Life Science Incubation at LabCentral/BioLabs with Partners Extending from the USA to Europe.

This chapter provides a blueprint for accelerating biotech and life sciences innovation using public-private partnerships to create innovation infrastructure that become a platform for scientific breakthroughs and economic growth. Examples are provided on creating standalone co-working labs as well as through partnerships with academic and healthcare system partners both in the United States and Europe. Risks and challenges are addressed as well as the overall benefits to the broader public of investing public funds in biotech and life science infrastructure versus individual companies based on the potential impact to global public health from new treatments, therapies, devices, and diagnostics.

The Legal Framework for Public-Private Partnerships in Drug R&D.

Public-private partnerships in drug R&D have great potential for driving innovation. They can bridge between excellent fundamental research and development and commercialization of innovative medicines to address unmet needs for the therapy of severe diseases in the interest of public health and human welfare. Therefore, public-private partnerships in drug R&D are promoted and publicly funded by governments and the European Commission. Nonetheless, they need to comply with legal requirements, particularly stemming from State aid law and competition law. Those requirements do not only protect a fair competition, but rather also further open information exchange as well as fair sharing of risks and fair participation in gains and results with the goal of having a successful collaboration and increasing the chance of successful commercialization of pharmaceutical innovations.

From Innovator Result-driven to Multi-actor Impact-oriented Public-Private Partnerships: Integrating the Patient Perspective.

Public-Private Partnerships (PPPs) have been crucial in medicine research and development (R&D) for decades. Initially, PPPs involved private and academic innovators working in bilateral collaborations to advance pharmaceutical innovation. Later, a precompetitive open innovation environment was created, where multiple public and private innovators collaborated on mutual interests. The entry of regulators and patient interest organizations into PPPs has triggered a third shift from an innovator result-driven to a multi-actor impact-oriented partnership model. Using the second Innovative Medicines Initiative program (IMI2) as an example, this chapter focuses on the increasing roles of patient interest organizations in PPPs in roughly the last decade.Most IMI2 partnerships focused on raising awareness and sharing information tailored to patient needs (listener role) and inviting patients to share their experiences and needs (co-thinker role). Many partnerships also integrated the patient perspective by implementing patient advisory bodies (advisor role) or including patients as equal partners in steering the project (partner role). Notably, partnerships like EUPATI and PARADIGM showed that patient interest organizations can lead initiatives, especially those aiming at advancing patient engagement across the medicine R&D lifecycle (decision-maker role). While the overall impact of patient involvement in the IMI2 program is still being assessed, it has exposed many innovators and regulators to the patient perspective and created a community of patient experts with access to tools and guidelines for meaningful involvement.The PPP model continues to evolve, shifting from a treatment-only to a comprehensive diagnosis, treatment, and monitoring approach by incorporating digital and medical technology actors. This development, alongside continued patient and public integration could revolutionize the R&D and accessibility of new treatments and diagnostics.

Quality improvement in public-private partnerships in low- and middle-income countries: a systematic review.

BACKGROUND: Public-private partnerships (PPP) are often how health improvement programs are implemented in low-and-middle-income countries (LMICs). We therefore aimed to systematically review the literature about the aim and impacts of quality improvement (QI) approaches in PPP in LMICs. METHODS: We searched SCOPUS and grey literature for studies published before March 2022. One reviewer screened abstracts and full-text studies for inclusion. The study characteristics, setting, design, outcomes, and lessons learned were abstracted using a standard tool and reviewed in detail by a second author. RESULTS: We identified 9,457 citations, of which 144 met the inclusion criteria and underwent full-text abstraction. We identified five key themes for successful QI projects in LMICs: 1) leadership support and alignment with overarching priorities, 2) local ownership and engagement of frontline teams, 3) shared authentic learning across teams, 4) resilience in managing external challenges, and 5) robust data and data visualization to track progress. We found great heterogeneity in QI tools, study designs, participants, and outcome measures. Most studies had diffuse aims and poor descriptions of the intervention components and their follow-up. Few papers formally reported on actual deployment of private-sector capital, and either provided insufficient information or did not follow the formal PPP model, which involves capital investment for a explicit return on investment. Few studies discussed the response to their findings and the organizational willingness to change. CONCLUSIONS: Many of the same factors that impact the success of QI in healthcare in high-income countries are relevant for PPP in LMICs. Vague descriptions of the structure and financial arrangements of the PPPs, and the roles of public and private entities made it difficult to draw meaningful conclusions about the impacts of the organizational governance on the outcomes of QI programs in LMICs. While we found many articles in the published literature on PPP-funded QI partnerships in LMICs, there is a dire need for research that more clearly describes the intervention details, implementation challenges, contextual factors, leadership and organizational structures. These details are needed to better align incentives to support the kinds of collaboration needed for guiding accountability in advancing global health. More ownership and power needs to be shifted to local leaders and researchers to improve research equity and sustainability.

