Life Science Leader Magazine Supplements

CMO 2017

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

Issue link:

Contents of this Issue


Page 20 of 81

LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 19 and risk mitigation. But do you want those two facilities to be owned by the same CMO? That's another thought process. Moreover, consider that redundant suppliers can be set up for a "cold start" (requiring new procedural activities and longer time) or a "warm start" (where product may already be in smaller pro- duction at a provider but needs to be ramped up). These have to be recognized as quite different strategies. "What if " analyses may be quite useful to understand the various scenarios that could impact product supply: What if a key supplier had a compliance issue? If a natural disaster (e.g., hurricane) occurred, how long could production be curtailed? What if a key ingredient was not available for three months or six months? Again, your current and potential outsourcing partners are good sources to consult, particularly since any disruption will affect them as well. Finally, another important consid- eration is the accuracy — or uncertainty — of your product forecasts. Has ade- quate capacity been reserved if the prod- uct meets or exceeds upside forecasts? We've all heard of issues with incorrect forecasts, and because of the difficulty in understanding future needs and markets, the best policy is to be ready when the forecast is off. Chances are, it will be. 3. CAN THE PRODUCT BE SUPPORTED WITH REDUNDANCY? It isn't always easy – or even possible – to qualify a backup supplier. For example, as products are launched, looking to simply divide launch volumes between multiple suppliers may be problematic. That's because real-world timing, availability, costs, etc., make this more difficult than it may seem at first. Nowadays, with newer and narrower therapy targets, you may have too small quantities to interest a new supplier to make the investment to prepare to manufacture your material. In other cases, it may be difficult to identify a backup supplier with enough available capacity and the appropriate equipment to manufacture or package the product. Of course, cost — to the suppliers and you, the drug owner — is almost always a — if not the — key contributing factor. The risk-cost analysis you perform has to make sense to your entire organization. 4. WHAT TYPE OF REDUNDANCY SHOULD BE CONSIDERED? While redundancy overall is a vital risk- mitigation tool, all redundancy is not created equal. For example, qualifying two equipment/manufacturing trains within a single facility may be one tactic, and this occurs probably more than you might think. However, qualifying manu- facturing trains in two separate facilities often provides a higher level of comfort

Articles in this issue

Links on this page

Archives of this issue

view archives of Life Science Leader Magazine Supplements - CMO 2017