News

PedCRIN webinar series: An opportunity to discover our tools for the setup and management of paediatric and neonatal clinical trials

From April 7th to June 16th the PedCRIN project is launching a webinar series to share some of the most interesting outcomes of the project. The webinars are aimed to present the tools that have been developed to facilitate the execution of clinical trials for neonates, children and young people. On April 7th 2021, Viviana Giannuzzi from Gianni Benzi Foundation and Cristina Manfredi from CVBF, PedCRIN’s Partner, will explain the tools for the management of paediatric trials: handling biosamples and assessing causality of adverse events. You can register here. For more information visit the webinars dedicated webpage.

2021-03-17T09:50:53+00:00 17/03/2021|Categories: News|

cASPerCF study can start recruiting

We are happy to announce you the cASPerCF has opened the first two sites participating in the Study and can now start the patient’s recruitment. The first Site Initiation Visit (SIV) was held on February 12th, 2021 at the Ospedale Pediatrico Bambino Gesù (OPBG) in Rome, followed by the second SIV held on March 9th, 2021 at the Azienda Socio Sanitaria Territoriale degli Spedali Civili in Brescia. cASPerCF study will test an antifungal drug called posaconazole in children and young people aged 8-17 years with Cystic Fibrosis and Aspergillus infection. cASPerCF is a non-industry proof of viability study performed under the c4c Project. The Sponsor of the Study is Ospedale Pediatrico Bambino Gesù (OPBG), Italy and the Coordinating Centre for the study is the Exeter Clinical Trials Unit located at the University of Exeter, UK. In this study CVBF is responsible for Sites Assessment, Data Management, Study Monitoring, Trial Master File preparation and maintenance.

2021-03-29T10:14:07+00:00 17/03/2021|Categories: News|

Partecipazione, interazione e incontri one-to-one durante il webinar di Estrazione dei Talenti

Lo scorso 4 marzo si è tenuto il webinar di presentazione delle Factory dell’area Salute dell’uomo e dell’ambiente selezionate dall’intervento “Estrazione dei Talenti” per accompagnare i Team di aspiranti imprenditori innovatori nella valorizzazione dei loro progetti con percorsi personalizzati di accelerazione di impresa. A presentare la Factory EVOLUTIO START UP con un intervento è stato il Direttore dell’Istituto di Cristallografia – CNR, Dott. Michele Saviano che ha illustrato le peculiarità del partenariato coinvolto nonché i servizi offerti. EVOLUTIO START UP supporterà le idee innovative negli ambiti ricerca biomedicale e sviluppo farmaceutico, mediante percorsi di valorizzazione, azioni di trasferimento tecnologico e business development. Al termine della sessione mattutina, i rappresentanti di EVOLUTIO START UP, Sara Falvo (BIPCA – Bioindustry Park Silvano Fumero), Mariangela Lupo (CVBF – Consorzio per Valutazioni Biologiche e Farmacologiche) e Michele Saviano (CNR IC) hanno incontrato direttamente gli interessati durante i colloqui one-to-one. L’avviso Selezione Team, dell’intervento promosso da Regione Puglia e ARTI Estrazione dei Talenti, si rivolge ad aspiranti imprenditori innovativi, occupati o inoccupati – anche se beneficiari di strumenti di sostegno al reddito – che abbiano voglia di rendere concreto un progetto d’innovazione e ricevere i servizi di accompagnamento e tutorship di 300 ore forniti dalle Factory. Come candidarsi Possono candidarsi per accedere ai programmi proposti dalle Factory gruppi informali di aspiranti imprenditori e/o potenziali startupper (minimo tre persone) che condividono un’idea imprenditoriale ad alta intensità di conoscenza. L’avviso “Selezione Team” è attivo ed è organizzato a sportello: le candidature che pervengono sono valutate con cadenza bimestrale, fino all’esaurimento delle risorse disponibili.

2021-03-10T11:03:56+00:00 10/03/2021|Categories: News|

PedCRIN survey submitted to Contemporary Clinical Trials

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.

2021-02-25T08:37:14+00:00 25/02/2021|Categories: News|

SAVE THE DATE: Webinar di presentazione Evolutio Start Up Factory

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.

2021-02-23T14:35:37+00:00 23/02/2021|Categories: News|

The Current Status of European Research related to COVID-19: The EUCROF Perspective

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.

2021-03-24T10:59:38+00:00 02/02/2021|Categories: News|

DIVA: Final event of the project – January 21, 2021

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.

2021-01-27T15:16:51+00:00 27/01/2021|Categories: News|

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.

2021-01-28T12:59:54+00:00 27/01/2021|Categories: News|

SAVE THE DATE. 04 February 2021: How Can Europe Enhance the Benefits of AI-Enabled Health Care?

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.

2021-01-28T11:17:37+00:00 27/01/2021|Categories: News|

Moderna Sets U.S. Trial for Assessing COVID-19 Vaccine in Teenagers

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.  

2021-01-28T10:31:07+00:00 27/01/2021|Categories: News|