«Translational medicine is based on the feedback loop “from bench to bedside and back again”, which allows the search for a cure to be complemented with the understanding of the biological basis of a disease. Specifically, the key elements of this discipline are:
1.  Basic science research defining biological aspects of a disease and effects of therapies.
2.  Human studies to define the molecular basis of a disease and provide the rationale for the development of therapeutics for human diseases.
3.  Pre-clinical experimental studies that develop principles for the application of therapies to human disease or that aim to advance research into bringing therapies into the clinic.
4.  Appropriately designed clinical trials that originate in the types of studies mentioned above, with efficacy or toxicity as an endpoint.

»Revolutionary advances in genomics, functional genomics and proteomics have allowed us to identify new diagnostic, prognostic and predictive biomarkers that are now used as tools for the precise selection of patients who might benefit from therapies or as potential surrogate endpoints. These biomarkers have the capacity to identify those patients who would obtain the most benefit from a certain therapy, and are the mainstay of precision medicine. In addition, biomarkers provide insight into the mechanisms of action of a particular drug and serve as a tool for selecting appropriate patients for enrollment in a clinical trial based on their molecular characteristics. Indeed, patient selection is one of the most important issues in designing clinical trials for targeted therapies, since the treatment being tested could appear ineffective or even deleterious in an unselected patient population.

»The use of biomarkers as surrogate markers of a pathogenic process or of drug efficacy is changing the paradigm of patient management. More and more, this is allowing a more precise approach based on the detection and targeting of specific genetic alterations in order to achieve better treatment responses. These approaches, for instance, have led to major advances in the therapeutic field of difficult-to-treat cancers. Clear examples of this include the detection of ALK fusion protein in non-small cell lung cancer (targetable by crizotinib) or BRAF mutations in melanoma (targetable by vemurabenib), which enables us to treat only those patients who will benefit from a given therapy.

»Thanks to translational research, standard-of-care treatments for many fatal diseases are moving from a plain clinical-pathological basis to a targeted approach based on the molecular characteristics of the disease. Also, the biological knowledge gained in preclinical studies is used to design clinical trials for novel therapies or diagnostic strategies. Subsequent results obtained from phase III studies whose design is based upon the understanding acquired of the molecular basis of the disease are finally incorporated into clinical practice. Thus, by having an impact on the diagnosis, prognosis and treatment of patients, translational medicine has allowed us to develop more individualized treatments for many diseases.»