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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM APRIL 2014 30 uring my face-to-face meeting with Merck SeronoÕs EVP and global head of R&D;, Annalisa Jenkins, I was pleasantly sur- prised at her candor. She shared with me her opinion as to the state of Merck Serono when she joined the company in 2011, which I found to be most interesting: It was an organization that took a decid- edly Euro-centric approach to manufac- turing, R&D;, and business in general. She said that despite the company conducting business in 60+ countries, the owners and leaders of Merck KGaA recognized that for Merck Serono to truly be a global R&D; player it needed more access to global talent and R&D; innovation. That would require Jenkins to be willing to make some game-changing decisions. But she also needed a CRO willing to help rewrite the rules of collaboration. REDESIGNING THE SPONSOR/CRO MODEL In April 2012, Merck Serono announced it was closing the Geneva headquarters of its pharma unit. Jenkins says, ÒIt wasnÕt a cost thing, because we placed resources else- where,Ó citing the company now operating four R&D; centers Ñ one in each of the four largest global pharmaceutical markets (i.e., Beijing, Boston, EU's Darmstadt, Tokyo). ÒIt was more about achieving a cultural shift and becoming more of a global, cultural- embracing type of company.Ó Around the same time, Jenkins had what some might describe as an "aha" moment. ÒWe had no new drugs from the pipeline for years, we were closing a major R&D; hub where many of the companyÕs studies were being run, and we had a major restructuring and a fail- ing model,Ó she says. In other words, it was the perfect time for new leadership to do something really innovative and interesting. The company was working with a multi- tude of suppliers and providers. According to Jenkins, ÒWe had not applied any good managerial business processes and approaches to clinical study, design, and execution.Ó At a previous company, she had experienced going from multiple CROs down to three. But questions always lin- gered as to if that number should be even smaller. With that experience, as well as the belief that the companyÕs current CRO partnering model was not working, Jenkins decided to change the game. She rede- signed the CRO model to be more of a bio- tech partnership rather than a basic client/ service provider relationship. And most sur- prisingly, she created a model that included only one CRO. But to do so required a differ- ent approach and a new set of rules. CHANGING THE CRO COLLABORATION GAME Before this plan could be implemented, Jenkins needed buy-in from her team. She started by challenging them to look closely at their assumptions about CROs. ÒLetÕs assume the ideal CRO has data, informa- tion, and knowledge we do not have. It brings specific skill sets to the table that we donÕt possess, and it is operating at above traditional benchmarks,Ó she states. ÒThen why would we feel we couldnÕt construct a partnership with this CRO with a com- mon vision, purpose, and shared goals?Ó According to Jenkins, when developing this type of collaboration, you also would want to make sure the CRO has a seat at the decision-making table. After gaining inter- A Game-Changing Approach To CRO Collaboration We were building an innovation model, so we also needed to take feedback from the CROs on how they would build this model. A N N A L I S A J E N K I N S EVP & Global Head of R&D; at Merck Serono D R O B W R I G H T Chief Editor MERCK SERONO'S PRESIDENT & CEO BELÉN GARIJO — ENABLING RISK AND REFUSING TO PLAY IT SAFE By R. Wright 0 4 1 4 _ F e a t u r e _ M e r c k . i n d d 6 0414_Feature_Merck.indd 6 3 / 2 4 / 2 0 1 4 3 : 5 6 : 4 0 P M 3/24/2014 3:56:40 PM