Looking forward to the future, the trends and challenges regarding the increasing utilization of real-world data and single-arm trials in the oncology drug approval pathway by European Medicines Agency (EMA) is very important, especially in the context of personalized medicine that will become the future.

Dr. Francesco Pignatti, Scientific advisor for Oncology in the Human Medicine Division of the European Medicines Agency, is the guest of this TJ Talks episode - led by dr. Luca Moscetti, Adjunct Professor in Oncology at the Residency Program in Oncology at the University of Modena Reggio Emilia - that addresses the relevant question for cancer patients about the EMA’s position on the use of real-world data in drug approvals.

It emerged during the thick TJ Talks that for big changes in the use of real-world data much will also depend on the uncertainty one is willing to accept in a specific situation. Single-arm trial, for example, comes with a lot of uncertainty, mostly about the time related endpoints like survival, then you have to you tend to accept them more where you have high unmet medical needs.

The goal of the scientific community is to focus the efforts on what really matters, trying to be more efficient, cleverer and to design quality criteria that are fit for purpose and that are proportionate to the objectives. Regulators, academics and the sponsors need to facilitate this type of research, maximising the opportunities that come from its data.

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Le parole del prof. Paolo Marchetti restituiscono il quadro complesso dell’oncologia di precisione con il ritmo epico delle grandi imprese di frontiera. E’ lui - Professore Ordinario di Oncologia Medica dell’Università degli Studi di Roma “La Sapienza”, Direttore Scientifico di IDI-IRCCS, Presidente della Fondazione per la Medicina Personalizzata e promotore dello studio clinico Trial Rome - grande esperto dell’oncologia di precisione in Italia, l’ospite di questo episodio di TJ Talks, condotto dal prof. Giancarlo Pruneri.

Un concetto ampio quello dell’oncologia di precisione, basato sullo studio del genoma delle cellule tumorali, per illustrare il quale il prof. Marchetti sottolinea i vantaggi clinici che l’applicazione di questo percorso comporta, senza dimenticare quei fattori perturbanti la possibile risposta a un determinato farmaco: come le interazioni, le modificazioni del microbiota, stili di vita e attività fisica. Un quadro complesso che promuove il confronto tra clinici, biologi molecolari, patologi e genetisti su un numero crescente di dati eterogenei.

E l’intelligenza artificiale? Fondamentale per gestire i dati provenienti da studi clinici a livello europeo, o presenti in piattaforme nazionali; indispensabile per comprendere i potenziali meccanismi di resistenza ai farmaci e per la sintesi delle conoscenze più appropriate e personalizzate per la cura del paziente.

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In this episode of TJ Talks, the guest is Professor Paolo Marchetti, a well-known expert in precision oncology in Italy, Full Professor of Medical Oncology at the University of Rome "La Sapienza", Scientific Director of IDI-IRCCS, President of the Foundation for Personalized Medicine and promoter of the Trial of Rome clinical study.

Precision oncology is a broad concept based on the study of the genome of tumour cells and Prof. Marchetti – interviewed by Prof. Giancarlo Pruneri - highlights the clinical advantages of applying this path, without forgetting the factors that interfere with the possible response to a given drug: such factors include interactions, alterations of the microbiota, lifestyle and physical activity, making the scenario even more complex and fostering comparison among clinicians, molecular biologists, pathologists and geneticists on an ever-increasing number of heterogeneous data.

In precision oncology, the role of artificial intelligence in managing data from clinical trials is essential to understand potential mechanisms of drug resistance and synthesize the most appropriate and personalized knowledge for patient care.

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If we were to stop at a first glance, the use of liquid biopsy would be limited in the clinical practice of colorectal cancer to cases where tumour tissue is unavailable or insufficient. In reality, we are at the beginning of a pathway where the true potential of liquid biopsy is developing rapidly in several directions. This is confirmed by the research results of Prof. Andrea Sartore Bianchi - Director of the Division of Clinical Research and Innovation in Medical Oncology at the Grande Ospedale Metropolitano Niguarda in Milan. One of the most promising applications of liquid biopsy is the detection of minimal residual disease, a potentially game-changing application for oncologists in the field of colorectal cancer, that guides the choice of the most appropriate treatment for patients.

Find out how liquid biopsy is absolutely the new goal of precision oncology, capable of technologically and culturally revolutionising clinical practice, in this TJ Talks podcast, hosted by Prof. Giancarlo Pruneri.

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The field of bioinformatics is rapidly evolving, shaping the future of biomedical research and precision medicine. From cutting-edge advancements in computational biology to AI-driven solutions, what will the landscape look like in Italy in the coming years, and what opportunities will emerge for young bioinformaticians?In this TJ Talks event, the Bioinformatics Section Editor of Tumori Journal, Prof. Lorenzo Ferrando - Research Associate of Applied Medical Technology and Sciences, Department of Internal Medicine, University of Genoa - guides us through a discussion on the key trends and career prospects in bioinformatics. Joining him is Prof. Matteo Benelli, Associate Professor of Biochemistry at the University of Florence and Co-Principal Investigator of AURORA, an international research program dedicated to uncovering the molecular mechanisms driving therapy response and resistance in recurrent metastatic breast cancer.

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Drug resistance is a major challenge in oncology and genetically-engineered mouse models represent powerful tools to identify new approaches for its overcoming.

In this TJ Talks podcast, Prof Paola Perego, Pharmacology Section Editor of Tumori Journal and Adjunct Professor at the University of Insubria, talks with Professor Sven Rottenberg, head of the Institute of Animal Pathology at the University of Bern, about drug resistance and the reasons why it is so difficult to eradicate tumors during treatment.

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Dr. Arsela Prelaj is confident: the implementation of Artificial Intelligence in Oncology, in the near future, will be aimed at advances in screening and the use of images, such as radiomics; in digital pathology, for a diagnostic task, and in applying Large Language Model for automation tasks. However, there will be climbs to overcome along the way.

In this TJ Talks podcast, Dr Arsela Prelaj, Thoracic Oncologist and Director of the Artificial Intelligence for Oncology Lab at the National Cancer Institute of Milan, talks with Prof. Giancarlo Pruneri about a new world where physicians will interact with Artificial Intelligence in daily clinical practice.

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In this TJ Talks podcast, Dr Luca Agnelli, Tumori Journal Section Editor for Bioinformatics, meets Prof George Calin, a distinguished scientist with an extraordinary career dedicated to studying microRNAs, non-coding RNAs, and their impact on cancer.

Listening to their exciting conversation, you will be engaged in the Prof. Calin's diverse research experiences across Eastern Europe, Western Europe, and the USA, while knowing into key topics in scientific research. These include challenges to amend the peer-review process and the pressing question of whether to focus on generating more big data or optimizing the use of existing -omics datasets.

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