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Re: ohsaycanyousee82 post# 181319

Monday, 02/11/2019 7:50:08 AM

Monday, February 11, 2019 7:50:08 AM

Post# of 470183
This article is well written, accurate and timely. Considering where we are in the cycle, the need to do a build now is driven by simple good judgment and risk mitigation.

The marketplace currently faces shortages in the pharmacology/toxicology capacity and animal supplies required for drug-development studies. These constraints have forced companies to reserve biology CRO capacity 3–6 months in advance. In addition to delaying ultimate approval and revenue, any deficiency in API quantity or quality at this stage can trigger significant penalties as CROs demand compensation for scheduled work that must now be postponed—and essentially paid for twice.
In the end, it is critical to have confidence that the CRO selected for API production during drug development will deliver. There is no better way to gain this confidence than through the personal interactions experienced during a site visit. All of this interaction builds understanding and trust with the CRO and will result in a true collaboration rather than a simple material supplier-buyer relationship.


http://www.pharmtech.com/api-sourcing?id=&sk=&date=&&pageID=1
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