When Stephen Castel first met with a group of Maori and other Pacific Islanders in New Zealand and told them about a pharmaceutical company's genetic research plans, the locals realized that he wanted to benefit without thinking too much about the genes of the local population. I was worried that he might be doing something wrong.
Instead, Dr. Castel and his colleagues explained, they were aiming to strike an unconventional deal in which participating communities would receive a cut of the company's profits in exchange for depositing their genetic heritage. Dr. Castel also vowed to patent the drugs his company develops from its partnerships, rather than patenting genes, as many other companies have done.
“A lot of people said this was a crazy idea and wouldn't work,” Dr. Castel says. But five years after that first conversation at the Indigenous Health Research Council in March 2019, Dr. Castel's gamble is starting to pay off for both sides.
On Tuesday, his Seattle-based company Valiant Bio entered into a $50 million deal with pharmaceutical company Novo Nordisk to develop treatments for metabolic diseases such as diabetes and obesity using data collected from indigenous peoples. announced a partnership. Valiant Bio will distribute a portion of the funding to the communities it works with in nine countries and territories, including Māori, to ensure that medicines resulting from its work are affordable and accessible to those communities. .
Indigenous genetics experts said the agreement was a positive step for a field that has been plagued by accusations of exploitation and a gulf of mistrust.
“Researchers used to go into Native communities with empty promises,” said Crystal Tsosie, a geneticist and bioethicist at Arizona State University who runs a nonprofit genetic repository for Native peoples. “It was,” he says. “Variant Bio is, to my knowledge, the only company that explicitly talks about profit sharing as part of its mission.”
The concept for Variant Bio was hatched over drinks in August 2018 at a bar in Manhattan between Dr. Kastel and Kaja Wasik, who became friends while doing graduate work in genetics at Cold Spring Harbor Laboratory on Long Island. Born.
Although they were exposed to the glare of fluorescent lights for their laboratory research, they shared a passion for international travel, and they backpacked together in Peru and Chile. I fell in love with it. They dreamed of starting a company that could reach remote locations.
At the time, drug companies were establishing partnerships with biological repositories such as the UK Biobank, which stores biological samples and health records of half a million people living in the UK, to explore links between genes and disease.
However, these databases primarily consist of genes from people of European descent.
“What is the value of sequencing the 500,001st British person?'' Dr. Castel said. “There is so much insight that can be gained by studying the same group of people.”
He and Dr. Wasik were more enthusiastic about recent discoveries from underrepresented groups, such as the discovery of a novel genetic variant that affects metabolism, first identified in the Inuit population of Greenland.
Such mutations are more common in historically isolated populations, either because they confer some functional benefit to people with a particular diet or lifestyle, or simply because of historical coincidences, and their As a result, they may be easier to identify. However, they may also serve as promising drug targets to help a wider population of the world.
With $16 million in seed funding from Lux Capital, a New York City venture capital firm, Dr. Castel and Dr. Wasik quit their jobs and began working full time for the startup. Although Dr. Wasik traveled to eight countries in Africa, Asia, Europe, and the Pacific during the company's first year, Dr. Kastel faithfully built the software platform from his base in the United States most of the time.
They asked an ethics advisor to develop a profit-sharing model and went on a hearing tour. They knew from the beginning that they had to tread carefully.
In 2007, members of the Carichiana tribe in Brazil claimed that their community had been “cheated, lied to and exploited” by scientists who had their blood and DNA taken, which was later sold for $85 per sample. he told the New York Times. Tribal members say they were wooed with promises of medicine, but received none.
Ten years later, there was still no consensus on the best way to do such work. To protect against so-called biological piracy, many countries have ratified the Nagoya Protocol under the United Nations Convention on Biological Diversity. This protocol calls for “equitable sharing of the benefits” derived from genetic resources. However, this protocol excluded human genomic information.
During Dr. Castel and Dr. Wasik's visit to New Zealand in 2019, researchers and community members spoke of an earlier attempt by U.S. researchers to patent an obesity risk test based on genetic research conducted in Samoa. I was troubled by this. The researchers' universities did not include their Samoan collaborators as co-inventors on their patent applications, nor did they have formal profit-sharing agreements with local institutions. (That patent application has since been abandoned, and the researchers said they always intended to share the profits with their partners.)
One of Valeant's first advisers was Keol Fox, an outspoken geneticist at the University of California, San Diego, who was a harsh critic of the Samoan research.
“This is an extension of other forms of colonialism,” said Dr. Fox, a Native Hawaiian who accompanied Dr. Wasik and Dr. Castel on their visit to New Zealand. He believed Valiant could lead by example.
The company's profit-sharing program dedicates up to 10 percent of a project's budget to community programs, typically by providing funding to local organizations.
For example, the company has funded scholarships and academic conferences for several local health organizations as part of New Zealand-based research into the genetic causes of kidney disease and other metabolic disorders in Māori and other Pacific peoples. Spent $100,000 to provide. Indigenous people.
“Before Variant, we didn't do that because we couldn't afford it,” said Tony Merriman, a gout expert at the University of Alabama at Birmingham who has worked with the company on two projects in the Pacific region. ” he said. .
Dr. Merriman said he was also grateful that the company made sure to share its findings with the community. In French Polynesia, the company's research concluded that the local population was not at increased risk of fatal drug reactions that had been observed in certain populations in Asia, leading to increased access to gout medications. promoted.
Novo Nordisk's new agreement begins the second long-term phase of its profit-sharing program. The community will share 4 percent of Valeant's profits and 4 percent of its shares if the company is sold or goes public. This percentage is comparable to the royalties universities receive for patent licenses.
