The pharmaceutical industry has its origins in antiquity when apothecaries and alchemists began to play a crucial role in the preparation and dispensing of medicines to treat diseases and alleviate symptoms. The medicines used at that time were mainly based on dried plant parts, extracts, mineral substances, or simple chemicals.

Possibly the first pharmaceutical company was the Dutch East India Company, established by the Netherlands in 1602, and involved in the trade of spices, medicinal herbs, and other exotic products from the East Indies. Recognizing the commercial value of these products, the company established a pharmaceutical division in Amsterdam in 1625. This division was responsible for the production, preparation, and distribution of medicines through its vast trading network.

The industrial revolution in the 19th century marked a significant change in this industry, supported by major scientific breakthroughs, especially in the synthesis of organic compounds. The synthesis of acetophenidine, the precursor of paracetamol and acetylsalicylic acid at Bayer Leverkusen, marked a turning point in the way individual health was approached and laid the foundations for a new industry model that would continue throughout the 20th century, evolving and expanding with the emergence of biotechnology and, more recently, advanced therapies. It was also during this period that regulations were established for the approval and marketing of these medicines.

But especially since the last two decades, a revolution is taking place because of technological and digital integration through the application of robotics, AI (artificial intelligence), VR (virtual reality), AR (augmented reality), nanotechnology, etc. for the improvement of patients’ health.

Traditionally, the healthcare model has focused on the use of drugs as the main therapeutic tool to treat illnesses and improve health. But with the emergence of these technologies comes the term “Beyond the Pill” where a person’s health and wellbeing goes beyond simply taking a pill or medication and a much more holistic, patient-centered approach is adopted, encompassing not only drug therapy but also lifestyle changes, health technology, etc.

Examples of Beyond the Pill initiatives include the use of connected medical devices, mobile health apps, self-care programs, among others.

This term Beyond the Pill then becomes part of a new vision of medicine—the so-called 5P. This refers to medicine that is:

• Personalized – specific to each patient;
• Predictive – able to calculate the probability of a person developing a disease;
• Preventive – helps to prevent disease;
• Participatory – puts the patient at the center by providing them with tools to care for their health; and
• Population-based – ensures access to the entire population.

This new vision has forced the pharmaceutical industry, focused on drug development, to adapt to this paradigm shift in the approach to the patient, acquiring new models as an industry solution provider. An example of this new holistic approach of the industry can be found in the new patient stratification tools, where diagnostic medical devices (such as Companion Diagnostic Devices) are used together with certain drugs and also with new technologies and algorithms (radiomics, imaging biomarkers, etc.) to contribute to the correct stratification of patients and the application of personalized therapy, resulting in cost-effective innovations in our healthcare systems, and achieving the desired value-based medicine.

An exciting era is opening up with this new approach to medicine. However, this more general and holistic vision presents major challenges, possibly one of the most difficult of which is the adaptation and emergence of new regulations to protect both the security and privacy of patient data.

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Natalia de la Figuera is co-founder and chief operating officer at Genesis Biomed, a strategy and operations consultancy specialized in early-stage R&D projects in entrepreneurship in the biomedical sector. More info: www.genesis-biomed.com