If the past few years have taught us anything, it is the importance of medicinal drugs when it comes to public health. This is especially true for anti-viral serums and treatments, as historically viruses have been more difficult to treat than bacterial infections due to their different natures.
While there are plenty of websites out there like this one, https://www.webmd.com/a-to-z-guides/bacterial-and-viral-infections, that can teach us about that, it still seems like there are many people who do not understand the difference. These types of things are critical, as we have well learned through Covid 19 and now monkeypox.
Now, most professionals in the STEM field (science, technology, engineering, and mathematics) probably know this information. Perhaps I am preaching to the choir here or repeating things you already know. Stick with me here, because I have a point to all of this.
We have realized now more than ever that honing skills in terms of drug development is something that all young professionals in STEM should probably do. What might be the purpose of doing this? Well, you can make yourself invaluable during times of crisis.
To understand why that matters, and what else I am getting at, continue reading. I will explain more shortly!
Drug Development: The Basics
There are many facets to drug development, and as you can likely imagine, there are several steps along the way. For now, let me give a simple overview of it. For more in depth information, consider reading some of the scholarly articles published on this topic. Of course, you could also think about drug development courses which are available online.
Stage One: Discovery And Development
This mostly comes down to how new drugs are discovered. There are a few ways in which this typically happens. Of course, other methods are available as well, but these are the “common” ones (using that phrase loosely).
As we develop new technologies, it is no surprise that some of them lead to us finding new compounds or molecules that can help treat diseases. In addition to that, some of this new tech allows us to have those compounds target specific parts of the body. We are even able to alter or manipulate genetic materials now.
This also lends into our improving understanding of diseases and how they work. This means that we can develop things to target them more effectively. As we study molecular structures, this knowledge only grows.
So, that is discovery. What about development, though? Once a compound that appears to be promising is found, researchers involved can start to gather more information on it. How do they do that?
For the most part, it is via experimentation. A series of tests are usually run on the compound to help us learn more about it and how it might work in these contexts. This could look like studying the ways it is absorbed by cells, how it impacts different groups of people or patients, any potential side effects that it could cause, the ways that it could interact with other compounds or drugs, and more.
Stage Two: Pre-Clinical Research
Most professionals in this field have heard of clinical trials. That is the golden ticket for many of us, in fact. What comes before that, though, is a bit of a grueling process all on its own. The goal is to determine whether the proposed drug compound is toxic or could cause harm somehow.
In terms of how it works, there are two different types. These are in vitro and in vivo. The former means that it is tested in a controlled environment, while the latter means testing in living beings.
There are standards set for all of this, which you could learn about in a few places. They are set by the FDA (Food and Drug Administration), so it is a good idea to learn them as well as you can. You can read more about it on this page, but I will cover some as well. There are protocols to follow with the following: study reports, personnel, operating procedures, study conduct, equipment, facilities, and written protocols.
Stage Three: Clinical Trials
As I mentioned above, this is one of the most exciting parts of this process. The previous stage is to determine whether something will be harmful to any living beings. However, this one is for tests on humans to figure out safety, effectiveness, and possible side effects along the way.
Because the stakes are higher here, a lot of thought must go into these trials. So, designing them is a huge step along the way. It is critical that we do not overlook this, lest we have a study that ends up harming someone due to negligence.
What are some of the things that we need to think about here? While most courses cover this in terms of this entire process, let me give some explanation as well. You will need to establish a goal of your study and plan it out.
Now, what might be a part of this protocol that you create? First thing is first, you will have to decide who you want to participate. So, that means that you should establish some criteria for who is eligible and create a screening method to make sure that your participants fall within those categories.
Along that line, you should decide how large of a group you want to run the study with and ensure that it is as replicable as possible. Obviously, no clinical trial can be perfectly replicated due to the variance in humans, but each step in the process should still be documented.
A final thing to consider before I move on is whether you want to have a control group or not. They can help with locating potential bias, but not every research team opts to have one, so that will be up to your own discretion for the most part.
Stage Four: FDA Review
To some extent, this is where the fate of your proposed drug is no longer in your own hands. After you have demonstrated that you have followed the protocols and expectations set by the Food and Drug Administration, they will review your creation. This is what will determine whether it will end up on shelves or not, at the end of the day.
Starting this is relatively simple in comparison to the other steps, though still not necessarily “easy.” You fill out a New Drug Application, often called an NDA. Within, you need to include any results from your previous studies and trials, along with the following details: usage directions, the details on the patent, drug abuse information, the label you propose, any updates to safety, and any review board compliance details.
If your drug is approved, it will proceed and be approved for the next part of this, which is refining the information for anyone looking to prescribe it. This is usually done in conjunction with FDA researchers in some manner or another. Just keep in mind that there is often some sort of problems along the way during the review process, and you will likely not get approved on your first go around.
Stage Five: Post-Market Safety Monitoring
So, you have gone through all of the stages above. Your hard work has finally paid off, and the drug that you have developed has reached the shelves of pharmacies across the nation, and maybe even across the world. What happens now?
It would be nice if we could simply call it a day at that point and ignore any further considerations, but that is of course not how it works. Rather, there is constant monitoring by the FDA to ensure that any drugs that are on the market remain safe and do not have any defects. That can happen during the manufacturing process, after all.
For anyone who has found this article on drug development helpful, I am glad. Ideally, you have been able to learn something about how the development process for medicinal drugs works and why it is so important that we understand it. Without these carefully constructed protocols, after all, we could end up with untested and potentially dangerous “medicines” on the market.
It might feel like a pain to have to go through the bureaucracy, but it is for good reason in this case. Do not be discouraged if you are not approved the first time!