CROs Will Play A Critical Role In The Future Of Drug Development

By Ed Miseta, Chief Editor, Clinical Leader

There are a couple of differences you will see in this 2016 installment of our annual CRO Supplement. The first, which you may have already noticed, is the cover. In the past, these covers have featured an image that seemed to best illustrate a concept we addressed in the issue. That was very different from the typical cover you see on Life Science Leader, which always features a prominent executive from the pharma and biotech industries. Beginning with this CRO supplement, we will feature a clinical executive whom you will likely know and recognize.

I was thrilled when Dr. Corsee Sanders agreed to be the first executive to grace the cover of this issue. I first spoke with her last fall while preparing an article for our December Industry Outlook. Her comments and insights into the future of clinical trials were refreshing and insightful. Part of that had to do with her background, which is in math and statistics, rather than pharmaceutical development. This gives her a different perspective on how we should be gathering, analyzing, and using the data gathered from trials.

In this article, Sanders discusses a challenge she faced when stepping into the role of global head of clinical operations at Roche. As a statistician, she was uncomfortable with decisions based on information that employees knew from experience but couldn’t back up with hard data. In addition, it seemed the same data sets could exist in different systems, and yet yield different results. One of her current projects attempts to bring those systems together under one umbrella, with a single dashboard providing executives with the answers they need. What does she see as the benefits of such an endeavor? You can read about it beginning on page 6.

If you’re a regular reader of Life Science Leader, then you also know our editorial focus is on executives at bio and pharma companies rather than technology or service providers. But an article in this issue examining the CRO of the future features an executive from Merck, as well as leaders from three contract research firms. When I heard these gentlemen speak at the Disruptive Innovations conference last fall, I knew the discussion belonged in this issue. Some of the topics covered in the article include the growth of CROs, standardization, and the challenges faced by CROs and what they will need to do to continue to be a vendor of choice for sponsors.

With the way clinical trials are changing, it should come as no surprise that sponsors expect their CROs to adapt to those changes. It wasn’t too long ago that many pharma companies were not dealing with patient-centricity issue, risk-based monitoring, adaptive trials, electronic files and records, and wearable technologies. While many of these changes have the potential to fundamentally transform clinical trials, they also have the potential to disrupt operations within companies.

In the past, a CRO might be expected to perform a task requested by a client. Today, those same clients are expecting the CRO to come to them with innovative ideas and new methods of incorporating novel technologies. Rob DiCicco, VP of clinical innovation and digital platforms at GSK, recently summed up this expectation for me. “I am always interested in what the CRO is able to bring to the table in terms of know-how,” he says. “We are always looking for ideas that can disrupt the company. We celebrate the fact that there are companies that know things we don’t. When a CRO can bring innovative knowledge and expertise to the relationship, it helps both of us to get to a better place, and we welcome their ideas that will help us come up with the best possible plan.”

I hope the insights in this issue will help you come up with better clinical plans, as well.