Today, in the XXIth century, there are many important human diseases without effective treatments which impact severely in quality of life, familiar relationships and economy. One of the main global goals for our society is to find drugs active against many pathologies as cancer, viral infections and metabolic or neurodegenerative diseases.
Drug discovery is a long and risky process that involved multidisciplinary teams working with the same goal for long time periods and great human and financial investments. All the tasks involved in the process are very well established by regulatory agencies to guarantee the human safety. Only after a carefully revision by FDA or EMA of all the data provided by high level research, the approval of a new drug to be tested or to used in human beings is obtained.
There are two points in drug discovery pathway critically reviewed by regulatory authorities: the start of clinical trials, in where the new drug will be assayed in humans (healthy volunteers and patients) to test its safety and efficacy, and the market approval after the successfully end of clinical development. The possibilities for a new drug candidate to reach the market are very low. Only 1 new molecule discovered in a laboratory, with good biological properties and efficacy in animal models, among 5.000 will have the chances to reach the patients. But the risk is different in the different stages of drug development. Thus, one drug candidate among 5 that enter in clinical trials will obtain the market registration, while only 1 molecule among 1.000 will have the chance to start clinical development. The only way to speed up the number of drugs for human use is to push more valuable candidates to the clinical phases of research, that means to cover all tasks that allow one drug candidate to obtain the IND approval for further development. ANKAR PHARMA has born to fill the gap between basic drug discovery translational research and clinical trials mainly in the field of neurodegenerative diseases.