Takeda is sorting through the rubble of a chaotic year in R&D to figure out what worked and what didn’t as it overcame an unprecedented disruption amid the pandemic.
Internally, they’re calling the project Silver Linings. Jeremy Chadwick, head of the company’s global development office, said the goal is to take some of the things they learned and apply them to Takeda’s future R&D operation, which typically has 100 or so trials going at any given time.
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“You have multiple therapeutic areas in the hundreds of clinical studies in multiple geographies, and you're trying to manage this impact of COVID,” Chadwick said.
Takeda quickly halted all research, both ongoing trials and studies in development, save for a few in rare diseases and cancer. This was necessary as the spread and threat of the virus remained uncertain and information was changing quickly.
Chadwick puts the challenge to restart research into two buckets, the most difficult being getting medicine to the patients.
“Having run studies for over 30 years, there's nothing worse: if you've got an ongoing study, and a patient who's in a clinical trial, if all of a sudden you can't get drug to that patient,” Chadwick said.
The second problem was getting studies started and enrolled, but, again, if there’s no medicine to give a patient, there’s no trial.
“We had this on a global basis,” Chadwick said. “It’s really complex, in thousands of patients and dozens of countries.”
Takeda first faced disruption in China—the virus is believed to have emerged from the city of Wuhan in late 2019—where the company was conducting a number of studies.
Chadwick remembers early conversations, where they said, “Boy, imagine if this got worse and went to multiple other geographies?” The company began brainstorming ways to ship drugs to patients in other jurisdictions during those early days, even as they assumed the outbreak would be beaten before it advanced beyond China.
And of course, the virus did not stay within any border, eventually erupting into a global pandemic that has since killed more than 4 million people.
“I for one did not foresee COVID becoming as bad as it was,” Chadwick admitted. Companies are always evaluating risk, but Chadwick doesn’t think anyone was prepared for a situation where “the whole world grinds to a halt.”
But everyone rose up to make sure critical research could keep going, from the doctors and nurses operating studies to Takeda’s staff, from vendors who move drugs to patients to clinical research organizations that monitor the studies.
“We have folks who worked basically all through the night,” Chadwick said. “I was just incredibly impressed. We've had people pull together.”
Chadwick was also impressed by how much companies in the industry pulled together to share their lessons learned along the way. He remembers being on the phone with his peers at GlaxoSmithKline, Sanofi, Pfizer or Merck, asking how they were tackling a particular issue.
“Nobody was sitting, saying, ‘Hey, this is some piece that I've learned, I'm not going to share,’” Chadwick said.
The industry has collaborated in the past, but this was different. Everyone knew, “the quicker we can get beyond this, the better.”
And eventually, Takeda and its peers figured out ways to use technology to minimize interaction in clinical trials and ensure patients got their medicine, regardless of where they were in the world. Chadwick said Takeda began hearing from patients who were eager to get involved again once they understood the risks and how to keep themselves safe.
“As the impacts of COVID started to be better managed at a country level and … at the regional level, Takeda like many, many companies started to get studies going,” Chadwick said. “Patients started to want to come back on site.”
Chadwick credits regulators in the many countries where Takeda operates with quickly handing out guidance to support remote patient monitoring and other technology, which allowed the company to respond to the rapidly changing situation.
“It was constant changes in regulations and they weren't consistent—and this isn't a criticism. They vary from country to country,” Chadwick said.
Takeda brought together a team across its operations to address regulatory issues in “a massive communication process.” At the same time, the company’s employees were dealing with the transition to remote work just like the rest of the world.
All the small things
The company has slowly ramped back up to its previous operations. Things are not back to normal—Chadwick said “that doesn’t exist” anymore—but research is once again happening.
The Silver Linings project has identified many lessons already, most obviously, the realization that more communication can be done virtually. But the company is also looking more at virtual clinical trials and telehealth to improve future studies.
“Obviously, the more you can make [clinical trials] virtual, the easier it is for the patient and the better it is for everybody, because you're also saving money, which ultimately benefits everybody,” Chadwick said.
Takeda is considering both technology and process improvements. They want to design study protocols that require the fewest patients to get the best-quality results. That means using more real-world data to inform research. Technology can also be used to ship drugs to patients or create electronic consent forms.
Trials have been getting more expensive and more difficult to run, Chadwick said. Enrollment is getting more competitive, and recruitment is just taking longer.
“Everybody knows that running clinical studies is expensive,” Chadwick said. If trial visits can be cut down and turned virtual where possible, or data can be recorded by the patient on an iPhone instead of via a clinic visit, “that saves costs, and it's small things like that.”
The pandemic is not yet over, but Chadwick is confident that Takeda, and the entire industry, is much better placed to weather future spikes or catastrophic events.
“We've already been through so many things. We've got the playbooks. We're using technology. We know what to do,” Chadwick said. “We're much better prepared to deal with something like this again.”