Quintiles Chairman Reflects On 33 Years In Drug Development

By Ed Miseta, Chief Editor, Clinical Leader

On December 31, 2015 Dennis Gillings will officially step down as the Executive Chairman of Quintiles. When Gillings began working with pharma companies in 1974, shortly after coming to the U.S. from England, he was a professor of biostatistics at the University of North Carolina at Chapel Hill. His career in pharma started when he received a call from Hoechst, which later became Aventis and, subsequently, Sanofi.   

In 1982 Gillings founded Quintiles, which has since grown to become the largest CRO in the world. Along the way, he has consulted numerous companies and organizations including the National Cancer Institute and the Institute of Medicine. He has served on numerous advisory boards, was the founding Chairman of the Association of Clinical Research Organizations, and has received several prestigious awards in England.

On this occasion of his impending retirement, I spoke to Gillings about his time in the industry, the growth of his company, and the trends that will continue to shape the clinical trials landscape.

Ed Miseta: What was your first experience working with a pharma company like?

Dennis Gillings: The first one I worked with was Hoechst, which at the time was the largest pharma company in the world. They were trying to bring a new diabetes drug to market and it was associated with deaths in what was then West Germany. I was asked to do an expert statistical analysis, which I agreed to do as a consulting project. It worked out well because I determined that the drug was not being excreted properly, which caused low blood sugar. It was not easy because I was sent 56 hospital charts that were all in German, and had to get translators involved. After that I had more consulting opportunities with pharma that came along.

Miseta: What type of work was Quintiles doing in those early days?

Gillings: It was mostly data management and statistical analysis. And this was back in the days when the rules for how things were analyzed weren’t as well defined as they are today. There was certainly more flexibility, but I don't believe the quality was as high as it is today. But that means there was also a lot of opportunity to bring to bear start-of-the-art methodology to make some advances in the way data was analyzed for clinical trials.

Miseta: Quintiles has experienced phenomenal growth, going from that small company that did statistical analysis to what it is today. What primarily fueled the growth?

Gillings: I believe there were two sets of growth. One was in the services, which was statistics and data management which then moved into the full clinical services, and later on into full drug development services. That took place over about a 12 year period. At the same time that was happening there was also geographic expansion. Since I was from the U.K., in 1987 I added a branch there. Then we gradually expanded all over Europe as well as out to the west coast in the U.S. In the 1990s we took that expansion into Asia and Latin America. So we had a progressive global expansion as well as the services expansion.

Miseta: Was that rapid expansion a large part of your success?

Gillings: I believe we grew faster than any of our peers, and that allowed us to gain the largest market share by the end of the 1990s. 1n 1998 we surpassed $1 billion in revenue. I believe we will soon top $5 billion. I certainly believe the expansion of both services and geographies enabled that dramatic revenue growth. Being that size, we were obviously able to work on a large number of programs. In fact, Quintiles has been involved with 75 percent of all drugs approved over the last 20 years.

Miseta: Is there anything you can point to that allowed the company to grow faster than its competitors?

Gillings: Building on the data route was very important. When it comes right down to it, a new drug application is basically a set of data that is submitted to regulators. I think we had a lot of expertise in that area that was certainly state-of-the-art. Others would look at that and try to catch up, but that certainly placed us in a very good position.

Another base that served us very well was our expansion into Asia. There wasn’t very much done there in terms of clinical trials, but of course pharmaceutical products are sold globally. That expansion in Asia, particularly bringing medical, data, and regulatory expertise across Asia, was very powerful. A lot of sponsor companies like global programs because their intent is to eventually have the drugs sold globally.

Miseta: In what ways have you seen the industry change over the last 30 years that allowed clinical outsourcing to become a successful strategy for sponsors?

Gillings: We could have a lot of debate over this, but in reality it is cheaper to outsource and patients will get recruited a lot faster. When I say cheaper, I’m sure there will be people who contest that. But companies have to decide if they want to look at total cost, or just the marginal cost of the tasks being performed. Things may not be cheaper at the margin, because we perform tasks by employing the same sorts of people with the same types of salaries.

But I also think it’s fair to say that the big pharma companies have much higher overhead. I know that because we have taken over some units of pharma companies and understand the magnitude of the overhead. The CRO industry could not work with such a substantial overhead. So the cheaper advantage that I mentioned earlier really comes from the total cost, including all of that overhead. The faster recruitment comes from the fact that we employ over 35,000 people. That advantage comes from our relationships with doctors and sites, and their ability to recruit patients. We know doctors around the world and we know how they work. When you build up a large market share there are economies of scale that accrue in that area. We now do more of that than our customers.

Miseta: Do you see the industry continuing to evolve towards strategic partnerships?

Gillings: I certainly believe it is a model that is here to stay. But at the same time I would say there is not any one model that will perfectly reflect what every company wants. The industry is large enough, and the variation in demand is large enough to support other models as well. Still, there is an advantage to both parties when engaging in larger, strategic relationships. For example, sponsors might spend a lot of money on business development, and many of those costs will disappear if you have large relationships. Likewise, the administrative processes of handling things become much more streamlined. Finally, there is a greater predictability of work, which is also helpful. The predictability of work is one of the biggest factors, especially globally. When you have a large network if gives you increased flexibility to move projects around the globe. It again comes back to economies of scale. Any one pharma company would not have the mass of work in any one arena, to enable a global delivery network to be put in place.

Miseta: What can pharma companies do to create better relationships with their CROs?

Gillings:  There are many types of outsourcing but let’s look at just two of them. There is one type where you just need a lot of hands and another where you need hands and knowledge. I think companies need to differentiate between the two. Unfortunately, some Big Pharma companies want just hands while others want both hands and knowledge. We work with both types of companies and employ over 1,000 physicians and over 1,000 PhDs. That degree of technical expertise gives us both the hands and knowledge.

Miseta: Any trends you see impacting clinical trials going forward?

Gillings: I think there are two. One is the growth of real-world studies, which are very different from randomized clinical trials. That includes the growth of and access to big data, and studies that are not randomized. The other arena that plays into the hands of knowledge is the fact that genetics and molecular medicine have created a very deep science and a lot of the products coming along are quite futuristic and highly targeted at the diseases they’re intended to cure. They are also likely to be safer than many of their predecessors. However, the studies for these medicines tend to be more complex.

Put those two things together and it leaves us with both a broadening and a deepening of clinical research. I think that trend will certainly continue. With electronic health records, social media, and other new methods for recruitment of patients, and digital methods of starting trials, we have technology options that didn’t exist 10 years ago. Both these trends will be particularly important.           

Miseta: What happens after you step down as Executive Chairman on December 31^st?

Gillings: I will still remain involved in a lot of activities and I will remain on the board of Quintiles. I hope to help the company continue to grow. I simply will not be running the show on a day-to-day basis.