Supporting the nation in crisis: the military health system's role in enhancing public health capacity through public-private partnerships.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic caused significant global disruptions to the healthcare system, which was forced to make rapid changes in healthcare delivery. The pandemic necessitated closer collaboration between the US civilian healthcare sector and the military health system (MHS), resulting in new and strengthened partnerships that can ultimately benefit public health and healthcare for the nation. In this study, we sought to understand the full range of partnerships in which the MHS engaged with the civilian sector during the COVID-19 pandemic and to elicit lessons for the future. METHODS: We conducted key informant interviews with MHS policymakers and advisers, program managers and providers who were affiliated with the MHS from March 2020 through December 2022. Key themes were derived using thematic analysis and open coding methods. RESULTS: We conducted 28 interviews between December 2022 and March 2023. During the pandemic, the MHS collaborated with federal and local healthcare authorities and private sector entities through endeavours such as Operation Warp Speed. Lessons and recommendations for future pandemics were also identified, including investment in biosurveillance systems and integration of behavioural and social sciences. CONCLUSIONS: The MHS rapidly established and fostered key partnerships with the public and private sectors during the COVID-19 pandemic. The pandemic experience showed that while the MHS is a useful resource for the nation, it also benefits from partnering with a variety of organizations, agencies and private companies. Continuing to develop these partnerships will be crucial for coordinated, effective responses to future pandemics.

Data sharing as the foundation of discovery: ADNI and breakthroughs in Alzheimer's disease.

The COVID pandemic has shown that when the research community comes together, we can conquer the most complex biomedical challenges. Collaboration and teamwork among federal agencies, private organizations, and researchers have been crucial in the development of vaccines and therapeutics against COVID. Possibly the first example of such cross-functional collaboration is the Alzheimer's Disease Neuroimaging Initiative (ADNI), the largest and longest continually monitored Alzheimer's study. ADNI was designed and operated as a public-private partnership, managed by the Foundation for the National Institutes of Health. This article shows how recent successes in the Alzheimer's field are directly a result of ADNI's open and transparent sharing of knowledge, expertise, and resources, which have allowed researchers to advance their understanding of Alzheimer's and tackle challenges in a relatively short period of time. ADNI's approach to open-source innovation also served as a model for addressing other complex diseases and led to numerous collaborative research initiatives. HIGHLIGHTS: The Alzheimer's Disease Neuroimaging Initiative (ADNI) was designed, structured, and operated as a public-private partnership, managed by the Foundation for the National Institutes of Health. The recent successes in the Alzheimer's field are directly a result of ADNI's efforts. Open and transparent sharing of knowledge, expertise, and resources allowed researchers to advance their understanding of Alzheimer's and tackle challenges in a relatively short period of time.

The origins of ADNI.

A brief history of events surrounding the conceptualization and original implementation of the Alzheimer's Disease Neuroimaging Initiative (ADNI) as a public-private partnership (PPP) is provided from the perspective of three individuals directly involved from the outset. Potential barriers and how they were addressed are summarized, especially the decision to make all data freely accessible in real-time. Decisions made at the beginning of ADNI are revisited in light of what has been learned over the past 20 years, especially the importance of the investment in cerebrospinal fluid (CSF) and blood measures and the commitment to data sharing. The key elements of ADNI's success from the authors' perspective are also summarized. HIGHLIGHTS: Informal interactions among colleagues were the beginning of something big. An NIH Director's personal decision on open data sharing has had perhaps the greatest impact of any single decision in the past several decades in terms of advancing clinical biomarker research. After 20 years, blood-based biomarkers of brain disease may soon take the place of brain imaging for purposes of diagnosis and drug development.

