Over 20 new therapies and 50 therapeutic indications for already approved drugs: this Johnson & Johnson’s Future by 2030. “For 138 years, Johnson & Johnson’s mission has been to transform the lives of millions of people by pioneering the medicine of the future through the research and development of innovative therapies that can address some of the world’s most devastating diseases,” says Alessandra Baldini, Medical Director Johnson & Johnson Innovative Medicine Italy. The company’s strong vocation for innovation is also demonstrated by the 6 new Fast Track and Breakthrough Therapy designations received from 2021 to date – a note reports – and by over 60% of development programs dedicated to first-in-class drugs for mechanism of action or route of administration.
“Innovation is not only in the therapies that we at Johnson & Johnson develop and make available to clinicians and patients – Baldini emphasizes – but also in our approach which consists of combining internal research with acquisitions and strategic collaborations in therapeutic areas of interest to us. Today, with an increasingly important role of precision medicine, as a tool to best respond to patient care needs, we are changing the paradigm of the development of therapeutic solutions, moving from a focus on the disease to that on a specific mechanism of action in all clinical areas in which it is relevant”.
Johnson & Johnson’s commitment to clinical research was the focus of the third day of the Johnson & Johnson Week ‘Together for the Medicine of the Future’the week of events and meetings with clinicians, patient associations, institutions, universities and research centers designed to imagine the next evolutions of Italian healthcare.
In 2023 – the note reads – Johnson & Johnson invested over 25 million euros in Italy alone, of which over 40% (around 10 million) in the area of research and development.. In the same year, the company had 114 active clinical studies, 70% of which were in phase 3 and 4, involving almost 1,000 centers in 19 Italian regions and over 5,000 patients with diseases that fall within the therapeutic areas of oncology, immunology, neuroscience and other areas such as cardiovascular and infectious diseases. “Investing and promoting clinical research – Baldini highlights – means concretely giving patients the possibility of having access to innovative therapies often years before they are actually available on the market, with a possible early improvement in their clinical condition and quality of life, not only for them, but also for their families. For us at Johnson & Johnson, the quality of life of patients is fundamental, to the point that we have included this parameter in the questionnaires of all our clinical studies”.
Taking into account the needs of patients is increasingly considered the key to developing and making available appropriate therapies adapted to their care needs. “Patient involvement in all phases of drug development is a fundamental resource for clinical research – says Paola Kruger, Academy of the Expert Patient Eupati– Only those who live with a certain disease can know what it means to face daily life with certain symptoms and taking therapies. Listening to their experience and their needs contributes to the discovery, development and evaluation of new drugs that are truly effective, because it allows the scientific community to know their needs and priorities. No one better than the patient can report what the burden of a therapy is and its impact in terms of quality of life, going beyond what researchers can detect on the effectiveness of the drug”.
Give the role of the patient is central within a clinical study It is also a tool to encourage their participation. “Thanks to the digital transformation in clinical research, it is possible to meet and support patients in trials – he underlines Lorenzo Cottini, advisor and coordinator of the clinical research working group Afi – Association of pharmaceutical industry and Country Director Evidence – For example, there are decentralized clinical studies that allow research activities to be moved to the patient’s home or to closer facilities, with a consequent reduction in time and costs, as well as an improvement in the quality of life and patient experience”.
“To date – adds Cottini – much can still be done for their complete implementation. There are limitations linked above all to the need to update and modernize the regulatory frameworks, which do not in reality only concern the area of decentralized clinical trials, but Italian clinical research in general. Although we have certainly seen an improvement compared to the past, in Italy there are still obstacles to overcome. For this reason, we could take an example from countries like Spain that have focused a lot on research, intervening both from the point of view of regulatory simplification and at a cultural level”.
In the oncology field, “Italian research is in a discrete situation within the European panorama as regards the availability of clinical studies in oncology – he observes Silvia Novello, full professor of medical oncology at the Department of Oncology of the University of Turin, head of the Medical Oncology Division at the Aou San Luigi Gonzaga in Orbassano and president of Walce – Women Against Lung Cancer in Europe – The 2018 Luce report indicated that Italy is among the European countries with the highest number of active trials for targeted therapies, as well as for immunotherapy, together with France, the United Kingdom, Spain and Germany. There are certainly some barriers, including limited funding, which can often be accessed with complex procedures and non-optimal timelines; complex training paths that are not competitive compared to alternative job offers; non-facilitating regulations”.
“It is precisely in this context – he adds – that collaboration between research centers and companies can be a tool for improving the research scenario in Italy, for example, thanks to economic support, the sharing of professionals and skills, and common project designs that prevent redundancies between studies and optimize time and resources”.
Always with the aim of promoting innovation, Johnson & Johnson combines internal research with acquisitions and strategic collaborations with research centers and companies involved in therapeutic areas of interest. Since 2021 – the note recalls – the company has activated over 80 partnerships. Among these, the one with Humanitas in 2023 stands out, which will lead to the realization of several projects, including the use of artificial eyes obtained with 3D printing by Humanitas University, which can be used for training purposes by doctors for the use of gene therapies to treat some hereditary retinal diseases.
“We are very pleased to announce today the memorandum of understanding between Humanitas and Johnson & Johnson. This collaboration will allow us to implement and integrate our skills, making it possible to speed up innovation with important implications for teaching and research, which are the pillars of the Humanitas hospital and university”, he concludes. Maurizio Cecconi, Director of the School of Specialization in Anesthesia, Vice President of the Medtec School, Humanitas University, Deputy Scientific Director for Clinical Research, Head of the Department of Anesthesia and Intensive Care, Irccs Humanitas Clinical Institute.
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