During a keynote presentation at Veeva R&D and Quality Summit 2023, Penny Carlson, vice president, head of innovation and data at Takeda, outlined the company’s new future fit development model – a key strategy moving forward.
Carlson began the discussion by acknowledging that change is a ‘constant’ in the industry and that Takeda is no stranger to development or innovation.
“I've been at Takeda for 12 years and this is not our first rodeo. This is not our first time trying to bring change to the organization. While it is not our first time trying to do better, I do think this time is quite different,” she said at the event.
While delivering medicines to patients efficiently remains a priority, Carlson admits that this objective can be difficult when a company is not growing in the same direction or is ‘entirely reliant on another organization’s infrastructure, technology, resources and global footprint – which is where we were’.
“In order to go faster, there were many things we needed to do, one of which was to absolutely own our own technology. We had next to nothing in terms of our own infrastructure, so we knew establishing our own was a pretty core foundation," she says.
In addition, Carlson explains that future fit is comprised of four work streams, all designed to be end-to-end.
“Ultimately, this particular work stream is foundational for everything we're doing. You need operational data to be able to bring feasibility into your study design and to make good decisions about which countries you select, which sites you select, how you work with those sites and where you manage your rights,” she says.
“Two years ago – we had a ton of operational complexity. We were entirely reliant on our CRO partners, who were fabulous partners, but we didn’t have sufficient accountability and ownership in Takeda.”
In the past, Takeda did not have a ‘single source of truth’ for either operational data or clinical data and relied heavily on its CRO partners to manage site relationships
“If we have 12 vendors for one site in one study and we have 150 active studies in our portfolio, each with different vendors and different platforms - it's incredibly complex. When you don't have that infrastructure, you won’t be able to manage all of it. It becomes incredibly hard,” Carlson adds.
“Particularly during the pandemic, when we were trying to get so much information about our ongoing trials, it was challenging. That was our first real example of when that the lack of operational data and cohesive, single source of truth was really problematic.”
However, since adopting future fit, the biopharma giant has seen significant benefit and has heard ‘vastly different’ information when it engages directly.
“We see predictable delivery and improved quality. In particular, for those programs in our highest priority, where we've really been able to focus our energy resources, time and effort. You can’t implement technology or hire new people if you don't change the way that all that's working together,” Carlson says.
“In terms of the future, it's really all about delivering our portfolio with the patients at the center of everything we do. We want to enhance the quality and think there's significant opportunity in terms of automation and efficiency. We also want to give Takeda a sustainable future and be able to thrive in those competitive times, which to be honest, I think everyone did at the beginning of the pandemic, but that time is when we started to notice how critical it would be to have our own operational data.”
“When you're trying to figure out which of your 150 studies are going to be deeply impacted by the pandemic versus those that might be able to continue and you have to do it via slides, maybe you realize it's time for a change.”
For Takeda, Carlson emphasises that unification is crucial and it is important that each system talks to each other and exchanges data, which will enable automation.
“When you bring the technology and the innovation together with the people and the processes - this is where we believe this particular transformation for Takeda will be different. So what's next? We are working towards full ownership of both clinical and operational data. Bringing those two together is so powerful in terms of how it is that we do clinical development," she says.
“We believe that having that internal accountability and ownership is really driving change. When you add that with everything else, including the technology that we're working with Veeva on, you get back our key objective, which is bringing medicines to patients faster.”