A researcher is a person who:
- targets the unknown,
- aims to solve problems, and
- addresses areas of improvement and identifies ways to solve problems.
Conducts research in a structured manner to elucidate the matter at hand, leveraging the method of scientific reflection based on previous work and publications.
What is a research-based pharmaceutical company?
Being a research-based pharmaceutical company means working passionately on a molecule that has a slight chance of turning into a useful drug and spending hundreds of millions of dollars on the work of tens of thousands of scientists spanning years for a marginal possibility.
Everything begins with a single molecule that can produce a beneficial effect!
Drug research begins by identifying one molecule that can exert a beneficial effect for a disease or improve patients’ quality of life, among thousands of molecules developed as a result of lengthy laboratory efforts .
A patent application is then filed for the invention right in the newly-discovered molecule and, if granted, a patent right is gained for up to 20 years .
For the new molecule, an application is filed with the competent authority for pharmaceuticals to obtain approval for research.
The molecule is then investigated in the laboratory for toxicity and for pharmacological characteristics, and if determined to be safe, another application is filed with the competent authority to initiate clinical investigations in humans.
Clinical investigations conducted in human subjects span many years and consist of four phases.
Phase I, which is the first stage, is conducted in 20 to 80 healthy subjects in a controlled hospital setting. In Phase I, the goal is to determine the dose of medicine, and gather information on its metabolism and excretion characteristics and identify any acute side effects .
The second stage, Phase II, is conducted in 100 to 300 patient subjects who have the illness which the medicine intends to treat, aims at collecting data on the efficacy and safety of the medicine.
In the third stage, which is called Phase III, the medicine is investigated for efficacy and side effects and compared to the standard treatment in 1000 to 3000 patient subjects. In some cases, the clinical trials continue even after a product has been approved and placed on the market.
In Phase IV, the goal is to collect information on the product’s long-term risks and benefits and the dose to be used.
The number of participants increase with the phase of clinical trial.
Research-based pharmaceutical companies remain responsible at all times.
Patients from the country in which a study is being conducted may be enrolled alongside patients from other countries around the world. To enable this type of research, it is preferable that intellectual property rights, such as patents and data protection, are afforded legal safeguards.
After its safety and benefit are scientifically demonstrated in clinical trials, an application is filed with the competent authority for approval of the product and placing it on the market. A research-based pharmaceutical company’s responsibility does not end with gaining approval for placing the product on the market; on the contrary, the company is required to continue researching, and collect and report new data on the product’s use.
Research-based pharmaceutical companies have developed more than 90% of innovative medicines and treatments placed on the markets around the world over the past two decades.