Life Science Leader Magazine Supplements

CMO 2017

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 72 By L. Garguilo EMERGING BIOPHARMA & THEIR CMOS — CRAZY LIKE A FOX BEST PRACTICES Outsourcing Besides the willingness of the CMO to engage, these issues can be resolved only because of the makeup of this young and experienced biopharma sponsor. The second defining attribute of the new biopharma is that it kept early research at home and, for the most part, out of the hands of CROs. Perhaps this is the most intriguing com- ponent we are documenting. "[This model of strong CMC and in-house research] has been vitally important to our business strategy and approach to partnership with external partners." Let's finish with this final point on CROs. NOT THE BEST MODEL FOR CROS? This class of emerging biopharma sponsors doesn't engage as inti- mately with CROs as we might see in the more traditional virtual bio- tech model, where the trend has been to outsource as much as possible throughout the product life cycle. That virtual paradigm calls for ven- ture capital-funded biotechs to out- source to CROs for the testing and developing of ideas, new science, and technology. Upon proof-of-concept, programs are transferred to a later- stage development (and manufac- turing) organization. VCs get to stay away from funding fixed assets and incurring up-front, often nonreturn- able costs. (CROs themselves have tried to elongate their services so that transfer stays internal, the "one-stop- shop CRO/CMO model.") But what we heard at the confer- ence was a strategy of increased internal investments from the spon- sor, to better nurture the emerging science and technology. Some believe there's more flexibility in this model of outfitting labs and even beyond, and that more VC firms, "even with very early-stage startups," will start to think the same. These proponents say they'd be surprised "if the future has a lot of CRO-to-CMO transfers, particularly for unique, nonstandard, nonplatform products." L This article is based on panel discus- sions at the Outsourced Pharma Boston conference, Westin Copley Place, April 20-21, 2016. Here are the questions raised: ▶ How does that tech transfer take place, practically and contractually? ▶ How is IP — transferred and newly generated — dealt with? From the outset, there also must be some long-term strategy for success and a future left for the CMO should the sponsor's project fail in the clinic.

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