomics, metabolomics, and... more Diagnostics spanning a wide range of new biotechnologies, including proteomics, metabolomics, and nanotechnology, are emerging as companion tests to innovative medicines. In this Opinion, we present the rationale for promulgating an "Essential Diagnostics List." Additionally, we explain the ways in which adopting a vision for…
Confidence in vaccine safety is critical to national immunization strategies and to global public... more Confidence in vaccine safety is critical to national immunization strategies and to global public health. To meet the Millenium Development Goals, and buoyed by the success of new vaccines produced in developing countries, the World Health Organization has been developing a strategy to establish a global system for effective vaccine pharmacovigilance in all countries. This paper reports the findings of a qualitative survey, conducted for the WHO Global Vaccine Safety Blueprint project, on the perspectives of national regulatory authorities responsible for vaccine safety in manufacturing and procuring countries. Capacity and capabilities of detecting, reporting and responding to adverse events following immunization (AEFI), and expectations of minimum capacity necessary for vaccine pharmacovigilance were explored. Key barriers to establishing a functional national vaccine safety system in developing countries were identified. The lack of infrastructure, information technology for stable communications and data exchange, and human resources affect vaccine safety monitoring in developing countries. A persistent "fear of reporting" in several low and middle income countries due to insufficient training and insecure employment underlies a perceived lack of political will in many governments for vaccine pharmacovigilance. Regulators recommended standardized and internationally harmonized safety reporting forms, improved surveillance mechanisms, and a global network for access and exchange of safety data independent of industry.
OMICS - A Journal of Integrative Biology, 2014
Metadata refer to descriptions about data or as some put it, ‘‘data about data.’’ Metadata captur... more Metadata refer to descriptions about data or as some put it, ‘‘data about data.’’ Metadata capture what happens on the backstage of science, on the trajectory from study conception, design, funding, implementation, and analysis to reporting. Definitions of metadata vary, but they can include the context information surrounding the
practice of science, or data generated as one uses a technology, including transactional information about the user. As the pursuit of knowledge broadens in the 21st century from traditional ‘‘science of whats’’ (data) to include ‘‘science of hows’’ (metadata), we analyze the ways in which metadata serve as a catalyst for responsible and open innovation, and by extension, science diplomacy. In 2015, the United Nations Millennium Development Goals (MDGs) will formally come to an end. Therefore, we propose that metadata, as an ingredient of responsible innovation, can help achieve the Sustainable Development Goals (SDGs) on the post-2015 agenda. Such responsible innovation, as a collective learning process, has become a key component, for example, of the European Union’s 80 billion Euro Horizon 2020 R&D Program from 2014–2020. Looking ahead, OMICS: A Journal of Integrative Biology, is launching an initiative for a multi-omics metadata checklist that is flexible yet comprehensive, and will enable more complete utilization of single and multi-omics data sets through data harmonization and greater visibility and accessibility. The generation of metadata that shed light
on how omics research is carried out, by whom and under what circumstances, will create an ‘‘intervention space’’ for integration of science with its socio-technical context. This will go a long way to addressing responsible innovation for a fairer and more transparent society. If we believe in science, then such reflexive qualities and commitments attained by availability of omics metadata are preconditions for a robust and socially attuned science, which can then remain broadly respected, independent, and responsibly innovative.
Trends in biotechnology, 2015
Despite greater certainty for biosimilar markets and regulation, the change that was seen in the ... more 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.
OMICS: A Journal of Integrative Biology, 2014
Metadata refer to descriptions about data or as some put it, ''data about data.'' Metadata captur... more Metadata refer to descriptions about data or as some put it, ''data about data.'' Metadata capture what happens on the backstage of science, on the trajectory from study conception, design, funding, implementation, and analysis to reporting. Definitions of metadata vary, but they can include the context information surrounding the practice of science, or data generated as one uses a technology, including transactional information about the user. As the pursuit of knowledge broadens in the 21 st century from traditional '
Current pharmacogenomics and personalized medicine, 2013
Genomics and development; genomics without borders; global governance of biotechnology innovation... more Genomics and development; genomics without borders; global governance of biotechnology innovation and uncertainty; P5 medicine; public health pharmacogenomics; responsible innovation; STS and organizations; theranostic medicine "Evidence in the clinical care context differs from evidence in the public health and health policy domains. It is often difficult to apply rigid hierarchies of evidence to public health policy."
