We are pleased to announce that the collaborative work developed within the PedCRIN project on the survey administered to capture the needs to receive infrastructural support to cover specific paediatric research gaps, has been accepted for publication in Contemporary Clinical Trials Communications journal. From April to May 2017, the questionnaire was submitted to the various stakeholders and showed that the application of innovative study design, the preparation of protocols for paediatric interventional clinical trials as well as the identification and applications to relevant calls for funding were acknowledged as areas in which support is needed. The results of the survey demonstrated the need of structured support to paediatric research and highlighted the importance of supporting the cooperation with biomedical research infrastructures, clinical trials specialty networks, national hubs, and large collaborative research initiatives. PedCRIN is a Horizon 2020 project which has the aim to develop, a paediatric component of ECRIN (European Clinical Research Infrastructure Network) including tools supporting the conduct of neonatal and paediatric trials. CVBF, as partner in collaboration with TEDDY Network, is responsible for the creation of tools specific for paediatric trials or for the upgrade of tools and databases, already developed by ECRIN for adult trials, to take into consideration paediatric specificities. The full article is available here.
Il prossimo 4 marzo l’Agenzia Regionale per la Tecnologia e l’Innovazione – ARTI Puglia ha organizzato il webinar di presentazione dell’avviso "Selezione Team" e delle Factory dell’area Salute dell’uomo e dell’ambiente. L’obiettivo del webinar è quello di presentare l’intervento "Estrazione dei Talenti" e le opportunità offerte dall’avviso Selezione Team, illustrare le modalità di partecipazione e presentare le Factory che trasferiranno competenze e know-how ai Team con progetti nei settori della salute dell’uomo e dell’ambiente, tra cui, salute e farmaceutica, green e blue economy. EVOLUTIO START UP sarà presentata nella sessione mattutina dal Dott. Michele Saviano, Direttore dell’Istituto di Cristallografia – CNR che esporrà il potenziale della Factory nel sviluppare le idee di business proposte dai Team grazie alle competenze e alle relazioni dei Partner di cui è composta. La Factory EVOLUTIO START UP nasce dall’esperienza di BIPCA (Bioindustry Park Silvano Fumero), CNR IC (Consiglio Nazionale delle Ricerche-Istitute of Crystallography), e CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche) che collaborano per promuovere e supportare il lancio di idee imprenditoriali innovative nel settore della salute. Per seguire la diretta streaming del 4 marzo, è necessario registrarsi entro il 3 marzo alle ore 12.00, al seguente link.
The unexpected SARS-CoV-2 impacted on all aspects of ordinary life especially when it comes to research activities. To face COVID-19 pandemic, many hospitals have been forced to drastically change their organisation in order to find as much space as possible to accommodate COVID-19 patients; this situation has created an organisational chaos as regards both to therapies for patients not affected by COVID-19 and the stand-by of Clinical Trials (CTs) activities. EUCROF has released a survey to collect data from EUCROF affiliated member-CROs, to obtain an overview of their contribution to COVID-19 related research, and to collect information on pandemic impact on CTs, measuring the active participation to research activities planned to face coronavirus outbreak. On January 25, 2021, Applied Clinical Trials published the paper on the survey results that show how EUCROF affiliated member-CROs have worked to create new innovative projects to tackle the pandemic. Moreover, the survey shows that the majority of EUCROF CROs are supporting clinical research activities aimed at developing effective and safe medicines, vaccines, and diagnostics for COVID-19. Mariangela Lupo, Marta Lettieri and Donato Bonifazi from CVBF are among the authors of the paper that highlights the importance of cooperation between CROs and industry, academia, policy makers, patients’ associations, and society, to find efficient solutions for this and future pandemics. The article also showed how promptly the respondent CROs have oriented towards research activities to fulfil the current needs which have arisen from the COVID-19 pandemic. You can read the full article at this link.
DIVA (Innovative Devices for the prevention of recurrent VAginitis) is a project focused on the development of an innovative treatment for vaginitis in order to reduce the use of antibiotic therapy. In this project, CVBF is a partner responsible for the clinical trial conduct including medical writing, clinical study planning and management, regulatory and ethical activities, pharmacovigilance, data management, monitoring and auditing. The project has come to its conclusion and the final event has been held on 21 January 2021 where the results of the project have been illustrated.
