Every so often, a revolutionary new drug hits the market that gets everyone’s attention. It may address a chronic problem that has proven stubbornly difficult to treat, or it could kill a notorious pathogen. Whatever the case may be, its arrival seems instantaneous, and the public often wonders why it took so long for the new product to emerge.
Of course, the reality is that the development of any pharmaceutical is an incredibly long and complicated process. It begins with years of research followed by a series of trials. Next comes FDA review, and finally the product is made available to patients.
Not surprisingly, this long process involves a large number of skilled people doing a great deal of work, coordinating complex tasks, and using specialized equipment. Any deficiency at any step of the process can ruin years of work.
In addition, a number of outside factors can interfere with the work being done. Government regulations can often lag behind innovations, stalling process while various authorities review standards to ensure that the work is being done ethically and safely.
And perhaps most influential of all is the role of funding. Some projects go from one source of money to another during the development of the final product, requiring the research to move from one site to another. It may have begun with a grant supporting its work at one university, then moved to a pharmaceutical company after the money ran out. Later the company might move itself to a modernized facility, forcing the work to pull up stakes yet again.
In addition to countless expensive instruments, these labs also are filled with biological samples that must be properly stored and transported. Any aberration from proper temperatures and humidity could ruin them, and any distortions to labeling or identification could render them useless. Pacific Bio Storage specializes in properly managing biological materials in just these situations.
Within this framework is a process that sounds very straightforward but ultimately requires considerable time.
The Underlying Problem
The research begins when a problem is identified. It could be an issue that has plagued us for generations, such as congestive heart failure. It could be an emerging infectious disease or a performance-related need for athletes.
Regardless of the source, the issue is narrowed down to a manageable scope and work begins.
Next, the research attempts to identify what has caused the problem. Can we isolate a bacterium or a hormonal imbalance? Could there be an anatomical issue like a faulty heart valve? Is it simply a result of aging? A problem that cannot be clearly attributed to a single problem is not yet a good candidate for treatment, so the process must continue until that one trigger is figured out.
At this point, the work gets into the familiar pattern of the scientific method, which we all studied in elementary school. Researchers must hypothesize about what might reverse the condition that is causing the problem. For example, if it’s an infectious condition, they must study the bacterium or virus and attempt to come up with ideas about what will kill them, or what might induce an immune response.
At this point, experiments begin. Potential cures are developed and then attempted in the lab, trying to create some response to the condition. When one or more options show potential, they are attempted repeatedly in order to establish that the therapy is both effective and consistent.
After surviving this process, the product is presented for FDA review and approval. Their staff may require considerable additional information from the research team, so their availability must continue throughout this final stage.
Finally, the drug is approved. Protocols for its use are developed, and medical professionals are trained on its uses, contraindications, dosages, interactions, and side effects. It begins to show up in pharmacies and finds its way into the medicine cabinets of patients and the formularies of hospitals, yielding the end result of a process that, on the surface, seems so fast.