Bari Kowal, Senior Vice President, Head Development Operations & Portfolio Management at Regeneron, discusses her experiences about how Regeneron rapidly and successfully developed a therapy to treat COVID-19.
Regeneron’s monoclonal antibody therapy was one of the first therapies to enter the market to treat COVID-19. The treatment was used early in the pandemic and received emergency use authorization by the FDA in November 2020. Many in the industry have been curious about how Regeneron rapidly and successfully developed a therapy to treat COVID-19. In this interview, Bari Kowal, Senior Vice President, Head Development Operations & Portfolio Management at Regeneron, will discuss her experiences.
Moe Alsumidaie: Among the many obstacles faced when executing clinical trials under such urgent circumstances, what was the most challenging from a clinical development perspective, and how did Regeneron overcome it?
Bari Kowal: The sense of urgency required to manage clinical trials amidst a pandemic is something we’re used to at Regeneron. Our response was to ensure we were resourcing appropriately to tackle what lay ahead of us. Early in the pandemic (Q1 2020), we began to think about three things: what kind of antibody cocktail we needed to develop, how we were going to plan in a matter of days—not weeks or months—and finally, how were we going to conduct the studies and execute them efficiently. It was groundbreaking to develop an antibody cocktail that quickly. There was a shared sense of determination across the company to complete the analysis to get it from a concept to an Emergency Use Authorization (EUA) approved therapy.
MA: Regeneron’s monoclonal antibody therapy was pushed through quickly. What was that experience like when it came to getting that therapy through trials and out to patients in such a short time frame?
BK: Our company commitment to doing the right thing, our decision-making process, and our experience creating innovative technologies enabled the process to happen quickly. Early in the pandemic, we did some work on our IL-6 receptor antibody, sarilumab, which we thought could be a potential COVID-19 treatment. Although we didn’t see efficacy there, we ran those trials swiftly, which gave us a strong foundation for the monoclonal antibody cocktail. We also presented our results from the monoclonal antibody trial to the FDA, other regulatory agencies, and physicians. All parties had the necessary confidence in the safety and efficacy of our therapy and that this would be a viable treatment for patients. It was fascinating to see how we could positively impact the globe with treatment options for COVID-19.
MA:Tell me about how you upheld Regeneron’s scientific values when the globe was desperate for vaccines and therapies.
BK: Scientific rigor is at the heart of what we do. Our tagline is “Science to Medicine.” We adapt rapidly, even in a remote environment. Every time I’m asked how we did this so fast, I note we didn’t have to change how we went about doing things. We were already taking thoughtful action when we needed to, and we’ve always adapted rather nimbly to evolving situations and new data. So, while the speed and demand during the pandemic were like nothing we’d ever come across, we were able to pivot based on our demonstrated ability to remain flexible. Of course, one crucial element to our success is that Regeneron has built an unprecedented end-to-end suite of proprietary technologies for drug discovery, development, and manufacturing that has been used to develop transformational medicines over the last three decades for several different diseases, including COVID-19.
I don’t know many other companies that have instituted such a rigorous and robust program for COVID-19. Ultimately, we felt it was essential to have the necessary data to be confident in the therapy we developed.
MA: How did you keep your non COVID-19 pipelines moving forward during the ongoing pandemic?
BK: Managing our pipeline during the pandemic was undoubtedly not an easy task. Some colleagues and I were reminiscing about our work in January 2020. At that time, my team put together an impact assessment given our early knowledge of COVID-19 appearing in several countries outside the US. We could not have predicted what was coming, but we felt prudent to plan for the best- and worst-case scenarios proactively. We started by looking at our drug depot locations and whether they were affected before COVID-19 impacted the US. We acted on then-current data to plan for additional supplies for our existing trials.
This ability to assess and direct the situation early was how we limited the effect on our portfolio at large. Some of our studies had to pause at specific sites with some countries on lockdown, but where we could keep going, we kept going. Ultimately, we began employing some of the decentralized tactics that aren’t necessarily new but weren’t utilized on an ongoing and consistent basis. For example, as we look at home health, you can do a fair amount to treat patients remotely with a home nurse—such as drawing blood and virological sampling. We also used telemedicine when patients could not visit our sites and asked patients to record their symptoms using their own electronic devices. I’m grateful to say the impact on our pipeline has been limited during this pandemic, and I indeed attribute that towards the planning that we did to prepare ourselves.
MA: Professionals in clinical operations tend to be very conservative about running their trials and want things to be done the traditional way. And you keep mentioning that Regeneron has an innovative culture, but I’m sure there are always naysayers out there. How has this challenge essentially changed the perspectives around implementing novel decentralized approaches in clinical trials?
BK: I think this is a turning point for our industry and clinical trials. I have seen the industry as a whole recognize how we have progressed our trials at a speed that we hadn’t in the past. Regeneron intends to take advantage of the lessons learned from this past year. With that being said, I don’t expect us to constantly be moving at the speed of the pandemic in the future. I think that’s unreasonable for a standard trial, but I know we can take away key learnings on how to plan and conduct tests faster and be nimbler as an industry, not just at Regeneron.
There are limitations to our innovation from a regulatory standpoint. There are regulations and guidelines that we must follow. As a leader of our clinical trial execution at Regeneron, I have spent much time this year thinking about how we can make development more innovative. For example, we’ve developed novel digital endpoints using wearables to get information for our trials, which we hadn’t in the past. We’re using insoles to predict gait and falls in some of our skeletal muscle trials. We’re also conducting pulse wave analysis to predict heart failure. These are technologies that we hadn’t been looking at as much in the past that we’re starting to look at now to get more real-time data.Through the pandemic, it’s become apparent there are easier, less costly, and more patient-centric ways to execute a trial.
MA:What will drug development look like in the post-pandemic world?
BK: We’ve internalized more of our trials and assessed whether our operating model could adapt in ways that will enable speed and cost-efficiency. For example, we developed a role to focus specifically on innovation, which we didn’t have before. While we’ve had pockets of innovation roles in our patient and digital endpoint groups, this role will coordinate across all of global development and look at how we utilize the various aspects of innovation—whether that’s happened in our systems group or even within the Regeneron Genetics Center, to benefit the system as a whole. We’ve also hired those who specialize in operational analytics within clinical development. These data scientists are reviewing operational data, not just our clinical data, to extensively benefit our modernization of clinical trial work.
It’s through that lens that I’ve been thinking about our work. What are the roles, and who are the right people to carry the future of Regeneron? We thought a lot about what the clinical research associate of the future looks like. I believe remote monitoring is taking place, and analyzing data in ways that we haven’t been able to before is within our immediate future. This new, transparent digital data flow hasn’t been perfected yet, but we’re certainly on our way.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.