Government subsidy and benefit distribution mechanisms for transportation PPP projects: An evolutionary game perspective.

Public-private partnerships (PPP), as an important model for collaboration between the public and private sectors, is an urgent and critical topic due to the serious financial losses of governments involved in transportation PPP projects in recent years. Current research focuses on the government subsidy model, in which the effective implementation of government subsidies relies on the design of incentives for stakeholder behavior. Although the positive externalities are strong, they are prone to the problem of "free riding," which leads to low project performance and challenges in compensating for the government's financial losses. Therefore, this study proposes a novel dynamic subsidy mechanism that can be adjusted based on actual changes in transportation demand and that is linked to project performance. We use evolutionary game theory to construct a two-party evolutionary game model of the government and social capital, focusing on the stability and influencing factors of these interactions. Our research unveils that reaching specific thresholds in both the incentive coefficient and benefit distribution ratio induces an "positive management-negative management" shift in the behavior of involved parties, leading to enhanced project outcomes. Notably, fluctuations in operational quality substantially enhance the efficiency of the active management of private sector, with no discernible impact on the subsidy efficiency of the government. Therefore, our study provides a theoretical framework for improving the revenue allocation and government subsidy mechanism, which has theoretical and practical implications for enhancing the effect of government incentives and improving the quality of operational social capital.

Risk allocation schemes between public and private sectors in green energy projects.

In this research, we analyse how project risk allocation strategies impact the volume of private investment in renewable energy projects with the participation of both the public and private sectors. To this purpose, we analyse a sample formed by 2215 projects performed in 73 developing countries in the period 1997-2019 involving the following technologies: solar, hydro, wind, waste, biogas, biomass, and geothermal. Our findings reveal that those projects performed through governance schemes in which the private partner takes more project responsibilities attract more private money. Additional drivers for attracting private investment at the project level and institutional level are found. Furthermore, we reveal that the transference of project risks to the private partner emerges as a very relevant project feature that interacts with some of the project and institutional factors, revealing both complementary and substitution effects. The significance of this research extends beyond academia, since there are factors influencing private investment that can be controlled by various stakeholders in projects (such as policymakers, private investors, and project managers). Understanding their impact, significance, and interaction effects-factors that sometimes moderate or accentuate private investment-is crucial. The identified patterns illuminate optimal risk allocation practices, offering practical insights to enhance the effectiveness and sustainability of projects.

Critical elements of successful partnership in public health-A case study.

ISSUE ADDRESSED: Intersectoral action is integral in promoting population health and health equity. In South Australia, public health partnership authorities (PHPAs) are one mechanism to promote intersectoral collaboration for addressing complex public health issues. This case study examined contemporary evidence on the critical elements of successful partnerships, explored the role of formalisation in success, and examined how identified critical elements were operationalised over time in an existing PHPA. METHODS: In the first phase, a scoping review was conducted. The second phase was a retrospective longitudinal case study of a government-academic PHPA agreement, involving partnership document review and key informant interviews. Data triangulation and iterative thematic analysis were performed. RESULTS: The critical elements of successful partnership, triangulated through multiple data sources, are mutuality, governance, communication, resources, leadership, and interactions and relationships. These elements have a high degree of interdependence. Trust supports and is reinforced by these elements, particularly during times of change or crisis. Formalisation of a partnership supports success in many ways but is insufficient on its own. CONCLUSION: Operating in dynamic environments, a partnership requires dedicated time and effort to be successful. Attention to the strength and interconnectedness of the critical elements over the course of a partnership is crucial. SO WHAT?: This case study describes how the elements of successful partnership can be applied to progress beyond transactional relationships towards authentic collaboration and overcome cross-border and cross-boundary public health challenges to promote population health and well-being.

Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies.

