Challenges Chief Medical Officers face in clinical trial operations

Interview with: Bernard Coulie, Chief Executive Officer & Chief Medical Officer, ActoGeniX

“One of the major issues that Chief Medical Officers (CMO) encounter in their day to day practice is the variety of countries that they deal with and the different regulatory issues that they need to solve.”

Having control over clinical trial operations when many countries and regulations are involved is not always so easy, says Bernard Coulie, Chief Executive Officer and Chief Medical Officer at ActoGeniX. Therefore, early interaction with the different authorities is crucial, he says. A speaker at the marcus evans Evolution Summit 2010 taking place in Switzerland, 27 - 29 October, Coulie discusses the steps he follows for overcoming international hurdles and achieving smoother clinical trial operations.

What challenges are Chief Medical Officers dealing with at the moment?

Bernard Coulie: "One of the major issues that Chief Medical Officers (CMO) encounter in their day to day practice is the variety of countries that they deal with and the different regulatory issues that they need to solve.

If you have a multi-center multi-national trial in Europe, for example, you have local regulations and processes which are very much country specific. This is one of the hurdles I am facing. There are organisations that take care of this, but as a CMO, I need to have oversight of the clinical trial operations and with many countries involved, this is a significant challenge."

How can CMOs overcome these international hurdles?

Bernard Coulie: "The way we have tackled international hurdles, and this is specifically true for the type of products we are working with which are advanced therapeutic medicinal products, which require very specific regulatory input, is that long before we start a clinical trial or even submit a clinical trial application, we start documenting these people. We go into a continuous dialogue based on available pre-clinical data or a draft protocol and start drafting their input.

We try to understand not only their thinking on the product, but also the processes: how they are going to review the trial, their criteria for approving the trial, the kind of documentation we will be requested to submit and the kind of reporting that will need to be done once the study has been completed. This early interaction with the different authorities is really crucial. It is not just enough to get their opinion or scientific advice; you have to understand the local interpretation of that regulation."

How can efficiency in clinical trials be enhanced?

Bernard Coulie: "There are many ways to make clinical trials more efficient. As a small company, we personally have to be very efficient with limited resources. We design our studies in such a way as to get the information we need to go to the next step with the minimum number of patients. We try not to do too many studies, instead focusing on the key studies that will help us get to that next step. Sometimes that means compromising in terms of the type and amount of data we get. Therefore, from time to time, we tend to defer some studies to a later phase, if we feel they are not on the critical path at that point in time."

What are some of the technologies that CMOs can take advantage of?

Bernard Coulie: "One of the trends that we are personally watching, which could help clinical trial efficiency, faster development and possibly more cost effective development of products, are the adaptive clinical trial design technologies that are available. These technologies give CMOs the opportunity to move forward and work faster and I see that as a good opportunity to tap into."

Source ActoGeniX