David Ricks, the CEO of Eli Lilly, said that the life sciences industry answered two of the biggest criticisms it faced prior to the COVID-19 pandemic.
“One is that we’re slow and the other is that we don’t work well together,” Ricks said at the Health Evolution Summit. “On those two dimensions, we have performed pretty well.”
The industry collaborated and worked at record speed to produce COVID-19 vaccines and therapies, Ricks said. In the case of Eli Lilly, they had the first emergency use authorization (EUA) for a monoclonal antibody therapy, a project that began in March 2020 and got the EUA in November. On the collaboration front, he said there was a shared purpose across the industry that made this drug development move quicker.
“I probably went one or two days between calls with other CEOs in the industry on how we can manufacture and support their efforts. It was really a remarkable moment to say, ‘What can we do to respond to the public health crisis?’ I hope that persists because I think together, we can do bigger things than just worrying about our own space,” Ricks said.
Ricks was joined at the Summit by Christophe Weber, CEO of Takeda Pharmaceutical, Amy Abernethy, MD, PhD, President of Verily’s Clinical Studies Platforms, and Chris Toth, CEO of Varian. The four shared what lessons life sciences companies can take from COVID and how these learnings can inform quicker drug development and improved clinical trials.
Lessons and opportunities from COVID
Weber agreed that COVID proved that flexibility leads to greater industry collaboration and faster speed of approval. “I think the COVID crisis has demonstrated that for a very regulated industry and environment, when you bring more flexibility and more judgment, things can go much faster,” he said. “All the different partners have been more flexible, have collaborated and we’ve seen the speed of approval and the speed of partnership has been much greater.”
He says that the number of tools that can be used to develop breakthrough therapies is a huge opportunity for a research and development-driven company like Takeda. Cell therapy, gene therapy, monoclonal antibodies, AI and digital are potential modalities for disruption, Weber said.
Abernethy was at the FDA as COVID vaccines and therapies were developed and approved in record time. She says that it was clear there was a value in the industry’s “ruthless collaboration,” as she called it, which led to the quicker approvals. Moreover, she noted, this wasn’t just collaboration between public and private health organizations, but within the government itself between FDA, CDC, and HHS.
Abernethy also saw how innovation engines and medical discoveries began to move faster during COVID, which is one reason she left FDA to go to the private sector. She is concerned, however, that the regulatory infrastructure isn’t ready for the wave of innovation that’s coming down the pike, particularly when it comes to therapies for rare diseases and small populations.
“If we’re going to have all of these new innovations that are for hyper-personalized therapies, we’ve got to actually have an infrastructure that’s ready to receive and review and get them to people who need them,” Abernethy said, adding that the coming wave of AI-based therapies is similarly going to need to be accommodated and regulated for faster, safe development and approvals. “I think it’s very important that we anticipate where this future is going, and then also anticipate how to solve for that, so we make sure safe and effective therapies get to patients.”
For Ricks at Eli Lilly, the company isn’t just dealing with the FDA but regulators across the globe as well. He sees that in many cases, there is a widening gulf of capabilities between the various global regulators, which makes drug development a challenge on an international scale. Weber was less concerned about regulators and said the biggest challenge in drug development will be the health care system accepting and integrating these breakthrough therapies.
“It will require more financing whether we like it or not because it doesn’t come free. And if the health care system is not efficient enough, what will happen is that with these breakthrough [therapies], patients won’t be able to access them. Discussions on how the U.S. health system can move towards value and greater efficiency are important because otherwise we won’t be able to leverage these breakthroughs,” Weber said.