Drug Development Research, 2012
Omics technologies and particular applications for diagnostics and pharmacogenomics, can potentia... more Omics technologies and particular applications for diagnostics and pharmacogenomics, can potentially identify disease risk, reduce disease burden, and provide better and more cost-effective health care. International institutions have recognized that global justice necessitates equity of access to medical technologies for developing and well as developed countries. The promise of the omics technologies may remain unfulfilled for developing countries unless capacities for exploitation and integration are created. These capacities are those that enable contribution efforts to upstream data collection and innovation, and downstream governance and regulation. Drug Dev Res 73 : 447-451, 2012.
Current Pharmacogenomics and Personalized Medicine, 2011
Abstract Biobanks as collections of population level genetic and health data will be central to t... more Abstract Biobanks as collections of population level genetic and health data will be central to the innovation of new drugs and drug targets. The UK Biobank, funded by massive public and charitable investment, was created to store and manage the genetic and health data of over 500,000 people in the UK. The UK Biobank will be available to researchers from both private and public sectors, and is intended to support innovation and serve the public good. We argue that the UK Biobank faces a dilemma in that the knowledge generated is ...
Vaccine, 2012
Confidence in vaccine safety is critical to national immunization strategies and to global public... more Confidence in vaccine safety is critical to national immunization strategies and to global public health. To meet the Millenium Development Goals, and buoyed by the success of new vaccines produced in developing countries, the World Health Organization has been developing a strategy to establish a global system for effective vaccine pharmacovigilance in all countries. This paper reports the findings of a qualitative survey, conducted for the WHO Global Vaccine Safety Blueprint project, on the perspectives of national regulatory authorities responsible for vaccine safety in manufacturing and procuring countries. Capacity and capabilities of detecting, reporting and responding to adverse events following immunization (AEFI), and expectations of minimum capacity necessary for vaccine pharmacovigilance were explored. Key barriers to establishing a functional national vaccine safety system in developing countries were identified. The lack of infrastructure, information technology for stable communications and data exchange, and human resources affect vaccine safety monitoring in developing countries. A persistent "fear of reporting" in several low and middle income countries due to insufficient training and insecure employment underlies a perceived lack of political will in many governments for vaccine pharmacovigilance. Regulators recommended standardized and internationally harmonized safety reporting forms, improved surveillance mechanisms, and a global network for access and exchange of safety data independent of industry.
Human vaccines & immunotherapeutics, 2012
As Product Development Partnerships (PDPs) emerge and evolve in response to the need for vaccines... more As Product Development Partnerships (PDPs) emerge and evolve in response to the need for vaccines, this paper re-examines the oldest and most successful PDP in the vaccine field; that which year after year, produces and reinvents influenza vaccines. This paper describes the influenza vaccine production and innovation system and reviews some of its most recent major innovations. Innovation in this system is a result of collaborative partnerships between various actors from both the public and private sector. It is argued that the influenza vaccine innovation system is a Product Development Partnership (PDP), be it an unconventional one, with a central coordination role allocated to the WHO rather than a private company or charitable/not for profit entity. The unusual structure of this PDP overcomes some of the organizational issues surrounding vaccine research and production faced by other documented PDPs. These are first, the need to coordinate knowledge flow via an effective knowledge broker. Second, the need to build in-house capacity and fund essential research and elements of production where private partners find involvement too risky or costly.
The approval, from 1986, of a series of recombinant hepatitis B vaccines was a landmark both in t... more 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 recombi-nant 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.
About the book: Recent decades have witnessed the transition from the government of rural areas t... more About the book: Recent decades have witnessed the transition from the government of rural areas towards processes of governance in which the boundaries between the state and civil society are blurred. As a result, governance is commonly linked to ‘bottom-up’ or community-based approaches to planning and development, which are said to ‘empower’ rural citizens and liberate them from the disabling structures of top-down government control. At the same time, however, a range of other actors beyond the local level have also become increasingly influential in determining the future of rural spaces, thereby embedding rural citizens within new configurations of power relations. This book critically explores the social causes and consequences of these emerging governance arrangements. In particular, the book seeks to move beyond questions of empowerment in governance debates and to consider how new kinds of power relations arise between the various actors involved. The book addresses questio...
OMICS: A Journal of Integrative Biology, 2015
The use of pharmacogenomics (PGx) knowledge in treatment of individual patients is becoming a com... more 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.
