Best Practice Guidance for Creation and Management of Innovations in Health care and Information and Communications Technologies.

Governments and publics in Europe and around the world have turned to innovation in response to the manifold economic, environmental, and societal challenges we are facing. However, innovations often end up in what is popularly termed as the "valley of death" between upstream creation and downstream product development and implementation. Consequently, the benefits of innovation do not always reach the citizens. In addition, critically informed governance of innovations matter because it allows steering of innovations in response to the values and end points desired by society. With the COVID-19 pandemic, we have witnessed the rise of digital health and new information and communications technologies (ICTs). The pandemic underscored the need for innovation governance between global North and the global South. We report and discuss, in this study, the development of the innXchange innovation wheel to improve innovation creation and management, using a case study of cooperation between Europe and Africa. The innovation wheel offers best practice guidance and framework to build capacity for innovation dimensions such as partnership mobilization, evaluation, and monitoring, not to mention innovation literacy. The framework emphasizes active engagement of all key stakeholders from the very beginning, also referred to as "systematic early dialog." We propose the incorporation of systematic early dialog as the best practice guidance in global South and global North cooperation for health care and ICT innovation. The framework is a novel instrument to help overcome the current barriers in planetary health innovation management and consequently, bring breakthrough discoveries in ICTs and innovative ideas to the people.

The Creation and Management of Innovations in Healthcare and ICT: The European and African Experience.

The purpose of the study was to gain new insights into innovation systems by comparing state-of-the-art of existing approaches of innovation creation and innovation management in healthcare and ICT. It is unique, in that it compares countries in Africa with countries in Europe in order to identify similarities and differences regarding the creation and management of innovations. The main similarity is that early dialogue between different stakeholders was underrepresented during the whole innovation process in all countries. Our results also indicated that the various stakeholders often work in silos. The main difference was that the countries face problems at different stages of the innovation process. Whereas European countries face more problems in the innovation creation process, African countries experience difficulty sustaining and managing innovation. To overcome barriers, we suggest the application of systematic early dialogue between all key stakeholders.

Personalized Medicine: What's in it for Rare Diseases?

Personalised Medicine has become a reality over the last years. The emergence of 'omics' and big data has started revolutionizing healthcare. New 'omics' technologies lead to a better molecular characterization of diseases and a new understanding of the complexity of diseases. The approach of PM is already successfully applied in different healthcare areas such as oncology, cardiology, nutrition and for rare diseases. However, health systems across the EU are often still promoting the 'one-size fits all' approach, even if it is known that patients do greatly vary in their molecular characteristics and response to drugs and other interventions. To make use of the full potentials of PM in the next years ahead several challenges need to be addressed such as the integration of big data, patient empowerment, translation of basic to clinical research, bringing the innovation to the market and shaping sustainable healthcare systems.

European healthcare systems readiness to shift from 'one-size fits all' to personalized medicine.

Personalized medicine (PM) is no longer an abstract healthcare approach. It has become a reality over the last years and is already successfully applied in the various medical fields. Although there are success stories of implementing PM, there are still many more opportunities to further implement and make full use of the potential of PM. We assessed the system readiness of healthcare systems in Europe to shift from the predominant 'one size fits all' healthcare approach to PM. We conclude that European healthcare systems are only partially ready for PM. Key challenges such as integration of big data, health literacy, reimbursement and regulatory issues need to be overcome in order to strengthen the implementation and uptake of PM.

Clinical Trials, Data Protection and Patient Empowerment in the Era of the New EU Regulations.

Cancer clinical trials and, in general, cancer clinical research by definition need a multi-modality approach. It is not enough to discover and register new drugs. To get cancer under control requires us to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures and new radiotherapy approaches as well as, most importantly, to integrate all available information. This includes biological material and, of increasing importance, large amounts of data using big data technologies. To personalise treatment, genetic data are more and more frequently used. Therefore, the general approach is holistic. Legislators, on the other hand, work in a silo mentality; the needs of clinical research are poorly understood, and legislation focuses on either health care or the commercialisation of a product, and not on clinical research. In the last 2 years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, although the silo mentality makes the overall framework inconsistent and potentially highly damaging to the EU's capacity to make rapid progress in the field of personalised medicine.