SAVE THE DATE. 11 February 2021- EFGCP Webinar Paediatric Clinical Trial Preparedness: New Enpr-EMA Guideline
On Thursday 11 February from 5 to 6.30 (CET), EFGCP, the European Forum for Good Clinical Practice, will hold the webinar “Paediatric Clinical Trial Preparedness: New Enpr-EMA Guideline”. Daily, researchers face the problem of delays in the conduct and completion of paediatric clinical trials when medicines for children are developed. The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has been commissioned by the EMA Paediatric Action Plan to release a new guidance document that sets out recommendations for clinical trial preparedness focusing on factors which facilitate or hamper the conduct of trials in children. In this webinar, members of the Enpr-EMA working group for this guidance will discuss these recommendations and provide some practical insights from Industry, Research Networks and Patients, how to operationalize these ideas in practice, as reported in the webinar presentation on EFGCP website. The webinar is addressed to EFGCP Members and not members, with different costs; patients can take part, without costs, to the webinar, contacting Ingrid Heyne at [email protected] Donato Bonifazi, TEDDY Representative in the Enpr-EMA Coordinating Group, will hold a presentation entitled “Research Network Point of View”. Further information about the webinar, speakers, cost and registration, is available on EFGCP website.
Artificial intelligence (AI) conjugated to medicine is making many steps forward, but these innovations do not always bring the desired results. Often, still today, there is no proper use of technologies due to lack of ability to use certain devices. The Centre for Data Innovation has organised, on February 4, 2021, a webinar to discuss “the health-care sector needs to create a positive impact and increase innovation using AI”. The questions that this event will try to answer are the following: How is the health-care sector using AI to enhance the accessibility, sustainability, and quality of health care? Can the European Commission’s proposed approach to AI work in the health-care sector? And more broadly, how can Europe create a conducive regulatory environment that encourages the development and use of the technology and facilitates access to data as health care moves into the digital age? You can register to the webinar here. Any question can be submitted on Slido using the code #AI4Health and using the hashtag #datainnovation, you can join the discussion directly on Twitter! Further information is available on the Centre for Data Innovation website.
Last December 10th, 2020 on the official website of the pharmaceutical company Moderna was announced the plan to begin a phase 2/3 Covid-19 vaccine trial including adolescents between 12-18 years old. This study is being conducted by Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. As reported by Stéphane Bancel, CEO of Moderna “We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy adolescents in the U.S. Our goal is to generate data during spring 2021 that will support the use of mRNA-1273 in adolescents.” Further information and details about this study can be found on Moderna website.
We are delighted to inform you that CVBF will provide its support in the RACERS study, a new clinical trial approved by AIFA (Agenzia Italiana del Farmaco) and coordinated by the University Hospital Polyclinic of Bari. Acute Kidney Injury (AKI) is a common occurrence in patients hospitalized in the Intensive Care Units, with an estimated incidence of more than 50%. Sepsis is the major cause of AKI and increasing AKI severity is associated with increased mortality. Currently, treatment options for sepsis-induced AKI are limited to supportive care. The profound inflammatory response that takes place in this condition is the major cause of hemodynamic destabilization and progression to renal failure in septic patients. The main objective of the RACERS study, that will last two years, is to investigate whether the use of a novel drug (CER-001, a bioengineered HDL from Abionyx Pharma), in combination with standard of care treatment, is safe and effective, providing new potential strategies to treat septic patients, reducing the inflammatory response and preventing the progression to renal injury. Due to the mechanism of inflammatory response reduction, CER-001 can be considered a pleiotropic drug that will be tested in a wide range of medical conditions in which the inflammatory cascade becomes detrimental. CVBF will be involved in the study as a CRO and will provide its support in the regulatory and monitoring activities.
On 25 November 2020, the European Commission published the Inception Impact Assessment on the revision of the Orphan and Paediatric Regulations. The public consultation was closed on 6 January 2021 and was useful to collect opinions and suggestions from the different stakeholders and explore the need for adequate measures to address several shortcomings in the functioning of the existing European paediatric framework. CVBF, as EPTRI coordinator, provided its feedback, underlining the need for a coherent and joint approach in the procedures related to paediatric and orphan medicines interaction and addressed the following points: 1. Paediatric and orphan medicines interaction 2. Unmet medical needs specific to children of different ages 3. PRIME scheme 4. Modifications of the rewards system 5. Improvement of the procedures and regulatory framework for paediatric medicines evaluation 6. Public funding for research In particular, in the annexes to the comments the need and the relevance to include the paediatric topics in the new EC research strategy 'Horizon Europe' as well as in the already planned European Partnerships have been clearly described. The entire feedback provided by EPTRI is available here.
The pandemic crisis has shown many problems linked to medicines and the mechanism ahead of their regulation. For this reason, EMA (European Medicines Agency) and HMA (Head of Medicines Agencies) came together to look ahead and develop an overarching European medicines agencies network strategy which sets precise targets until 2025 to shape the future role of medicines regulation nationally and at the EU level, and enhance the partnership approaches necessary to ensure that Europe is proactively positioned to deal with similar emergencies. Six priorities have been identified which must be fulfilled by 2025 in this organisational and planning framework drawn up by EMA and HMA: availability and accessibility of medicines; data analytics, digital tools and digital transformation; innovation; antimicrobial resistance and other emerging health threats; supply chain challenges; sustainability of the network and operational excellence. Further information about the strategy settled by EMA and HMA can be found on EMA website.