Life Science Leader Magazine Supplements

CMO 2015

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 9 PLANNING AND DESIGN DESIGN IN A CULTURE OF QUALITY • Owner Project Management • Supplier Selection and Audits • Process Design • Concept Design • Reliability Centered Design • Asset Design • Tech Transfer • Commissioning Plan • Validation Master Plan COMMISSIONING AGENTS, INC. | CAI CONSULTING WWW.COMMISSIONINGAGENTS.COM SOLUTIONS@CAGENTS.COM always make your expectations very clear from day one. Heidi Hoffmann, Sutro Biopharma: I rec- ommend that every sponsor take some time right up front to determine what their business model is and how far they want to take the project. It's important to delve down into the details and under- stand the strengths of your company. Only then can you try to identify a CMO that complements those capabilities and has expertise that you lack. This will allow you to prepare a busi- ness plan and determine what capabilities you intend to develop over the course of a project versus what you would prefer to outsource and not commit resources to having in-house. Understanding that will make the CMO selection process much easier. Joe Guiles, Medivation: One point that Terry mentioned really resonates with me: The people involved in the process are critical. If you are the customer, you have to have access to the best people you can get at your CMO. Turnover is important because you need to have an understanding of their stability. In the end, it's the people work- ing for that CMO who will deliver the product you need. Most service providers have the same technologies in-house. The people who operate those technologies will be the difference makers. Finally I would just add a short comment about the RFP process. Companies that do not put a lot of time and thought into their RFP will end up in most cases not getting what they want in a response. I think there are different strategies on how to approach it. I believe you need to put enough information in the RFP to get your responders to think and hopefully open a dialogue with you. How CMOs behave in the RFP process is often a mirror of how they will behave under contract. Are they alert, attentive, on-time, thinkers/ problem-solvers, during the RFP process? Firelli Alonso-Caplen, Pfizer: At Pfizer, we do not believe cost should be the major driver when selecting a CMO. That may surprise some people, but what's more important to us in pre-commercial outsourcing is getting the quality and timeliness we desire. The time schedule we have set for getting the drug to the clinic has to be reached, and therefore we need a CMO that can meet our schedule. Cost has to be taken into consideration, but it is never the most important con- sideration. In a recent outsourcing decision I was involved in, we started off with a list of five CMOs and then started narrow- ing it down. One CMO was being taken over by another company. It was elimi- nated because we didn't know whether it would still be in existence at the end of the project. Another CMO was elimi- nated because it had no prior experience with the FDA. Experience was a factor we looked at very closely, and the CMO we ultimately selected was one that had a pre-approval inspection waived by the FDA earlier in the year. That CMO was more expensive than the others, but the FDA decision resulted in a huge savings for us, which made the decision to go with them much easier. That CMO ended up having a waived PAI for our project as well. I believe sponsors need to take a very detailed approach to these partnerships, much like performing due diligence when acquiring a new product. T E R R Y N O V A K

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