The University of Pavia has launched the XVII second level post-graduate Master in Regulatory Sciences “G.Benzi”. The aim of the master is to provide the participants with the necessary expertise and knowledge in the regulatory activities, that are currently searched for by pharmaceutical companies and academia. The 17th edition of the Master is promoted by Fondazione per la Ricerca Farmacologica “Gianni Benzi” and SIARV (Società Italiana Attività Regolatorie, Accesso, FarmacoVigilanza). The Master is entitled to Professor Gianni Benzi, who was Full Professor and Director of the Institute of Pharmacology of the University of Pavia and founder of Consorzio per Valutazioni Biologiche e Farmacologiche. In 1999 he founded the Specialty School in Regulatory Sciences at the University of Pavia, which was then turned into the Second Level Biennal Master, now called Master in Regulatory Sciences “G. Benzi”. Prof. Gianmartino Benzi was leader in pharmacological circles, both at national and international level, in the field of cerebral and muscular bioenergetics, neurobiology and neuropathology of cerebral aging, that have characterised and still characterise the Pavia School of Pharmacology of the Faculty of Science. More details about the master's call and instructions on how to apply are available here. Applications can be submitted until January 26, 2021.
Since February 2020, the pandemic has shown a new and, unfortunately, dangerous way of living and facing everyday life. Since then, EU government is working to grant to all Member States the adequate instruments to fight against this terrible pandemic. As it is explained in the European Commission’s report dated 11.11.2020 “Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats”, these months have been very difficult to overcome and the need for a stronger EU Health security framework is becoming relevant. The collective effort to fight the ongoing COVID-19 pandemic, as well as other future health emergencies, call for strengthened coordination at EU level. Moreover, in some specific therapeutical areas, such as the paediatrics, the pandemic has settled in an already difficult healthcare context due to the chronic shortage of paediatric medicines. This constant issue, in fact, has proven to increase the risk of undercured paediatric patients affected by COVID-19 and its complications. What do we, as EU, have to do right now? We need absolutely to reinforce ECDC (European Centre for Disease Prevention and Control) ‘s role in EU’s health system and EMA’s system “to monitor and mitigate shortages of critical medicines”. It is necessary “to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry”. To this aim, some steps forward has been made by the European Commission with the launch of the Pharmaceutical Strategy that will try to find concrete solutions to stop medicines shortage. Covid-19 has shown a huge amount of medicines shortage in many scientific fields, especially in paediatrics where the situation was, and still is, very severe. The chronic shortage of paediatric medicines, available for [...]
The pandemic has changed and, in many ways, distorted our lives. Every system has collapsed and, as it can be easily assumed, particularly the healthcare system is suffering from ineffectiveness, staff shortages and financial problems. Donato Bonifazi, Chief Executive Officer of CVBF and President of AICRO, the Italian CRO Association, has given his mind about how the world of clinical trials has changed due to COVID-19 emergency. We asked him to provide us some explanations and examples of how clinical trials, research and patients’ lives had to change course: “This pandemic has been unexpected and very destructive. In order to face and save patients affected from COVID-19, many hospitals have been compelled to stop studies about specific medical fields, burding also on therapeutical areas such as rare diseases and paediatrics, and this has stopped also the enrolment of new patients in clinical trials. Actually, we don’t know the ultimate effect of this pandemic, but if it goes on, we will lose the possibility to find new treatments and make patients’ life expectancies better. The European Agency Medicine (EMA) has been really active in keeping in touch with developers who were studying treatments and vaccines for COVID-19, as they continue doing in these days; the Agency has provided a guideline with a set of criteria that developers should follow to submit their researches in order to render the situation clearer and facilitate clinical trial conduct." New frameworks and technologies are needed to accelerate the clinical research by avoiding unnecessary accesses of patients to centers. It’s time to bring innovation, decentralize trials, monitor remotely.
The EU has awarded €9.5m to a ground breaking research project into the treatment of faecal incontinence. The aim of the research is to use revolutionary cell therapy to find a possible cure for a condition which affects an estimated 67 million people in Europe. The funding will go to a consortium of 13 organisations across nine countries called AMELIE (Anchored Muscle cELls for IncontinencE). The project will be co-ordinated by UCL and led by Richard Day, Professor of Regenerative Medicine Technology at UCL. Other partners in the UK include Queen Mary University of London, NHS Blood and Transplant and the charity Bowel Research UK, which will take the lead in patient involvement. The research will be conducted over five years, with separate institutions in the UK, Spain and Portugal taking the lead role at each new stage. The project will focus on taking the patient’s own muscle cells, loading them onto specially designed microcarriers and implanting them into the damaged muscle to promote regeneration and restore normal function. Professor Day said that such regenerative medicine therapy offers hope to many people whose lives are severely impaired by incontinence: “We are tremendously excited by the prospect of the AMELIE project and the potential benefits that may arise from the new therapeutic approach being investigated. “We look forward to working with the exceptional consortium of academics, clinicians, industry and charity partners from across Europe to develop our pioneering regenerative medicine approach for treating this debilitating condition. “This will be a radical and innovative approach never before attempted at such a scale.” Lesley Booth MBE, Director of Research and PPI at Bowel Research UK, said that, whilst the condition is extremely common, it is not much talked [...]
