The pharmaceutical industry is probably one of the most profitable industries in the world. Successful development of a new pharmaceutical product can deliver revenue of about 500 times the total investment.
But for the pharmaceutical company, the successful development of new pharmaceutical products is not as easy as it sounds.
From the discovery of a new drug to registering it for marketing and commercialization, pharmaceutical organizations have to go through very complex and lengthy processes.
In this process, a drug has to pass from initial discovery to laboratory and animal testing to clinical trials in people.
Regulatory authorities play an important role in these processes.
On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average.
Here are the stages of a drug development:
- Basic research and drug discovery
- Preclinical testing
- Clinical trials
- Post approval research and monitoring
1. Basic Research and Drug Discovery
This phase includes the initial phase of research, in which researchers try to discover an investigative drug and then do initial testing of that drug in the laboratory. This first phase of the process itself takes about three to six years. By the end, the researchers hope to identify a promising drug candidate that can be further studied in lab, animals and then humans.
2. Preclinical Testing
In this phase laboratory and animal tests are performed to determine whether the drug is safe for human testing. Through these techniques, scientists try to understand how medicine works and what possible side effects the drug can have on humans. Preclinical testing is very important before being allowed to study the candidate drug in humans.
3. Clinical Trials
This phase consists of three phases of clinical trials, each with its own specific goals and requirements. The clinical trials process is both expensive and time-consuming, and ends more often in failure than success. Only 12 percent of the candidates who are included in the clinical trials phase get approval. And from beginning to end, the clinical trial phase takes an average of six to seven years. Here are the three phases of clinical trials:
- Phase I: In this phase, the candidate drug is tested on a small number of healthy people and people with a disease (usually 100 or less) to identify drug safety and detect side-effects.
- Phase II: In this phase, the candidate drug is is given to 100 to 500 patient volunteers with a disease to identify its possible side-effects and to analyze optimal dose strength.
- Phase III: Phase III trials are costliest and longest trials, in which the candidate drug is is given to 1,000 to 5,000 patients across to world. This phase helps to ensure proper use of the drug and also helps to determine whether the drug is safe and effective. It also provides information about possible interactions with other drugs, and specific dosage instructions.
4. Post Approval Research and Monitoring (Phase IV)
In this stage, drugs become available to patients after the successful completion of discovery, preclinical testing, and clinical trials. But the FDA still requires that companies conduct extensive post-approval research on approved drugs to monitor safety and long-term side effects as long as they stay on the market.
How COVID-19 Vaccines Developed in Such a Short Time?
If we take into account all the above facts, then it should have taken about 10 years to develop a COVID-19 drug or vaccine.
But this did not happen. Rather the vaccine was developed and a lot of people got vaccinated as well. This rapid process has made it difficult for some people to believe how effective vaccines can be produced in such a short time.
Well, in the case of COVID-19, scientists have received a lot of boost from the researches running on similar coronaviruses called SARS and MERS that accelerated the development of the first COVID-19 vaccine.
Also, in the development of COVID-19 vaccines, both mRNA and adenovirus techniques which are based on decades of research have been used.
Apart from this, a lot of money for doing research on COVID-19 was also released.
For these reasons, the development of COVID-19 vaccines became possible in sucha record time.