Guest Lectures: Dr. Adriele Prina Mello Ussher Assistant Professor, Clinical Medicine • prinamea@tcd.ie • www.medicine.tcd.ie/research/researchers/Adriele-Prina-Mello.php Adriele Prina-Mello, PhD is Ussher Assistant Professor in Translational Nanomedicine at the Department of Clinical Medicine, Trinity Translational Medicine Institute (TTMI), School of Medicine, Trinity College Dublin. Fellow of Trinity College Dublin, Former Associate Director for Research, School of Medicine, He is a Principal Investigator at TTMI, CRANN, and AMBER. Founder and Director of the Laboratory for Biological Characterization of Advanced Materials (LBCAM), TCD Sustainability leader and TTMI Executive Management Committee member. Members of several EU initiatives, organisation and associations; among these EIT Health PI lead and Supervisory Board, Metrino Infrastructure and European Technology Platform for Nanomedicine. His research focuses on the translation of nanotechnology-enabled medical products, including medical devices, medicinal products and hybrid theranostic systems, with strong emphasis on safe-by-design approaches, responsible innovation, and regulatory compliance. His expertise spans nanodiagnostics, theranostics and personalized medicine, regenerative medicine, and nano-characterization for safety and clinical translation. He has a long successful track record in EU fundings. He has extensive experience in undergraduate and postgraduate teaching in medicine and life sciences and has mentored numerous students now active in academia, industry, and clinical research; with an excellent track record and impact in education with many PhD, MSc and undergraduate students graduated and into their full professional career. His scientific track record accounts for more than 160 peer-reviewed publications, more than 70 invited lectures internationally, 10 book chapters, 8 reviews, 5 perspectives papers, 2 Science Policy documents, 2 Regulatory papers, 2 Roadmap documents, 1 International Standard document. Alice Zoso, Ricercatore a tempo determinato di tipo A DIMEAS-Politecnico di Torino Email: alice.zoso@polito.it Dr. Alice Zoso has a fixed-term position at Politecnico di Torino as Researcher (Ricercatore a tempo determinato di tipo A). She has a long-term interdisciplinary and international experience in academic research. She earned a master’s degree (2010) in Industrial Biotechnology at the University of Padova. Here, she also obtained her PhD in Bioscience and Biotechnology (2014), working on the development of (i) in vitro model of skeletal muscle on hydrogel for Duchenne Dystrophy investigation and (ii) human tissues models integrated in a microfluidic technology for physio-pathological studies of Type 2 Diabetes. During her PhD, she has been visiting student at the University of Geneva (CH) where she mastered human primary skeletal muscle cell extraction and characterization for diabetic phenotype, financed by the Albert Renold Travel Fellowship for Young Scientist. In 2014- 2015 she worked as post-doctoral fellow at the Dept. of Genetic Medicine and Development (University of Geneva, CH) where she studied the crosstalk between human skeletal muscle and pancreatic beta-cells in Type 2 Diabetes. In 2015- 2017 she was a post-doctoral fellow at the Dept. of Cell Physiology and Metabolism (University of Geneva, CH), studying the uncontrolled repair of airway epithelium in Cystic Fibrosis. She arrived at Politecnico di Torino in 2018. Here she is currently focusing on the development of in vitro models of different tissues based on bioartificial materials, spanning from fibrotic cardiac tissue to skeletal muscle and bone. She is also involved in the European project INJECTHEAL, where POLITO team is developing a self-healing injectable hydrogel for chronic wound care. Dr. Zoso is currently member of the TERMIS (Tissue Engineering and Regenerative Medicine International Society). She is also Guest Editor for multiple Special Issues in different journals (International Journal of Molecular Sciences; Frontiers in Biomaterials Science) and Review Editor in the Editorial Board of Nanobiotechnology (Frontiers in Bioengineering and Biotechnology, Frontiers in Molecular Biosciences, Frontiers in Materials). She authored 25 publications in peer-reviewed journals and 1 book chapter (h-index 14, 658 total citations - Scholar Source). Besides research, she delivers academic lectures in the following courses for undergraduate students: Cell and Tissue Engineering (Bachelor’s Biomedical Engineering, 15 hours/semester), Tissue Engineering for Regenerative Medicine (Master’s Biomedical Engineering, 10.5 hours/semester), Laboratory of Tissues and Physiological Processes' Models (Master’s Biomedical Engineering, 15 hours/semester). Her lectures focus mainly on in vitro modelling and on the importance of the application of 3R’s in Biomedical research. Dr. Alessandro Torchio, PhD Senior R&D, Quality Assurance, and Regulatory Affairs Engineer • Email: alessandro.torchio.ing@gmail.com • LinkedIn: alessandro-torchio-ph-d-187719128 Alessandro Torchio, PhD, is a Senior R&D and Quality Assurance Engineer with an interuniversity PhD in Bioengineering and Medical-Surgical Sciences from the Polytechnic University of Turin and the University of Turin. His professional profile is built on a multidisciplinary foundation, bridging advanced engineering with the optimization of complex translational processes. He serves as the lead accountable person for Regulatory Affairs (RA) and Quality Assurance (QA), overseeing the certification and maintenance of Quality Management Systems (QMS). His expertise includes navigating the MDR 2017/745 and international harmonized standards, with extensive experience managing third-party inspections and coordinating R&D activities to ensure full regulatory compliance for market entry. His core activity focuses on end-to-end medical device lifecycle management, guiding products from initial design and simulation through to prototyping and commercialization. By employing a data-driven approach, he ensures that technical innovation and strategic product development remain aligned with rigorous safety and certification standards. In addition to his industrial roles, Dr. Torchio has a significant background in academic training and research, having authored peer-reviewed publications in international journals and developed technical scientific materials for specialized teaching. The course aims to provide PhD students with a highly interdisciplinary teaching and problem-based learning with a set of tools and skillset for advancing biomaterials-based technology to become innovation and potential products. The students will be challenged and stimulated to work in a group and individually to develop a mindset towards the design and development of advanced biomaterials-based technology, ranging from medical devices, medicinal products, advanced therapy medicinal products (ATMPs) or hybrid/borderline products. Students will learn how to integrate safe-by-design principles, responsible research and innovation (RRI), in silico and Artificial Intelligence (AI)-based approaches, preclinical models, and regulatory requirements early in research planning, to accelerate the product assessment. Learning objectives: At the end of the course, PhD students will be able to: • Design research projects for product development and translation • Apply safe-by-design and RRI principles to advanced technologies • Understand how AI and in silico models support translational research • Identify regulatory constraints and opportunities early in development • Develop sustainable research adherent to the EU strategic development goals • Communicate effectively within and outside interdisciplinary teams The course aims to provide PhD students with a highly interdisciplinary teaching and problem-based learning with a set of tools and skillset for advancing biomaterials-based technology to become innovation and potential products. The students will be challenged and stimulated to work in a group and individually to develop a mindset towards the design and development of advanced biomaterials-based technology, ranging from medical devices, medicinal products, advanced therapy medicinal products (ATMPs) or hybrid/borderline products. Students will learn how to integrate safe-by-design principles, responsible research and innovation (RRI), in silico and Artificial Intelligence (AI)-based approaches, preclinical models, and regulatory requirements early in research planning, to accelerate the product assessment. Learning objectives: At the end of the course, PhD students will be able to: • Design research projects for product development and translation • Apply safe-by-design and RRI principles to advanced technologies • Understand how AI and in silico models support translational research • Identify regulatory constraints and opportunities early in development • Develop sustainable research adherent to the EU strategic development goals • Communicate effectively within and outside interdisciplinary teams