Current Pharmacogenomics and Personalized Medicine, 2012
Abstract Biobanks as collections of population level genetic and health data will be central to t... more Abstract Biobanks as collections of population level genetic and health data will be central to the innovation of new drugs and drug targets. The UK Biobank, funded by massive public and charitable investment, was created to store and manage the genetic and health data of over 500,000 people in the UK. The UK Biobank will be available to researchers from both private and public sectors, and is intended to support innovation and serve the public good. We argue that the UK Biobank faces a dilemma in that the knowledge generated is ...
Abstract Biobanks as collections of population level genetic and health data will be central to t... more Abstract Biobanks as collections of population level genetic and health data will be central to the innovation of new drugs and drug targets. The UK Biobank, funded by massive public and charitable investment, was created to store and manage the genetic and health data of over 500,000 people in the UK. The UK Biobank will be available to researchers from both private and public sectors, and is intended to support innovation and serve the public good.
Current Pharmacogenomics and Personalized Medicine, Mar 2013
Keywords: Genomics and development, genomics without borders, global governance of biotechnology ... more Keywords: Genomics and development, genomics without borders, global governance of biotechnology innovation and uncertainty, P5 medicine, public health pharmacogenomics, responsible innovation, STS and organizations, theranostic medicine.
OMICS: A Journal of Integrative Biology, 2015
Diagnostics spanning a wide range of new biotechnologies, including proteomics, metabolomics, and... more Diagnostics spanning a wide range of new biotechnologies, including proteomics, metabolomics, and nanotechnology, are emerging as companion tests to innovative medicines. In this Opinion, we present the rationale for promulgating an "Essential Diagnostics List." Additionally, we explain the ways in which adopting a vision for…
Confidence in vaccine safety is critical to national immunization strategies and to global public... more Confidence in vaccine safety is critical to national immunization strategies and to global public health. To meet the Millenium Development Goals, and buoyed by the success of new vaccines produced in developing countries, the World Health Organization has been developing a strategy to establish a global system for effective vaccine pharmacovigilance in all countries. This paper reports the findings of a qualitative survey, conducted for the WHO Global Vaccine Safety Blueprint project, on the perspectives of national regulatory authorities responsible for vaccine safety in manufacturing and procuring countries. Capacity and capabilities of detecting, reporting and responding to adverse events following immunization (AEFI), and expectations of minimum capacity necessary for vaccine pharmacovigilance were explored. Key barriers to establishing a functional national vaccine safety system in developing countries were identified. The lack of infrastructure, information technology for stable communications and data exchange, and human resources affect vaccine safety monitoring in developing countries. A persistent "fear of reporting" in several low and middle income countries due to insufficient training and insecure employment underlies a perceived lack of political will in many governments for vaccine pharmacovigilance. Regulators recommended standardized and internationally harmonized safety reporting forms, improved surveillance mechanisms, and a global network for access and exchange of safety data independent of industry.
OMICS - A Journal of Integrative Biology, 2014
Metadata refer to descriptions about data or as some put it, ‘‘data about data.’’ Metadata captur... more Metadata refer to descriptions about data or as some put it, ‘‘data about data.’’ Metadata capture what happens on the backstage of science, on the trajectory from study conception, design, funding, implementation, and analysis to reporting. Definitions of metadata vary, but they can include the context information surrounding the
practice of science, or data generated as one uses a technology, including transactional information about the user. As the pursuit of knowledge broadens in the 21st century from traditional ‘‘science of whats’’ (data) to include ‘‘science of hows’’ (metadata), we analyze the ways in which metadata serve as a catalyst for responsible and open innovation, and by extension, science diplomacy. In 2015, the United Nations Millennium Development Goals (MDGs) will formally come to an end. Therefore, we propose that metadata, as an ingredient of responsible innovation, can help achieve the Sustainable Development Goals (SDGs) on the post-2015 agenda. Such responsible innovation, as a collective learning process, has become a key component, for example, of the European Union’s 80 billion Euro Horizon 2020 R&D Program from 2014–2020. Looking ahead, OMICS: A Journal of Integrative Biology, is launching an initiative for a multi-omics metadata checklist that is flexible yet comprehensive, and will enable more complete utilization of single and multi-omics data sets through data harmonization and greater visibility and accessibility. The generation of metadata that shed light
on how omics research is carried out, by whom and under what circumstances, will create an ‘‘intervention space’’ for integration of science with its socio-technical context. This will go a long way to addressing responsible innovation for a fairer and more transparent society. If we believe in science, then such reflexive qualities and commitments attained by availability of omics metadata are preconditions for a robust and socially attuned science, which can then remain broadly respected, independent, and responsibly innovative.
