4 January 2019

The Rise of Gene Editing: How Did We Get Here

The scientific community and the world at large are still reeling from the news that a rogue Chinese scientist conducted experiments that ultimately resulted in CRISPR-edited twin girls. The scientist's behavior may have been anomalous, but the use of CRISPR and other gene-editing technologies is something we've been tracking here at Stratfor for a number of years. The potential applications spread across a wide swath of sectors, from agriculture to industry to medicine. Much as we see a tech race on artificial intelligence between China and the United States, we expect a similar one in biotech. And just as we see countries trying to regulate and set ethical standards for other technology, the same is true for CRISPR. In this compendium, you'll find not only our coverage from 2018 but also our foundational analysis on this geopolitically relevant technology.

The rapid development of gene-editing techniques is outpacing humankind's ability to answer fundamental questions about the ethics of altering the structure of life: DNA. In addition, the relatively low cost of such techniques — CRISPR, in particular — is making their use in agriculture and medicine inevitable. But, in the end, economics and religion may play as much a role in resolving these questions as science and ethics.

The most difficult ethical questions and moral dilemmas will arise when the technology is applied to human health problems. For example, should gene editing be used to prevent malaria? The obvious answer would seem to be yes. CRISPR has been used to edit the genomes of mosquitoes in research labs, now making the elimination of some populations that carry the malaria parasite a possibility. Through gene drives, an edited or inserted gene can be spread throughout a natural population, and additional field trials are likely in the near future.

Taking gene editing even further — experimenting with the human body — involves even greater ethical questions: When does life begin and how moral is it to alter the DNA of Homo sapiens? The debate will also be colored by arguments about risk vs. reward and right vs. wrong. And the discussion is likely to be shaped more by religion than science and raise question about whether humans should "play God."

Gene editing is also part of the emerging technology battle between China and the United States. For China, a looming demographic crunch makes the continued development of a domestic biotech sector in agriculture and health care particularly important.

When we look at CRISPR applications more broadly, China is second only to the United States in the number of CRISPR patents owned. The United States holds 19 percent (447) of the more than 2,000 CRISPR-related patents while China holds 17 percent (410), according to iRunway Analysis.

Perhaps it is more interesting to look at where patents are being filed compared to where the research is being done. Researchers based in the United States and Europe (be they academic or commercial) are far more likely to file patents in China than in the other direction. This illustrates the importance of China to the future global gene-editing market. The same underlying constraints that are compelling China to develop its domestic sector also present a potential import market for those exporting the new technology.

Despite its truly revolutionary potential, CRISPR had several shortcomings — limited precision and accuracy — when it made its first splash on the world stage. It took the work of scientists at the Massachusetts Institute of Technology and Harvard University to make strides toward overcoming these deficiencies.

[CRISPR] lacked accuracy because it was difficult to control accidental cuts from happening elsewhere in the genetic code, which could have detrimental or even dangerous results. It lacked precision because it was limited in how small the cuts or modifications to the code could be. But the people working with and on CRISPR systems knew the technology, with some improvement, could become more accurate and precise.

They were correct: Researchers from Harvard and MIT published two key advancements of the technique in the academic journals Science and Nature on Oct. 25. The two separate developments have successfully made the CRISPR technique more accurate and precise. In addition, the report published in Science by one of the labs that pioneered the technique even expanded the technology to include more genetic material in the form of RNA.

Besides the ethical questions about its use, CRISPR has spawned disagreements over its legal ownership. And in 2017, judges at the U.S. Patent and Trademark Office ruled for MIT and Harvard, even though others had pioneered the technique.

The ruling is at odds with the opinions of most of the scientific community, which views the discoveries of Jennifer Doudna at U.C. Berkeley and Emmanuelle Charpentier at the University of Vienna and Umea University as the seminal work. The two researchers used the technique first on simpler organisms, but the jump to eukaryotes was considered a natural step by many of their scientific peers. This is evidenced, in part, by the numerous awards that have been lauded on them in recent years.

Beyond the scientific ramifications of the ruling, there are obvious financial incentives for biotechnology companies able to license CRISPR. Not only could the decision influence the success or failure of individual companies, but it also brings to light a broader issue: In an age of rapidly advancing technology, patent holders of disruptive or geopolitically significant technologies have the ability to wield disproportionate influence as government policy catches up with scientific advances.

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