DPHARM 2024: Problem Solving in the Clinical Trial Realm
According to the session panelists, tackling challenges and finding efficiencies is imperative for success.
When it comes to addressing pain points in the clinical trial space, many would agree that there is no “magic bullet,” no one-size-fits-all approach, which is why this idea of collaborating to share one’s thoughts could not be more valuable.
In a DPHARM leadership panel on “Aligning Innovations to Solve the Big Problems in Clinical Trials in a Resource-Constrained Environment,” Nick Slack, MBE, chairman and CEO at The START Center for Cancer Research, served as the moderator, and was joined by Shoibal Datta, PhD, head of digital health sciences, Data Sciences Institute at Takeda; Bari Kowal, SVP, development operations, portfolio management & biostatistics data management at Regeneron Pharmaceuticals Inc.; Jim Murphy, CEO at Greenphire; Peyton Howell, MHA, CEO at Parexel; Andy Lee, SVP, head of global clinical trial operations at Merck & Co., Inc.; and Zachary Sigal, partner at LLR Partners.
Essentially, the aim was to offer various perspectives on the innovation needed to solve these challenges by making sure that trial sponsors, investors, and solution providers are on the same page in regard to solutions.
Slack started off the session by providing an overview of data. “I think it's important to note that the pharma industry does not operate in a vacuum. It is influenced and shaped by larger economic macro forces … When money's cheap to borrow, pharma will spend. When money gets more expensive, pharma will reprioritize and optimize.”
However, one should also point out that M&A activity has been experiencing strong growth since Q3 2023, even with portfolio optimization, while in the preclinical and early phase, assets have doubled in the last decade.
Constrained resources and adaptations being made
Merck runs 300 clinical trials, locks 300 databases a year, and has about 700-800 milestones. It also delivers 100 regulatory inspections, with 95% of milestones being delivered on time.
“What we're seeing in this environment now is that we have to become more productive. We've been challenged with this concept of bending the curve, which really means finding efficiencies,” said Lee. “One of the ways we do that is we do two things. We say, what are we going to stop doing, and what are we going to start? Stop doing would consist of using unproductive sites, shut them down, quickly, reduce the queries, reduce the data collection, reduce the complexity, and start doing things in terms of going more patient-centric, more innovative, and more automated.”
Parexel has faced its share of challenges in 2023—specifically in the biotech side—including not have the funding to initiate trials, but the CRO has seen overall pipeline growth. Indeed, Howell alluded to this situation as a dichotomy. The objective lies in bending the curve and being able to quicker with less resources, and without doing it differently. But, making productive change signifies looking at different sites, different country mix, and being able to push boundaries that the industry hasn’t pushed before.
Persistent and new market challenges
For Regeneron, some of the major difficulties start with regulations that are coming to light, EU CTR (clinical trial regulations), so embracing conversations with regulators is key in order to better understand the process and impact.
“We're trying to get more face time, more input on some of the regulations, so that we can actually help drive the change instead of the change driving us, and I think that's one of the things that changes the way that we're thinking about working,” Kowal explained. “But I also would say it requires investment; it may not be the reality that we can add more resources, but you do have to invest in order to change the way we work. It takes an upfront investment, sometimes in time, sometimes in resource, and very often in dollars.
“One of the things that we're thinking about are, what are the major investments that we want to make? What are the things that are going to move the needle from an automation technology perspective? We've been doing a lot of the work that you'll hear about today for a long time. What are things that are going to change the environment really dramatically, versus incremental change that can be alluded to? A lot of the things we do are really incremental. They're not going to have a major difference in our output. What we're spending our time on, is trying to weed through all the different options for ways to work differently, and figure out the ones that are going to change the way you work. And one of our major focus areas is EHR and EDC [electronic data capture]. I do think that if we can actually streamline data collection, it's an organizational improvement, it's a site improvement, and it helps everyone. It'll speed things up, and it'll reduce costs.”
Leveraging digital solutions
In Datta’s eyes, the healthcare industry has evolved to really embrace technology, shifting away from manual processes.
“The reality is, we have a legacy way of executing clinical products. Running clinical trials, and all that's left in that model, is a very resource intensive kind of human mediated model that's often error prone,” he said. “The improvements remaining are most incremental, and if you were to look at other industries, this has been a time where these are ripe for disruption. I looked at how healthcare has practiced. Healthcare has changed from a mostly manual process to a far more automated and often technology process, and we see some of those changes now coming into the way we do thing. There to be an investment up front, but that doesn't mean we have the workforce and the skills needed to carry out this change.”
Greenphire and financial perspectives
Greenphire, a provider of clinical trial financial solutions and payments, often has a front row seat to shifts in the market, particularly when it comes to how the sites are impacted. The company has noticed that 80% of sites still declare that they have six months of operating capital available and substantial DSO (days sales outstanding) debt payments that are outstanding on 90 days.
Overall, he commented, sites are constrained to some degree. As he explained—a theme at this year’s DPHARM—it’s lot harder to acquire a participant in a trial today than it was five or 10 years ago. As a result, you have a smaller patient to site ratio, which adds financial pressure, in terms of cash coming in.
When it comes to a portfolio company perspective, finding new technology innovations has served advantageous.
“We are noticing that our companies are seeing their customers looking to find new ways of doing things drive efficiency in their operations, and really looking for technologies to support them in doing that,” Sigal pointed out. “Our companies really have benefitted from the ability to come into these situations and provide new solutions, partner with our customers, to help them do things in new ways, and really reduce the number of relationships that they're managing, because there are a lot of different technology point solutions out there that support this market. I think that's probably the biggest shift that we've seen over the last couple of years—more of a focus on platforms, and aligning around platform systems to really help around the day to day.
Reference
Slack N, Datta S, Kowal B, Murphy J, Howell P, Lee A, Sigal Z. Aligning Innovations to Solve the Big Problems in Clinical Trials in a Resource-Constrained Environment. September 17, 2024. DPHARM 2024. Philadelphia.
