Life Science Leader Magazine Supplements

CMO 2015

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 11 folks whose quality of work and technical skill you understand and whose opinions you can trust based on how well you know them. I recommend leveraging social media tools, like LinkedIn, as a means to get in touch and have conversa- tions with them about their experiences with CMOs they may have used or are currently using. 4 ONCE YOU HAVE AN INTERNAL CHAMPION IN PLACE AT THE CMO, HOW DO YOU MANAGE THE RISK OF THAT PERSON LEAVING, BEING REPLACED, OR GETTING OVERBURDENED? Alonso-Caplen: I believe project manage- ment is key to the success or failure of your contract. The folks running the pro- cesses are certainly important as well, but having an efficient project manager is critical. At some point, a project manager you are working with is going to leave, so it's important to look at how deep the bench is. Ask that person if they were to leave, who the likely replacement would be. Get to know that person, too, if you can. One of the parameters I look for in a CMO is that project management capability. One small CMO we looked at years ago asked, "What is project man- agement?" That should definitely send up a red flag. Hoffmann: I completely agree with those comments. A good project man- ager is vital. I would add that if you are not happy with a project manager, don't be afraid to ask for a change. Go to the sales department or the person you originally contracted with and tell them it's not working and that you need someone new. If you are an unhappy customer, someone there will want to make you happy. Alonso-Caplen: I like to compare the CMO/client relationship to a marriage. The RFP process is the courtship where both companies present their best sides. This will lead to a contract being put in place, which is the marriage. Then you go through the tech transfer process and production, which could lead to many happy anniversaries or an unhappy divorce. As in other relationships, if there is a break, it usually occurs in the communi- cations process. I cannot overemphasize the importance of communication. It is always better to over-communicate than to under-communicate, and having that project manager be the center of com- munications between the CMO and the client will help the process. 5 HOW CAN YOU BALANCE THE DESIRE TO PICK A TRUSTED PARTNER VERSUS THE NEED TO SELECT THE BEST CMO FOR YOUR CURRENT STAGE OF DEVELOPMENT? Lee: Both factors are very important. I think selecting the right CMO is a must in the first phase. Once you have I have seen agreements that will not even let you get a secondary supplier. That is risky, and I have seen companies get burned by it. J U N N I N G L E E INSTALLATION AND STARTUP INSPECT TO GET WHAT YOU EXPECT SOLUTIONS@CAGENTS.COM • Project Management • Contractor Oversight • Construction QA • Design Qualification • Maintenance Strategy • CQV and LEED Cx • IQ/OQ/PQ • Functional Testing • Start-Up • Reliability Tracking COMMISSIONING AGENTS, INC. | CAI CONSULTING WWW.COMMISSIONINGAGENTS.COM

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