Clinical research is the basis of medicines, but the path to a pill, emulsion or injectable solution is a process that often takes years, sometimes decades, of research. For Dr. Gabriela Dávila, regional director of Clinical Research for Europe, Canada and Latin America at Pfizer, “bringing a drug to market is like finding a needle in a haystack”, and this is because not all molecules can be effective for a certain purpose.
For this reason, pharmaceutical companies carry out constant research in parallel and are in one of the four phases of research, a regulation proposed by the World Health Organization (WHO). Few of them reach the last stage when applying for permits to register molecules that have previously proven their efficacy and safety for certain disease treatments.
The doctor explains that the pharmaceutical company, which is headquartered in New York City, has 30 molecules in phase 1. Another 31 molecules are already testing their effectiveness in small groups of up to 500 people, while 29 more molecules are in phase 3, that is, its effectiveness and risks are tested in larger groups of thousands of people and globally to determine its effectiveness in various regions. In phase 4, in which all the information about the drug is already available and registration is requested, Pfizer has 6 molecules.
“To carry out clinical research, you have to adhere to local and international regulations, then follow a process to collect information to move from one phase to another,” says Dávila. “Pfizer has different strategic areas that we focus on. among them, mainly rare diseases, internal medicine, inflammation, vaccines, immunology, oncology, anti-infective”, he adds.
For the development of these investigations and that of new molecules, worldwide, the pharmaceutical company invests 15% of its income, although the figure is not set in stone, since if any indication is presented during the investigation, the budget can be increased.
The regional director of Clinical Research for Europe, Canada and Latin America of Pfizer, details that the company has 36 research centers in different countries, in which entire teams are dedicated to these investigations. But on-site studies are also carried out, which are determined according to the indications required by the investigation, such as certain infrastructure, the characteristics of the population and the available researchers.
In Mexico, in the last decade, Pfizer has invested 1,000 million pesos in research, for clinical studies. In the country, the pharmaceutical company has 81 research sites, to which 30 more will be added throughout the year, to close at more than 100. “This speaks of growth and the expansion that we have in Mexico, and if the investment for the number of pharmaceutical companies we find that it is a very high figure that is invested in research and development”, he points out.
According to the World Health Organization (WHO), rare diseases are those that occur in fewer than five people per 10,000 inhabitants and there are more than 7,000 diseases. In Mexico, 20 rare diseases are recognized, including hemophilia, cystic fibrosis and congenital hypothyroidism, according to the federal government.
The purpose of medical research is to bring drugs to market that help treat and alleviate diseases, and some of the pharmaceutical companies focus their efforts on areas such as rare diseases and oncology. Although some of the drugs have a patent, which allows pharmaceutical companies to manufacture and sell them exclusively, but after a while they can be generic drugs.
“Patents are obtained for between 15 or 20 years, then they are lost and anyone can use it and make it generic and Pfizer also has its generics area,” explains the Pfizer directive.
The company, one of the pharmaceutical companies that developed and marketed one of the anti-Covid-19 vaccines, reported revenue of $25.7 billion in the first quarter of 2022, an increase of 77% over the same period last year.
The company projects that its pill to prevent this disease, called Paxlovid, will generate annual revenues of 22,000 million dollars, in addition to marketing a generic at a lower price for final buyers.