Public-private Consortium Research Articles

Towards Preanalytical Best Practices for Liquid Biopsy Studies: A BLOODPAC Landscape Analysis.

BLOODPAC is a public-private consortium that develops best practices, coordinates clinical and translational research, and manages the BLOODPAC Data Commons to broadly support the liquid biopsy community and accelerate regulatory review to aid patient accessibility. BLOODPAC previously recommended 11 preanalytical minimal technical data elements (MTDEs) for BLOODPAC-sponsored studies and data submitted to BLOODPAC Data Commons. The current landscape analysis evaluates the overlap of the BLOODPAC MTDEs with current best practices, guidelines, and standards documents related to clinical and research liquid biopsy applications. Our findings indicate an existing high degree of concordance among these documents. Where differences exist, the BLOODPAC preanalytical MTDEs can be considered a minimal practicable set for organizations to utilize. These MTDEs were developed following extensive examination of best practices and iterative conversations with the U.S. FDA. BLOODPAC recommends the use of these MTDEs in submissions to data commons and to support liquid biopsy clinical trials and research globally.

Re-inventing housing finance with blockchain. The case of Sweden

This article examines the ongoing transformation of mortgage markets induced by blockchain applications for property transactions. It argues that their adoption can reshape housing finance by re-inventing the qualities of products circulating therein. This process was evident in Sweden, where a public–private consortium pioneered the use of blockchain to orchestrate the conveyance and mortgaging of residential across the entire country. Drawing from several distinct fields and building on the analysis of 24 semi-structured interviews, this article follows the interdisciplinary cultural economy literature on marketization. It demonstrates that by integrating technology with the legacy Land Administration System (LAS), the experiment offered a way to “fix” the Swedish mortgage market, through re-engineering conveyance workflow and supplying mortgages with a transparent audit trail. Circulating such radically new products could reconcile contradictions between Swedish mortgage market liquidity and risk-taking on the one hand and longstanding concerns about its financial safety for consumers on the other. This created unanticipated risks, however, which shaped the outcome of the experiment. This research contends that, at this early stage of the technology adoption, taking a step back to better understand the role of LAS in structuring concrete configurations of housing and mortgage markets opens the door to considering the mechanisms that shape the outcomes of such experiments – a reintroduction of existing and profoundly uneven socioeconomic relations.

Patient and community engagement in clinical platform trials

Platform trials measure the effects of multiple treatments against each other and against one control group simultaneously. Such approaches have the potential to revolutionize how clinical trials are conducted. Treatments can be developed faster, comparisons be made more easily, resources can be saved, and less participants are needed for trials. Within the Innovative Medicines Initiative (IMI) EU Patient Centric Clinical Trial Platform (EU PEARL) project, a public-private consortium aimed to build a framework for patient-centric platform trials together with patients and members of communities affected by four different conditions. The structured involvement of patient and community perspectives and input in research projects is increasingly viewed as a crucial and beneficial trial design factor. However, platform trials are complex endeavours, posing the question of how to involve patients and communities meaningfully. In this paper, we present a repository for Patient and Community Engagement in Platform Trials (PaCEPT), how it was developed, and how it can be used. PaCEPT contains information on general patient and community engagement, which is applicable to platform trials, as well as materials specifically developed for platform trials. The repository can support patients and communities in understanding what platform trials are and how they can benefit them, so that they can make evidence-informed decisions about participating in a platform trial. Further, people interested in becoming actively involved as an advisor for platform trials can gain in-depth insights that can prepare them well for such a role. PaCEPT also features materials that can help researchers to learn about the benefits of patient and community engagement for trial design and execution, and how to approach and include this stakeholder group. We encourage researchers to make use of this resource and call for evaluations of the implementation of the developed materials and the repository as a whole.

Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines

Routine batch quality testing before vaccine release, notably for potency evaluation, still relies on animal use for several animal and human vaccines. In this context, the VAC2VAC project is a public-private consortium of 22 partners funded by EU whose the main objective is to reduce the number of animal used for batch testing by developing immunoassays that could be implemented for routine potency assessment of vaccines. This paper focused on the development of a Luminex-based multiplex assay to monitor the consistency of antigen quantity and quality throughout the production process of DTaP vaccines from two human vaccine manufacturers. Indepth characterized monoclonal antibody pairs were used for development and optimization of the Luminex assay with non-adsorbed and adsorbed antigens and with complete vaccine formulations from both manufacturers. The multiplex assay demonstrated good specificity, reproducibility and absence of cross-reactivity. Analysis of over and underdosed formulations, heat and H2O2-degraded products as well as batch to batch consistency of vaccines from both manufacturers brought the proof of concept for a future application of the multiplex immunoassay as a useful tool in the frame of DTaP vaccine quality control.