The development of medical products that can delay or prevent progression to stage 3 type 1 diabetes faces many challenges. Of note, optimising patient selection for type 1 diabetes prevention clinical trials is hindered by significant patient heterogeneity and a lack of characterisation of the time-varying probability of progression to stage 3 type 1 diabetes in individuals positive for two or more islet autoantibodies. To meet these needs, the Critical Path Institute's Type 1 Diabetes Consortium was launched in 2017 as a pre-competitive public-private partnership between stakeholders from the pharmaceutical industry, patient advocacy groups, philanthropic organisations, clinical researchers, the National Institutes of Health and the Food and Drug Administration. The Type 1 Diabetes Consortium acquired and aggregated data from three longitudinal observational studies, Environmental Determinants of Diabetes in the Young (TEDDY), Diabetes Autoimmunity Study in the Young (DAISY) and TrialNet Pathway to Prevention (TN01), and used analysis subsets of these data to support the model-based qualification of islet autoantibodies as enrichment biomarkers for patient selection in type 1 diabetes prevention trials, including registration studies. The Type 1 Diabetes Consortium has now received a qualification opinion from the European Medicines Agency for the use of these biomarkers, a major success for the field of type 1 diabetes. This endorsement will improve product developers' ability to design clinical trials of agents intended to prevent or delay type 1 diabetes that are reduced in size and/or length, while being adequately powered.

Development of medicines for rare diseases and inborn errors of metabolism: Toward novel public-private partnerships.

Medicine development for rare diseases, including inborn errors of metabolism (IEMs) is challenging. Many academic innovations fail to reach the patient, either by stranding in the translational stage or due to suboptimal patient access related to pricing or uncertain effectiveness. Expanding and solidifying the role of the academic in public-private partnerships (PPPs) may present an innovative solution to help overcome these complexities. This narrative review explores the literature on traditional and novel collaborative approaches to medicine development for rare diseases and analyzes examples of PPPs, with a specific focus on IEMs. Several academic institutions have introduced guidelines for socially responsible licensing of innovations for private development. The PPP model offers a more integrative approach toward academic involvement of medicine development. By sharing risks and rewards, failures in the translational stage can be mutually absorbed. If socially responsible terms are not included, however, high pricing can impede patient access. Therefore, we propose a framework for socially responsible PPPs aimed at medicine development for metabolic disorders. This socially responsible PPP framework could stimulate successful and accessible medicine development for IEMs as well as other rare diseases if the establishment of such collaborations includes terms securing joint data ownership and evidence generation, fast access, and socially responsible pricing.

Real-life experiments in supermarkets to encourage healthy dietary-related behaviours: opportunities, challenges and lessons learned.

BACKGROUND: Supermarkets are the primary source of food for many people yet their full potential as a setting to encourage healthy dietary-related behaviours remains underutilised. Sharing the experiences from research groups who have worked with supermarket chains to evaluate strategies that promote healthy eating could improve the efficiency of building such relationships and enhance the design quality of future research studies. METHODS: A collective case study approach was used to synthesise experiences of engaging and sustaining research collaborations with national supermarket chains to test the effectiveness of health-focused in-store interventions. The collective narrative covers studies conducted in three high-income countries: Australia, the Netherlands and the United Kingdom. RESULTS: We have distilled our experiences and lessons learned into six recommendations for conducting high quality public health research with commercial supermarket chains. These include: (i) using personal contacts, knowledge of supermarket activities and engaging executive management to establish a partnership and allowing time to build trust; (ii) using scientifically robust study designs with appropriate sample size calculations; (iii) formalising data exchange arrangements and allocating adequate resource for data extraction and re-categorisation; (iv) assessing effects at individual/households level where possible; (v) designing a mixed-methods process evaluation to measure intervention fidelity, dose and unintended consequences; and (vi) ensuring scientific independence through formal contract agreements. CONCLUSIONS: Our collective experiences of working in non-financial partnerships with national supermarket chains could be useful for other research groups looking to develop and implement supermarket studies in an efficient manner. Further evidence from real-life supermarket interventions is necessary to identify sustainable strategies that can improve population diet and maintain necessary commercial outcomes.

Fifty shades of partnerships: a governance typology for public private engagement in the nutrition sector.

