Introduction
Tylenol, Advil, Robitussin. These are all the names of modern, over-the-counter drugs that we all use in our everyday lives. Drugs play a large role in our day-to-day lives, even if we don't always acknowledge it. Whether it's the pain reliever we use for a headache, the prescriptions that control chronic conditions, or the vitamins that keep us healthy, drugs are everywhere.
So how does the idea for a certain drug become a market product? In this blog post, we’re going to look at both the science and business of producing new drugs. Drug development is a risky business, and many ultimately fail to reach consumers - how do we raise money to finance every step of the development process? We’ll also talk about how recent breakthroughs in artificial intelligence might affect the way we develop drugs.
Body
To start, let’s first talk about how a certain drug is produced. Beginning in a lab with a particular, very simple, scientific hypothesis, this is the stage of the pre-discovery where basic research and screening is performed. Then comes the initial stage of testing - where this original hypothesis is investigated in the laboratory under various conditions through animal testing. If, after testing on animals like monkeys, dogs, rats, and more, the solution seems to be valid and may successfully work on humans, as that is ultimately the end goal, in order to move on with the drug development process, the company would submit an application to the Food and Drug Administration (FDA) entailing all the research, data, and work. This is a crucial step, since introducing humans into the picture causes a significant increase in the risks for these subjects, and ensuring that the drug is fully functional is not an easy criteria to meet. After approval is given by the FDA for further development and research of the drug, the clinical trial stages begin.
Phase 1 is the very beginning stage of a long and tedious process of clinical trials. It’s where companies try out their therapy on a very small number of patients with only one main question in mind - “is the drug safe?” - because at the end of the day, this is a matter of ethics and human health and safety. After ensuring that a maximum dosage is found without any dangerous or even lethal side effects, and the FDA is satisfied with these results, they can begin Phase 2, where a larger population of subjects (around 100 to 500 individuals) for the trials is introduced and the questions of both safety and efficacy of the drug are taken into consideration. If Phase 2 is successful, then the drug will be allowed to move on to Phase 3 - the final stage of clinical trials. Phase 3 is where everything starts to come together. A larger number of patients, around 1,000 to 5,000, is set for this phase, and in addition to safety and efficacy, another major determining factor of whether or not the drug is deemed “good enough” is the consistency at scale. After all of this, then only can a pharmaceutical company approach the FDA asking for a drug license, and the FDA begins reviewing the drugs efficacy, and other statistics(phase 4). With permission comes the mass production of this drug. This entire process takes about a decade, and chances of success are quite slim. But, apart from the time it takes and the low success probability, there is one major factor behind why many drugs ultimately fail to reach the public - the cost. (1)
Although it may seem like an increase in production of various successful drugs is beneficial for our society, as even more drugs are produced, the amount of risk increases exponentially with it. In fact, the chance of true success for a cancer drug is 1 in 20 - that's only 5%! As a result, the number of drugs approved by the FDA decreases each year, making it even harder for producers to get their therapy out on the market. On top of this comes the issue of cost - even for successful drugs with FDA approval, how do companies have the money for the research, trials, and production in the first place?
To answer this vital question, we must dive deeper into the business aspect of the whole production process. When it comes to drug development, the key investors vary at different stages. Basic discovery research is primarily supported by government agencies and philanthropic organizations, whereas late-stage development is mostly financed by pharmaceutical companies or venture capitalists. (2) Furthermore, to consider and make up for the research and development (R&D) expenses necessary to bring a drug to consumers, companies play with the pricing of the drugs on the market. Most of a pharmaceutical company's revenue is generated from the consistent rise in prices of established drugs. When setting prices, pharmaceutical companies take into account the drug's distinctiveness and efficacy, along with the competitive landscape. (3)
Another major aspect of drug development involves something we as a society are all familiar with - artificial intelligence (AI). As our modern, fast-paced world embraces the use of AI more and more with each and every day, AI is steadily making its way into the field of modern medicine. Although generative AI is not yet advanced enough to accelerate the clinical testing of a drug, it has the potential to shorten the lengthy process of identifying the biological target associated with a disease, screening for molecules that might interact with it (the discovery phase), and the future clinical testing of the drug itself.
The ability to quickly analyze and go through billions of data points certainly expands the potential for discovering new drugs. As machine learning technology progresses, it will further accelerate the drug discovery process. The current system of spending billions of dollars on drug development with many failing in clinical trials is not sustainable, as previously mentioned. AI has the potential to address diseases for which no treatments currently exist and to aid with drugs with dangerous side effects. However, at the same time, AI does have its many flaws. While learning tools have potential in enhancing drug discovery, they are still far from capable of managing the entire drug creation process or completely getting rid of human involvement. There are still concerns about the reliability of AI and whether we can trust AI in making critical decisions in this crucial field. (4)
Conclusion
Overall, drug development is a challenging and expensive process that involves detailed research, testing, and funding. With high failure rates and significant costs, it's clear that we need different approaches to bring new treatments to the market. While advancements in artificial intelligence and technology could help with the flow of some of these steps, it is essential to balance innovation with set methods in order to ensure that new drugs are safe, effective, and consistent. As the industry evolves, finding newer, better ways to manage these complex processes will be crucial for improving the success rate and reducing the costs of developing new medicines for us all.
Bibliography:
- MITx Videos. (2019). The Challenge of Drug Development. In YouTube. https://www.youtube.com/watch?v=jZzB9qrPFzg
- Institute of Medicine (US) Forum on Drug Discovery, D. (2009). Current Model for Financing Drug Development: From Concept Through Approval. In www.ncbi.nlm.nih.gov. National Academies Press (US). https://www.ncbi.nlm.nih.gov/books/NBK50972/#:~:text=The%20principal%20investors%20in%20drug
- How Pharmaceutical Companies Price Their Drugs. (n.d.). Investopedia. https://www.investopedia.com/articles/investing/020316/how-pharmaceutical-companies-price-their-drugs.asp#:~:text=The%20majority%20of%20a%20pharmaceutical
- Windsor, R. (2024, April 3). How AI is changing drug development. Theweek; The Week. https://theweek.com/health/how-ai-is-changing-drug-development
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