Life sciences researchers, industry and regulators responded to the COVID-19 pandemic not only with urgency but with cooperation, innovative trial designs and new technologies and approaches that could reshape work across the industry – but it will take effort and intention to ensure these changes endure past the crisis, according to experts who joined “The Post-Pandemic Life Sciences Landscape,” a roundtable hosted by SmartBrief.
Decentralized trials, hybrid approaches and remote monitoring were talked about fondly and frequently before the arrival of the coronavirus, though they were infrequently put into practice, said Kristin Schneeman, director of programs at FasterCures, a center of the Milken Institute, and co-author of the report “Lessons Learned From COVID-19: Are There Silver Linings for Biomedical Innovation?”
The pandemic accelerated use of these tools, and the FDA played a key role by quickly issuing guidance on how to continue trials in the context of COVID-19 with an emphasis on putting patient safety first and on documenting changes.
So what lessons can be carried forward?
Keep the innovation mindset. Approaches that previously might have been labeled risky because they were new quickly became necessary for risk mitigation, Schneeman said. While the current scale of funding and time investment are not sustainable, the mindset can persist after the crisis is over, enabling the industry to operationalize some of the things that have worked.
One of those is FDA master files, said Phyllis Arthur, the Biotechnology Innovation Organization’s vice president for infectious diseases and diagnostics policy. Master files are submissions not about specific products but about manufacturing processes and development platforms that might be used for multiple products, streamlining the review process.
Master protocols — which look at multiple treatments at once — and pragmatic trial design — trials in real-world conditions — also are getting more attention in the pandemic.
Take advantage of new means of communication. Meanwhile, tools that have allowed remote followup and communication with trial participants have the potential to foster better communication with patients going forward, Arthur said, creating new opportunities to educate people about their conditions and the care they need.
Put patients – all patients — first. A balance is needed that allows the treatment of patients with critical and life-limiting illnesses to continue during a crisis, said Dr. Ted Feldman, vice president of global medical affairs for Transcatheter Mitral and Tricuspid Therapies at Edwards Lifesciences. “It’s been a very difficult lesson to learn and it’s still not fully implemented. We still have many patients with life-threatening illness who are not getting therapy.”
The best innovations will need nurturing to stick around. It will be easy for the rubber band to snap back into place, Schneeman said. Obstacles that prevented adoption of new approaches to research can easily return. Changes made for the duration of the public health emergency that proved their value will require a lot of work, optimization and advocacy to remain in place for the long term.
Communication matters. Communicating badly has implications, as does communicating clearly, Arthur said. Managing expectations and communicating in a time of crisis is an art form, and leaders who can do it well are needed so people are prepared and know what to expect.
Share data. When facing a disease no one understood, the life sciences community needed real-time data about the physiology of COVID-19, Arthur said, noting that a faster, more centralized outlet than peer-reviewed journals would improve information sharing. The NIH’s National Center for Advancing Translational Sciences has been working for years on a platform for its Clinical and Translational Science Awards institutions to share and harmonize data, and the pandemic provided the impetus to get the work done and put data-use agreements in place. Those will be useful going forward, Schneeman said.
Keep the collaboration going. A lot of academic research sandboxes popped up with little or no financial or institutional support. Companies created collaborative agreements in a week that might have taken two years in the past. “We would like to capture and bottle some of those,” Schneeman said.
The entire system matters. “You can’t just have great medicines,” Arthur said. You have to have vials to put them in and people who know how to deliver them, and that takes investment across the full ecosystem of biomedicine, not from just the manufacturer of the final product. “I’m hoping as we go into the after-action part of this pandemic that we think about these products really truly from end to end as well as the resilience of the American populations and health care system to take an event like this.”
A transformative time
One of the greatest challenges from the early days of the pandemic persists today, in an industry where some functions translate readily to remote environments, but many do not. The shift was a big one at Abbot, said Ann Graves, divisional vice president for global clinical and regulatory affairs.
“I would say for the most part some of our facilities feel pretty empty right now,” Graves said. “But we have really just focused on the groups that really need to be there to continue building our devices.”
That work ramped up almost immediately, Graves noted. For example, scientists and engineers at Abbott, some of whom worked on the first test for HIV, worked around the clock to develop a test for COVID-19 in 30 days — a process that typically takes years, Graves said.
The breadth of drug development, too, was stunning. BIO developed a COVID-19 pipeline tracker to follow the progress of vaccine and treatment candidates. Within weeks, 500 programs were mobilized as the scope of the crisis became clear. Innovative discovery and vaccine platforms were put to work, and drug discovery programs looked at existing therapies that might help treat COVID-19 and its symptoms.
Despite the fierce pace of change and adaptation and the fast development of vaccines and treatments for COVID-19, that doesn’t mean trials for other conditions are proceeding faster. Enrollment overall is down, trials in all therapeutic areas have experienced disruptions or been stopped, and a lot of effort will be needed to regain momentum and speed.
“Research kind of ground to a halt at hospitals everywhere for a couple of months,” Feldman said.
The recovery has been bumpy as cases have continued to surge in the US and around the world, but work continues where feasible, including at Edwards, where five pivotal trials in the mitral and tricuspid space are underway. “We’re looking forward to making progress at whatever pace,” Feldman said.
Tom Parks is a health editor at SmartBrief who focuses on health care, leadership and nursing as well as care at the beginning and end of life.
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