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Enhancing Human, Animal and Environmental Health: Will We Realize the Promises of Animal Biotechnology?

May 25, 2018
Editor’s Note: As part of BIO’s 25th Anniversary celebration we will be spotlighting biotechnology innovations that have made a major impact over the past 25 years. This “Innovation Series” will publish on the 25th of every month throughout 2018. In the fifth installment we spotlight food and agriculture biotechnology. 

In February, we wrote about how the discovery and harnessing of agrobacterium has enabled us to improve plants to benefit humans and the environment. We can thank this technology for the sustainable supply of commodity crops, healthy fruits and vegetables, and the products that can be made from them, that fill our local grocery stores. But, the benefits of biotechnology don’t stop with plants.

While it's well known that humans have been genetically modifying organisms for thousands of years, the modern era of genetic modification in animals actually began in the 1970’s with the first genetically engineered animal (a mouse created in 1974 by Rudolf Jaenisch and Beatrice Mintz) and really took off in 1996 with the birth of Dolly the Sheep at The Roslin Institute.

Since then, we’ve seen tremendous promise in the applications of animal biotechnology.

Take the salmon for instance. Today, salmon ranks as one of the most consumed seafoods in the United States, along with shrimp and tuna – and for good reason. The pink-fleshed fish is a great source of high quality protein and the heart healthy omega-3 fatty acids. However, both wild Atlantic and Pacific salmon are endangered and threatened, respectively, igniting an industry for farm-raised salmon. To meet demand for the popular fish, researchers began innovating ways to raise salmon sustainably, and in 1989 AquaBounty Technologies unveiled the AquAdvantage® Salmon – a genetically engineered salmon that requires 25% less feed to grow to market size when compared to conventional Atlantic salmon. This is a significant advancement in the production of farmed salmon, which comprises two-thirds of the salmon consumed in the United States.

Moreover, animal biotechnology can also help solve human health challenges. For example, ATryn® is a recombinant form of human antithrombin developed in genetically engineered goats, by what was formerly GTC Biotherapeutics, to prevent blood clots in antithrombin deficient patients. Similarly, SAB Biotherapeutics is using genetically engineered cattle and goats to develop antibodies for human diseases such as influenza, MERS, SARS and Ebola.

Looking to the future, there is promise that animal biotechnology can provide benefits to farmers’ and ranchers’ livelihood and animal welfare as well. Researchers have begun genetically engineering cows to be resistant to mastitis – a common bacterial infection found in a cow’s udder that can be costly to farmers due to decreases in milk production, labor to tend to infected-cows and veterinary care.

Researchers were also able to use animal biotechnology to mitigate environmental impact. Using genetic engineering, they developed Enviropigs, which contained an enzyme in their saliva to break down phosphorous and prevent it from passing through to the animal’s manure. Without this enzyme, phosphorous can run off from waste into bodies of water causing extensive algae blooms. These blooms kill fish and plants by restricting light and oxygen in the water. Using biotechnology to prevent this form of pollution is notable, especially when considering the amount of pigs that need to be raised to meet demand, as pork is the most widely consumed meat in the world.

However, when the first genetically engineered animal – the AquAdvantage® Salmon - was created back in 1989, regulations for this new type of biotechnology were non-existent. It wasn’t until nearly 20 years after the creation of the genetically engineered salmon that officials began considering how to regulate animal biotechnology.

In 2008, now-FDA Commissioner Dr. Scott Gottlieb, who at the time was with the American Enterprise Institute, and Matthew Wheeler, PhD, of the Institute for Genomic Biology at the University of Illinois at Urbana-Champaign, authored the report “Genetically Engineered Animals and Public Health – Compelling Benefits for Health Care, Nutrition, the Environment and Animal Welfare.” In it, the authors detailed the promises of animal biotechnology through five buckets, including benefits for human health, food production and quality, environmental impact, animal welfare and the making of industrial products. In the report, the authors also made a strong case for creating a regulatory pathway for commercialization of these beneficial technologies.

“There are now dozens of products under development derived from genetically engineered animals that hold promise of benefit to human health,” said Dr. Gottlieb at the time the report was issued. “But the practical benefits of this technology have not yet reached American patients and consumers primarily because of regulatory and political obstacles rather than the limits of science.”

A little less than one year later, in 2009, the FDA made final it’s regulatory guidance governing animal biotechnology. More than a decade in the making, the process is based on the Food, Drug and Cosmetic Act’s New Animal Drug (NAD) framework.

And in less than one month after, the FDA approved ATryn®. However, it took another five and a half years for the AquAdvantage® Salmon to be approved, which was in 2015 – 26 years after the salmon’s creation. To date, these two products are the only ones to be approved by FDA, with the salmon still in political limbo and not commercially available.

Livestock producer groups – excited by research that modifies animals to resist disease – are reluctant to invest in a technology with such an unpredictable regulatory environment.

With only two animal biotechnology products approved to date, much of the funding for research has dried up. Taking the lessons from AquaBounty’s experience to heart, some companies have halted animal biotechnology projects altogether, such as the Enviropig, whose funding ran out in 2012. The only trace left of the Enviropig is in the form of genetic material currently stored in a genetics repository in Canada.

Even so, the promises of animal biotechnology are considerable. And as new challenges arise, there is hope that animal biotechnology will solve real-world challenges.

In October 2017 the FDA ceded its regulatory authority of animal biotechnology to the Environmental Protection Agency for the regulatory approval of the Oxitec Mosquito to combat the Zika virus. The Oxitec mosquitoes are engineered to be self-limiting by producing offspring that causes them to die before adulthood, thus reducing the overall mosquito population and risk of Zika spreading.

Researchers are also using animal biotechnology to develop hornless dairy cows, reducing risk of injury for dairy farmers working in close proximity to animals and saving the cows from horn removal.  Similar research has created pigs resistant to porcine reproductive and respiratory syndrome (PRRS), a virus that can kill the animal, spread rapidly though the herd and costs pork producers $600 million annually in preventing and addressing.

Exactly one decade ago, the report, “Genetically Engineered Animals and Public Health” was released with the objective of outlining the compelling benefits of animal biotechnology:
“Genetically engineered animals embody an innovative technology that is transforming public health through biomedical, environmental and food applications… These numerous benefits will be realized only when we resolve policy obstacles that are limiting investment in research and holding back product development.”

As BIO celebrates 25 years of innovation, we can reflect on the promises seen in animal biotech research. Looking ahead, will these promises be realized?  Or will we let other countries be at the forefront of this innovation?