Life Science Leader Magazine Supplements

CMO 2016

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Page 35 of 63

CMO/SPONSOR SYNERGY PARTNERSHIPS By S. Wollowitz CMOs AND PHARMA SPONSORS: WHO'S THE RHINO AND WHO'S THE TICKBIRD? LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 36 evidence of spoiled behavior. Rather, the behaviors and requests are the result of the real-world timeline pressures that require making deci- sions — and often providing project guidance — with less information than desirable. It is a constant struggle to identify what needs to be evaluated in the current phase of activity and what could drag the project out. With breakthrough designations and fast- track status trending in the pharma business today, flexibility and respon- siveness on the part of the CMO are even more important for the sponsor to achieve its business needs. This is understood by the CMO, but this flexibility comes with costs to them, as mentioned above. What are the CMO's needs then? It starts with an understanding by sponsors this will mean more personnel time in managing increased internal and intercompany communications, scope changes, and scheduling regardless of whether it results in the CMO asking for additional fees or not. To provide this additional manufacturing responsiveness, it also means the CMO has to somehow main- tain an even more flexible or open (idle) capacity in both labs and production areas. Interestingly, it is the CMOs that operate at very high capacity with great efficiency of personnel and equipment (i.e., the most successful CMOs) that might be less responsive to the customer who is dealing with uncertainties and incomplete knowledge on their own end. All of this harkens back to all of those articles we mentioned dealing with the subject of "what the customer wants"! There is still a lot to uncover in get- ting to a fully mutual sponsor-provider relationship. Finally, let's all face it, our business is cyclic. Supply and demand says that the service providers will spend a lot more time worrying about accommodating the customer in dry years, but less in "wet" years. The most recent era of a favorable economy, and such things as new therapeutic technologies, may be providing the CMOs with more work and filled capacity, but at the same time take away from the ability to add this layer of flexibility sponsors now need. But as with the rhino and the tickbird, living in the same environment but having very different needs for survival, sponsors and providers rely on each other to thrive. And by the way, are we sure which is the rhino and which the tickbird? L Custom Synthesis APIs and IMs Portfolio APIs Azide Chemistry and Phos- genation Technology Expansion Siegfried offers more integrated capability with new facilities spanning the Western and Eastern hemispheres Siegfried now has worldwide presence with chemical manufacturing multipurpose cGMP sites located in: Zofngen, Switzerland; Pennsville, New Jersey USA; Nantong, China; BASF (3) Minden, Germany; Saint-Vulbas, France; Evionnaz, Switzerland, and drug product manufactu- ring sites in Zofngen, Switzerland (Pilot); Malta, Irvine USA and Hameln, Germany. The acquisition of BASF marks another step in Siegfried's Transform Strategy to become the leading fully integrated drug substance and drug product partner of the pharmaceutical industry. Earlier phases of the Transform Strategy included Siegfried acquiring California-based AMP and the German company Hameln Pharma, both active in the sterile flling drug delivery business. Siegfried offers solid oral dosage capability at a third site located in Malta. In addition, to backward integrate, Siegfried built a new facility in China's most modern industrial park in Nantong, offering a brand new State of the Art plant with GMP-capacity of 300 m 3 , which was inaugurated in August 2015! Siegfried acquires BASF custom synthesis and part API business 3 new sites Minden Germany Saint-Vulbas France Evionnaz Switzerland Zofngen Switzerland Drug Substance Drug Product Hameln Germany Drug Product Saint-Vulbas France Drug Substance Pennsville USA Drug Substance Irvine USA Drug Product Evionnaz Switzerland Drug Substance Hal Far Malta Drug Product Nantong China Drug Substance Minden Germany Drug Substance

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