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Newsletter, December 2023
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Starting the new year in a larger, more accessible office at Viale Cesare Battisti 17, Pavia (IT), CVBF embodies growth in space, identity and market.
Our refreshed logo, maintaining our heritage in the acronym, now represents our global inclusivity as Clinical Validation from Biopharmaceutical Findings.
Starting January 2024, we welcome you to visit us in our new offices.
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We are committed to covering highly unmet medical needs and to providing sponsors with the best research services.
We provide support in all phases of a clinical study through cutting-edge services ranging from study start-up to biostatistics analysis.
CVBF is always up-to-date and ready to tackle every challenge the future has in store.
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In today’s fast-paced digital world, a company’s online presence is often its first point of contact with customers. It’s not just a virtual business card but a dynamic platform that reflects your brand, services, and values. We understand the significance of this connection, which is why we are thrilled to announce the launch of our revamped website.
At CVBF, we believe in keeping up with the latest trends and technologies to provide our customers with the best possible experience. The new website is the result of careful planning, design, and development, aimed at making your journey through our online world smoother, more enjoyable, and more informative than ever before.
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| Phase 1 trials, be they conducted on healthy volunteers or patients, focus on generation of initial knowledge on tolerability, safety and PK/PD. These trials determine the maximum tolerated dose without unacceptable side effects and may involve some risks, even after passing preclinical testing. While typically conducted with healthy subjects, Phase 1 trials may include severely or terminally ill patients. The process takes several months, and around 70% of experimental drugs successfully advance beyond this initial phase.
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| Arianna Bertolani, our Head of Project Development, participated as a speaker at the 16th Foresight Training Course entitled “Repurposing to cover unmet needs: the current scenario in Europe and the proposed changes to the Pharmaceutical Legislation” organised by Fondazione per la Ricerca Farmacologica Gianni Benzi onlus and Università degli Studi di Bari that was held on 18 December in Bari.
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| Bonka Georgieva, CVBF’s Project Manager, presented at the “ERICA & EJP RD Joint Conference” held in Amsterdam. The event served as a platform for advancing coordination and support in rare disease research. CVBF, in collaboration with EATRIS, leads Task 19.1: Accelerating Translation. The Innovation Management Toolbox (IMT), developed under Subtask 19.1.1, stands as a testament to CVBF’s dedication to driving innovation and translation in the rare disease landscape.
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Giovanni Migliaccio, the Scientific Director of CVBF, recently participated at the MEP Interest Group 2023 Conference organized by the European Alliance for Transformative Therapies (TRANSFORM) and held at the European Parliament on 12 October 2023. The event provided a platform for profound deliberation on various critical issues concerning highly specialized Advanced therapy medicinal products, known as ATMPs.
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| In the ever-advancing world of clinical research, staying at the forefront of knowledge and practices is imperative. On 12 September 2023, our CEO, Donato Bonifazi who is a member of the Coordinating Group at the Enpr-EMA (the EMA network of paediatric research), participated in the EUCROF Paediatric Training at the Children Hospital “Bambino Gesù” in Rome, themed “Essentials of Paediatric Clinical Research – What you need to know when preparing, conducting, and monitoring paediatric clinical trials.”
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On 27 June 2023, Mariagrazia Felisi, our Quality Assurance Head and Internal Auditor, co-chairing the “AICRO Clinical Trial Center Working Group”, opened and led the workshop, titled “Applicazione del regolamento UE sulla sperimentazione clinica in Italia: esperienze a confronto”, took place at the “Salone di Rappresentanza dell’Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo” in Alessandria.”
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A new article published on 6 October 2023 in the Journal of the British Pharmacological Society titled “Dose rationale for gabapentin and tramadol in paediatric patients with chronic pain” co-authored by Prof Adriana Ceci and Dr Mariagrazia Felisi, respectively CVBF’s Scientific Advisor and Quality Assurance Head, shedding light on the dearth of substantial evidence regarding the effectiveness and safety of these drugs, currently used off-label, in the management of chronic pain in the paediatric population.
READ MORE
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| CVBF provides regulatory, site management, and monitoring support for the AMELIE (Anchored Muscle cELls for IncontinencE) project, Ana Dilo as our Clinical Project Manager of the study oversees and coordinates these activities. AMELIE is a collaborative study funded under the European Union’s Horizon 2020 programme that aims to develop new treatments for faecal incontinence using regenerative medicine approaches.
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| A new international clinical trial is underway across Europe to test whether low-dose atropine eye drops can effectively slow the progression of myopia (nearsightedness) in children and adolescents. The 40-month study, known as the MODERATO, is being conducted in children ages 3 to less than 18 with progressive myopia.
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CVBF has achieved a major milestone by securing a significant role in the Horizon Europe-funded ERAMET project. Guided by Prof Adriana Ceci, the Lead Scientist of ERAMET for FGB-CVBF, this project is set to transform paediatric and orphan drug development. CVBF contribution is important as we will provide the expertise to enable the adoption of Modelling & Simulation (M&S) techniques gained with DEEP (DEferiprone Evaluation in Paediatrics), which aimed to study the efficacy and safety of deferiprone in children affected by β-thalassemia and other transfusion dependent haemoglobinopathies.
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CVBF is willing to assist you as Sponsor in all types of Clinical Studies in the EU. Please contact us at [email protected].
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