It is possible to capture and communicate the essence of International Children's Advisory Network (iCAN) through the art? Can a drawing explain the importance of the role of iCAN organisation? This was asked to Emanuela Ruscitto, one of the members of KIDS Bari, who succeeded to create a drawing and a video representing the strength, the multiculturality and tenacity of the iCAN members. In occasion of the year-end thanks and greetings, iCAN invited its youth members to share a creative idea showing special thanks from iCAN to all its members for the work performed and the efforts put in 2019. Emanuela’s idea was selected for this purpose and she shared her original work entitled “Different but same”. As Emanuela explained “it could be nice to recollect all the iCAN members in a singular one, portrayed with a selection of our different characteristics." Have a look at Emanuela’s video and read iCAN’s special thanks here.
In December 2019 started Share4Brain (Sharing Good Practices for Brain Education in Europe), the project funded within the European Programme Erasmus Plus – Strategic partnership for adult education that will be kicked off officially on 15 and 16 March, 2020. The project, led by Belgian Brain Council, gathers a consortium of 4 partners beyond the coordinator: Greek Carers Network EPIONI, Consejo Español del Cerebro, Serbian Brain Council, Consorzio per Valutazioni Biologiche e Farmacologiche. The aim of Share4Brain is to connect patients, brain researchers, scientists, clinicians and carers at national and international level, providing them with the skills and knowledge necessary to promote brain research and raise awareness about the societal impact of brain diseases. Representatives of the above groups will meet on multiple occasions during the lifecycle of the project in order to share best practices, exchange perspectives on effective advocacy strategies and learn how to engage with decision-makers at national and EU levels. What is more, the project aims to bring them together within National Brain Councils (NBCs), thereby uniting all stakeholders involved in brain research within transversal platforms that operate at country level. Lastly, “Share4Brain” will aim to enhance cross-border cooperation between NBCs for the purpose of defining key priorities for National Brain Plans, which will ultimately benefit people living with mental or neurological conditions. CVBF will be involved in the implementation of training activities and sharing of good practices through workshops and translational meetings. The press release published on EU Commission portal is available at this link.
We are glad to announce that Consorzio per Valutazioni Biologiche e Farmacologiche was included in the list of “2020 Leaders of Growth”, realised by Sole 24 Ore and Statista. Among 6000 companies considered, 400 Companies were deemed eligible based on ad hoc assessment criteria, above all the growth of company’s turnover since 2015 to 2018 as well as the annual average growth in the three years. The competition was held for the second year and considered both private and listed companies. The most relevant information of the list is the prevalence of small and medium companies able to compete at European level rather than the big names of the industrial landscape. The list is available at the following link.
By means of ARTI–Regional Agency for Technology and Innovation, Puglia Region launched “Estrazione dei Talenti” (Talents mining) action, aimed at funding custom training paths to help entrepreneurs teams creating new companies under priority innovation areas, as stated in the regional Research and Innovation Strategy. The Factory EVOLUTIO START UP stems from the experience of Bioindustry Park, CNR IC (Consiglio Nazionale delle Ricerche-Istitute of Crystallography), and CVBF which collaborate to promote and support innovative business ideas in the Health sector. EVOLUTIO START UP can help your Team to develop your business idea and build a talented company, through enhancement paths, technology transfer actions and business development, thanks to our significant and global experience in r&d, pharm, biotech, medical devices and eHEalth as well as in boosting innovative initiatives in the life science field. EVOLUTIO START UP integrated approach is: to support temporary settlements (incubation in the CNR areas); to provide services’ platform to promote the growth (acceleration) of an individual Team, according to their specific needs. Together with the Teams, the Factory will elaborate a personalised Action Plan according to the degree of maturity of the business idea and to define a long-term objectives for its realistion to be achieved during the 6 months coaching period. To participate in the selection, the Teams wishing to receive tutorship services provided by the Factory must present an entrepreneurial project in the "Human health" field. Useful documents: Informative sheet “Selezione Team” (available only in Italian) Video infographic of the call “Selezione Team” (available only in Italian)
A new TEDDY Publication: Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe‐wide trials
CVBF is member of TEDDY Network that is always proactive in enhancing clinical research and paediatric medicines availability. Ensuring high-quality ethical research on the safety and efficacy of medicines for children represents one of the main objectives of the paediatric sector! However, there are no summary data in the public domain about the capacity and competence of European paediatric centres to carry out research studies. To this end, the TEDDY Network developed and piloted a survey, whose results are described in the article “Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe‐wide trials” prepared by Lucia Ruggieri from the Gianni Benzi Foundation, in collaboration with other TEDDY representatives and published on Acta Paediatrica Journal. Among the authors also the CEO of CVBF, Donato Bonifazi and the Clinical Research Director, Mariagrazia Felisi. CVBF is, indeed, member of TEDDY Network that is always proactive in enhancing clinical research and paediatric medicines availability. The paper presents the results of the survey aimed to determine the capacity and competence of paediatric centres to perform research studies and highlights that there is the potential for performing European paediatric trials, but further improvements and collaborations should be enhanced. Children are not little adults, so specific efforts should be tailored for them! You can find the article here.
