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CMO 2017

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By L. Garguilo EMERGING BIOPHARMA & THEIR CMOs — CRAZY LIKE A FOX BEST PRACTICES Outsourcing LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 70 new biotech, it doesn't mean we can't have a mature and experienced CMC (chemistry, manufacturing, and controls) infrastructure and strategy," as one sponsor at Outsourced Pharma Boston 2016 put it. With such companies, "from the very beginning, CMC is a core capability, vitally important to our business strategy and approach to partnership with external partners." In-house, CMC expertise facilitated the quick and comprehensive tech transfer we're describing here. A testament to that success, and the progress of the program and relationship, is how quickly others in the industry started to take notice. "A lot of people stopped thinking we were crazy when we moved through Phase 1 to a Phase 2 study and had clinical supplies manufac- tured in a relatively short time period." For those CMOs asking how they might get involved in these tighter integrations with sponsors (i.e., become this new breed of service provider), the answer we heard is "it starts by being identified as an organization fully willing to leap into the emerging field, take on that new knowledge and training, and have the sponsor on the premises 24 hours a day." SUCCESS FOR THE CMO? No one is suggesting, though, that a CMO leap before looking. The CMO in this type of business relationship, to a large degree, takes on the risk profile of the spon- sor. Accordingly, potential rewards should be hashed out in equal measure. Getting this balance right will ultimately determine if these partnerships flourish or new models develop yet again. Here's what the sponsor provides the CMO: special- ized scientific knowledge and unique processing expe- rience. The CMO gets to design a whole new capability in an advancing technology and drug type, and if the product is successful, long-term business is created. razy, that is, like a fox. And this sponsor found an equally crafty CDMO willing to join its pursuit in developing a new class of medi- cines. Today, that sponsor-provider relation- ship exemplifies a new model of alliance between emerging biopharma and CMOs. ARE YOU SURE YOU WANT TO DO THIS? The biopharma of this chronicle believes it leads the world in developing a new class of therapeutics, those that include the daunting challenges of producing nonsterile, live bacterial for oral-dose drugs. The com- pany spoke to over 60 CMOs worldwide. Only a handful responded affirmatively. To be clear, this wasn't a quo- tidian request for an outsourcing relationship. These CMOs were, in effect, being asked to think about alter- ing what they do, what they may become, and who they may be able to serve in the future. That a partner emerged points to the existence of a different breed of CMO, one willing to take a larger bet on a single-sponsor relationship. This organization had some background in the scientific field. However, to the emerging sponsor, the more important consideration was the CMO's fit to strategic purpose. It was relatively small and owned a strategy not necessarily of large growth and client diversity. YOUNG AND EXPERIENCED The subsequent business agreements and tech trans- fer between sponsor and provider were successful for at least two reasons, both of which place the sponsor in a group of emerging biopharma separate from the currently popularized virtual biotechs. One of those reasons is the biopharma's stance vis-à-vis CROs. We'll save this explanation for last. We'll start with the attitude that "although we're a Emerging Biopharma & Their CMOs – Crazy Like A Fox L O U I S G A R G U I L O Chief Editor, Outsourced Pharma @Louis_Garguilo (As Previously Seen On Most of the CMOs we spoke to, frankly, just thought we were crazy. – Comment from a biopharma executive at Outsourced Pharma Boston 2016 C

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