BACKGROUND: Multistakeholder collaboration has emerged as a dominant approach for engaging and mobilising non-state actors; notably embedded in the paradigm of the UN Sustainable Development Goals. Yet, considerable ambiguity and contestation surrounds the appropriate terms of public private engagement (PPE) with industry actors. MAIN BODY: This paper seeks to conceptualise different forms of engagement with the food industry in tackling diet-related noncommunicable disease, within the context of power asymmetries across engaged stakeholders. It does so by introducing the Governance Typology for Public Private Engagement in the Nutrition Sector, a typology for government-led engagement with food industry actors across three domains: (i) the form of industry and civil society actor engagement (i.e., rules of exercising institutional power), based on the degree of participation in formal decision-making as well as participation at different stages in the policy cycle; (ii) the type of industry actors being engaged (i.e., pre-existing power attributes), based on function, size, and product portfolios for profit; and (iii) the substantive policy focus of engagement. CONCLUSIONS: The Governance Typology for Public Private Engagement in the Nutrition Sector seeks to inform national level nutrition policy makers on good engagement practice with food industry actors and complements existing risk assessment tools. This typology has the potential to inform decision-making on public sector engagement with other industries that profit from products detrimental to human and planetary health.

Constructing public-private partnerships to undermine the public interest: critical discourse analysis of Working Together published by the International Alliance for Responsible Drinking.

BACKGROUND: The global burden of alcohol harm has increased and is forecast to grow further without effective policy implementation. Public-private partnerships aiming to address global health, and other societal challenges, are a burgeoning feature of neoliberal governance. Rhetorically distancing themselves from tobacco, the major alcohol companies are committed to tackling 'harmful drinking' and have created a distinct type of public relations organization for this purpose. The activities of such organizations are increasingly recognized as an impediment to the implementation of policies to reduce alcohol harm, including in low- and middle-income countries where markets are expanding. METHODS: The approach of critical discourse analysis is used to examine the discursive tactics and strategies used in Working Together; a 'toolkit' published by the key global level alcohol industry public relations organization, the International Alliance for Responsible Drinking (IARD). This study considers how it works discursively to set the terms of, and overcome skepticism about partnerships, to define aims and position various actors by constructing their roles. The construction of prospective partners provides insights into the alcohol industry itself. RESULTS: The toolkit operates as an ideological resource for forming public-private partnerships across the world based on the accumulated know-how of the major companies through IARD. This allows the largest alcohol companies to exercise leadership of the industry, while remaining off-stage. The toolkit relies on a form of rhetorical work which creates distance from obvious corporate interests and the harms caused to population health and society. This is accomplished by working against evidence-informed population level approaches, and thus avoiding policies that will make any significant difference to overall alcohol harm. Unspecific "complexity" affords opportunity for preferred types of "actions", and "partnership" provides opportunity to gain credibility by association, further minimizing the likelihood of any material harm being reduced. CONCLUSIONS: The toolkit is designed to not only legitimate the inclusion of alcohol industry actors as initiating 'partners', but also assigns them roles as managers of a set of carefully constructed relationships. This vision of public-private partnership reproduces the hegemonic narrative that has successfully blocked policy advances for decades and led to growing alcohol harm globally.

Under the influence: system-level effects of alcohol industry-funded health information organizations.

There is now an established body of evidence that the alcohol industry seeks to obstruct public health policies that could affect the availability, affordability or marketing of alcohol. In parallel, the alcohol industry is active in funding corporate social responsibility initiatives, with a particular focus on 'responsible drinking' campaigns, often facilitated by national-level charities established and/or funded by the alcohol industry and associated organizations. While evidence continues to grow regarding biases in the content produced by such health information organizations, they remain active in partnerships with government health departments on national health promotion campaigns and provide a range of health-related information to the public, community organizations and schools. To understand the implications of such access for policymakers, researchers and the public, there is a need to consider the wider, system-level influences of such organizations and their place in wider alcohol industry strategies. In this article, we describe evolving evidence of the direct and indirect strategic effects of such organizations and demonstrate how they serve key roles in the alcohol industry through their existence, content, partnerships and public profiles. We end by considering the implications for how we conceptualize charities established or funded (entirely or partly) by harmful commodity industries, and to what extent current conflicts of interest guidelines are sufficiently effective.

Basel: A Hotspot for Drug Discovery and Development Against Poverty-Related Diseases.

