Craig Serra, who works in Clinical Technology and Innovation at Novartis, discusses his perspectives on clinical innovation implementation during COVID.
Many biopharmaceutical enterprises who have invested in clinical innovation pilots before the COVID-19 pandemic have now benefited—not from the innovative technologies themselves, but rather from the processes they have established to evaluate and implement novel solutions rapidly during the pandemic. This is especially the case in larger biopharmaceutical enterprises, such as Novartis, that have established a culture of innovation. In this interview, Craig Serra, who works in Clinical Technology and Innovation at Novartis, will discuss his perspectives on clinical innovation implementation during COVID.
Moe Alsumidaie: We’ve seen many challenges with COVID throughout the industry. Was Novartis prepared to address these challenges? If so, how?
Craig Serra: Unequivocally yes, and I think there were two main places that we were prepared. First, organizationally and culturally. As this once-in-a-half-century event came avalanching at us, I saw all levels of leadership enabling us to focus on being safe and to take care of ourselves, family, and each other. This has been a continual message to make sure we stay focused on that. Since that culture already existed, it appears effortless, which is just truly remarkable. Second, from that position of strength and safety, we were able to stay sharp on running clinical trials. One of the earliest actions was an extremely robust and comprehensive risk assessment of the entire portfolio, with support and leadership from a central cross-functional team made up of tremendously smart and dedicated colleagues. Based on that assessment, strategies and tactics were reviewed and changed where needed, and those could be related to areas like process, technology, and resourcing. We have enacted mitigation plans where needed to protect the integrity of our trials and ensure continuity of treatment and trial integrity.
From a trial monitoring perspective, this has included collaborating differently with the clinicians who conduct our trials, as well as with regulatory bodies. This has enabled our CRAs to undertake a number of activities remotely that traditionally would only be conducted at clinics and hospitals, such as remote monitoring and remote consent. We are successfully minimizing impact by enabling direct-to-patient medication delivery supported by home nursing services and virtual safety assessments. We remain confident in the advancement of our pipeline and at this time, the impact on our ongoing clinical trials is manageable. Essentially, having the right culture was the driver of solving problems rapidly across one of the industry’s broadest portfolios, and it was accomplished with grace and elegance in the face of such a tremendous challenge.
MA: As an innovation leader, how do the investments in innovation impact clinical operations’ adaptability and speed? For example, did you use any technologies you’ve vetted before during pilots and implemented during COVID? And if so, what were those technologies?
CS: This is another area of strength stemming from our culture. There is a tremendous organizational investment of time, money, resources, and effort into innovation. We often think of innovation from a technology point of view, but there is much more to it. You can innovate and disrupt in areas like process, methodology, partnering, standards, and mindset. It is about investing in the destination. Of course, we pilot and test out new capabilities and technologies related to all sorts of buzzwordy things, but it was our decision-making process that was the real innovation. We had very thoughtful but rapid decisions being made with equally fast execution. To quote Apollo 13 astronaut Jim Lovell when talking about the Apollo 11 moon landing: “It’s not a miracle - we just decided to go.” Our significant investment in technology and digital solutions has helped us to support our drug development activities during this unprecedented time. For example, we are utilizing the SENSE digital technology implemented in 2018 that allows us to track, in real time, all of our clinical trials (500+) in more than 70 countries at the level of individual patients and shift to contingency plans rapidly as the situation evolves. We’ve also developed and deployed predictive surveillance tools that give teams the ability to proactively and dynamically manage current and future waves to minimize impact of COVID-19-related disruptions.
MA: The culture in ClinOps tends to be conservative; they tend to not want to take any added risks in their studies, and the existing process already works. How has that changed during deployment and after COVID?
CS: There’s this surrealness to the world right now, and the evidence that I see is that a lot of excess risk aversion has been shelved. There continues to be unwavering executive leadership support and an ability to go for it, whatever the “it” happens to be for any given person. I think that will continue to be baked into the fabric of an already progressive organization. I am talking about achievements like clinical database builds in two days and protocols being finalized in a week. We know that isn’t sustainable, but we see what is achievable, and that is key. I like to use a physics analogy. Momentum is mass times velocity. Mass is the sheer amount of matter, and velocity is the rate at which a position of something changes. We have this enormous mass of an industry, and even if the rate of us moving forward slows down, the net effect is still forward momentum for an entire industry.
MA: Could you tell me a bit about how the innovation paradigm has changed? People used to call eConsenting pilots innovation, decentralization innovation. What becomes that new definition of innovation after COVID?
CS: I often refer to an imaginary bar that we need to get over for something to be innovative or a continuum related to incremental vs. disruptive innovation. However, the more I have thought of it, the less interested I’ve become in a label. The perception of what is “innovative” ranges from what most would consider process improvement to quantum computing level innovation with a Grand Canyon-sized bucket of stuff in between. We inherently want to solve problems and deliver value, which has to be at the cellular level of an organization. Of course, I tend to go to a big pharma thinking way regarding having infrastructure and resources available. Small companies and those trying to solely deliver their core products or services experience much more difficulty in implementing innovation if it isn’t already in their corporate DNA, as there are only so many hours in the day. The solution to that is inter and intra industry collaboration, and the shift is seeing that in big bold letters on the marquee. I am witness to the sharing of knowledge and de-siloing happening exponentially. And while there is obvious “foot-in-the-door” and advertising value for service and technology providers offering solutions for free, they need to be thanked for doing so and inherently helping in a paradigm shift.
MA: How will the business process for running pilots change after COVID?
CS: I sure hope it doesn’t remain the same! Of course, this is now part of our program, where I lose some friends. The depth and breadth of our industry’s development world is truly astounding, but anyone that’s been to a doctor in the last few years sees that we are still held hostage by the magical fax machine. Most of the time, it seems like Guttenberg himself made a Faustian bargain with the healthcare industry. With that and the myriad of stakeholders to consider as table stakes, I think the way we approach “innovation realization” will change relative to a couple of core aspects. First, everyone talks about “failing fast,” but that ends up being worthless (literally, worth less) if we take two years to decide to try. Let’s borrow from our pandemic learnings and make rapid, thoughtful decisions on what we want to do, including funding those ideas.
From there, we can at least get substantial experience with whatever it is we are interested in, specifically for novel and ultra-transformative ideas—sort of like an “innovation idea internship,” which I just made up now. The second change is closely related to that, with this almost inherent need for pilots and proof of concepts (which I am as guilty of as anyone), often for ideas that aren’t that groundbreaking. If we wanted to implement MS Office, we wouldn’t pilot it, would we? So why pilot something like eConsent? We know enough about its value, what regulators think of it, what patients think of it, and so on. I would urge just going for it or not going for it, but why pretend it’s a Falcon 9 launch? Of course, going for it still includes a comprehensive project deploying the solution at scale, with all the bells and whistles of PMBOK-worthy project management. We owe it to patients to go for it. We can’t wait for the last dance to have our first dance, and anyone that’s been in middle school understands what I mean.
Read more about Craig Serra’s role in pharma, here.
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.