From molecular research to the pre-clinical stage

After singling out the therapeutic target, that is the biologic mechanism on which to intervene to cure a specific pathology, the research team may choose from a number of different methods to select the substances to be tested:

• Find and test natural substances
• Examine and select the most adequate synthesized substances, utilizing complex computerized systems and innovative drug design techniques
• Utilize biological systems (bacteria, yeasts or cells from mammals) to produce therapeutic substances, also maximizing the use of the most modern techniques of recombinant DNA

These methods allow the selection of a group of "promising" substances to be tested in stage 0, also called the pre-clinical stage. This stage, which lasts approximately 4 years, is indispensable to test, in a laboratory, the greatest number of characteristics of the substances, before clinical testing. The first step consists of a pharmaceutical screening, to test in vitro possible toxicities of the substance; on the basis of the principle primum non nocere (first, do no harm). The substances that pass this test are then tested on living organisms, that is, on animals

However very controversial, this stage of testing is invaluable, and currently often inescapable, because national and international laws often require it as a compulsory stage before moving on to the clinical stage.

R|M is committed to minimize the number of animals utilized for research and, whenever possible, to utilize alternative methodologies (computer simulations either on cellular cultures or tissues) showing responsibility in research. Tests on living organisms are carried out in full respect to the national and international laws ratified to avoid the suffering of animals and to protect their rights.

After obtaining the authorizations specific to each case, the next step is the stage of clinical development.