In the past, biotech companies relied heavily on good science and a true technical breakthrough to get their products to market. According to Keith Ruark of Syneos One, investors also want to see the full asset journey, including a solid team and relatable story that connects with investors while staying true to the biotech company’s narrative. In an investor’s market, differentiating the company is essential, thanks to potential changes in pricing and disruption in the talent pool.
Ruark also notes some promising trends in the biotech sector. New channel participants are entering the space, including stakeholders who have not traditionally been involved with scientific research and clinical development. On the tech side, AI and machine learning are taking on larger roles that can drive efficiencies and lower costs. With potential pricing changes and reform on the table in the U.S. market, being able to control costs is becoming increasingly important for investors.
Rebecca Willumson:
Hi there. My name's Rebecca Willumson and I'm the publisher of Fierce Biotech and I'm here today with Keith Ruark, senior vice president at Syneos Health. Keith, thanks so much for joining me.
Keith Ruark:
It's nice to be here with you.
Rebecca Willumson:
So before we begin, can you tell me a little bit about your background and your role at Syneos Health?
Keith Ruark:
Sure. I'm working within a division that's a corporate development group, and we're sitting on the bridge between our clinical side businesses and our commercial side businesses. We get involved in supporting biotech clients, which is the reason we're here this week. And really leveraging our capability in infrastructure in a broader partnering way. So, it's that kind of remit that our group is involved in, really to pull from the power of support across the whole enterprise.
Rebecca Willumson:
So tell me, where do you see the biggest need for innovation in the biotech space?
Keith Ruark:
I have such an affinity and a passion for biotech being an engineer myself back in the day. So, I always gravitate towards the science and true technical breakthrough. But I think in today's day and age where we're spending a lot of our time is actually not there. I think good science will solve itself in the long run, set up in part by the funding environment. I think what investors are looking for is good science, certainly good assets, but also good team and how to appreciate that story. So, I think the need that we're seeing, and we spend a lot of time working within our partnerships in this way, is helping our clients structure what that full value proposition looks like for the full asset journey.
And so, we get into a lot of discussions around getting from point A to the end destination of what good and success looks like in the commercial market. But actually mapping that all out in terms of very detailed asset level gantts, all the different cross-functional participation that need to come together in an integrated way to achieve that. And then ultimately, that becomes a return on investment equation to the investor. The steps along the way are obviously activities and costs. Once you file and receive a regulatory approval, commercial launch happens, and then that's the return on investment. So, how to tell that whole story so that there's a viable path to market that's communicated within the biotech company's narrative, we spend a lot of time doing that. And I guess with the funding environment now being more a buyers or an investor's market it's differentiating for a company to be able to make that business case.
Rebecca Willumson:
So tell me, how have you seen companies create value given the current state of the market?
Keith Ruark:
There were three examples that I've thought of just coming into today's discussion. And this is where we're spending a lot of time within our strategic partnerships. The first I would call talent, and the context here is set up by the pandemic certainly, and sort the great resignation in the lay press. There's a lot of disruption and change. And we know for our biotech sector, I think turnover rates and retention rates are sort of at all time high for turnover and retention rates getting slower or more turnover within jobs. And so the quest for talent, I think is quickly becoming even a C level and a board issue, that we're finding within our conversations. And we're spending a lot of time saying, "Well, how can we work with our partners and solve that with them?"
It's everything the company does with its own identity in terms of retaining talent and treating talent as a valuable asset, But it extends beyond our biotech clients into all their interface points as well. So that's certainly with us as a trusted partner, but also with sites, with investigators, with patients. And so, how that whole representation looks, I think is an important way, even culturally or relationship wise to build and infuse what you want to do in talent retention. The second area that I thought about spending a lot of time with our data scientists and taking analytical approaches to what's kind of the biggest expense item for a lot of our clients, and that's development spend on studies. There's some unique insights in that data as we've looked at it. And we can use predictive analytical techniques to sort of get underneath what we see in those insights. But just for example, 30% of all sites never even enroll a single patient.
And everybody has an idea of which sites and investigators they'd like to work with, but you can have a high performing, high enrolling site and investigator on one study, and on the very next one, they don't enroll a single patient. So, I think we find that the solution needs to be really getting into the analysis of what a specific protocol looks like in the local healthcare ecosystem. Looking at sites and looking at specific investigators. And performance is very much a function of how many concurrent trials are happening at that same site. So, with our biotech clients, often going to the same places and wanting to work with the same key leaders, it's important to look at what that local competition looks like around that set of site and investigator choices. And then really run the numbers, run the analytics to say, "Here's actually the best return on investment in a micro targeting way, to achieve what we want to achieve."
And then the third idea and we spend a lot of time here, is thinking about how you can bring commercial and market insights to de-risk the clinical and the regulatory pathway. And the payer agenda is a quick one we spend a lot of time on. There's a lot of talk and even sort the binary event of possible US pricing reform and US payers are becoming more and more restrictive and using tools like ICER and the like to adapt how they're going to manage the medical and the pharmacy benefits. So, understanding what type of evidence is necessary in the positioning of what becomes that future therapy in the eyes of the payer, becomes important for access and a key piece to the commercial ROI part of the investment decision.
Rebecca Willumson:
So, what are some of the key trends that you're watching in the biotech sector over the next 12 to 18 months?
Keith Ruark:
I have my eye on new players, even stakeholders that are not traditionally even in our sector today, are showing interest or in fact showing up. Walmart has just filed trademarks indicating they want to get into scientific research and clinical studies. CVS and Walgreens Boots Alliance is getting into studies in the clinical development space as well, as a site of site hub in basically everyone's local neighborhood. And also, really what the patient data that they have through the pharmacy. So that's a key one is how new channel participants and that disruption happen. A second for me is more on the tech side. So artificial intelligence, machine learning, has been kind of a hotpot in drug discovery. And I think the next frontier might be applications in drug development in a new way. There's a lot of manual processes and basically human resource. That's our fundamental model today.
And so you can think about a theme like pharmacovigilance and safety reporting, for example, where we're using a lot of horsepower in terms of human resource just now. But a AI machine learning approach might be a way to totally disrupt that, drive efficiencies, move a lot quicker. Certainly, much less costs. So, thinking about those technology disruptors for sure. And then the third I think would be maybe I mentioned a little bit earlier, the specter of potential pricing change and reform. It's still active within the Senate here in the US for example. If pricing power really fundamentally changed in the United States, the rebalancing that would happen, really globally, from a portfolio prioritization standpoint, I think changes a lot of dynamics in our industry. Some of those might be very good for biotech, I think. Because we see already in large cap pharma, some of the portfolio prioritization work they're doing is reflecting more conservatism around how much price is in the sales equation for them.
Rebecca Willumson:
Well, I think that's a great place to end. Thank you so much for joining me today. I appreciate the conversation.
Keith Ruark:
I've enjoyed it. Thank you.