In discussion with Lukas Meier from the Swiss Tropical and Public Health Institute (Swiss TPH), Lutz Hegemann, Head of Novartis Global Health and Sustainability and Marcel Tanner, President of the Swiss Academies of Arts and Sciences, give their opinions on the changes that occurred in drug discovery and development for poverty-related diseases over the past 30 years. They emphasise the power of public-private partnerships and provide their points of views on what needs to be done in the future to ensure that the poorest of the poor also have access to important therapies.

Repurposing Know-how for Drug Development: Case Studies from the Swiss Tropical and Public Health Institute.

In pursuing novel therapeutic solutions, drug discovery and development rely on efficiently utilising existing knowledge and resources. Repurposing know-how, a strategy that capitalises on previously acquired information and expertise, has emerged as a powerful approach to accelerate drug discovery and development processes, often at a fraction of the costs of de novo developments. For 80 years, collaborating within a network of partnerships, the Swiss Tropical and Public Health Institute (Swiss TPH) has been working along a value chain from innovation to validation and application to combat poverty-related diseases. This article presents an overview of selected know-how repurposing initiatives conducted at Swiss TPH with a particular emphasis on the exploration of drug development pathways in the context of neglected tropical diseases and other infectious diseases of poverty, such as schistosomiasis, malaria and human African trypanosomiasis.

Reinsuring pandemics: the role of government and public-private partnerships between reinsurers and governments.

Pandemic-related business interruption (BI) losses are generally considered 'uninsurable' because, in order to pool sufficient premium revenue to meet valid claims, premiums would be unaffordable for the majority of policyholders. This paper explores whether and how such losses might be made insurable in the U.K. The authors consider post-pandemic governmental responses, including the role of the Financial Conduct Authority (FCA) and the meaning and implications of FCA v Arch Insurance (U.K.) Ltd ([2021] UKSC 1). The central premise of the paper is to highlight the importance of reinsurance in increasing an underwriter's insuring capacity and to illustrate how, with the support of government in the form of a public-private partnership (PPP), 'uninsurable' risks of this type may be made insurable. The authors propose a PPP, 'Pandemic Business Interruption Re', which provides, in their view, a feasible and defensible solution that would confer the benefit of increasing policyholders' faith in the industry's ability to underwrite pandemic-related BI claims and reduce reliance on ex post government aid.

Private sector engagement in the COVID-19 response: experiences and lessons from the Democratic Republic of Congo, Nigeria, Senegal and Uganda.

BACKGROUND: Private entities play a major role in health globally. However, their contribution has not been fully optimized to strengthen delivery of public health services. The COVID-19 pandemic has overwhelmed health systems and precipitated coalitions between public and private sectors to address critical gaps in the response. We conducted a study to document the public and private sector partnerships and engagements to inform current and future responses to public health emergencies. METHODS: This was a multi-country cross-sectional study conducted in the Democratic Republic of Congo, Nigeria, Senegal and Uganda between November 2020 and March 2021 to assess responses to the COVID-19 pandemic. We conducted a scoping literature review and key informant interviews (KIIs) with private and public health sector stakeholders. The literature reviewed included COVID-19 country guidelines and response plans, program reports and peer-reviewed and non-peer-reviewed publications. KIIs elicited information on country approaches and response strategies specifically the engagement of the private sector in any of the strategic response operations. RESULTS: Across the 4 countries, private sector strengthened laboratory systems, COVID-19 case management, risk communication and health service continuity. In the DRC and Nigeria, private entities supported contact tracing and surveillance activities. Across the 4 countries, the private sector supported expansion of access to COVID-19 testing services through establishing partnerships with the public health sector albeit at unregulated fees. In Senegal and Uganda, governments established partnerships with private sector to manufacture COVID-19 rapid diagnostic tests. The private sector also contributed to treatment and management of COVID-19 cases. In addition, private entities provided personal protective equipment, conducted risk communication to promote adherence to safety procedures and health promotion for health service continuity. However, there were concerns related to reporting, quality and cost of services, calling for quality and price regulation in the provision of services. CONCLUSIONS: The private sector contributed to the COVID-19 response through engagement in COVID-19 surveillance and testing, management of COVID-19 cases, and health promotion to maintain health access. There is a need to develop regulatory frameworks for sustainable public-private engagements including regulation of pricing, quality assurance and alignment with national plans and priorities during response to epidemics.