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CRO Leadership Awards 2017

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the indication, know what countries to work in, and how to best develop the asset. That was the more challenging part. " We felt there were few CROs with the capabili- ty to bring that end-to-end offering to the table," notes Curtiss. "Our meetings really forced us to test them on that early development piece. We need- ed to know if they could provide the operational expertise necessary to develop the molecule. But we also needed to know if they had the global reach to pull it off. There are not many CROs that can run a large global Phase 3 trial in the number of coun- tries where we operate. Third-party vendors play a role in the clinical process. The CRO would be allowed to pick those vendors but would also have to be competent enough to manage them through- out the course of the trial." When it came to demonstrating its capabilities to develop a molecule, some CROs seemed to understand the assignment while others did not. Curtiss notes some CROs brought the wrong people to the meeting. Others brought a team that attempted to make a sales presentation. This did not allow the cross-functional team to see what they had to offer or if they would be able to embrace a different way of thinking that involved doing a lot of the planning rather than simply following direction. "We started this process in 2012 and made our final decision in 2013," says Curtiss. "It takes a significant amount of time and energy for a true partnership to begin to deliver benefits. Your portfolio, teams, and the industry will all undergo changes. In addition, you need to be willing to adjust your model as the situation changes. This includes a continued need for sponsor oversight and associated applicable regulatory require- ments. It's important to give these partnerships time to mature." L define what the company needed. The grid was like a decision tree that created a list of potential service pro- viders that was then winnowed down. Initially there were eight CROs on the list. Because the biopharma business would be fully outsourced from end-to-end, the process of getting down to four CROs was relatively easy. Several of the CROs did not have the desired capa- bilities and would not be able to help the company with its early planning work. From there it got a bit more difficult. A significant amount of time was spent evalu- ating the final four CROs. "Each of the four CROs was sent a profile of one of our molecules," says Curtiss. " We simply said, 'Develop this for us.' No other directions were given. We wanted them to come up with a development plan, whether it was right or wrong. We just wanted to know that they had the expertise and the staff to be able to do this, as well as the commitment to actually sit down and get it done. It also allowed us to see what each CRO considered to be a good clinical develop- ment plan in this highly competitive landscape." The four CROs were then brought in for a structured, day-long meeting with the cross-functional team. The meetings were run exactly the same for each CRO, and the entire team received a thorough download at the end of the day on the performance of each CRO. "The mornings were set aside for us to evaluate their development plan," says Curtiss. "The afternoon fea- tured breakout sessions to determine standard capa- bilities, such as IT, medical, and regulatory. I was in the session looking at the clinical trial management system (CTMS) to determine how our systems might work together and interface." Once the meetings were over, the team unanimously chose to pursue a one-CRO model, with QuintilesIMS being the unanimous choice and the primary partner for trials in Phase 1 to 3 and even some Phase 4 work. (Depending on the scope of the trial, another CRO could be used in some specialty cases, and a very detailed pro- cess notes how and when the company can go outside the partnership.) Some Got It, Others Didn't The evaluation team knew the CRO selected would have to offer end-to-end services. On the back end, they would have to understand the needs of reg- ulatory submissions. But that is the easy part. On the front end, the partner would have to help the company determine the clinical development plan based on their operational feasibility, understand Oftentimes the CRO waits to be told what to do to ensure they get paid for doing it. ... That dynamic doesn't work well. LIFE SCIENCE EXCLUSIVE CONTENT Leaders By E. Miseta THE RISK & REWARDS OF A FULLY OUTSOURCED CLINICAL MODEL LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 10

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