The management of chronic diseases represents one of the main challenges for modern health systems. The aging of the population and the spread of chronic-degenerative diseases require care models capable of guaranteeing continuity of care, improving therapeutic adherence and supporting the patient over time.
In this context, Polifarma established a Bio-Digital Research and Development (R&D) division in 2022. We interviewed the Research and Development team and the Company’s top management to learn more about the scientific and industrial approach that guides the development of bio-digital solutions for the management of chronic diseases.
Polifarma is a pharmaceutical company with over 100 years of history. How was the Bio-Digital R&D division born and what vision supports it?
Silvana D’Alessio – Head of R&D, Polifarma
“The increasing prevalence of chronic diseases requires an evolution of research and development models. The management of these conditions cannot be based only on drug therapy but must integrate tools capable of supporting the patient throughout the entire course of treatment.
Bio-Digital R&D was born from this awareness: to combine traditional pharmaceutical research with the development of clinically validated digital solutions, designed to promote therapeutic adherence, monitoring over time and generate evidence of “real world data” useful for clinical practice.
From a scientific and design point of view, we apply the same rigorous standards as for drugs, both in terms of clinical validation and regulatory compliance. Digital is not an accessory, but a therapeutic component that must demonstrate efficacy, safety and clinical value.”
In this context, what role do Digital Therapeutics play?
Gabriele Sabatino – Digital Innovation Manager, Polifarma
“Digital Therapeutics (DTx) are software-based, clinically validated therapies designed to prevent, manage or treat a disease through evidence-based digital interventions and scientific guidelines. They can be used alone or in combination with drug therapies.
For the development of these solutions, Polifarma makes use of a collaborative ecosystem that sees the support of Software Houses, CROs and innovative Startups, including Laife Reply, Advice Pharma and daVi Digital Medicine, with the aim of integrating technological, clinical and regulatory skills along the entire development path.“
The development of digital solutions in healthcare requires structured processes. What are the main steps to get certified as a Digital Medical Device?
Daniele Pierno – R&D Manager, Polifarma
“The development of a digital medical device follows a rigorous and structured path. It starts with the identification of an unmet clinical need that is analysed by considering the scientific aspects and the experience of doctors, patients and caregivers.
We believe in participatory development, which allows us to design solutions that are truly applicable in clinical practice and useful in the patient’s daily life. The design and development phase is followed by technical and clinical validation, which is necessary to demonstrate safety, efficacy and clinical benefit. Completion of the process allows certification as a Medical Device and the achievement of the CE mark.”
What are the most advanced projects in your pipeline and what therapeutic areas are you focusing on?
Daniele Pierno – R&D Manager, Polifarma
“One of the areas of greatest interest is the cardiovascular one, with a focus on arterial hypertension. Among Polifarma’s projects in development is QPress®, a DTx candidate designed to support the management of this condition through the provision of educational interventions mediated by a cognitive behavioral approach.
QPress® is designed to support the patient in his or her treatment pathway, alone and/or in support of drug therapy, helping to improve monitoring, therapeutic adherence and awareness and knowledge of their clinical condition.”
In conclusion, what vision guides Polifarma in the development of Bio-Digital R&D?
Andrea Bracci – Chief Executive Officer, Polifarma
“Bio-Digital R&D represents for Polifarma a strategic evolution of our commitment to research and development. The management of chronic diseases requires integrated solutions, capable of combining scientific innovation, technology and sustainability.
The integration between medicine and digital makes it possible to generate value throughout the care pathway, improving the patient experience and supporting the work of healthcare professionals. Our goal is to develop scientifically sound, clinically validated and industrially scalable solutions, transforming innovation into concrete benefits for the healthcare system and for people’s quality of life.”
