Life Science Leader Magazine Supplements

CMO 2015

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 45 Visit eClinicalOS cloud-based clinical software solutions to streamline clinical research. Data management with efciency, productivity, communication, and collaboration. eClinicalOS is a solution of Merge Healthcare Incorporated. © 2015 All rights reserved. 866.387.4257 | We're Changing Watch Us Fly Before leaving this debate and going back briefly to the specific decision for batch size, sometimes bigger is better. This is particularly true heading toward Phases 2 and 3 when the need and the cost for cGMP material both rise. To flip our earlier bias for "smaller is better," a best practice for sponsors is to allow the CDMO to make additional material when that opportunity makes sense. For example, if a biotech requests a quote for three kilos, but that amount will fill up only half of the equipment train at the CDMO, it might reconsider. One of our panelists put it this way: "A better idea is to also ask for a quote for all the material to fill up the equipment train to its reasonable capacity." Maximizing output can save money on running more batches in the future, and the cost differential for running large batches per se might be pleasantly surprising. That's because most times the biggest contributor to the cost of goods is the labor or equipment time at the plant. Regarding the extra material itself, as somebody at OPW remarked, "Trust me, the additional material will get used. There's always somebody chomping at the bit for material, so they will use it. It's quite a benefit to suddenly have more material at relatively little extra cost." cGMP AND MORE DECISIONS Our "batch-sized drama" above has provided a clear example of time-and-phase decisions in drug development. It is one of the most crucial elements for successful project progress for small molecule and perhaps even more for the burgeoning biologics industry. Of course, the wise know there are many more examples, including the timing for production of an initial cGMP batch. Unsuccessful cGMP batches are not only costly from a financial standpoint but also create a batch history for your drug that you'd rather not have documented. As one participant at OPW said, "The cGMP profile of product development change is dramatic and important as we go from early preclinical GLP [Good Laboratory Practices] through all the phases." Our four experts say this is an area where spon- sors, particularly inexperienced companies, need that close relationship and advice with a CMO who has been through the process many times. "Biotechs particularly should ensure they understand the fact that it is step-by-step going from research to full com- mercial," advises our panel. "It's key to know when to go from Phase 1 appropriate material to a Phase 2 to a Phase 3 registration. Having an internal understanding, but also with your CDMO advising you up front, is critical. If you haven't got that, then you've got an enormous problem." At least one decision on the drug development continuum, then, seems straightforward: If you are utilizing outsourcing services, it's always the "time and phase" to be actively engaged with your CDMO. L

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