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Health

Four Current Challenges in Drug Development

There are many diseases, disorders, and conditions that negatively affect the human body—and an even more significant number of drugs and therapies designed specifically to combat them. Before drugs can make it to market, they must first make it through a remarkably complicated process to prove their worth. This process, known as drug development, begins by identifying a target within the human body that, with some manipulation, could show a therapeutic effect on the disease.

After the target is identified and validated to show a therapeutic effect, researchers develop assays of compounds that could theoretically act upon the identified target. Researchers screen potential compounds and select a promising few for further research to determine their efficacy on the target. The lead compound that emerges undergoes optimization to home in on its potency and selectivity. It may also undergo animal testing for safety before reaching the clinical trial stages of human testing. 

Fortunately, new tools, new techniques, and new research methods are enhancing the efficiency of the drug development process. A technique known as MicroScaleThermophoresis (MST) helps researchers optimize assays to study biomolecular interactions. Using an MST tool, researchers can measure biomolecular interactions by detecting changes in fluorescence intensity while applying a temperature gradient over time. This method requires far less sample material than traditional methods and is also much quicker since researchers can obtain a dissociation constant in as little as 10 minutes.

Challenges in Drug Development

Each stage of drug development is time-consuming and complicated. Drug development requires careful analysis and repeated testing during each step of the process. Significant challenges in drug development can inhibit effective drugs from efficiently reaching the market. Current challenges include: 

  • Lack of knowledge regarding biological processes. Many diseases and disorders affect the body in a variety of ways, some of which remain unknown. It is often difficult to identify a potential biological target at which researchers can direct drug discovery efforts. As a result, researchers often spend inordinate amounts of time during the target identification, target validation, and discovery stages, determining which targets and molecules may influence the disease process.
  • A high degree of uncertainty. Even after target validation, there remains a high degree of uncertainty regarding which—if any—molecular compounds may act upon the target in question. At any point, there exists the possibility that the potential compound may fail before proceeding to the next stage. As a result, most potential drug compounds never make it past the early stages, and those that do may later be proven unsafe or ineffective for humans.
  • High costs. Currently, most drug development stages come with high costs—including the investment of resources, time, and effort by laboratory personnel. In particular, the optimization stage—the elaborate process of adjusting the chemical and pharmacological properties of a compound—often requires an enormous investment of time, money, and resources. Because most compounds never reach clinical trials, drug development’s overall cost can prove to be a serious concern.
  • Lengthy timeline. Each of the above challenges lengthens the development process, and further delays access to potentially life-changing—or life-saving—pharmaceuticals. Steps must be taken to expedite the drug development process to alleviate these timelines.

How Can We Overcome These Challenges?

New techniques and tools can speed the drug development process and help eliminate unsatisfactory compounds earlier in the process, saving time, money, and resources. With modern methods like MST, faster, more accurate, more cost-effective research could translate into early access to more effective drugs at a lower cost to consumers. 

Sources: 

https://www.ncbi.nlm.nih.gov/books/NBK195047/  

https://www.biocompare.com/Bench-Tips/148452-Measuring-Interactions-Using-Microscale-Thermophoresis/ 

https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process 

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