Life Science Leader Magazine Supplements

CMO 2016

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Page 34 of 63

LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 35 are more about scope and flexibility. Sponsors need flexibility to make scope changes in requested project activities as data is obtained and analyzed. Results obtained in the sponsors' facilities or the CMOs can narrow, expand, or refocus the subsequent activities required to move the project along. Results from safety, pharmacology, clinical trials, or market- ing assessments can impact the scope of activities at the CMO. Flexibility may also mean speed of progress needed, changes in batch sizes, amount of testing required, inability of CMOs to be more flexible and accommodate schedule change requests. For example, the inability to obtain material on time may be costing the sponsor in lost revenue, in extra costs for back-up options, or in marketing losses even before production starts. On the other side, the production facility tries to schedule six months to a year out so that it can more efficiently plan personnel and equipment needs to lower its costs and raise operating margins. To accommodate the sponsors' schedule changes for whatever reasons, CMOs have to maintain idle capacity, perhaps expand to a seven-day week to then shorten a production run, take on the expense of storing larger inventories of raw materials, and mess up the queue for analytical work. Moreover, where production is all about scheduling, development projects etc. It may mean changes in process or formulation definitions that call for less frequently used equipment, and at a vari- ety of operating scales, e.g., for isolation and drying, purification, granulation, or testing. Oh, and of course, through it all the sponsors will demand their project remains prioritized over competing activities at the CMO. SPOILED OR SUCCESSFUL BEHAVIOR? Having been on the side of the sponsor, I know that all the above are not necessarily What becomes important in an outsourcing relationship is how to ensure the two parties effectively contribute to the business goals of each company. In an industry where regulatory compliance is just the starting point, WellSpring is committed to quality beyond compliance. With WellSpring as your formulation, development, manufacturing and packaging partner for solid, semi-solid and non-sterile liquid products, you'll get the kind of scientific expertise and technical support that result in consistently high product quality and complete fulfillment of your to-market goals. Any CDMO can make it. If you want it made better, choose WellSpring. Your product can be manufactured, TRUST CAN'T. made better MEET US AT: DCAT – March 14-17 | INTERPHEX – April 26-28

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