The COVID-19 pandemic has prompted an extraordinary response from all stakeholders in health care, including the pharmaceutical industry, regulatory agencies, clinical research sites, and public health institutions, in addition to the societal realization of the complexities of the drug development process and the value of collaboration.  Innovative approaches to managing clinical trials and regulatory submissions are now in place, resulting in the availability of new drugs and promising perspectives for those disciplines associated with Pharmaceutical Medicine.

For the past two years, the healthcare industry was forced to accept digital technologies for decentralized clinical trials as well as telemedicine and telehealth, with the related data generation and need to document outcomes through real-world evidence and build predictive scenarios with the support of artificial intelligence, machine learning, and advanced biostatistics.

Health and disease are now perceived manifestations of complex factors across biology, genetics, personal and collective behavior, including the critical role of socio-economical factors and the pervasive effect of health care inequalities across societies worldwide. Patient access to new medicines and their involvement in drug development is now part of our daily business lexicon and new initiatives.

The IQVIA Institute for Human Data Science delivers objective, relevant insights and research reports that accelerate our understanding of how health systems function, how treatments are evolving, and how care is being delivered. These insights are critical to sound decision-making and ultimately to improved human health outcomes. The IQVIA Institute for Human Data Science – IQVIA

A recent IQVIA report underscores the relevance of clinical research and medicines development sponsored by new players in bringing new medicines to the marketplace.

As an example, the Clinical Trial Productivity Index, a composite metric of success rates, clinical trial complexity, and trial duration, rose in 2020 after having declined since 2015. This was mostly due to an improvement in Phase III trials. However, the ethnic minorities (e.g., African American, Asian, and Latino, in the U.S. population) are under-represented in the clinical trials mix, underscoring the need to foster diversity among the clinical trial industry.   Interestingly, China-headquartered companies now represent 12 % of the exploratory development trials, up from 2 % in 2010. The USA’s share of global early-stage R&D has remained relatively stable over the past 15 years (42 %). Europe’s share has declined from 33 % to 22 % over the past 5 years, whereas the combined participation of China, Japan, and South Korea represents 23 % of early-stage clinical trials. Modest, although significant increases have also been observed in a few countries in Latin America and Africa.

Emerging biopharma companies – defined as less than $ 500 M in sales and less than $ 200 M investment in R&D – originated and launched 40 % of all new drugs in 2020.

However, clinical research productivity continues to be below the long-term average. Global Trends in R&D – IQVIA

The new perspectives in drug development and trends in the geographical distribution of sites pose a challenge for all biomedical professionals involved. New capabilities are to be gained to adapt to the challenging requirements of the health systems. At the IFAPP Academy level, we are getting prepared to offer our students, alumni, and stakeholders the proper tools for education and training to help gain or maintain competence. New programs will be offered in 2022, aiming to meet these educational needs.