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CMO Leadership Awards 2013

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Contract Sourcing the details of a lost opportunity, so I will attempt to elaborate on my point with some hypotheticals. Consider the case of "Hypothetical Pharma," a drug sponsor, and Pretensin, a leading CMO. HP relies on Pretensin for both API and finished product for its novel drug in development, a potential blockbuster for neuralgia. Pretensin executives attempt to approach HP about a new technology for producing high-potency, ultra-pure formulations and bulk runs of compounds in the same class as the sponsor's product. It starts with its chief contact at Hypothetical — yes, the procurement officer (PO) — who, unlike many other POs I'm sure, thoughtlessly assumes the CMO just wants to expand its business by selling "accessories" to its main line. As a result, the connection short-circuits, either because Pretensin's offer goes no further in HP or, when it does reach an executive who could make a decision, that person sees no reason to proceed. A year later, the drug washes out of clinical development because, at the purity and potency possible with existing technology, the sponsor fails to find a satisfactory dosage. You could play out the same or a similar scenario substituting other suppliers and supplier types for the CMO; namely, drugdelivery, formulation, equipment, and so on. But the point in every case is simply this: The sponsor missed the boat because of an institutional bias. Like the "racially blind," it did so without seeing its own prejudice or learning anything from it. Yes, this really is discrimination, folks, and not the kind practiced by wine tasters. It is destructive (of opportunity), and it is costly. The only lasting difference you could make in all this, however, is not by changing the players but by changing their minds. We don't treat doctors like servants just because they serve us. An alternate universe of opportunities could arise from a simple exchange of passive disinterest to active pursuit of innovative solutions developed by organizations outside the sponsor company, whether we call them contractors or partners or just late for dinner. Suppliers are not second-class citizens. When they lead rather than follow, when they take steps forward not just give support, when they offer bold innovation instead of blind iteration to their clients, suppliers deserve a higher measure of credit. If not for them, this industry would feel little pressure for change from within, and its total reliance on R&D; for innovation would wither because every other function it depends on — manufacturing, clinical research, preclinical testing, and more — would simply stand still, trapping industry in the past. a Novartis company Biopharmaceuticals BIOTECH MANUFACTURING SOLUTIONS Because experience matters Customized solutions for: • Process development/optimization • Process characterization • Microbial cGMP manufacturing at 1300L, 3000L, 13000L and 40000L scale • Mammalian cell culture cGMP manufacturing at 3000L, 13000L and 2x13000L scale • FDA/EMEA/PMDA approved facilities For further information please contact: Dr. Friedrich Nachtmann, Biopharmaceuticals, Head Biotech Cooperations, 6250 Kundl, Austria, Phone: +43 (0) 5338 200 680, friedrich.nachtmann@sandoz.com, www.sandoz.com The CMO Leadership Awards 2013 21

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