The Small Pharma Approach to Innovation, with Kyowa Kirin’s SVP of Global Clinical Operations
Dr Mitchell Katz, SVP, Global Clinical Operations, Kyowa Kirin, to give us his thoughts on what big pharma can learn from small pharma about innovation, and vice versa, and how he approaches investment in innovation to accelerate patient-finding, manufacturing, and more.
What can big pharma learn from small companies about innovation?
Being nimble. When large pharma starts something, they often don’t start small. If they could descope, and do something quicker, it might result in more adoption. A single poor experience with a promising technology can slow adoption across the industry — delaying progress for patients who could urgently need better options. It often only takes one bad impression of a technology to turn pharma off from something, which hurts the industry as a whole.
"If you’re pitching a technology to the leadership of a smaller or mid-size company, they want to know if a big investment will generate a big impact."
What insights are you taking from big pharma investments in certain innovations?
I’ve always believed in being a thoughtful, fast follower — because every investment we make needs to ultimately serve patients. In big pharma, there are resources to experiment broadly across many technologies. In smaller organizations, we have to be more intentional because any decision we make, we want to make sure that the ROI is there. That means prioritizing ideas and solutions with proven value, so that every decision brings us closer to delivering meaningful outcomes for the patients who rely on us. If it’s shown to be successful in big pharma, then it’s something to consider.
The beauty of meetings like DPHARM is getting together with colleagues across the industry. I’ve had discussions with other pharma folks about, for example, AI. Some people were using it and when they assessed its utility at the end of a trial, it had helped a little here and a little there. But if you’re pitching a technology to the leadership of a smaller or mid-size company, they want to know if a big investment will generate a big impact.
What innovations for clinical operations are you focused on at Kyowa Kirin?
Our goal is to make the greatest impact for patients by continuously improving how we operate and conduct our clinical trials. In our early Phase I studies, we bring programs to an important inflection point where we then actively seek strong partners to help advance them further. When we move into Phase II and III, we recognize the increasing competition for patients and resources — which drives us to explore innovative approaches to connect with patients more effectively and to run trials faster, so that potential therapies can reach those who need them sooner.
What are the innovations you’re trying to identify to help in your rare disease trials?
Finding and engaging patients is one of the greatest challenges in rare disease research, and we dedicate significant effort to it because every patient matters. We’ve had strong success in building trusted relationships with investigators who care for these patients, and those connections have been invaluable in supporting recruitment and enrollment.
In manufacturing, especially in the complex field of cell and gene therapy, we’re focused on exploring innovative approaches to streamline and or accelerate production. Our goal is to always align with regulatory standards while finding smarter, more efficient ways to deliver these therapies — so that patients can access them more quickly and reliably.
As part of the company’s North American strategy, Kyowa Kirin will begin manufacturing beyond Japan and are currently building a new state of the art biologic manufacturing facility in Sanford, NC. Excitingly, the facility will expand the company’s global capacity, while also creating more resilient and efficient supply lines domestically. We expect to begin operations in 2027.
"For us, innovation is about striking the right balance between technology and process."
What areas of operations are you most focused on making faster?
Trial site selection, particularly in therapeutic areas that we’re not as experienced in. We want to identify sites with good performance records and, if they don’t have a lot of trial experience, make the decision as to whether or not we will spend time training them. In that case, we’re then looking at how we can do that effectively.
The other thing is documentation and how we can speed up the process of pharmacy manual training, startup plans, feasibility, etc. Are there ways we can use technology and AI to do things more quickly? How can we prepare documents more quickly, and speed up the things that we can control?
What is the balance between process-based innovations and technology-based innovations when you’re making potential investments?
For us, innovation is about striking the right balance between technology and process. We’ll invest in new technologies when they truly add value to how we support patients, but we’re very mindful that they must also be recognized and accepted by regulators like the FDA — otherwise they risk slowing us down rather than moving us forward.
Process innovation is where we see significant opportunity. As we expand into global trials, evolving our processes is essential to becoming more efficient, aligning with industry best practices, and meeting regulatory standards
When you’re doing a clinical trial in a new geographic area, the practice of medicine is different and you have to ensure that your protocols are aligned with that, in order to create a truly global protocol. One of the biggest investments here is in training investigators who may not have prior experience in global studies, and adapting our protocols to account for differences in medical practice across geographies. By getting these processes right, we can ensure our trials are more consistent, inclusive, and ultimately bring new therapies to patients around the world faster.
What are some of the challenges you’re handling as you bring on new technologies or tools to help make operations more efficient?
We tend to in-license these platforms, and the data are immense. There is information on where the patients are, what the prescribing habits of doctors are, etc, but because we’re not that experienced in utilizing all the information generated from these tools, we might not get the full value.
What we’re looking at now is appreciating the value if we are willing to pay money for these innovations. We deal with CROs and third-party vendors in an outsourcing model. Many CROs attempt to implement innovation but they will follow the lead because the more they do from a technology and innovation standpoint, the more expensive it is. That’s where we have to have a balance.
"In this industry, it’s the sites and patients we have to consider when implementing new technology."
What are your thoughts about the era of change and innovation we’re in, compared to previous moments of growth in the industry?
We are learning lessons, and the competitive landscape looks differently today than it has in the past, particularly with more ex-US trials and less investigators in the US, but the duration of developing a product and the cost associated with it is just as long and just as costly. While the duration and cost of clinical development remain significant, we’re encouraged by the progress being made. Our interactions with the FDA have been very constructive, especially around accelerated approvals in rare diseases and areas of high unmet need. These collaborations give us confidence that, together, we can continue finding ways to bring therapies to patients faster
What do you want to see the industry keep in focus as we move forward to make clinical research more modern?
In this industry, it’s the sites and patients we have to consider when implementing new technology. When we moved to electronic data capture and stopped using 3-part NCR papers, sites had a difficult time making the transition to doing data entry. They eventually saw the benefit over handwritten case report forms. Or take nurses going to someone’s house to do a procedure. Some patients want to have the trial come to them, but a lot of patients really want to see a doctor and go into the office.
I thought that the implementation of electronic consents would be a fantastic opportunity. Some sites embraced it, but there were a lot of barriers to implementing it, especially among academic centers, and a large number of sites didn’t want to deal with another piece of technology. Having another piece of technology can be burdensome so anything additional has to be quick, easy and simple.
