Life Science Leader Magazine Supplements

CMO 2015

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Page 39 of 83

GLOBAL BUSINESS UPDATE insights Snapshot analyses of selected companies developing new life sciences products and... SUPPLY CHAIN outsourcing By E. Miseta SUPPLY CHAIN AND CONTINGENCY PLANNING BEST PRACTICES LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 40 panel recommends digging in and asking a lot of hard questions to find out what is the true culture of the organization. Have a good understanding of what you hope to accomplish and what the keys to success for the project will be. Every plant and inspection will be different. Therefore, don't reuse a checklist that was written for another CMO; always start fresh with a new checklist specifically tailored to the plant you are visiting. As one panelist noted, you will often look back and wish you had done a better job on an assess- ment, but no one has ever said they regret putting too much effort into one. One metric that should always strike fear into someone performing an assess- ment is turnover, especially in the areas of quality and analytical. "If a CMO is turning over its quality group every two or three years, there is no consistency that can exist there, and that scares me," said one speaker. This also illustrates the importance of having a relationship with individuals at several levels. If the person you like and work with suddenly leaves the company, it's possible you will be stuck with someone you don't like or who doesn't understand your business. Having other key relationships in the company can help alleviate that problem. INVESTIGATE YOUR SUPPLIER'S SUPPLIER It's one thing to manage the risks that you know exist. You determine the risk level, identify possible solutions, evaluate them, and then select the best option. But what about the risks that you don't know exist? Those are the ones that can sneak up on you and sink your project before you even know they exist. One of the biggest mistakes you can make in auditing a CMO — which can lead to unknown risks — is not digging deep enough into the companies they do busi- ness with. One speaker told the story of a project where a sponsor was sourcing a product from three different suppliers. Everything was going great, and the redun- dancy gave the company peace of mind. Unfortunately, all three suppliers were obtaining product from the same source. Therefore, the company was sole-sourcing the product and did not even know it, nor did they know exactly who was producing it. Eventually they did find out. A fertilizer factory next to the supplier exploded and created a shortage of the product overnight. It did not occur to anyone at the sponsor company to do a little more digging into the company's suppliers to determine the ultimate source of the product, much less check to see where that supplier was located and who its neighbors were. Many pharma execs have been burned by hidden risks, and only by digging deeper into your a Novartis company Biopharmaceuticals BIOTECH MANUFACTURING SOLUTIONS Because experience matters Customized solutions for: • Process development/optimization • Process characterization • Microbial cGMP manufacturing at 1300L, 3000L, 13000L and 40000L scale • Mammalian cell culture cGMP manufacturing at 3000L, 13000L and 2 x 13000L scale • FDA/EMEA/PMDA approved facilities For further information please contact: Sandoz Biopharmaceuticals, Biotech Cooperations 6250 Kundl, Austria,,

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