Life Science Leader Magazine Supplements

CMO 2015

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 36 CHOOSING A CMO sourcing By E. Miseta HOW TO MATCH A VENDOR TO YOUR STAGE OF DEVELOPMENT ing this selection process, you might be dooming your effort from the start. If you don't like the team at one location, look into the possibility of relocating the project to a different site. IS A ONE-STOP SHOP THE RIGHT CHOICE? Finally, a decision always has to be made regarding whether to employ a number of specialty CMOs or select one that can do all of the tasks you might need done. Most CMOs today seem to be moving towards the one-stop shop model. One thing you should ask yourself at this point is whether you have ever found a CMO that is capable of doing everything. Most companies will have an advantage when performing a specific task, such as early clinical or late clinical. Every client will want to select a CMO that is honest about its capabilities. If you need some- one to run your cell-based bio assays, do you want a company that specializes in that, or one that says it can do it and will then subcontract it out to a company you have never heard of? If you ask who will perform the work, most CMOs will give you an honest answer. But even if they tell you they will send the work to another service provider, it is your responsibility to vet that service provider as if it is the CMO you selected. The panel had one final piece of advice that might help you navigate your vendor relationships: a joint steering commit- tee. Often, an issue might arise that cannot be resolved at the team level. When that happens, a team of decision makers is needed to resolve the issue. Typically, this committee should consist of VP-level executives from both the CMO and the client. They should represent all areas of a project where disputes might arise, including operations, quality, and regulatory. "On the pre-commercial side, we have employed a steering com- mittee for the last 10 years," noted one speaker. "We have found it to be quite successful at managing a number of dis- putes." L but also checking with other pharma professionals and consultants in your professional network. Take the time to find out if they are interested in produc- ing your product, and whether they have the bandwidth to do it. Meet the people who will be working on your product and determine their level of expertise. While you will always want to have a CMO's A-team working on your project, we all know that will not always be the case. There will always be project managers with 30 years of experience and others that have 30 minutes. Do your best to ferret that out and know who will be doing your work. This is also a good time to develop those one-on-one relationships, so ask as many questions as you can. Regardless of whether you get the best project team at the CMO, you can never waiver on quality. The CMO either has a quality operation or it doesn't. It has a culture of quality or it doesn't. It's the job of your team to understand the company, its people, and its culture and its capabilities. If you cut corners dur- finger-pointing going on. Everyone will talk to their counterparts and get the situation resolved quickly. This is especially important for smaller bio and pharma companies trying to establish working relationships with CMOs that also happen to be working with Pfizer, Merck, Lilly, and other large pharma companies. Many of those CMOs will have to decide whether or not you are worth their time and effort. In those situations, you will need to sell them on your company and why they should invest their time with you. Treat these relationships as a marriage. They take time to develop, and they are designed to last a long time. The more time and effort you can put into building those personal relationships with key people in the company, the better it will work out for you in the long run. WHEN YOU HAVE TO GO WITH ONE PROVIDER, CHOOSE CAREFULLY Big Pharma companies do not like being put in a situation where they have product coming from a single source. Diversification reduces risk, and in no industry is that more true than life sciences. Unfortunately, for many smaller bio and pharma companies, having mul- tiple suppliers is not a choice. Some may not have the money or resources to seek a secondary supplier, or there is not enough volume to make multiple suppliers cost-effective. Suddenly, the importance of selecting the right CMO is significantly magnified. Make the wrong choice and you may not get a second chance. No one knows which CMO will be the next to receive an FDA Warning Letter. In those situations, how do you go about mitigating risk of having your eggs in one basket? Panel members stressed the necessity of having a consistent process in place to make the right selection. Identify all of the parameters that will be important to you in a CMO. Then thoroughly inves- tigate and screen all of the candidates on your short list. That investigation should include the aforementioned site visits While you will always want to have a CMO's A-team working on your project, we all know that will not always be the case.

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