A public-private consortium approach for sustainable bitter gourd breeding and production in Asia

A public-private consortium approach for sustainable bitter gourd breeding and production in Asia

Nutrition in City Ecosystems (NICE): Protocol of a multi-sectoral development project to improve food and nutrition security of secondary city populations in Bangladesh, Kenya and Rwanda.

Secondary cities tend to be better linked with local food systems than primate cities, acting as important platforms to trade agricultural produce with rural surrounding. COVID-19, conflicts and climate change continue to expose inefficiencies in food systems and have further exacerbated malnutrition, calling for substantial food systems transformations. However, tackling current food systems' challenges requires new approaches to ensure food and nutrition security. Nutritious and agroecologically produced food offer the potential to transform food systems by improving diets and alleviating pressure on the environment, as well as by creating jobs and reducing poverty. This paper describes the design of a project by a Swiss public-private consortium to improve food and nutrition security and to reduce poverty in city ecosystems in six secondary cities in Bangladesh, Kenya and Rwanda through governance/policy and supply and demand side interventions. The Nutrition in City Ecosystems (NICE) project promotes well-balanced nutrition for city populations through interdisciplinary agricultural, food, and health sector collaborations along city-specific value chains. Adopting a transdiciplinary systems approach, the main interventions of NICE are (i) advocacy and policy dialogue, (ii) building of decentralized institutional capacity in multi-sectoral collaborations, (iii) support of data-driven planning, coordination and resource mobilization, (iv) anchoring of innovations and new approaches in city-level partnerships, (v) capacity building in the agricultural, retail, health and education sectors, as well as (vi) evidence generation from putting policies into practice at the local level. NICE is coordinated by in-country partners and local offices of the Swiss public-private consortium partners. The NICE project seeks to contribute to urban food system resilience and enhanced sustainable nutrition for city populations by (A) strengthening urban governance structures involving key stakeholders including women and youth, (B) generating income for producers along the supply chain, (C) triggering change in producers' and consumers' behavior such that nutritious and agroecologically produced foods are both in demand as well as available and affordable in urban markets, and (D) allowing a scale up of successful approaches to other national and international cities and city networks.

Current Challenges and Perspectives on Developing a Clinical Trial Design for ADPKD.

Current Challenges and Perspectives on Developing a Clinical Trial Design for ADPKD.

The blockchain challenge for Sweden's housing and mortgage markets

This paper investigates how blockchain technology may alter the defining mechanisms of residential real estate transactions in Sweden. It departs from the assumption that blockchain applications do not merely change complex socio-economic, organisational and governance arrangements of mature housing and mortgage markets. Rather, they may trigger resistance among incumbents in the current organisational model, which will drive incremental change. This analysis shows that housing transactions in Sweden are long and complex endeavours, underpinned by exclusivity, uncertainty and information inequalities. A public-private consortium led by Lantmäteriet – a Swedish government agency – has pioneered the use of blockchain technology for the conveyance of a house to address these deficiencies. This project has not moved beyond the proof-of-concept phase, while the socio-technical organisation of transactions has evolved. Insights from institutional and evolutionary approaches help conceptualise how technologically induced and qualitatively different structures and functional effects may change the way housing and mortgage markets will work, thereby highlighting both disruptive potentialities and limitations of blockchain applications for the legacy design underpinning the current Swedish housing transaction system. Following a forensic empirical approach, this paper dissects the organisational architecture, key practices and the linked network of actor groups running Sweden's property and mortgage markets. Results illustrate that understanding concrete blockchain-induced changes and their unintended consequences requires closer scholarly attention at the scale of actor networks, the types of knowledge and technologies, and the micro-geographies in which they are embedded. Such in-depth understanding enables better-informed assessments of the blockchain challenge for complex housing and mortgage markets.

Utilizing public and private sector data to build better machine learning models for the prediction of pharmacokinetic parameters

One solution to compensate for the shortage of publicly available data is to collect more quality-controlled data from the private sector through public-private partnerships. However, several issues must be resolved before implementing such a system. Here, we review the technical aspects of public-private partnerships using our initiative in Japan as an example. In particular, we focus on the procedure for collecting data from multiple private sector companies and building prediction models and discuss how merging public and private sector datasets will help to improve the chemical space coverage and prediction performance. Teaser: Japan's first public-private consortium in pharmacokinetics has incorporated data from multiple pharmaceutical companies to create useful predictive models.

Dispatches from Biotech beginning BeginNGS: Rapid newborn genome sequencing to end the diagnostic and therapeutic odyssey.

