Patent landscape analysis-Contributing to the identification of technology trends and informing research and innovation funding policy.

Patents and the systematic analysis thereof provide important decision information for a range of stakeholders pursuing diverse goals. However, in particular academia and small-scale private sector innovators underappreciate the value of patent information for identifying research gaps, ensuring originality of their work and, in turn, maximisation of limited (public) funds. By the same token, pertinent public sector organisations, such as regulators, require overviews of potentially upcoming technologies to adequately adapt regulatory protocols. The latter, in particular if contemporary scientific evidence is not sufficient, can require a substantial amount of time and lead to a delay in the marketing of important innovations. Patent landscape analysis (PLA) is a very useful method to create overviews of technology fields and thereby indicate if, inter alia, a specific line of scientific enquiry and its application have already been pursued or potential regulatory gaps will exist in the near- to mid-term future. The objective of this communication is to increase awareness of the utility of patent information and provide support in retrieval and analysis of pertinent information for those involved in biotech R&D. Based on Espacenet, a patent search engine, we provide basic guidance on search strategy development, piloting and execution, and data preparation and analysis. To highlight the value of PLA, we also summarise selected results of a PLA we performed recently for microbiome targeting interventions, also referred to as live biotherapeutic products.

Stakeholder Perspectives on Barriers and Facilitators for the Adoption of Virtual Clinical Trials: Qualitative Study.

BACKGROUND: Conventional clinical trials are essential for generating high-quality evidence by measuring the efficacy of interventions in rigorously controlled clinical environments. However, their execution can be expensive and time-consuming. In addition, clinical trials face several logistical challenges regarding the identification, recruitment, and retention of participants; consistent data collection during trials; and adequate patient follow-up. This might lead to inefficient resource utilization. In order to partially address the current problems with conventional clinical trials, there exists the need for innovations. One such innovation is the virtual clinical trial (VCT). VCTs allow for the collection and integration of diverse data from multiple information sources, such as electronic health records, clinical and demographic data, patient-reported outcomes, anthropometric and activity measurements, and data collected by digital biomarkers or (small) samples that participants can collect themselves. Although VCTs have the potential to provide substantial value to clinical research and patients because they can lower clinical trial costs, increase the volume of data collected from patients' daily environment, and reduce the burden of patient participation, so far VCT adoption is not commonplace. OBJECTIVE: This paper aims to better understand the barriers and facilitators to VCT adoption by determining the factors that influence individuals' considerations regarding VCTs from the perspective of various stakeholders. METHODS: Based on online semistructured interviews, a qualitative study was conducted with pharmaceutical companies, food and health organizations, and an applied research organization in Europe. Data were thematically analyzed using Rogers' diffusion of innovation theory. RESULTS: A total of 16 individuals with interest and experience in VCTs were interviewed, including persons from pharmaceutical companies (n=6), food and health organizations (n=4), and a research organization (n=6). Key barriers included a potentially low degree of acceptance by regulatory authorities, technical issues (standardization, validation, and data storage), compliance and adherence, and lack of knowledge or comprehension regarding the opportunities VCTs have to offer. Involvement of regulators in development processes, stakeholder exposure to the results of pilot studies, and clear and simple instructions and assistance for patients were considered key facilitators. CONCLUSIONS: Collaboration among all stakeholders in VCT development is crucial to increase knowledge and awareness. Organizations should invest in accurate data collection technologies, and compliance of patients in VCTs needs to be ensured. Multicriteria decision analysis can help determine if a VCT is a preferred option by stakeholders. The findings of this study can be a good starting point to accelerate the development and widespread implementation of VCTs.

Synthetic consortia of nanobody-coupled and formatted bacteria for prophylaxis and therapy interventions targeting microbiome dysbiosis-associated diseases and co-morbidities.

Designed nanobody-linked synthetic consortia for microbiota dysbiosis therapies. A. Nanobodies (Nb) are selected for specific antigens on target bacteria destined for a synthetic therapy consortium that may consist of two (B) or multiple (C) members. For the treatment of dysbiosis co-morbidities requiring two functionally distinct consortia, these may be linked through a common member to generate a single bi-functional microbiota therapy (D).

The contribution of microbial biotechnology to economic growth and employment creation.

Our communication discusses the profound impact of bio-based economies - in particular microbial biotechnologies - on SDG 8: Promote sustained, inclusive and sustainable economic growth, full and productive employment and decent work for all. A bio-based economy provides significant potential for improving labour supply, education and investment, and thereby for substantially increasing the demographic dividend. This, in turn, improves the sustainable development of economies.

Improving accountability in vaccine decision-making.

INTRODUCTION: Healthcare decisions, in particular those affecting entire populations, should be evidence-based and taken by decision-makers sharing broad alignment with affected stakeholders. However, criteria, priorities and procedures for decision-making are sometimes non-transparent, frequently vary considerably across equivalent decision-bodies, do not always consider the broader benefits of new health-measures, and therefore do not necessarily adequately represent the relevant stakeholder-spectrum. Areas covered: To address these issues in the context of the evaluation of new vaccines, we have proposed a first baseline set of core evaluation criteria, primarily selected by members of the vaccine research community, and suggested their implementation in vaccine evaluation procedures. In this communication, we review the consequences and utility of stakeholder-centered core considerations to increase transparency in and accountability of decision-making procedures, in general, and of the benefits gained by their inclusion in Multi-Criteria-Decision-Analysis tools, exemplified by SMART Vaccines, specifically. Expert commentary: To increase effectiveness and comparability of health decision outcomes, decision procedures should be properly standardized across equivalent (national) decision bodies. To this end, including stakeholder-centered criteria in decision procedures would significantly increase their transparency and accountability, support international capacity building to improve health, and reduce societal costs and inequity resulting from suboptimal health decision-making.

