Can synthetic biology reverse drug discovery’s ballooning costs and timelines?

While a lot of things in the world are getting cheaper, the creation of new drugs is becoming more expensive—and taking longer. Like, really expensive, and a lot longer.

The creation of a new drug today can cost an eye-popping $4 billion and take more than a decade. Compare that to, oh, I don’t know—the cost and time to develop literally almost anything. The world’s tallest building, the Burj Khalifa, was constructed for $1.5 billion and took 3.5 years. America’s newest submarine, the USS Indiana, cost a mere $2.5 billion and was wrapped up and ready to go in about seven years.

Escalating Price of New Drug Development

The escalating price of drugs can be tracked using Eroom’s law, which illustrates the expanding price and time needed for drug development. As observed since the 1980s, the cost to develop a new drug doubles roughly every nine years despite advancements such as high-throughput screening, biotechnology, and computational drug design. (If “Eroom” looks funny, it’s intentional. It’s “Moore” spelled backwards, Moore’s law being the observation that the overall processing power for computers doubles every two years.)

But change may be coming, thanks to our good friend synthetic biology.

As related in a recent Forbes article, the structure of the synthetic biology industry could offer inspiration to the pharma industry in much the same way that the Japanese revolutionized the auto industry in the 1970s.

The Forbes article piggybacked off a 2015 article published in the journal Drug Design, Development and Therapy, which stated that synthetic biology “brings the engineer’s view into biology, which transforms a biological cell into an industrial biofactory…With the recent advanced genome editing, molecular biology, and protein engineering tools, [synthetic biology] has focused its aim at creating biological devices that can produce controlled phenotypes from a given input, such as a molecular or light switch.”

With most drugs tied to discoveries of applications of natural materials, synthetic biology is poised to help by expanding nature’s chemical diversity, wrote researchers in a 2016 article in Nature Reviews Microbiology.

“There has been an emphasis on creating genetic parts, such as promoters, that generate precise levels of gene expression,” the article stated. “The generation of large libraries of well-characterized parts and the development of biophysical and bioinformatic models to predict the behaviour of genetic parts in different organisms will aid in the transfer of biosynthetic gene clusters between hosts.”

An early example, as related in “Synthetic Biology: Science, Business, and Policy,” came when the company Amyris applied synbio technology to manufacture artemisinin, an anti-malarial naturally extracted from sweet wormwood. While sweet wormwood is a great anti-malarial, it’s rare and the purification process uses diesel, which means the final product could contain toxic impurities. Amyris made about 50 genetic changes and persuaded brewer’s yeast to produce artemisinic acid, putting the drug on its way to production.

Example: Less Expensive Insulin

Another example is in the production of less expensive insulin, as reported in a different Forbes article; here, synbio can be applied to increase productivity, improve quality, and slash costs as it “designs and produces entirely new systems and functions that can be implemented in organisms.”

“With the advent of synthetic biology, the ability to explore, select and optimise the biology around us is greatly enhanced,” wrote Dr. Tim Brears for Drug Target Review. “This has led to much anticipation of significant and broad impact in the drug discovery and development field, building on some notable successes already achieved.”

Those achievements, he said, include:

• More efficient production of biologically active substances.
• Novel discoveries, such as better understanding of metabolic pathways and their interactions, and new uses of organism components to create new and interesting target molecules.
• New vaccines such as antigen genes and nucleic acid vaccines.

Synbio’s role in pharma drug discovery is still in its infancy, concludes the article in Drug Design, Development and Therapy, although it is already helping to reorient pharmaceutical research.

“The abundance of experimental chemical proteomics data has revealed the existence of multiple biological targets for a given drug,” the article states. “This raises a systemic view of poly-pharmacology, which completely aligns with the cell-based phenotypic and holistic approaches of SB. The rational-based genetic design is to SB what rational-based drug design is to medicinal chemistry.”