Gabriel Perna | September 15, 2021
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.
David Ricks, Eli Lilly
At the heart of drug development is evidence-based clinical trials, which Ricks said has needed a transformation for some time. The industry standard, he said, from when a company files an Investigational New Drug Application (IND) to when it gets FDA approval is nine years.
Eli Lilly has cut that down a little in recent years through process improvements. The biggest impediment, Ricks said, remains recruiting patients for clinical trials and studies. It typically takes two to three years. The traditional approach, finding patients through academic medical centers, isn’t efficient, is costly and doesn’t result in a balanced mix of patients.
“When we did our COVID therapeutics, we didn’t do it that way. We learned a lot by having more of a direct patient approach. I think in a few years that will become much more of the standard. And with good data support and self measurement for many diseases, we can make a lot of progress that way,” Ricks said. “We’re reaching out to people directly. If they have risk factors, we screen them, and they’ll enter the study. I think for large and common diseases, this is a breakthrough.”
Abernethy said that two trends will dictate the future of drug development and evidence-based clinical trials. One is the 21st Century Cures Act will lead to earlier stage trials and faster approvals, with the expectation of continued evaluation since these therapies will have been tested on a smaller number of people. The second trend is that the industry’s one-to-one clinical trial strategy will give way to platform trials, which pairs clinical trial data with real-world evidence on multiple treatments. She noted that the U.K. has used this method during COVID.
Along with the questions around reimbursement, faster drug development also brings up potential ethical and moral concerns. This is particularly the case, Toth noted, when it comes to CRISPR, which is used to edit genes. Weber said it’s something the industry has had to thoughtfully address as these breakthrough innovations start to make waves.
“In our case, we created an ethical advisory board with ethics experts to discuss this issue because of course you want to do the right thing for society. It’s not an easy domain, but it would be too easy to dismiss these innovations just because there are ethical issues. We need to leverage them in the right way otherwise we’ll miss out on enormous potential benefits,” Weber said.
Areas of impact
In general, Toth said that he expects the industry to come out of COVID collaborating more frequently with the federal government to expedite clinical trials. “It’s going to be on the industry, obviously in partnership with FDA and various regulatory agencies, to look at how do we go faster? How do we do it in a responsible way? Just because we have a hypothesis doesn’t automatically mean that the drug or the therapy approach will be the right approach, but this nine-year cycle…can we get that to five years? How do we take some of the one-to-many approaches? How do we look at this with an additional sense of urgency?” he said.
To close out the session, Toth asked the other three discussion leaders which area of medicine they thought these new innovations could impact the most.
Weber said that neuroscience, infectious diseases, and oncology are all areas where there is a lot of potential, which makes it hard for companies like Takeda to pick and choose areas of focus. Abernethy said as the cycle time continues to speed up, there will be more changes in what evidence generation looks like and the industry’s ability to understand matching treatments to patients. On the point of patient matching, Ricks said the biggest changes need to continue within industry collaboration.
“I think we have a huge opportunity to affect the lives of people with these conditions with new technologies and innovations. Right now, I don’t see the parts lined up particularly well, and I think innovators, regulators, and then health care providers need to collaborate more to find ways to match the right patient to these important breakthroughs,” Ricks said.