The DIY Digital Medical Centre.

Healthcare systems worldwide are confronted with major economic, organizational and logistical challenges. Historic evolution of health care has led to significant healthcare sector fragmentation, resulting in systemic inefficiencies and suboptimal resource exploitation. To attain a sustainable healthcare model, fundamental, system-wide improvements that effectively network, and ensure fulfilment of potential synergies between sectors, and include and facilitate coherent strategic planning and organisation of healthcare infrastructure are needed. Critically, they must be specifically designed to sustainably achieve peak performance within the current policy environment for cost-control, and efficiency and quality improvement for service delivery. We propose creation of a new healthcare cluster, to be embedded in existing healthcare systems. It consists of (i) local 24/7 walk-in virtually autonomous do-it-yourself Digital Medical Centres performing routine diagnosis, monitoring, prevention, treatment and standardized documentation and health outcome assessment/reporting, which are online interfaced with (ii) regional 24/7 eClinician Centres providing on-demand clinical supervision/assistance to Digital Medical Centre patients. Both of these are, in turn, online interfaced with (iii) the National Clinical Informatics Centre, which houses the national patient data centre (cloud) and data analysis units that conduct patient- and population-level, personalized and predictive(-medicine) intervention optimization analyses. The National Clinical Informatics Centre also interfaces with biomedical research and prioritizes and accelerates the translation of new discoveries into clinical practice. The associated Health Policy Innovation and Evaluation Centre rapidly integrates new findings with health policy/regulatory discussions. This new cluster would synergistically link all health system components in a circular format, enable not only access by all arms of the health service to latest patient data, but also automatic algorithm analysis and prediction of clinical development of individual patients, reduce bureaucratic burden on medical professionals by enabling a greater level of focus of their expertise on non-routine medical tasks, lead to automatic translation of aggregate patient data/new knowledge into medical practice, and orient future evolution of health systems towards greater cohesion/integration and hence efficiency. A central plank of the proposed concept is increased emphasis on reduction of disease incidence and severity, to diminish both patient suffering and treatment costs. This will be achieved at the individual and population levels, through (i) significantly improved access to medical services, (ii) stronger focus on primary and secondary prevention and early treatment measures, and disease susceptibility prediction via personalized medicine, involving inter alia genome analysis at birth and periodic analysis of microbiomes and biomarkers, and integration with other patient health and epidemiology parameters, (iii) improved surveillance and (iv) intervention outcome benchmarking. The dMCs will become drivers of innovation and integrative evolution in health systems, of disease reduction and efficiency gains, and thus major contributors to development of sustainability of health care.

The contribution of microbial biotechnology to sustainable development goals.

The signature and almost unique characteristic of microbial technology is the exceptional diversity of applications it can address, and the exceptional range of human activities and needs to which it is and can be applied. Precisely because sustainability goals have very diverse and complex components and requirements, microbial technology has the ability to contribute substantively on many levels in many arenas to global efforts to achieve sustainability. Indeed, microbial technology could be viewed as a unifying element in our progress towards sustainability.

Core values for vaccine evaluation.

Currently, most health economic modelling approaches tend to inadequately incorporate crucial disease-specific criteria and other attributes of benefit resulting from vaccination, which limits their utility for evaluating vaccines and, in consequence, for optimally guiding vaccine decision-making. Additionally, vaccine evaluation methods are frequently poorly standardised and non-transparent, leading to a potentially low level of accountability that can hinder acceptance of resulting decisions. To address these issues, we have considered whether it is possible to identify a set of universal vaccine-disease considerations, which we have called Core Values. To begin to identify such a set of criteria, and to establish whether strong agreement around such core values exists, we conducted two studies based on the Delphi technique. Both studies surveyed a cohort consisting of expert members of the global vaccine community with diverse professional backgrounds. Formal statistical analysis of both studies identified four attributes with strong agreement: 1. Incidence disease cases prevented per year, 2. Cost-effectiveness (including cost-benefit and cost-utility analysis), 3. High mortality disease (case-fatality-rate), and 4. Severity of target disease (risk of morbidity and mortality). These results suggest the feasibility of identifying a clear consensus on a specific set of Core Values for Vaccine Evaluation.

Pipelines for New Chemicals: a strategy to create new value chains and stimulate innovation-based economic revival in Southern European countries.

Countries of Southern Europe are currently suffering from severe socio-economic pain resulting from high debt levels and austerity measures which constrain investment in innovation-based recovery strategies that are essential for entry into a long-term sustainable period of increasing employment and wealth creation. Young university-educated people are particularly innovative, and hence vital to the development of such strategies, but employment opportunities are poor and many are forced to seek employment that neither profits from their training nor satisfies their justified career expectations, or to emigrate. They are the 'lost generation'. A strategy is proposed here for the creation of Pipelines for New Chemicals, national centre-network partnerships for the discovery-synthesis of new chemicals obtained though harvesting new biological diversity, and their exploitation to develop new medicines, agrochemicals, materials, and other products and applications. The goal is to create new regional motors of economic growth and development, by harnessing the knowledge, motivation and innovation potential of the excellently educated young people of Europe to catalyse the development of new small, medium and large enterprises centred around novel chemicals, and the value chains that will evolve with them, and thereby develop a powerful sector of sustainable growth in employment and social and economic prosperity in Southern Europe.