- Basic knowledge on biomaterials, cell and tissue biology. - Skills in literature search and critical appraisal of scientific evidence

Course structure (10 h) 1. From idea to proof of concept (2 h) • What is a good idea with exploitation potential? • Technology readiness levels (TRLs) • From product development to product design 2. Design of advanced biomaterials-based products (3 h) • Basis for a product design: how to make it real • Design inputs, risk analysis, and performance requirements • Case studies from academia–industry–clinic 3. Safe-by-design and Quality-by-Design (2 h) • Safe-by-design concepts and implementation • Quality by design concepts and framework • Responsible innovation and sustainability 4. In silico and AI-based tools for translation (2 h) • Computational models and digital twins • AI for material design, prediction of safety and efficacy • In silico support for regulatory decision-making 5. Regulatory and ethical pathways (1 h) • Medical Device Regulation (MDR), IVDR, ATMP regulation • Early regulatory strategy and interaction with authorities • Ethics, data integrity, and compliance 6. Project Group Work (6 h + presentations) Interdisciplinary group activity: • PhD students form mixed-background teams • Development of a translational project idea related to their research • Integration of design, safety, regulatory aspects • Final 7-minute presentation + 3-minute discussion The exam consists of a team-based project developed during the course under the guidance of the instructors. The project will be presented by the PhD students in a 7-minute flash presentation followed by a 3-minute Q&A session. The project work should preferably be linked to the students’ own PhD research in order to leverage their specific expertise and maximize its relevance to their ongoing work. The aim of the exam is to foster connections among PhD students with complementary backgrounds and to encourage teams to reflect on the pathway from their doctoral research to their potential translation into a product.

In presenza

Presentazione orale

P.D.2-2 - Luglio

The course could be organized in continuity with, and in any case prior to, the Summer School entitled “Driving Innovation in Human-Relevant Approaches for 3Rs in One Health”, proposed by Dr. Alice Zoso and Camilla Paoletti, should it be approved. The topics covered in the course can provide a complementary training to the topics covered by the Summer School.