SAVE THE DATE: 25-26 November. EUPATI Fundamentals a training about Patient Engagement addressed to professionals in academia and pharmaceutical industry
On 25-26 November 2020, a new EUPATI Fundamentals will start. This will be a training about “Patient Engagement addressed to professionals in academia and pharmaceutical industry” divided in 4 modules: principles of patient engagement; patient engagement roadmap; setting up a patient engagement activity; quality criteria in patient engagement. Throughout this 2-day training, participants will learn about patient engagement and get hands-on lessons and experiences on how to engage with patients in a meaningful and sustainable way. Visit EUPATI website to know more about the training and to register. Any questions can be asked to Ingrid Heyne ([email protected]).
The Patient and Public Involvement Cross – Cutting Team in the c4c project has released a video to inform the public about c4c programmes and work and also to keep families and children always in touch with c4c activities. As stated on c4c website “At c4c we are working to give a voice to children, young people and families in research and YOU have much to say. Help us to do better research and develop better medicines for children.” To know more about c4c and watch the video, visit c4c website.
Europe Biobank Week 2020, the largest biobanking conference in Europe, will take place between 17-20 November in a virtual format for the first time. The conference is a joint effort of ESBB and BBMRI-ERIC. Last year’s edition in Lübeck saw the largest number of abstracts submitted (over 280) and over 750 professionals came together to discuss, network, engage, and promote knowledge around biobanking. This year’s edition will roll out completely online, creating new opportunities to attend sessions and fully enjoy all the great scientific insights from speakers and panellists. At the same time, it will keep allowing biobanking professionals to discuss, engage, share knowledge and best practices, as in a traditional edition of EBW. EPTRI has submitted two abstracts in the event that have been chosen as oral presentations. For registrations and more information about the event, please visit: europebiobankweek.eu.
The EU has awarded €9.5m to AMELIE, a ground-breaking research project into the treatment of faecal incontinence. AMELIE aims at using cell therapy to find a possible way to cure a disease that is suffered from almost 67 million people in Europe. The project will be co-ordinated by University College London (UCL). As reported in AMELIE Press Release (October 2020),“The research will be conducted over five years, with separate institutions in the UK, Spain and Portugal taking the lead role at each new stage. The project will focus on taking the patient’s own muscle cells, loading them onto specially designed microcarriers and implanting them into the damaged muscle to promote regeneration and restore normal function.” CVBF is involved in the AMELIE project as the beneficiary in charge of CRO-like activities, providing support both to the Sponsor and to the clinical sites in the set up and conduct of the study. The complete AMELIE Press Release is available at this link. Further information about this project can also be found on CVBF dedicated page.
On Wednesday 28 October, the first EPTRI-IT settlement meeting took place. Donato Bonifazi, Chief Executive Officer of CVBF and Coordinator of EPTRI (European Paediatric Translational Research Infrastructure), has initiated the meeting explaining what Research Infrastructures are, focusing the attention on the Italian hub of EPTRI (EPTRI-IT). Later, he underlined the lack of a Paediatric Research Infrastructure in the European Strategy Forum on Research Infrastructures (ESFRI) Roadmap where there are 13 RIs but EPTRI that has submitted the application to be included in the ESFRI Roadmap 2021 on the 9th of September, is the first RI focused on paediatrics. The aim of EPTRI is to create the framework for paediatric research by integrating all the technological aspects necessary to favour all phases of paediatric drug development In addition, EPTRI promotes the cooperation and integration of its proposals with those of existing infrastructures. Donato Bonifazi has also showed what the Italian Joint Research Unit of EPTRI-IT is going to do in these years. He stated that the settlement of an Italian hub of EPTRI would be fundamental to render the association among stakeholders, such as Universities, Hospitals and IRCSS even stronger. Consolidation, strengthening and expansion are the goals that EPTRI-IT wants to achieve, both at national and at European level. EPTRI-IT will be constituted by a Joint Research Unit which entrusts the institutional leadership to the CNR (President of the General Assembly), the scientific leadership to INCiPiT (President of the Scientific Committee) and the coordination to CVBF thanks to the work of 3 resources: a Coordinator, a Joint Research Unit Manager and a Liaison Officer.
Last month, the European Brain Council (EBC) was able to provide feedback and input to the European Commission on the draft of the “First Horizon Europe Work Programme 2021-2022 of the Health Cluster”. An overarching first response to the draft Work Programme was composed, representing the views of the brain research community as a whole. The Horizon Europe Health cluster aims at improving the understanding of health and diseases, developing innovative methodological and technological solutions to better manage health and diseases and designing sustainable approaches for the digital transformation and delivery of integrated, person-centred and equitable health and care services. EBC generally welcomes the programme, which includes relevant areas that relate to neurological and mental diseases within several calls. However, though the document mentions “non-communicable diseases” and “mental health/illness”, there are very few references to neurological diseases and no further prioritization of brain disorders reflected within the calls, which we see as a worrying oversight. The Consultation answer was discussed also in the framework of Share4Brain Translational Meeting that took place online on 28th and 29th September and provided the occasion to meet virtually not only all the partners of the project, including CVBF, but also the representatives of different Patient Associations of neurological and psychiatric disorders. Here you can find the letter from EBC and the summary of the Consultation answer. “Sharing Good practices for Brain Education in Europe” (Share4Brain) is a Erasmus+ project, coordinated by the Belgian Brain Council, that will draw the attention of the academic and general public as well as relevant state institutions to the importance of the development of basic and clinical research in neuroscience to ensure better prevention, diagnosis, and treatment of neurological and psychiatric disorders. The [...]