Life Science Leader Magazine Supplements

CRO Supplement 2015

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LIFESCIENCELEADER.COM 22 THE CRO LEADERSHIP AWARDS 2015 By E. Miseta THE CHALLENGES OF PERFORMING GLOBAL TRIALS What experience do you have performing trials in France? I recently conducted three melanoma trials in France. There was a fourth trial I conducted there, but that was pre-EU directives, which really changed the paradigm. France is one of the larg- est R&D member states in the EU. It has a large population, a good medical system in place, and has great thought leaders and scientists. This makes it a popular place to conduct Phase 2 and Phase 3 trials, and what primarily attracted us there. Are there specific challenges to performing trials there that are due to the current political climate? The political situation is stable and there were no concerns that we had in regard to the political climate. Getting needed medicines to patients can always be a challenge, but even more so when performing trials in different parts of the world. Were there any supply chain issues you had to deal with? There is a QP (qualified person) release that is required to ship investi- gational products into the EU. Most U.S. companies get QP release out of the U.K. and once you have a qualified person release your product, it can be distrib- uted throughout the EU. However, when shipping to France, there is an addi- tional release that is also required to be completed. Another way that France is different from the U.S. is in regard to privacy requirements. For example, you can- not use both initials and birthdate, which is how most case report forms are completed. We needed the birth- date because most protocols call for patients to be over the age of 18, and that is how we would determine age. To deal with this issue we actually came up with a code to use throughout the EU. Patient recruitment and retention is a hot topic in pharma today. Was this a challenge you faced and how were you able to overcome it? In France, patient recruitment can be a little tricky because they do not allow for direct patient recruitment through billboards, the Internet, or other forms of advertising. All recruitment must be done through doctors and patient orga- nizations. Patient consent forms are also much simpler than they are here in the U.S. There is an information sheet that cannot be longer than two pages. So often what we did was have a complete informed consent and a separate two- page information sheet to comply with that requirement. Everything is written in French so there are a lot of transla- tions that have to be performed as well. Because our study was for melanoma, we worked primarily through the physi- cians, because that made the most sense to us. They did the outreach and connected with hospitals as well. I have found you are really at the mercy of the investigator. The investigator drives everything, and I think that is true throughout the EU. Were there any specific regulatory issues you had to deal with that made the conduct of trials particu- larly challenging in this country? Ironically, the healthcare in Europe is different than the healthcare here. For example, you have to publically disclose your clinical trial for 90 days before you can do anything. That can be a challenge because there is certain information you need to disclose, but because it is public you don't want to disclose any propri- etary information that should be kept confidential. I have never heard of any- thing coming from this requirement, but if someone felt the trial might be unsafe for some reason, they would have the opportunity to make their voice heard. The EU directive was meant to harmo- nize across all member states but also allowed each member state to incorporate it into national laws. France was rather slow in implementing the directive. I do not believe that happened until several years after the directive was issued. For that reason not all EU states are created equal, and sponsors will have to do some research into the specific EU nation they wish to conduct trials in. But at the same time, France does have a true central ethics committee. It is one committee that governs all of the hospi- tals in the country, which makes working with that committee much easier. Any thoughts on what the future of clinical trials might look like in this country? I don't think so. It is one of the largest countries in which to conduct trials and I don't see that changing. The investiga- tors and key opinion leaders who run their labs, and the physicians who work for them, are really amazing. They also do a lot of speaking at conferences. Biologics are big right now, as are bio safety committees. France has a very active one. As we transition into person- alized medicine, I believe this will be a key place for pharma to conduct trials for years to come. EASTERN EUROPE Complex Supply Distribution Erin Bettine is a clinical supply chain con- sultant with over 20 years of experience in pharmaceutical and biotechnology product development. Much of her career was spent as Head of Clinical Supply Management at Wyeth Pharmaceuticals. In 2008, Erin joined the International Partnership for Microbicides (IPM) managing HIV prevention product devel- opment projects. More recently, she led the Clinical Supply Chain group at Nuron Biotech. ROUNDTABLE leaders

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