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CRO Leadership Awards 2017

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Finding The Right CRO For Rare Disease Trials for the trial. In that case, the concern was the individ- ual's technical knowledge of trials and how to handle a study where good clinical practice and adhering to requirements set by regulators was critical. But passion is also something we look for in a CRO. We need to have emotion, to have people who are dedicated to the study. Above all else, this is a human adventure. What is more important to me than the size of the CRO is choosing the one we feel will be most engaged in the study. Some of the larger CROs are not interested in a study involving 30 patients. As a result, we have struggled to find appropriate CROs and will often look for ones that are local to the areas where we are conducting the studies. I believe interactions with the CRO are essential to this relationship, and we are deeply involved with them. We will generally have interactions with them on a daily basis. MISETA: When you believe a personnel change is neces- sary, that must be a difficult conversation. Is it usually done at a high level? DASSEUX: Yes. We try to be a responsible company, and we certainly don't want anyone to take some- thing like that personally. What we will try to do is go to upper management within the company and let them know we believe an issue exists with one person involved in the trial, or that we feel there is a dedication issue. I tell them that a different type of person might be more appropriate and ask if they can resolve it internally. We are certainly not looking to be confrontational in any way. If we think a change is necessary, we want to handle it in the most delicate manner possible. In a his was the situation for Cerenis Therapeutics, which recently launched a Phase 3 trial for patients having very low levels of high-density lipoprotein (HDL), also known as good cholesterol. The low levels of HDL make patients prone to cardiovascular events such as stroke or heart attack. The Cerenis medicine, CER-001, attempts to mimic HDL, allowing the body to rid itself of cholesterol. In this Q&A, Cerenis founder and CEO Jean-Louis Dasseux discusses the challenges of rare disease trial and why the selection of the right CRO is so important to the success of the trial. ED MISETA: In rare disease trials, does the CRO selec- tion process become more difficult? JEAN-LOUIS DASSEUX: I think so. Since this is the first time a trial is addressing a rare ailment, there is really no CRO on the planet with experience dealing with this patient population. That means the experience is generally coming from the sponsor. Therefore, the role of the CRO becomes more critical. They have to be the liaison between the pharma company and the sites and patients and are responsible for transferring that experience from one group to the other. They also have to be experts in the conduct of a trial. It's a lot of responsibility for them. MISETA: Have there been any situations where you request- ed that someone at the CRO be removed from a study? DASSEUX: That was necessary once, and we felt the individual at the CRO was simply not the right person T CRO selection is a challenge for every company outsourcing clinical trials. When the trial you are about to launch is for a rare genetic disease and has 30 patients spread across several countries and continents, the challenges are multiplied. E D M I S E T A Chief Editor, Clinical Leader @EdClinical RARE DISEASES Clinical Trials By E. Miseta FINDING THE RIGHT CRO FOR RARE DISEASE TRIALS LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 40

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