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The drug development process

Every medicinal drug has to go through the drug development process before being approved for human consumption. The drug development process involves everything, from bringing up a novel drug right to the stage where it is ready for human use. It can take 10 to 15 years for a drug to be designed, developed before finally being approved for use in patients. In some circumstances, the drug development and approval process can be expedited, for example, if the drug is the first available treatment for a condition, or it shows a significant benefit over existing drugs.

 

Pharmaceutical regulatory authorities, like the U.S. Food and Drug Administration (FDA) in the USA and the Medicines and Healthcare Regulatory Agency (MHRA) in the UK, are responsible for overseeing and regulating therapeutics. These include prescription and over-the-counter drugs, vaccines, cell therapies, and medical devices. They play a key role throughout the drug development process and design rules to ensure the safety, efficacy, accessibility and security of approved drugs. Throughout the development of the drug, the responsible pharmaceutical company has to conduct pharmacovigilance activities. Ultimately, pharmaceutical companies develop drugs using various developmental techniques that are approved by the local pharmaceutical regulatory body.

 

Carol Livermore, professor of Engineering at the Northeastern University, along with her team of researchers recently launched a spinoff company named ApreX Biotech. At ApreX Biotech, the research team has used origami, the ancient Japanese art of folding paper into unique shapes, to develop tissues that mimic tissues in the human body. These tissues could potentially have a vast array of medical uses. These range from testing new medicines right up to growing organs suitable for transplants. These tissues can help detect what is safe or toxic to humans and thereby massively reduce the drug developmental expenses. Furthermore, they could even be potentially used to create advanced cosmetics, foods, and personalised medicine in the future.

 

Harman Singh