Life Science Leader Magazine Supplements

CMO 2015

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DRUG DEVELOPMENT outsourcing By L. Garguilo "PHASE-APPROPRIATE" DRUG DEVELOPMENT THE NEW "TIME AND PLACE" LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 42 ence, this comment regarding novice outsourcers stuck with me: "First of all, brace yourself for things taking longer than you are used to in your own labs. It's a scientific and business process working with a CDMO, so you must build that into your project timelines." Ulrich Ernst is senior vice president for manufacturing & quality operations at Amunix, a biotech focused on the design and preclinical development of protein pharmaceuticals with extended serum half-lives. Perhaps his most memorable comment at OPW was a sports analogy. "If you're coaching a football team, you want your first 10 plays all mapped out to march down the field and score a touchdown. It's no different in drug development. To avoid variability, you want your detailed plan set ahead of time. You really want to get to the goal line." Patrick Murphy is vice president, manu- facturing, at Versartis, Inc., an endocrine- focused biopharmaceutical company developing recombinant human growth hormones for the treatment of growth hormone deficiency. Murphy raised to a higher level the notion of understanding advance drug development projects from phase to phase. As one of the pan- elists said: "If there's no one in your organization experienced with CDMOs, you'll definitely want to bring expertise or a consultant in-house. If not, you'll be sending somebody out to build a dam with no engineering background. It's going to leak." What'll leak is money and time, and at worst the chances your drug makes it to commercial success. Therefore, experience and the ability to forge relationships with CDMOs form the ground beneath phase-appropriate decision making. Let's meet our "Fab Four" (or maybe that's "Lab Four") to see how to build on that, and then take a closer look at what goes into making scale-up decisions. THE EXPERTS IN TIME-AND-PHASE The Outsourced Pharma West discussion was moderated by Bikash Chatterjee, president and CSO, Pharmatech Associates, which provides consulting and services to the regulated and global life sciences industry. In a conversation with Chatterjee just prior to the confer- "Phase-Appropriate" Drug Development The New "Time And Place" Parents today still caution children with the phrase, "Everything in its time and place." For me, it just took "the look" for my parents to convey: This wasn't the right time or place. n our biopharma industry that axiom gets replaced with, "Everything in its time and phase ." And "the look" might come from veteran project managers, outsourcing providers, or consultants regarding scale-up strategies. Four such industry veterans led a free-flowing discussion on "phase appropriate" decisions at the inaugural Outsourced Pharma West (OPW) con- ference and exhibition in San Francisco last November. They had a common message directed at established pharma: "To find out whether the CDMO has exactly what you're looking for and understands what you're asking at each phase of your project, you need to forge a good relationship from nego- tiations ." This requires both sides fully understanding the long-term strategies that will guide step-by-step decisions throughout the business partnership. Our experts also had a consolidated message for virtual and smaller bio- pharmaceutical companies. Just as the inexperience of youth makes it hard to judge appropriate actions and timing, you need real-world experience to I L O U I S G A R G U I L O Executive Editor @Louis_Garguilo

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