Advanced therapy medicinal products (ATMPs) are innovative and effective medicines for human use based on genes, tissues or cells (gene therapy medicines, somatic-cell medicines, tissue engineered medicines). They offer outstanding progress for the treatment of diseases and injuries and have enormous hidden potential for the future of medicine.

Besides the fact that ATMP offers a major hope for various diseases for which there are limited or no therapeutic options, there are challenges related to: developmental timelines, patients’ access, regulatory considerations, pricing and reimbursement issues.

Digital Medicine (telemedicine, apps, wearable devices, communication tools, eHealth records) and Artificial Intelligence (AI) – will these cutting-edge approaches lead to prevention of sickness and improved patient care through data usage and, if yes, what is the way forward?

Implementation of new technologies, analyses and usage of complex medical data and information as well as the application of deep-learning algorithms can assist in caring for  patients; optimizing diagnostic and therapeutic methods, interpreting data and results, developing drugs and devices. AI and digitalization are already transforming biotechnology and the healthcare sector and are next level of the biomedical world but are we prepared for this step?

„Health technology assessment is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value.“ (EUnetHTA definition).

One of the main instruments used in the HTA process is namely the real world evidence (RWE) – “evidence derived from the analysis of real world data” (HTA Glossary), following the goal of improving patient outcomes, reducing costs and decreasing the  time to market.

Despite the fact that there still are challenges for using RWE in the context of HTA that need to be overcome, countless opportunities can be identified and used.

The COVID-19 pandemic is an ongoing pandemic of the coronavirus disease 2019, caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2). The outbreak was first identified in Wuhan, China, at the end of 2019. The World Health Organization declared the outbreak a Public Health Emergency of International Concern on 30th January 2020, and a pandemic on 11th March 2020. Since its emergence in Asia in December last year, the virus has spread to all of the continents, except Antarctica, and the number of new cases is increasing daily. The pandemic is prelude to a global health crisis and is one of the greatest challenges of our time.

Being a highly transmittable and pathogenic viral infection, the coronavirus disease leads not only to a health crisis, but it is also a cause of dreadful social, economic and political consequences.

The whole world is looking for answers and solutions in prevention, diagnostics and treatment as well as trying to minimize the harmful impact on society, healthcare systems and the global economy. No one knows what the future brings and how to adapt to the “new normal”

“If we make the right decisions now—informed by science, data and the experience of medical professionals—we can save lives and get the country back to work” (Bill Gates)