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CRO Leadership Awards 2017

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A New Strategy And A New Model The changes made at Merck KGaA, Darmstadt, Germany were primarily the result of an initiative called "Fit For 2018," a transformation and growth program ahead of the company 's 350th anniversary in 2018. "The operations group was asked to come up with a model that would allow us to conduct clinical opera- tions in a manner that was faster, less expensive, high quality, and more efficient than our previous model," says Jacqueline Curtiss, the company's global head of clinical trial management, global clinical opera- tions. "We knew it would be a fully outsourced model, but other than that we were given no parameters or restrictions. As a team, we just needed to figure out how to get it done." Questions were raised whether this type of outsourc- ing model would actually save the company money or if the company would maintain adequate accountability over the trials — and whether a CRO could run them better than the sponsor. What would be the efficiency and effectiveness of a fully outsourced model? The decision ultimately came down to cost and exper- tise. If the company was in a position where it had to undergo change, then why not find those areas of expertise that could be most easily outsourced? This operational piece was really just one component that would change how the R&D organization operated. Bring The Right Minds Together Once the decision was made to outsource all trials, a decision still had to be made regarding the number of outsourcing partners and who those CROs might be. As any operations person will tell you, selecting the right partner is never an easy task. "The cross-functional team went through a very detailed process that involved dedicating almost a full week's time to discussing the advantages and disad- vantages of a sole provider, and whether that would work for us considering the size of the company and our portfolio, as well as the global reach of the trials we had in development," said Curtiss. Some felt outsourcing to one CRO had its advantages, while others were concerned about transferring all trials to one partner. One of the biggest questions that came up during the process was whether the com- pany had a large enough portfolio to justify two CRO partners. Another concern was whether that portfolio would be important enough to two large CROs if it were to be split in half. What resulted was a complex and pointed conversation. There was a cross-functional group of about 22 people in the room. Clinical operations were a big part of it, but the group also included medics, statisticians, data managers, and representation from the early develop- ment team. Every department that could potentially be impacted by the decision had a voice present. or years, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany used a mixed clinical outsourcing model. The company con- ducted some trials in-house but outsourced others to external service providers. For trials in development around the world, the company had four global CRO providers. For regional Phase 4 and label expansion studies there were as many as 100 different providers, which included niche CROs from around the world. Merck KGaA, Darmstadt, Germany acquired Serono in 2006. Soon thereafter, the company closed the Serono hub in Geneva, Switzerland, and also decided to out- source the entire trial portfolio to CRO service providers. F LIFE SCIENCE EXCLUSIVE CONTENT Leaders By E. Miseta THE RISK & REWARDS OF A FULLY OUTSOURCED CLINICAL MODEL LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 6

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