Less is more
The elements are in place for a perfect storm to send clinical development costs skyrocketing even higher. More data required, ever-more challenging protocols, an increase in the number of patients required per clinical trial and a rise in the number of trials needed per new product approval don’t just impact biopharmaceutical companies. They impact consumers, too, because those expenses have to be recouped. That means some products become less affordable than others – bad news if you’re a patient who relies on a particular medication. Therefore it’s vital for companies to find cost efficiencies wherever they can to ensure affordable drugs. Kendle’s Steve Cutler talks about some of the ways in which CROs can help by creating efficiencies across the clinical development process.
Q: How can partnering with the right CRO improve the cost effectiveness of your clinical development program?
Choosing the right partner is everything. Not only do they need to be a good fit in terms of culture, they also must understand your business ambitions and therapeutic goals implicitly while possessing the global flexibility, resources and expertise you need. Only by establishing a partnership built on these attributes as well as honesty and transparency can you get the very most out of the relationship and drive maximum cost efficiencies into the process.
Q: But how do such attributes bring about savings?
The right partner will see the whole picture – where efficiencies can be created not only now, but in the future, too. And they’ll move their organization in a direction that builds on what the customer needs. For example, developing new tools to drive cost effectiveness. At Kendle we’ve built a tool that allows for evaluation of key aspects of clinical trial data while it’s still accumulating. This helps direct the right resources and support to the right places at the right time, in turn minimizing monitoring costs.
Q: How have strategic partnerships contributed to cost effectiveness in clinical development?
While it’s still relatively early days for strategic partnerships, several benefits are increasingly clear. One of these is cost savings that can be generated due to the high-volume workload involved in such relationships. But there are bigger, more innovative, opportunities to save money. For example, functional service provider (FSP) relationships capitalize on high-volume workloads to standardize the processes of a particular function across an entire sponsor or program, rather than just a single trial, thereby reducing cost and improving delivery and quality.
Q: You’ve talked a little about how technology can be used to reduce costs, but how else can tools help?
Clinical development technology is becoming more and more data driven. For example, at Kendle we’ve developed a patient recruitment simulation model that provides a probability of hitting certain timelines based on key assumptions. By mining our historical data and understanding what we’ve done previously, we can better predict how long a project is going to take and provide our customers with the probability of hitting aggressive, moderate and conservative timelines. And that means we can work with them up front on recruitment strategies to improve the likelihood of hitting their key dates. We discuss what we think will and won’t work at the start, saving them valuable time and expenses later in the process.
Q: What role do you think emerging markets will play in driving cost efficiencies?
From a cost effectiveness standpoint, I think the answer to that question is pretty straightforward – better patient availability at lower unit costs. In emerging markets, you tend to enroll more patients per site – about 50 to 100 percent more, in our experience. From a site monitoring point of view that’s great, because more patients per site means fewer sites needed and that decreases your monitoring costs and improves efficiency. And you also tend to recruit faster, so you save money on management costs, too.
Cost aside, one of the more interesting aspects of emerging markets is the quality of data gathered. Recent information based on regulatory inspections shows that data quality in emerging markets appears to be at least as good as, if not superior to, data in more traditional markets. What that essentially means is that the cost savings I mentioned previously don’t come at the expense of data quality. In fact, you may even generate better quality data for a fraction of the price. That has massive implications for an industry that spends billions of dollars in drug development every year.
And, when you consider the vast growth of these markets - China, for example, is predicted to become the world’s second largest biopharmaceutical market by 2020 – you really can’t afford not to undertake clinical development there.
Q: There are numerous CROs across the globe – what makes Kendle different?
There are a number of qualities distinguishing Kendle from other CROs, ranging from our global flexibility and regional expertise to the excellent cultural fit between our organization and our partners to our dedication to patients. Our determination to help our customers derive the maximum value from their resources and our focus on operational excellence and delivery (particularly in emerging markets) also helps to set us apart.
Perhaps the one thing that makes us stand out most though is our aspiration to be the best rather than the biggest. Size is important but it isn’t everything, especially in our industry, and we enjoy the flexibility that our size affords us. That’s why when it comes to our teams, we focus on quality rather than quantity.
Currently providing global leadership for Kendle’s worldwide clinical development operations, Dr. Cutler will become the Company’s next President and CEO as of May 1, as part of a recently announced succession plan. He has more than 20 years of senior management and operations leadership experience in the CRO and biopharmaceutical industries and joined Kendle in 2009, following 14 years with Quintiles. Dr. Cutler currently represents Kendle on the Board of Directors of the Association of Clinical Research Organizations (ACRO). He holds a Doctorate in Philosophy from the University of Sydney in Sydney, Australia, and a Master’s of Business Administration from the University of Birmingham in Birmingham, England.