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CRO Leadership Awards 2017

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them. That is just an additional cost of running a rare disease indication clinical trial. MISETA: Are there rewards to that type of model as well? DASSEUX: Yes. The other side of the coin is there are many CROs that share our philosophy. We now have many of them calling us and saying they would love to work with our company because of these relationships we develop. The value we get from these human rela- tionships will definitely work both ways. The ideal CRO for us is an organization that is pas- sionate about the disease and excited to be working on a trial that has the potential to become a breakthrough therapy that will save the lives of patients. With many CROs, we find they value in working closely with our team and not some faceless department within a much bigger organization. MISETA: Do you find there is an appreciation on the part of the CRO when they feel you are treating them the same way you want to be treated? DASSEUX: Yes, and that is a key point. At the end of the day we are all people, and drug discovery is definitely a human adventure, as I mentioned earlier. Every little step we take has a big impact on the over- all success of the trial. This includes patients being motivated and not being made to feel they are guinea pigs. Physicians have to understand the value the trial brings to their patients. Then consider all the other partners involved — the CROs, suppliers, carriers, and those teams involved in all of the different countries. We all have to be on the same page, working together, and personally involved with the effort. If one of those links fails, the trial will not be a success. Everyone has to be committed to working together as a team. L rare disease trial, we expect a great deal of commitment from all of our partners. That often includes a large time commitment on the part of key individuals. These are all good people, but sometimes that required com- mitment is just not possible due to personal reasons or family needs. In those cases, we will reach out to the person to see if they can perform better. If we still see some issues, then we will go to upper management at the CRO to see if they can help us find a solution. MISETA: Many sponsors also complain about personnel changes at the CRO. Is this ever an issue for you? DASSEUX: Yes, definitely. I think it is a problem for the entire industry. You have one team leader at the begin- ning of a study, and then three months later you are working with someone else. We all know this is due to the pressure and challenges these folks face, and the fact is they are always jumping from one CRO to anoth- er. It's a difficult situation for everyone. We will always explain to the CRO the difficult nature of rare disease trials and will request that they assign us someone who is stable and able to stick with the trial until the very end. We always stress the importance of that relation- ship, because we feel it is critical to the trial. MISETA: Everyone always wants the CRO's "A-Team," but we know it is not possible for every company to get it. DASSEUX: Exactly. And not being a Big Pharma com- pany, we do not have the deep pockets that allow us to always get our way. We also do not have a huge internal team that can help with the transition from one team leader to another. For that reason we have to be deeply involved in all of the activities being handled by the CRO and have regular meetings with CRA TURNOVER (U.S.) 50% 0% 25.1% 25.4% 2015 2014 50% 0% 16.4% 17.9% 2014 2015 50% 0% 20.1% 19.5% 2015 2014 CRA TURNOVER (GLOBAL) TURNOVER AT CROs (ALL POSITIONS) SOURCE: 18th annual CRO Industry Global Compensation and Turnover Survey - HR+Survey Solutions RARE DISEASES Clinical Trials By E. Miseta FINDING THE RIGHT CRO FOR RARE DISEASE TRIALS LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 42

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