In the wake of the pandemic, we may have developed a false sense of the amount of work that goes into the drug discovery process. The COVID-19 vaccine was developed, analyzed, and authorized for use in under a year. The underlying cause was that scientists had been studying coronaviruses for over five decades. Although the SARS-CoV-2 virus was new, it shared many traits with previously studied viruses. The “shortened timeline” associated with the COVID vaccine was in appearance only. Research surrounding mRNA vaccines began ten years ago.
Designing a new drug, developing it, and getting FDA approval lends itself to a significantly longer timeline than typical products and services. Companies can spend upward of a billion dollars or more to develop a drug that can gain the FDA’s approval in a process that is typically closer to 15 years. To give you an idea of the complexity of the drug development process, look at how these drugs go through a series of different phases before being reviewed by the FDA:
- Discovery and Development
- Preclinical Research
- Clinical Development
Drugs that go to market are safe, will serve as effective remedies, and can be delivered to patients on a mass scale. One way drugs are developed is to seek out targets that either treat someone with a disease or will prevent them from getting one (e.g., a vaccine). Neither diseases nor individuals are targets; they are molecules like proteins within the human body linked to disease. During the discovery, biotech companies attempt to isolate which molecules cause disease and establish how these molecules communicate with one another.
When a target has been identified, biotechnology companies have a variety of ways to determine which compounds can bind to previously identified targets, which disrupts how a disease can spread or develop within the body. This is what researchers will refer to as a “hit.” As complex and time-consuming as this process is, it is merely the ground floor. The compound still has to be studied to ensure it is safe for use and it is an effective solution for the disease. The odds are that the hit will lend itself to neither. Researchers may have upwards of 10,000 hits before they have one capable of becoming a drug that people can use safely.
Suffice it to say the drug development process demands a significant investment of time and money, often from outside investors. Life-science companies require attorneys who understand the industry and can advise you during any stage of the formation, fundraising and M&A process. For more information about how Inceptiv Law can assist you, contact us to schedule a consultation.
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