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 13 RELIABILITY AND OPTIMIZATION SOLUTIONS@CAGENTS.COM REDUCE THE COST OF DELIVERING HIGH QUALITY PRODUCT • CMO Oversight • Supplier Audits • Safety and Quality • Process Optimization • Remediation Support • Maintenance Programs • Maintenance Training • Warranty Checks COMMISSIONING AGENTS, INC. | CAI CONSULTING WWW.COMMISSIONINGAGENTS.COM 9 WHAT ARE SOME OF THE METRICS YOU USE TO GAUGE THE SUCCESS OF THE RELATIONSHIP? Alonso-Caplen: My quick answer would be cost and timelines. You will have a schedule, a GANT chart, right from the beginning, which both sides have agreed upon and signed. There are also costs that have been agreed upon. We will typically pay for milestones and deliverables. This illustrates the dif- ference between trying to get some- thing done internally versus externally. Internally, getting something done can be like pulling teeth. But externally, if you don't deliver, we don't pay. Hoffmann: Those are both important metrics. Once you get past those, I always try to think about how much time my team has to spend managing the project. If the sponsor/CMO relationship is going well, you should find yourself spending less and less time managing the project. It's a very easy and definitive metric. Just keep track of how much time you're spending on it. Novak: My three favorite metrics are related to quality: on time, in full, and right the first time. I also like to look at deviations and CAPA closures. I rec- ommend building a score card with all of the metrics on it and reviewing it monthly. Then quarterly, I recommend having a face-to-face business meeting with all team members from both sides to review the quarterly business metrics or your timeline. 10 DO YOU HAVE ANY ADVICE FOR DEALING WITH BAD CONTRACT TERMS THAT YOU INHERIT WHEN JOINING A COMPANY? Lee: That's a tough one. 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. When you select a CMO, you need a plan B as well as a backup. Many small pharma companies probably cannot afford to have two CMOs, but you really need to do what you have to in order to have a second supplier. Novak: When I first joined Pernix, I had six of those contracts. One of the first things I did was to try and redo all of them. I sat down with the CEO of each company and went over our strategy. I told them I needed more flexibility, and if they couldn't provide it, I would move the business. It might take me a year or two, but eventually I would do it. Four of the CMOs worked with me, but two of them refused to budge. Eventually I did move the business, and those are two companies I will not work with again. As much as you want to retain all of those relationships, in some cases you are just not able to do so. L Site visits are extremely important. Without them I don't think you can really get a sense of the true capabilities of a CMO. H E I D I H O F F M A N N

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