SVP and Virology Therapeutic Area Head, Gilead Sciences
On New Year's Eve 2019, Diana Brainard received a forwarded email from a team member that caught her attention.
A colleague had heard early reports about a cluster of undiagnosed viral cases around Wuhan, China, that looked a lot like pneumonia. Brainard, head of Gilead Sciences' viral therapeutics area, immediately thought of one of her team's clinical projects: remdesivir, an antiviral created to target Ebola then later tested against a suite of little-known respiratory viruses.
"We had just received the animal data for remdesivir for respiratory viruses," Brainard recalled of her thoughts at the time. "I thought, 'Oh my gosh, this might be something that remdesivir could address. Let's hold tight and keep our ear to the ground.'"
In early January, the People's Republic of China released the genome sequence for what would soon become known worldwide as the novel coronavirus, or SARS-CoV-2, and Brainard and her team immediately went into "overdrive" to get remdesivir into the clinic as a possible therapeutic—even before the virus took the world hostage.
Brainard and Gilead's speed in getting to remdesivir into clinical trials played a major part in the drug's early emergency use authorization to treat severe COVID-19 patients, one of the few therapies months into the pandemic with such an approval.
Remdesivir's story is one of teamwork, vision and a focus on the patient, but also key leadership from CEO Daniel O'Day, a Roche veteran who learned the pandemic ropes from his experience during the 2009 swine flu outbreak, Brainard said. But at the core of that effort was Brainard herself, a 10-year Gilead vet who took her experience in viral infections and helped spin a winner in remdesivir.
"There was a chance for us to make a difference, and if we were going to do that, we were going to have to work really hard," she said.
Brainard, once an HIV immunology physician at Massachusetts General Hospital, joined Gilead in 2010 as director of clinical research for its hepatitis C and liver disease portfolio. After seven years in that arena, Brainard switched over to Gilead's bustling HIV portfolio as head of viral therapeutics—a return to her roots, as she described it.
One of her projects was discovering exactly where remdesivir could fit into the company's plans after the drug failed a pivotal trial in Ebola, which has broken out periodically in West and Central Africa since 2013.
After the New Year's Eve email, Brainard's team identified remdesivir as a possible option for COVID-19 and acted quickly to get it into clinical trials. That hard work eventually proved tentatively successful: after years in development, remdesivir's early trial results in treating severe COVD-19 patients earned it the FDA's emergency use authorization in May. The agency followed that up with an expanded authorization in moderate patients in August.
Gilead accomplished that five-month sprint to an approval despite COVID-19 lockdowns that hampered clinical trials and took workers out of manufacturing facilities early in the process, Brainard said. Gilead forged ahead, even when it meant acting without knowing what came next.
"All of these things are shifting as we’re working, and I think that not being paralyzed has been a really critical element of our success," Brainard said. "But of course, you have to be comfortable with the idea that you’re going to make some decisions that don't work out."
Another issue was supply, which Brainard highlighted given that remdesivir is "hard to make." Gilead only recently announced it was prepared to meet remdesivir demand in real-time and signed a deal with the EU to provide up to six months of supply.
It's not a win set in stone, however. In October, the World Health Organization released preliminary results from a global trial involving 11,266 COVID-19 patients in 30 countries who were treated with one of four drug regimens, including remdesivir. The drug “appeared to have little or no effect on hospitalized COVID-19” patients, as measured by the need for ventilation, the length of hospital stay and overall mortality, according to the study, which was posted (PDF) on the journal preprint site medRxiv.
A 'collage' of influences
Months into the pandemic, Gilead isn't done looking at possible uses for remdesivir, marketed as Veklury, in COVID-19 patients.
Just last week, data from a U.S. government-led, placebo-controlled, double-blinded study showed remdesivir cut death rates by 70% in patients receiving low-flow oxygen and cut recovery time by 86% in severe patients.
Brainard's comfort level at the razor's edge for her company is the product of a number of mentors in her life: O'Day, who leads by example with his communication skills; CMO Merdad Parsey, who helped Brainard focus on thinking "really critically and focus in on the facts;" and her husband, who supported her during trying times. Those influences are a "collage," she said, that drives her work every day.
"I’ve been able to pull out lessons and recognize the piece of greatness in many different people and create a collage of what good looks like," she said. "One of the things that I love about my job is that projects that we work on are really bigger than one person."