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.