How ownership rights over microorganisms affect infectious disease control and innovation: A root-cause analysis of barriers to data sharing as experienced by key stakeholders.

Genetic information of pathogens is an essential input for infectious disease control, public health and for research. Efficiency in preventing and responding to global outbreaks relies on timely access to such information. Still, ownership barriers stand in the way of timely sharing of genetic data from pathogens, frustrating efficient public health responses and ultimately the potential use of such resources in innovations. Under a One Health approach, stakeholders, their interests and ownership issues are manifold and need to be investigated. We interviewed key actors from governmental and non-governmental bodies to identify overlapping and conflicting interests, and the overall challenges for sharing pathogen data, to provide essential inputs to the further development of political and practical strategies for improved data sharing practices

On the Verge of a Catastrophic Collapse? The Need for a Multi-Ecosystem Approach to Microbiome Studies

While the COVID-19 pandemic has led to increased focus on pathogenic microbes that cross the animal-human species barrier, calls to include non-pathogenic interactions in our perspective on public health are gaining traction in the academic community. Over generations, the diversity of the human gut microbiota is being challenged by external perturbations and reduced acquisition of symbiotic species throughout life. When such reduced diversity concerns not only the microbial species, but also the higher taxonomic levels and even the guild level, adequate compensation for possible losses may be lacking. Shifts from a high-abundance to a low-abundance state, known as a tipping point, may result in simultaneous shifts in covarying taxa and ultimately to a catastrophic collapse in which the ecosystem abruptly and possibly irreversibly shifts to an alternative state. Here, we propose that co-occurrence patterns within and between microbial communities across human, animal, soil, water, and other environmental domains should be studied in light of such critical transitions. Improved mechanistic understanding of factors that shape structure and function is needed to understand whether interventions can sustainably remodel disease-prone microbiota compositions to robust and resilient healthy microbiota. Prerequisites for a rational approach are a better understanding of the microbial interaction network, both within and inter-domain, as well as the identification of early warning signs for a catastrophic collapse, warranting a timely response for intervention. We should not forget that mutualism and pathogenicity are two sides of the same coin. Building upon the planetary health concept, we argue that microbiome research should include system level approaches to conserve ecosystem resilience.HIGHLIGHTS1. Non-pathogenic interactions between ecosystems play a key role in maintaining health.2. The human gut microbiome may be on the verge of a catastrophic collapse.3. Research should identify keystone taxa and guilds that interconnect different domains.4. We should not forget that mutualism and pathogenicity are two sides of the same coin

Identifying Cross-Utilization of RSV Vaccine Inventions across the Human and Veterinary Field

The respiratory syncytial virus (RSV) has two main variants with similar impact, a human and a bovine variant. The human respiratory syncytial virus (HRSV) is the most frequent cause of acute respiratory disease (pneumonia) in children, leading to hospitalization and causing premature death. In Europe, lower respiratory tract infections caused by HRSV are responsible for 42–45 percent of hospital admissions in children under two. Likewise, the bovine respiratory syncytial virus (BRSV) is a significant cause of acute viral broncho-pneumonia in calves. To date no licensed HRSV vaccine has been developed, despite the high burden of the disease. In contrast, BRSV vaccines have been on the market since the 1970s, but there is still an articulated unmet need for improved BRSV vaccines with greater efficacy. HRSV/BRSV vaccine development was chosen as a case to assess whether collaboration and knowledge-sharing between human and veterinary fields is taking place, benefiting the development of new vaccines in both fields. The genetic relatedness, comparable pathogeneses, and similar severity of the diseases suggests much can be gained by sharing knowledge and experiences between the human and veterinary fields. We analyzed patent data, as most of pharmaceutical inventions, such as the development of vaccines, are protected by patents. Our results show only little cross-utilization of inventions and no collaborations, as in shared IP as an exchange of knowledge. This suggests that, despite the similarities in the genetics and antigenicity of HRSV and BRSV, each fields follows its own process in developing new vaccines

A research agenda to reinforce rabies control: A qualitative and quantitative prioritization

