Journey into the world of research and development of new medicines
Pills of Research – Interview with Andrea Pellacani, General Manager of Research and Development at Menarini.
Have you ever wondered, how the medicines we all have in our homes are made? As you can imagine, the topic is quite complex. It is a long process and, for each one of its phases, specific goals must be achieved before moving on to the next step. Hence, we have decided to reserve a section of our blog for what we like to call “pills of research“: articles dedicated to each stage involved in the drug development process. We will discover together the work that researchers do daily to turn a molecule into an effective and safe medicine, able to meet the needs of patients.
To facilitate the orientation, we have created a summary map indicating the phases which will arise along our route.
So, what goes into actually producing a package of pills and information leaflet? To answer these questions, we need to take a step back and return to the place where the long journey a new molecule has to take to become a medicine begins: the research laboratories.
“Scientific research makes it possible to discover new “active substances”, the pharmacologically active part of the drug, which can be made available to the community only after a process which can last up to 10 or 12 years,” explains Andrea Pellacani, General Manager of Research and Development at Menarini. “This process involves various stages, the first of which is actually discovering the new molecule or active substance; this, naturally, is called the “Discovery” phase. This is then followed by preclinical tests and clinical studies on humans before finally obtaining marketing authorisation for the drug, issued by the regulatory authorities”.
The starting point, as always, is the patient. Researchers begin by studying the causes of the disease in order to identify a potential drug target, i.e. a biological mechanism that can be acted on to produce benefits for the patient. The more complex the disease, the more difficult it is to find the target: it might be a mutation in DNA, a defective protein, a micro-organism, etc. The work of the researchers does not end here, however. It is also necessary to identify new molecules capable of acting on the biological targets and producing the desired therapeutic effect. Thousands of molecules are assessed during this process, but only the one that the team of researchers believes may be suitable will go on to be tested in a series of studies to evaluate its safety and therapeutic efficacy.
How does a pharmaceutical industry work?
Once understood the meaning of discovering an active ingredient and its relevance for the identification of potential new therapy, it is also important to clarify that different companies can take different approaches to the research and development of new medicines. In fact, the phases following Discovery are not necessarily carried out by the same company that identified the new molecule. For example, “The approach taken by Menarini towards research and development entails close collaboration with startups, academic institutions and other partners in the pharmaceutical industry” states Andrea Pellacani. “Our strategy involves acquiring new molecules “discovered” by partners who often lack the resources and specific expertise which would allow them to move on to the subsequent stages of development with the necessary degree of efficiency. So, through licensing agreements, we bring together our partner’s scientific brilliance with the expertise and resources of our company. In this way, development of new molecules can be completed, starting from the preclinical stage, with the final aim of producing effective, innovative drugs for the benefit of patients’ health”.
Once the Discovery phase is over, the drug candidate progresses into preclinical development, another fundamental step which will be described in the next appointment with Pills of Research.