THE LONG ROAD ‘FROM MOLECULE TO MEDICINE’
It takes years to discover, develop and market a new drug. On average, it takes twelve to fourteen years for a molecule to become a saleable medication. Not only is it long-winded, it is also a high-risk and expensive undertaking, with no guarantee of success.
It isn’t only the scientific research that takes time, the development and registration process also requires the involvement of dozens of other departments.
During the basic research process, researchers try to identify a ‘target’, usually a ‘faulty’ protein. The aim is to discover the right molecule that would deliver the desired effect in a safe and efficient manner. During the preclinical development phase, the most promising molecules are tested both at cellular level (in vitro) and on live laboratory animals (in vivo). Only the most promising molecule(s) stand a chance of becoming potential drugs.
Is the selected potential drug safe enough to be tested on humans? That’s when clinical studies involving healthy volunteers (phase 1) are initiated, followed by studies involving small (phase 2) and larger groups of patients (phase 3). The safety and efficacy of the active ingredient and physical reaction of the body (assimilation, dissemination, excretion) are paramount. Only when an often highly complex dossier has been submitted to, and approved by, the relevant authorities can a registered drug be marketed. The registration dossier comprises all essential data from the earlier basic, pre-clinical and clinical research.
Upon registration, chemical and pharmaceutical production take off at full speed in order to be able to market the product as soon as possible. Meanwhile, the medical profession is provided with information about the drug and negotiations are conducted with the authorities about the cost and reimbursement for the drug. Only when this process is finalised can the drug be distributed via wholesalers and pharmacies. Obviously, the safety of the drug will continue to be monitored and additional clinical studies (phase 4) executed where necessary.
More information on the development of a drug can be found here: