Think about it for a moment… within the vast array of combinations of atoms in the universe, there exists potential for unique molecular arrangements that hold the power to interfere with the intricate mechanisms behind human diseases.
Finding those “magic” molecules and determining how to utilize them is far more complicated than the cliche “needle in a haystack” analogy and far more costly than many people realize. Historically, random trial and error has led mankind to discover some of the more easily obtainable therapeutics that occur in nature. Today, pharmaceutical and biotechnology research has opened the door for the discovery of obscure molecules (synthesized via chemical or biological processes) that are highly specified to interfere with unique biological targets in known disease mechanisms.
The Drug Discovery Infographic
To demonstrate the mega-investments necessary to develop a new drug (or biologic, biopharmaceutical, therapeutic, etc), I created “A Tough Pill to Swallow: illustrated guide to drug discovery” to visually explain each step in the process while giving the viewer a sense of the staggering amounts of time and money spent along the way.
Disclaimer: time & money invested in each step are not drawn to scale… it’s merely a visual representation of average overall estimates.
Enjoy! and please feel free to share….
[ Note to Mobile/Tablet Users ]
Image may be downsampled on some devices. If it looks bad, try this instead: Drug Discovery Infographic – Mobile
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The Pharmaceutical R&D Process
The first step is a developing detailed understanding the disease and forming an appropriate strategy to interfere with it. From there, high-throughput screening methods allow researchers to filter through large numbers of potential candidate molecules to find potential leads. These leads are tested and tweaked in various conditions until one or more drug candidates emerge that display all of the characteristics required to test in humans. If the molecule is determined to be safe and efficacious in a marathon of highly-regulated human clinical trials, it then goes into evaluation by the FDA for approval as a new drug.
Often, small biotechnology and pharmaceutical companies are involved in the earlier steps of lead generation and drug candidate discovery. Their technologies are usually sold to larger pharmaceutical companies to complete the more expensive stages of clinical trials, manufacturing, marketing, and distribution.
The farther along in the process that a molecule has survived, the greater the losses become if that molecule is determined to be unfit for use by the general public. It takes great diligence and honest practices to ensure that the risks are weighed against the benefits of a drug candidate. Conversely, it is possible that some drug candidates with extraordinary results (or perhaps drugs for orphan diseases with a small population of afflicted patients) may be pushed through clinical trials quickly, since withholding these molecules from suffering patients could be considered immoral.