In this Dispatch from Biotech, we briefly review the urgent need for extensive expansion of newborn screening (NBS) by genomic sequencing, and the reasons why early attempts had limited success. During the next decade transformative developments will continue in society and in the pharmaceutical, biotechnology, informatics, and medical sectors that enable prompt addition of genetic disorders to NBS by rapid whole genome sequencing (rWGS) upon introduction of new therapies that qualify them according to the Wilson and Jungner criteria (Wilson, J. M. G., & Jungner, G., World Health Organization. (1968). Principles and Practice of Screening for Disease. World Health Organization. Retrieved from https://apps.who.int/iris/handle/10665/37650). Herein we describe plans, progress, and clinical trial designs for BeginNGS (Newborn Genome Sequencing to end the diagnostic and therapeutic odyssey), a new international, pre-competitive, public-private consortium that proposes to implement a self-learning healthcare delivery system for screening all newborns for over 400 hundred genetic diseases, diagnostic confirmation, implementation of effective treatment, and acceleration of orphan drug development. We invite investigators and stakeholders worldwide to join the consortium in a prospective, multi-center, international trial of the clinical utility and cost effectiveness of BeginNGS.

Yes, IMMUcan! Unraveling the human tumor microenvironment

The great successes achieved by cancer immunotherapy cannot hide the fact that most patients do not respond to the treatment. A better understanding of the tumor microenvironment (TME) is a prerequisite for rational drug development and the discovery of more informative biomarkers. Previous efforts aimed at unraveling the human TME have either been limited by the choice of profiling modalities or by insufficient patient numbers. In addition, whereas much work focused on subjects with earlier disease stages, patients with unmet medical need often suffer from advanced cancer that is less well understood. Here, we introduce the IMMUcan project, a European Union-funded, public-private consortium. The aim of IMMUcan is to generate a tumor atlas focusing on patients with unmet medical need. IMMUcan will integrate molecular profiling data and cellular spatial data derived from multiplex immunofluorescence and imaging mass cytometry analyses. These data can contribute to a better understanding of treatment resistance mechanisms, help define patient populations that are likely to benefit from current therapeutic interventions and identify determinants of the tumor immune landscape composition. Finally, the characterization of altered biological pathways and molecular targets will inform precision oncology approaches and guide drug combination strategies for individual patients.

DIR reform, supply chain security, and more

DIR reform, supply chain security, and more

Editorial introductions.

Editorial introductions.

Strategies for delivering therapeutics across the blood-brain barrier.

Achieving sufficient delivery across the blood-brain barrier is a key challenge in the development of drugs to treat central nervous system (CNS) disorders. This is particularly the case for biopharmaceuticals such as monoclonal antibodies and enzyme replacement therapies, which are largely excluded from the brain following systemic administration. In recent years, increasing research efforts by pharmaceutical and biotechnology companies, academic institutions and public-private consortia have resulted in the evaluation of various technologies developed to deliver therapeutics to the CNS, some of which have entered clinical testing. Here we review recent developments and challenges related to selected blood-brain barrier-crossing strategies - with a focus on non-invasive approaches such as receptor-mediated transcytosis and the use of neurotropic viruses, nanoparticles and exosomes - and analyse their potential in the treatment of CNS disorders.

The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children.

The need for information about new and existing drugs used in children was recognized in the European Union (EU) with the implementation of the Paediatric Regulation in 2007. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials. Across Europe, the difficulties with clinical research are compounded by variation within countries and between countries. Ethics and regulatory review have national specificities. This paper describes the Collaborative Network for European Clinical Trials for Children (conect4children, c4c), which addresses selected difficulties in the design and conduct of paediatric clinical trials. c4c is a time-limited public–private consortium funded by the Innovative Medicines Initiative (IMI2). The elements of c4c are as follows: expert advice providing input on study design and/or paediatric development programmes (including patient involvement activities); a network of sites following harmonised procedures coordinated by National Hubs and a single point of contact for Europe; a facility for education and training for sites and trial teams; and support for managing data used by the network and a common paediatric data dictionary. c4c does not sponsor trials. c4c is taking a phased approach with careful piloting through industry and non-industry studies intended to demonstrate the viability of the network (proof-of-viability studies). c4c uses a co-design approach involving industry and academics within a clearly defined scope. A sustainable, successor organization open to all potential service users will be open for business before the end of IMI2 funding in 2024.

