Why might the development of a new drug take more than 10 years?
Source: www.lne.es
New drugs are responsible for 73% of the prolongation of life expectancy in developed countries and have managed to solve more and more diseases. But this therapeutic instrument contains a complex, expensive and long development process, from the beginning of its research until, finally, it reaches the patient.
Did you know that the development of a drug can take between 10 and 12 years? This is so because it is a complex process that requires the involvement of professionals with a high scientific level.
This research work begins in the laboratory, with the discovery of what is called a specific target, for example, the origin of a pathology. It is the highly trained and specialized researchers in a disease who will determine that target as a new objective towards which they will direct their studies. They will then determine the molecule or target with which the new drug will later be developed.
It is very common that this target is not suitable or that the selected compound cannot finally be converted into a drug. It is so common for these types of obstacles to appear that, as indicated by Farmaindustria, the employers’ association of innovative laboratories in Spain, only 1 out of every 10,000 compounds that are evaluated since the beginning of the investigation finally reaches the market.
The research process continues with the preclinical phase, which usually lasts one year, in which this compound is already tested in living organisms and studies on pharmacology and toxicology, among others, are carried out. Just to complete these first two stages, pharmaceutical companies need between 5 and 7 years.
After overcoming these first stages comes what is known as the clinical phase, in which the trial in people begins. These research studies usually involve healthy volunteers or patients, invited by doctors, to test the safety and efficacy of a new drug.
Clinical trials
Clinical trials are used to verify the safety and efficacy of new drugs, which will be the key to submitting them for approval by drug agencies. It is a complex process, which requires about 6-7 years of work and in which, together with the promoting pharmaceutical company, authorities, researchers, hospitals and, of course, patients are involved. They are developed in four phases in which the safety is first tested in both healthy volunteers and patients, and then the efficacy of the compound against a specific disease is evaluated. Then, the group of volunteers is expanded, and ends with the analysis of the drug already on the market.
This clinical phase can last seven years, to which must be added another 12 to 18 months of administrative procedure for the regulatory authorities to approve this new therapy and to proceed with its manufacture and distribution, to reach patients.
These trials in people are key in therapeutic innovation and represent a unique opportunity both for volunteer patients who have access to a treatment that, for many of them, may be the last chance to be cured, as well as for health professionals, who can participate in the most cutting-edge research processes. These trials also improve the quality of health care and the National Health System, since all the knowledge that has been generated in research can be applied to healthcare work.
Invest to save
In addition to being complex and long, the process of developing a new drug is expensive. It should be borne in mind that, on average, companies invest around 2,500 million euros per drug.
In addition, innovative therapies generate savings for health systems between 2 and 8 times their cost in the medium and long term since they avoid other health expenses. According to the report The value of medicine from a social perspective, prepared by the Weber Health Economics research center with the support of Farmaindustria, the use of new innovative therapies achieves, on the one hand, avoiding hospitalizations and consultations and, on the other, manages to reduce sick leave and improve productivity. All these factors make innovative medicines one of the instruments with the greatest capacity to generate added value to society.
