Wednesday 20 January 2021 at 3 pm SIMeF (Italian society of pharmaceutical medicine) will hold the webinar “Cooperative Groups in Italy and clinical research”. Donato Bonifazi, CEO of CVBF and president of AICRO, will intervene as speaker and moderator and, as EPTRI coordinator, the European Paediatric Translational Research Infrastructure, he will illustrate the aims and areas of interest of the aforementioned organisation. The focus of the webinar is to explain how effectively the Cooperative Groups bring satisfactory tools and results in the field of clinical research, taking into account all the entities active in the area of both research and innovation. Alike, the aim of the webinar is to provide the user with a multiple knowledge of how it is important, for these cooperative groups, to work together in order to improve the world of research, to overcome lack of funds, adequate infrastructures and fundamental information linked to the field of science and research. The other organizations involved will be: INCiPiT - Italian Network for Paediatric Clinical Trials GIMEMA – Gruppo Italiano Malattie Ematologiche dell’Adulto FICOG – Federation of Italian Cooperative Oncology Groups Network AIDS The webinar is aimed at representatives of Ethics Committees, CRCs, Clinical Trial Offices, Research Networks, Pharmaceuticals Companies, Data Managers.
With a special wish to all of you, we want to share, in the words of Donato Bonifazi, CEO at CVBF, some of our goals in the 2020 and wish you a Merry Christmas and a Healthy 2021. <<We are approaching the end of a year, full of challenges, but also of activities and achievements for CVBF. We are continuing the conduction of clinical trials in the best possible way, despite any difficulties and issues due to the pandemic. So far, we have 34 active projects among which I would like to mention two H2020 founded multinational clinical trials, cASPerCF – Finding the right dose of posaconazole for children & young people with Cystic Fibrosis and Aspergillus infection (sponsored by Bambino Gesù Children’s Hospital, within c4c) and AMELIE - Anchored Muscle cELls for IncontinencE (sponsored by University College of London). Moreover, we are providing our contribution as CVBF in the fight against COVID-19 emergency by supporting the University of Pittsburgh Medical Center (UPMC) in two studies on COVID-19 aimed to test two vaccines in the form of a patch (protein subunit) and an intranasal spray (Adenovirus). PittCoVacc studies are both phase I / II clinical trials on healthy volunteers. In the meanwhile, CVBF has successfully overcome 3 days of Good Clinical Practice (GCP) Inspection by the Italian Medicines Agency (AIFA). During this pandemic emergency, we have experienced what a lack of an efficient health system means for everybody, and we are actively working to provide safe and affordable medicines for all, as it is underlined in the Pharmaceutical Strategy developed by the EU Commission, for which we have provided our comments to the Public Consultation. In this context, we have underlined the necessity to stress new adequate health policies and actions promoting the development and the [...]
On December 6, the Duchenne Patient Academy training, opened to DMD/BMD reality, has concluded its third edition. As it has been already underlined before the start of the training on our webiste, this event had the aim to to create a wider understanding of Duchenne Muscular Dystrophy (DMD) and coordinate the global advocacy of the community. Together with this aim, a new way of approaching and a different connectivity, due to pandemic were the key topics of this edition. What really mattered was how to create a stronger and united community remotely. The main highlights of the event were: Duchenne Patient Academy is a training platform for Duchenne and Becker MD patient advocates In total, 120 participants from 52 countries joined the week-long training with 33 speakers The broader rare neuromuscular community was invited to join the first three days The online format enabled participation of young adults with Duchenne Topics discussed included research, capacity building, policy & regulations, data, fundraising and clinical trials DPA facilitated discussion among all stakeholders to explore new approaches and propose new frameworks for collaboration We are also glad to share a quote from Javier Torras, a DPA participant “It have been 7 days of very interesting presentations with more than 100 participants in every session. I am surprised to see so many Duchenne organizations all over the world involved and the big quantity of high talented people working hard and fighting against this disease. This gives me confidence that the battle to Duchenne will be won sooner or later.” The official press release is available on Duchenne Data Foundation website.
Unfortunately, it’s well known that the pandemic has transformed everybody’s life. This is particularly true in case of children, apparently little attacked by the virus. Although children infected with COVID-19 are fewer than adults, since February they are suffering from a series of problems linked to health and lifestyle. The fear of going to hospitals, considered at risk of infection, has unveiled a decline in paediatric healthcare and vaccination. As clenched by Giovanni Corsello, Past-President SIP (Italian Society of Paediatrics), during the most difficult phases of the sanitary emergency, children have been unable to follow the required checks and this has led to negative consequences not just on their physical health but, above all, on their psychological state. Together with this decrease in healthcare, what is worrying is that obesity and poverty are increasing dramatically; i.e., on a study conducted on 41 obese children in Verona, results have shown increase in daily meals consumed. At the Extraordinary Digital Congress of the Italian Society of Paediatrics held on 27 and 28 November 2020, what emerged was a common shortage in healthcare due to fear and the continue increasing of precarious life conditions in children. According to a survey conducted by SIMGEPed, Uniamo and Telethon friendly associations, it has been estimated that 40% of “fragile” children interrupted the checks often on the recommendation of the reference centres. Further information about the Italian Society of Paediatrics SIP Digital Congress is available on its website, including all the material related to the congress.
We are happy to announce that even this year and with an ongoing pandemic, the youths of KIDS Bari have kicked off their activities[ML1] ! On November 27, KIDS BARI went back to work to promote the involvement of young persons and patients in the research and clinical fields to favour the achievement of goals in the paediatric drug development and availability. KIDS BARI meets every 4-5 weeks and undergoes a training course on medical research. The group is made up of students, patients and non-patients, selected through hospitals and patient associations, schools, associations selected on the basis of their motivation and their interest in improving medical research and children's health. The group's training plan is focused on biomedicine, basic and clinical research, innovation and humanization of healthcare. This year KIDS BARI has also launched a first test of a serious game! A serious game is a game with an educational purpose. It’s a tool where serious and playful aspects are in balance, in order to create an effective and enjoyable learning experience. The purpose of the “My CTC” video game is to explain to children and young people what a pediatric clinical trial is and why it is important for the development of medicines for children. “My CTC” was developed with the support of KIDS Bari and Kids Albania young people, through a participatory design, in which the two groups contributed to the graphic choices of characters and interfaces and to the revision of the contents. During this last meeting, the members of KIDS Bari tested the trial version of the video game to verify its correct functioning and report any bugs or anomalies, technical or linguistic, and ensure an optimal user experience. The [...]
The European Commission has released a factsheet about the new Pharmaceutical Strategy for EU countries aimed to provide effective progresses in every field of scientific research, affordability and distribution of medicines. What EU has registered since the pandemic has begun, is an increase in spending pharmaceutical, shortage of drugs and often at inexpensive prices, absence of therapies for 95% of rare diseases and many deaths caused each year by antimicrobial resistance. The Commission had already published a communication last 11 November to underline the importance of new strategies and implementations to improve EU systems, in particular the one regarding health. EU Commission has provided a series of achievements to reach, in the field of pharmaceuticals, all included in the general factsheet. The main proposals are focused on research and innovation, clinical trials, policies relating to prices and refunds, Investments in research, development and production of new medicines, creation of an EU Preparation Authority and Health Emergency Response (HERA) and reduction of the environmental impact of medicines. A proposal for revision of the pharmaceutical legislation, as reported on EU Commission website, will be taken into account in 2022. The factsheet can be downloaded from EU Commission website, at the following link https://ec.europa.eu/commission/presscorner/detail/en/fs_20_2201
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.
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]).