Trends in biotechnology, 2015
Despite greater certainty for biosimilar markets and regulation, the change that was seen in the ... more 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.
OMICS: A Journal of Integrative Biology, 2014
Metadata refer to descriptions about data or as some put it, ''data about data.'' Metadata captur... more Metadata refer to descriptions about data or as some put it, ''data about data.'' Metadata capture what happens on the backstage of science, on the trajectory from study conception, design, funding, implementation, and analysis to reporting. Definitions of metadata vary, but they can include the context information surrounding the practice of science, or data generated as one uses a technology, including transactional information about the user. As the pursuit of knowledge broadens in the 21 st century from traditional '
Current pharmacogenomics and personalized medicine, 2013
Genomics and development; genomics without borders; global governance of biotechnology innovation... more Genomics and development; genomics without borders; global governance of biotechnology innovation and uncertainty; P5 medicine; public health pharmacogenomics; responsible innovation; STS and organizations; theranostic medicine "Evidence in the clinical care context differs from evidence in the public health and health policy domains. It is often difficult to apply rigid hierarchies of evidence to public health policy."
Drug Development Research, 2012
Omics technologies and particular applications for diagnostics and pharmacogenomics, can potentia... more Omics technologies and particular applications for diagnostics and pharmacogenomics, can potentially identify disease risk, reduce disease burden, and provide better and more cost-effective health care. International institutions have recognized that global justice necessitates equity of access to medical technologies for developing and well as developed countries. The promise of the omics technologies may remain unfulfilled for developing countries unless capacities for exploitation and integration are created. These capacities are those that enable contribution efforts to upstream data collection and innovation, and downstream governance and regulation. Drug Dev Res 73 : 447-451, 2012.
Current Pharmacogenomics and Personalized Medicine, 2011
Abstract Biobanks as collections of population level genetic and health data will be central to t... more Abstract Biobanks as collections of population level genetic and health data will be central to the innovation of new drugs and drug targets. The UK Biobank, funded by massive public and charitable investment, was created to store and manage the genetic and health data of over 500,000 people in the UK. The UK Biobank will be available to researchers from both private and public sectors, and is intended to support innovation and serve the public good. We argue that the UK Biobank faces a dilemma in that the knowledge generated is ...
Vaccine, 2012
Confidence in vaccine safety is critical to national immunization strategies and to global public... more Confidence in vaccine safety is critical to national immunization strategies and to global public health. To meet the Millenium Development Goals, and buoyed by the success of new vaccines produced in developing countries, the World Health Organization has been developing a strategy to establish a global system for effective vaccine pharmacovigilance in all countries. This paper reports the findings of a qualitative survey, conducted for the WHO Global Vaccine Safety Blueprint project, on the perspectives of national regulatory authorities responsible for vaccine safety in manufacturing and procuring countries. Capacity and capabilities of detecting, reporting and responding to adverse events following immunization (AEFI), and expectations of minimum capacity necessary for vaccine pharmacovigilance were explored. Key barriers to establishing a functional national vaccine safety system in developing countries were identified. The lack of infrastructure, information technology for stable communications and data exchange, and human resources affect vaccine safety monitoring in developing countries. A persistent "fear of reporting" in several low and middle income countries due to insufficient training and insecure employment underlies a perceived lack of political will in many governments for vaccine pharmacovigilance. Regulators recommended standardized and internationally harmonized safety reporting forms, improved surveillance mechanisms, and a global network for access and exchange of safety data independent of industry.
Human vaccines & immunotherapeutics, 2012
As Product Development Partnerships (PDPs) emerge and evolve in response to the need for vaccines... more As Product Development Partnerships (PDPs) emerge and evolve in response to the need for vaccines, this paper re-examines the oldest and most successful PDP in the vaccine field; that which year after year, produces and reinvents influenza vaccines. This paper describes the influenza vaccine production and innovation system and reviews some of its most recent major innovations. Innovation in this system is a result of collaborative partnerships between various actors from both the public and private sector. It is argued that the influenza vaccine innovation system is a Product Development Partnership (PDP), be it an unconventional one, with a central coordination role allocated to the WHO rather than a private company or charitable/not for profit entity. The unusual structure of this PDP overcomes some of the organizational issues surrounding vaccine research and production faced by other documented PDPs. These are first, the need to coordinate knowledge flow via an effective knowledge broker. Second, the need to build in-house capacity and fund essential research and elements of production where private partners find involvement too risky or costly.