How personalised medicine will transform healthcare by 2030: the ICPerMed vision

This commentary presents the vision of the International Consortium for Personalised Medicine (ICPerMed) on how personalised medicine (PM) will lead to the next generation of healthcare by 2030. This vision focuses on five perspectives: individual and public engagement, involvement of health professionals, implementation within healthcare systems, health-related data, and the development of sustainable economic models that allow improved therapy, diagnostic and preventive approaches as new healthcare concepts for the benefit of the public. We further identify four pillars representing transversal issues that are crucial for the successful implementation of PM in all perspectives. The implementation of PM will result in more efficient and equitable healthcare, access to modern healthcare methods, and improved control by individuals of their own health data, as well as economic development in the health sector.Funding Agencies|European Unions Horizon 2020 Research and Innovation Programme [731366]</p

The evolution of personalized healthcare and the pivotal role of European regions in its implementation

Personalized medicine (PM) moves at the same pace of data and technology and calls for important changes in healthcare. New players are participating, providing impulse to PM. We review the conceptual foundations for PM and personalized healthcare and their evolution through scientific publications where a clear definition and the features of the different formulations are identifiable. We then examined PM policy documents of the International Consortium for Personalised Medicine and related initiatives to understand how PM stakeholders have been changing. Regional authorities and stakeholders have joined the race to deliver personalized care and are driving toward what could be termed as the next personalized healthcare. Their role as a key stakeholder in PM is expected to be pivotal.The Coordination and Support Action Regions4PerMed has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 825812.Peer reviewe

An index of barriers for the implementation of personalised medicine and pharmacogenomics in Europe

Background: Personalised medicine (PM) is an innovative way to produce better patient outcomes by using an individualised or stratified approach to disease and treatment rather than a collective treatment approach for patients. Despite its tangible advantages, the complex process to translate PM into the member states and European healthcare systems has delayed its uptake. The aim of this study is to identify relevant barriers represented by an index to summarise challenging areas for the implementation of PM in Europe. Methods: A systematic literature review was conducted, and a gaps-and-needs assessment together with a strengths-weaknesses-opportunities-and-threats analysis were applied to review strategic reports and conduct interviews with key stakeholders. Furthermore, surveys were sent out to representatives of stakeholder groups. The index was constructed based on the priorisation of relevant factors by stakeholders. Results: A need for stakeholder-agreed standards at all levels of implementation of PM exists, from validating biomarkers to definitions of 'informed consent'. The barriers to implement PM are identified in 7 areas, namely, stakeholder involvement, standardisation, interoperable infrastructure, European-level policy making, funding, data and research, and healthcare systems. Conclusions: Challenges in the above-mentioned areas can and must be successfully tackled if we are to create a healthier Europe through PM. In order to create an environment in which PM can thrive for the patients' best outcomes, there is an urgent need for systematic actions to remove as many barriers as possible

Translating Academic Drug Discovery Into Clinical Development: A Survey of the Awareness of Regulatory Support and Requirements Among Stakeholders in Europe

Important discoveries by academic drug developers hold the promise of bringing innovative treatments that address unmet medical needs to the market. However, the drug development process has proved to be challenging and demanding for academic researchers, and regulatory challenges are an important barrier to implementing academic findings in clinical practice. European regulators offer varying degrees of support services to help drug developers meet regulatory standards and requirements. “Strengthening Training of Academia in Regulatory Sciences and Supporting Regulatory Scientific Advice” (STARS) is a European Commission–funded consortium aiming to strengthen the training of academics in regulatory science and requirements. Here, we report the results of four surveys that investigated the awareness and utilization of support tools offered by European regulators and identified the regulatory challenges and support needs of researchers. The surveys targeted four main European stakeholders in academic medicines research: academic research groups (706 respondents), academic research centers (99), funding organizations (49), and regulators (22). The results show that while European regulators provide various regulatory support tools, less than half of the responding academic researchers were aware of these tools and many experienced challenges in reaching a sufficient level of regulatory knowledge. There was a general lack of understanding of the regulatory environment that was aggravated by poor communication between stakeholders. The results of this study form a foundation for an improved European medicines regulatory network, in which regulatory challenges faced by academia are tackled

The ICPerMed vision for 2030: How can personalised approaches pave the way to Next-Generation Medicine?

Astrid M. Vicente - INSA (chair of Vision Paper Writing Group),This document presents the vision of the International Consortium for Personalised Medicine (ICPerMed) on personalised medicine (PM) research and implementation by 2030. ICPerMed connects more than 40 European and international institutions that aim to: The notion that individuals can experience unique clinical manifestations for the same disease, as well as variable responses to treatment, has long been recognized by the medical community. There are many long-standing paradigmatic examples of the use of such knowledge in medicine, for example the testing of blood type before blood transfusions or the neonatal screening programs. However, the prolific technological advancements in biomarker detection over the last few decades, including not only genomics but also other “omics” and body imaging methods, have spurred the development of novel approaches to health and disease management that are specifically optimised for each individual. The term PM, and its subtle variations, such as precision medicine or stratified medicine, today generally describe an approach to medicine that integrates an individual’s characteristics for early disease diagnosis, prognosis, optimal choice of treatment, accurate disease risk estimation, and targeted prevention.The Coordination and Support Action (CSA) ICPerMed Secretariat has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 731366info:eu-repo/semantics/publishedVersio