SAVE THE DATE. EUCROF’s 5th International Conference on Clinical Research, in Amsterdam, on 10 & 11 February 2020
On 10 and 11 February 2020 the EUCROF’s 5th International Conference on Clinical Research will be held in Amsterdam. The event will be the occasion to discuss the main challenges and future achievements of the pharmaceutical, biotechnology and medical device sectors as well as the regulatory environment with an ultimate aim to improve patients’ health. This year the main theme will be “Science, Technology and Regulations Coming Together for Better Patients’ Health”. The primary objective of the Conference is to ensure that all attendees are brought fully up to date with the current key topics in Science, Technology and Regulations and how each of these can contribute to improving patients’ health. The world is changing so rapidly and to such large extent that it is difficult to keep up with all changes around us: drug and medical device development require competences to cope with a continuously changing environment – always focussing on the ultimate goal: the benefit for the patient. For more information about the event, please visit the following webpage.
The annual AICRO Conference took place on 12 November 2019 in Milan at Assolombarda, Sala Auditorium Gio Ponti. The event was focused on the theme “Digital revolution in health and “connection” with the future: a challenge for the involved professionals” but it was declined based on the evolution of the professional figures operating in this sector. The speakers involved presented their experiences in “talk show” mode and the event provided the occasion for a fruitful exchange of views with the audience. AICRO is the Italian Association of Contract Research Organisation, founded in 2004 with the aim to ensure quality standards in the practice of clinical trials, promoting the use of GCP (Good Clinical Practice) and relevant regulations (GLP, GMP, etc.), as well as national and international guidelines, where applicable. The Organisation collaborates with other authorities and recognized associations in order to further develop clinical research, particularly taking into account the benefit for the patients. Every year AICRO organises an event dedicated to clinical research to address very topical issues on the evolution of management of clinical trials in Europe and Italy in particular. Donato Bonifazi, CEO at CVBF and President of AICRO, kicked-off the Conference with a presentation on “the relevant topics within the current landscape of clinical research” and took part as moderator Iin the session “The active role of the patients.”. More information about the 6th Conference on Clinical Research are available at this link.
Are you involved in clinical research and clinical trials? Do you need to acquire GCP knowledge? Register and follow the e-learning “ICH-Good Clinical Practice (GCP) Training Course”, promoted by Consorzio per Valutazioni Biologiche e Farmacologiche and meeting the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified as necessary to enable mutual recognition of GCP training among trial sponsors as recognised by TransCelerate BioPharma Inc., a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development of new therapies. The course is based on the international E6 ICH Good Clinical Practice (R2) and is aimed at providing a guide for all individuals that are involved in clinical research and clinical trials and they need to acquire GCP knowledge. In this way, the participant will be aware of his/her role and responsibilities and will understand how GCP can be applied practically in the research setting. Currently the course counts more than 900 users, it is completely free and is available at this link.
The first two patients are recruited and involved in the DIVA clinical study at the Polyclinic of Bari
In the framework of DIVA (Innovative devices for the prevention of recurrent vaginitis) the Site Initiation Visit at DIMO (Department of Biomedical Sciences and Human Oncology) of the Polyclinic of Bari was held on 7 November 2019. DIVA is a project aimed to develop a specific treatment for vaginitis relapsing with the aim of reducing the antibiotic-therapy. In particular, this objective is acquired through the development of: A food enriched with probiotic lactobacilli with antimicrobial activity and dietary fibres; Device / cosmetic with bacteriostatic and fungicidal action derived from plant products; Sanitary towels functionalized with bacteria and fungicidal extracts derived from plant products; In DIVA project, the CVBF will provide support for the clinical trial conduct, with the aim to evaluate the effects of the combination of the double approach (probiotics intestinal and vaginal products) compared to standard therapy in the prevention of recurrent vaginal infections. Moreover, the activities of the CVBF include medical writing, clinical study planning and management, regulatory and ethical activities, pharmacovigilance, data management, monitoring and auditing. Recently, the first two patients were recruited and involved in the study. Further details on DIVA project are available at this link.
c4c (conect4children) is a large collaborative European network that aims to facilitate the development of new drugs and other therapies for the entire paediatric population. In this sense, the voices of children, young people and their families are a pivotal part of the innovative approach of c4c project. It places patients at the centre and will assign them an active role in the development of the different clinical trials that are going to be conducted during this project. For this reason, and in order to guarantee patients’ involvement in all the activities of the project, c4c has setup a database to gather information on patients, caregivers, patients organizations and/or YPAGs (Young Person’s Advisory Groups) of rare/paediatric diseases (specially Kawasaki disease, Cystic Fibrosis, Osteogenesis Imperfecta and Patient Ductus arteriosus in neonates). If you wish (or know someone who could wish) to be part of the c4c pool of expert patients, you can find out more by following the instructions here!