<div><p>Background</p><p>Despite the existence of safe and effective vaccines, rabies disease still causes an estimated 59,000 human deaths a year in the endemic areas in Asia and Africa. These numbers reflect severe drawbacks regarding the implementation of PrEP and PEP in endemic settings, such as lack of political will and low priority given to rabies. Since these contextual factors have proven to be persistent, there is an urgency to improve current strategies or develop novel approaches in order to control rabies disease in the future.</p><p>Methods/Findings</p><p>This study aimed to identify and systematically prioritize the research needs, through interviews and questionnaires with key-opinion-leaders (KOLs). A total of 46 research needs were identified and prioritized. The top research needs are considered very high priority based on both importance for rabies control and need for improvement. KOLs agree that animal rabies control remains most important for rabies control, while research on human host, agent (rabies virus) and the environment should be prioritized in terms of need for improvement. A wide variety in perceptions is observed between and within the disciplines of virology, public health and veterinary health and between KOLs with more versus those with less experience in the field.</p><p>Conclusion/Significance</p><p>The results of this study give well-defined, prioritized issues that stress the drawbacks that are experienced by KOLs in daily practice. The most important research domains are: 1) cheap and scalable production system for RIG 2) efficacy of dog mass vaccination programs and 3) cheap human vaccines. Addressing these research needs should exist next to and may reinforce current awareness and mass vaccination campaigns. The differences in perspectives between actors revealed in this study are informative for effective execution of the One Health research agenda.</p></div

Saturation curve of research needs.

<p>Saturation was reached after 24 interviews.</p

Component prioritization.

<p>Although there is a high standard deviation, tackling rabies in the animal host is considered most important for rabies control. LMIC = low- and middle income countries; HIC = high income countries.</p

Research needs prioritized for need for improvement.

<p>A total of 125 KOLs assessed the research needs of their expertise: animal host (n = 96); human host (n = 88); agent (n = 83); environment (n = 78). Priority groups correspond to scores of 41–60 (moderate), 61–80 (high) and 81–100 (very high). Full descriptions of research priorities and scores can be found in <a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0006387#pntd.0006387.s001" target="_blank">S1 Table</a>. CNS = central nervous system; RABV = rabies virus; R&D = research and development; DALYs = disability adjusted life years; PEP = post-exposure prophylaxes; NTD = neglected tropical disease.</p

Blockchain-facilitated sharing to advance outbreak R&D.

Timely and widespread dissemination of resources and information related to pathogenic threats plays a critical role in outbreak recognition, research, containment, and mitigation, as stakeholders from government, public health (PH), industry, and academia seek to implement interventions and develop vaccines, diagnostics, and drugs. But there are persistent barriers to sharing and cooperative research and development (R&D) in the context of epidemics, rooted in a lack of trust in confidentiality and reciprocity, ambiguity over resource ownership, and conflicting public, private, and academic incentives. Here, we suggest how recent advances in blockchain and related technologies can enable decentralized mechanisms to help break down these systemic and largely nontechnological barriers. These mechanisms resolve scalability, energy consumption, and security concerns of early blockchain models and may be applied to underpin and interconnect, rather than supersede or conflict with existing, well-established systems and practices for storing, sharing, and governing resources

Self-Centric and Altruistic Unmet Needs for Ebola: Barriers to International Preparedness

OBJECTIVE: Barriers to international Ebola preparedness may be elucidated by identifying heterogeneities in arguments to invest in countermeasures during "peace time." METHODS: For each patent family (related patent documents that differed only by limited alterations to the same invention) concerning Ebola and published until the end of 2014 the oldest patent document was analyzed. Grounded theory coding identified 5 unmet needs for (1) vaccines and therapies, (2) control of outbreaks in endemic areas, (3) detection and control of outbreaks in nonendemic areas, (4) better understanding of filoviruses, and (5) protection against bioterrorism. Odds ratios for unmet needs by geographic regions and institution types were compared by using Pearson's chi-square test. RESULTS: Statistically significant heterogeneities in unmet need profiles were found. US applicants combined self-centric and altruistic arguments, focusing on medical unmet needs and bioterrorism protection. Russian and Asian applicants emphasized self-centric motives, specifically, detection and control of nonendemic outbreaks. A clear, statistically significant mismatch between industry and academia was found: whereas industrial applicants focused on bioterrorism and neglected detection and control of nonendemic outbreaks, academic applicants did the opposite. CONCLUSIONS: This research identified heterogeneities in articulated needs between geographic regions and stakeholder types. Structural articulation of unmet needs may form the basis for attuning stakeholder engagement strategies while progression across the demand-driven value chain might necessitate international concordance. (Disaster Med Public Health Preparedness. 2016;10:644-648)