Globally Redefining Drug Discovery
In times when the unexpected COVID-19 pandemic has made nations realize that they are generally unprepared for such extreme circumstances, it's important to realize that making small changes within national boundaries is crucial to development and progress.
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The COVID-19 outbreak that put many of China’s cities into isolation was an event that seemed to make little to no difference in our everyday lives four months ago. Now, it has become a crisis of global proportions, infecting over a million people and causing 56 thousand deaths worldwide. The pandemic has forced medical staff to work day and night, kept others out of their jobs and workplaces, and disrupted education systems and social lives. To stop the COVID-19 pandemic from further creating panic, systems biologist Nevan Krogan and many other researchers have gathered at the Quantitative Biosciences Institute (QBI) at the University of California to search for the perfect drug to fight COVID-19.
In order for Krogan and his team spanning 22 labs at QBI to accomplish their objectives, the group must resolve several issues beginning with the fact that SARS-CoV-2, the name of the virus, is a novel one. Just like any other virus, this one needs to hijack cells to reproduce. However, while some viruses simply inject their genetic material into a cell, SARS-CoV-2 uses its surface proteins to interact with host cell surface receptors. This allows the virus to enter the cell and control it so the virus can replicate itself. Because SARS-CoV-2 uses different sets of viral proteins to infect cells, QBI must identify which proteins it uses before the team can develop an effective drug against COVID-19.
Another issue in the search for a drug is drug testing. In the U.S., drug testing takes an average of 12 years to complete, and only one out of every 5000 drugs tested is approved for the market. The Food and Drug Administration (FDA) regulates the drug approval process and requires several different steps before approval, such as preclinical testing, clinical trial phases, and applications. These procedures are necessary to collect data on the drug, such as its effectiveness, safety profile, and side effects, and to determine if the drug should be sold in the market. First, the drug must pass preclinical testing, in which laboratory and animal studies must support the drug’s effectiveness in treating the disease. Following preclinical testing, the pharmaceutical company must file an Investigational New Drug Application for approval to test the drug on people. Afterwards, the drug undergoes three phases of clinical trials to test the drug’s safety profile and side effects. Once the results of these trials are submitted to the FDA, the drug manufacturer files a New Drug Application summarizing all the data about the drug they’ve gathered. Finally, once the FDA approves of the drug, the drug undergoes Phase IV studies, in which data is collected from patients taking the drug. Fortunately, many organizations are expediting or altering the drug approval process for COVID-19 drugs to find a cure faster. For example, the World Health Organization has been coordinating an international study known as the Solidarity Trials, which aimed to expedite the Phase II and Phase III clinical trials and narrow down drug testing to four of the most favorable COVID-19 drugs. The FDA has also stepped in to accelerate the U.S. drug approval process by reviewing newly submitted clinical trial protocols within 24 hours and granting single-patient requests for expanded access in three hours.
The clinical trials and testing described above are very methodical procedures that pharmaceutical companies base their drug discovery processes around. This is to ensure that the upcoming product makes it through the entire screening process. But to fully understand the actual methods by which these drugs make their way into medicine cabinets and eventually the body, one must understand the importance of maintaining these policies. These policies are meant to protect the general public from defective, placebo, or harmful products. Therefore, as the drug industry moves from traditional methods of drug discovery and distribution to increasingly modernized methods, the long and drawn-out COVID-19 drug screening is ultimately justified. There have been a multitude of new challenges as the public begins to view unprocessed drugs with a risk that has not been seen before. It is widely recognized that drug discovery has changed, with the last five years seeing significant restructuring of major pharmaceutical companies around the world.
In this COVID-19 pandemic, the general progression of pharmaceutical and vaccination treatments that should be produced at the moment is relatively unknown. It remains something that news media has yet to deeply dive into, but this is due to the difficulties that scientists are currently facing when presented with a problem that pharmaceutical companies generally do not have much control over. This can be exemplified using a drug that may be a potential option for treating COVID-19. Remdesivir should, for the most part, be a new term for many people unfamiliar with the drug discovery process, but it is, surprisingly enough, an antiviral drug that may potentially alleviate some COVID-19 symptoms. It is currently in the experimental process, and its effects and biological mechanisms have not yet been proven as fact. The way the coronavirus works is that it copies genetic material using an RNA polymerase. There were complications that prevented researchers from getting their experiments to work, but these were surpassed as it was found that remdesivir blocks a particular enzyme that is required for viral replication. Scientists found that enzymes can incorporate remdesivir into new RNA strands, which stops the coronavirus RNA polymerase from being able to add more RNA subunits, effectively halting genome replication. The remdesivir drug, similar to the COVID-19 vaccine, is currently undergoing pre-clinical testing and clinical trials, but it is unknown how long this process could take. This data could potentially help researchers develop future drugs that have even greater activity against the polymerase, but due to the drawbacks surrounding drug processing, it is unclear when this may be put into effect.
America continues to lead in life sciences, and its historically strong investments in biomedical research have propelled it to global life sciences leadership despite some of the aforementioned setbacks. America and other countries around the world continue the race to develop a coronavirus vaccine, and America has somewhat of a lead in containing large pharmaceutical companies. But if we continue to be underrepresented in medical communities due to the imposing of several strict regulations, there is a lot still up in the air. Clearly, along with national centers of excellence focusing on drug discovery and development, there is a greater need for international collaboration. It is not that there are fewer potential new targets for drugs; it is simply that the legal and regulatory framework is making it harder to bring new products to the market. Meanwhile, the regulatory system for the manufacture of generic drugs that are no longer within patent has become easier. In times when the unexpected COVID-19 pandemic has made nations realize that they are generally unprepared for such extreme circumstances, many are hoping that the process to produce a vaccine or drug treatment is expedited.