Life Science Leader Magazine Supplements

CMO 2016

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Page 13 of 63

LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 14 SUPPLY CHAIN OUTSOURCING Pfizer and ZZ Biotech. We have a single product. I believe they have more than that. Our company was set up to develop this product. We don't have many different things going on at differ- ent stages. We're either manufacturing that drug, or we're not manufacturing that drug this week. We're either doing a stability study on that drug or not doing a stability study. I make use of consul- tants who have specific backgrounds in specific areas as needed. "I actually just got back from Australia, where I was doing a site audit of the biomanufacturing facility we're going to use. I went with my quality consul- tant. I have other consultants for cell line development work and for helping design animal toxicology studies. I hope this doesn't offend anybody, but I only pay for them when I'm using them. Internally, we just keep things really, really small. You could say we are trying to get big by staying small." CLOSING CURTAIN Kaczmarek made some comments we can use for summing up. He said that supply chain management comes down to assessing your company's risk and tending relationships accordingly. "Up front in outsourcing, the technical piece is important, but you have to weigh the relationship with your company's risk profile. How much do you really need to invest in, and manage, each relationship?" And my final aside: As Pryor knows, humor can deliver the clearest mes- sage. He's shown us that for this era of burgeoning biotechs, startups, and virtual companies, the "supply chain" is a strictly scaled and lean apparatus built piece by piece and impermanent. "Like many companies today," Pryor says, "we have a single product on a tight budget. I'm involved with everything, the glue that holds the activities together. I hope I avoid getting stuck." L sell it. What are you going to do in that situation? Well, you simply start driving that tactical piece as hard as you can to gain your supply chain." Kaczmarek continues: "But as you grow and gain experience as a company, you start to understand how important it is to look at your integration of outsourc- ing, to manage that strategic profile, and understand the various capacities. You may start by designating someone within your organization to focus on the long-term strategy. Or, if you're just doing it step-by-step – even as a virtual exercise – it's critical to think about how the pieces are to be managed. "Yes, it's hard to look out past what you're dealing with on a daily basis. At the same time, there are so many potential faults at the back half of the process you can address earlier in your phases. This will help provide a success- ful commercial launch later on. "Even if you're looking to sell off the product during phase study, you need a scalable process. You want to ensure you put yourself in a position to sell profitably. Have you set milestones up? Internal oversight and consultants can help align a supply chain for small com- panies. I've been with big players in the past like Wyeth and Bayer; they all have those strategic plans and those planners. They are focused on how that whole product line is going to be developed and utilized, from nuts to bolts. These are the differences between big and small companies, but the small companies should plan ahead as much as possible." ON WITH THE SHOW Returning to Pryor, the next question he had to handle was on "alliance manage- ment." I thought he might say something poetic like, "Alliance shmalliance!" Here's what he actually said. "I don't have a group for handling that sort of thing. Perhaps here there are a few minor differences between Back to that panel discussion, the moderator skipped through thoughts on subjects such as "alliance management," and the processes in determining how to manage external outsourcing infra- structures. Pfizer and Sandoz represen- tatives had enlightening descriptions, some best practices, and interesting anecdotes. All the while, panelist Pryor listened intently, wearing the thin shadow of a Cheshire cat's smile. He was asked to explain the different plans for establishing an outsourcing infrastruc- ture if your goal is to take a program to Phase 2 and sell it, versus taking it through commercialization. "I don't know what my plan is," Kent said to some laughter. "Maybe somebody will buy us after we finish Phase 2 or after we finish Phase 2-B or maybe after we pursue another indication. Or we might take it all the way. But we are not going to build in a bigger infrastructure than what we need for ourselves to drive the project today. Right now, if we don't need it, we aren't building it. "That's not to say I don't think about different strategies," he added. "I think about our strategy every day. I know the types of people I would need to hire at different times in the development process, as we go as far down this road as it makes sense to go." INTERMEZZO Let's move the spotlight to Kaczmarek. He amplifies some of what Pryor says, but also tells us of an experience that saw some of Pryor's approach lead to an approved commercial product. "When I started Pacira, I can truly tell you we weren't looking at our long-term infrastructural pieces whatsoever. We were trying to survive day-to-day. Then, when in early 2012 we got approval for our drug, the only problem was we couldn't even manufacture it at scale yet. In other words, we had to figure out how to make it, because we were starting to By L. Garguilo DID YOU HEAR THE ONE ABOUT THE SUPPLY CHAIN INFRASTRUCTURE?

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