Abstract B65: Precompetitive collaboration on liquid biopsy for early cancer assessment

Abstract Precompetitive collaboration is a term used when competitors share early stages of research and development that are beneficial to all stakeholders. This Public-Private Partnership Consortium supports research to advance technologies and use these technologies for early cancer detection, to distinguish benign disease from cancer, and to distinguish aggressive from nonaggressive cancer. Combining the complementary expertise of both academics and industry may increase the likelihood of developing a viable diagnostic assay. In the era of personalized medicine, it is desirable to have noninvasive or minimally invasive methods to determine and follow longitudinally the molecular composition and characterization of a patient’s tumor, which will help gain a broader understanding of the disease. Liquid biopsy (CTC, ctDNA, extracellular vesicles, etc.) can be used to molecularly characterize the tumor and monitor genetic changes over time using repeat sampling of biofluids. The current technologies have shown great potential in diagnosis, predicting response to therapy, and monitoring relapse; however, the biologic and analytical challenges have rendered their usefulness for early detection/screening more difficult to establish. To address these challenges, the NCI developed this cooperative agreement program to support the work of six teams. Each team consists of a group of experts that include oncologists, bioinformaticians, researchers, and at least one industry partner. The current teams are developing a variety of unique assays/technologies that range from capture enhancements, microscope integration, nanoplasmonics, to specialized machine learning algorithms and bioinformatic analyses. Ovarian, breast, lung, and brain cancers are the model systems being studied, and there are at least two teams focused on each cancer type. The Consortium conducts work with the assistance of two working subgroups, Study Design and Biorepository, in conjunction with NCI staff. To monitor progress, there are yearly face-to-face Steering Committee meetings and monthly conference calls/Webex meetings. Progress in the first year of funding has been noteworthy. One of the teams has already achieved Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists Certification, while another team has an insurance reimbursable extracellular vesicles test for risk assessment for prostate cancer. Citation Format: Lynn Sorbara, David Wong, Carter Bob, Richard Cote, Hakho Lee, Nickolas Papadopoulos, Abhijit Patel, Sudhir Srivastava. Precompetitive collaboration on liquid biopsy for early cancer assessment [abstract]. In: Proceedings of the AACR Special Conference on Advances in Liquid Biopsies; Jan 13-16, 2020; Miami, FL. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(11_Suppl):Abstract nr B65.

Editorial introductions

Editorial introductions

Championing innovation for a resilient food system

Championing innovation for a resilient food system

How EU-funded Smart City experiments influence modes of planning for mobility: observations from Hamburg

Hamburg participates in the EU-funded research and development project mySMARTlife (mSL) with experiments involving smart city technologies, among others in the field of transportation infrastructure. These experiments are shaped by a public-private consortium in accordance with a call of the EU research and innovation program “Horizon 2020”. They focus on close to the market technologies. The experiments aim at citizen participation. Yet, what technologies are experimented with has been decided and contractually fixed by the consortium beforehand. We explore tensions in this kind of setup, and how entrenched approaches to planning of transportation infrastructure are challenged by new subjectivities, expectations, standards and procedures. From our perspective, it is highly questionable whether a purely expert driven process can produce outcomes that sufficiently reflects local residents’ ideas of sustainable and appropriate changes to urban infrastructures. For this reason, candidate ‘solutions’ for future mobility demands should be exposed to societal deliberation at an earlier stage in their development.Our exploration of (possible) interplays between such an experimental approach to the shaping of infrastructures and the pre-existing integrated approach to planning has been a modest first step, and more empirical research would be needed to draw solid conclusions. It seems worthwhile to analyse more deeply the in- and exclusiveness of the actor constellations in such processes, the role of coincidences or strategies behind the selection of partners, and a possible gate-keeper function of the process initiator.

The European FOOD programme (Fighting Obesity through Offer and Demand)

Abstract Designated by the WHO as one of the greatest public health challenge of our century, obesity in 2018 is still responsible for 1 in 5 deaths in different parts of Europe. A balanced diet is therefore essential for European citizens’ health. Moreover, as employees spend a significant amount of their waking hours at work, it is a designated place to convey health promotion messages and improve the workers’ eating behavior. The FOOD programme contributes to this objective by promoting healthy eating habits during the working day towards two complementary target groups: workers and restaurants, making the healthy choice more obvious and more accessible. The FOOD programme is a public-private consortium gathering representatives of Public Health Authorities, Nutritionists and Universities around the lead partner and coordinator Edenred in Austria, Belgium, Czech Republic, France, Spain, Italy, Portugal, Romania, and Slovakia. To meet its objectives, the Consortium followed a five-step methodology with a strong evaluation, enabling a qualitative and adapted set of actions. After a phase of analysis of the needs, communication tools were created to provide practical advice and recommendations to encourage healthy eating habits among the workers and restaurants. Since 2009, 380 communication tools have reached 6,9 million employees and 521,000 restaurants. In addition, as part of the annual evaluation, barometers are being conducted towards employees and restaurants in order to collect their habits and perception of healthy eating during the working day. Since 2012, 82,600 workers and 7,700 restaurants answered the questionnaires. Return from the target groups confirms a change of perception in the last years as almost half of employees choose a restaurant based on healthy options. On their side, restaurants state a regular increase in the demand for healthy meals and reckon that they could learn more about healthy eating. Key messages Creating healthier eating patterns during the working day. Making the healthy choice the easy choice.