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CMO 2017

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By L. Garguilo OUTSOURCING 2017: COUNTRIES, COSTS, & SOME CONCERNS BEST PRACTICES Outsourcing LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 74 that will be something to follow in the coming months and surely beyond. And there's another related challenge, according to Olsson. It has to do with the growing distances between CMOs themselves. "Coordination of activities between CMOs, for example API manufacturers and fill-finish providers, or external analytical services, has become a key to moving forward," he says. "For a company operating under a virtual business model of outsourcing everything, [the existence of this dis- tance] can be challenging." Specifically, he sees two immediate options. "Go with a lead CMO [or a consulting group as middleman] to basically work as your general contractor. However, while this may seem convenient, it can also mean giv- ing up another degree of control." The other option? "Immerse yourself in the manage- ment of each company involved in your supply chain," he says. "I think it's a matter of personal preference. But no matter where you outsource, quality and reliability of your products remain your responsibility." COSTS AND CMO CONSOLIDATION "A definite theme for us has been the need to drive toward lower costs," says Peter Bigelow, president, xCell Strategic Consulting, and former Pfizer and Patheon executive. But he's not talking about tougher negotiating between drug owners and service provid- ers. He's focused on improved partnering for better productivity and overall financial outcomes. COUNTRIES TO COUNT ON There was a time not too long ago when few Big Pharma or Big Biotech based in Europe or the U.S. would con- sider outsourcing important drug discovery or devel- opment work to Asia. Then came a new dawn, when it seemed everything was in the process of being sailed overseas to service providers in India, China, even South Korea and other distant destinations. Today, we hear it's coming back. There's been a backtracking to the days of keeping projects closer to the vest. Well, people like Nils Olsson, VP chemistry, manufac- turing and controls at Retrophin Inc., doesn't quite agree. For the foreseeable future, he says, "I suspect we'll see much more API manufacturing done in China. Also, as the market there matures, many of the perceptions of questionable confidentiality and looser protection of trade secrets will diminish. Some organizations in China are taking remarkable steps to protect a customer's IP, and those efforts become models for others there." Olsson is responsible for outsourcing his company's entire discovery, development, and manufacturing, including for three commercial products. "Retrophin is 100 percent virtual," he says. It's also focused on orphan diseases. Readers of know of concerns that consolidation and the growth of "Big CMOs" might not fit the needs of companies such as Retrophin, focused as they are on smaller target markets. Olsson predicts that the improvements in reputation and reliability in China and India may provide more options for virtual and smaller companies like his. Now Outsourcing 2017: Countries, Costs, & Some Concerns L O U I S G A R G U I L O Chief Editor, Outsourced Pharma @Louis_Garguilo (As Previously Seen On A renewed crossing into Asia or U-turn back to Europe and the U.S.? Thoughts of capacity and costs running over filling your head these days? Perhaps some of the following comments from Outsourced Pharma editorial board members will help answer some of the questions you have regarding outsourcing in 2017.

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