Contract Manufacturing proval inspections could be a deal breaker.
Rosenblatt: Assessment of the quality systems for adherence to regulatory guidelines is a common tool. Looking for references in documentation concerning adherence to U.S. (21CFR, points to consider, and USP), EU (CPMP [committee for proprietary medicinal products] documents, EP [European Pharmacopoeia]) and, most notably international (ICH [International Conference on Harmonization]) regulatory compliance documents, coupled with a cross examination of the procedures and the regulatory documents are good indicators of compliance. Inspection history (e.g. warning letters, 483 history), is also a key indicator of com- pany compliance.
WHAT IMPORTANT CMO ATTRIBUTE NOT PREVIOUSLY DISCUSSED OFTEN GETS OVERLOOKED AND WHY?
Alonso-Caplen: Flexibility of a CMO is an important attribute that typically gets overlooked, perhaps because it is difficult to measure. Timelines are quite dynamic, particularly in the precommercial landscape, where processes and control methods are not quite fully
established. Typically the timing of clinical trials drives the needs for clinical trial materials and other associated supplies. In R&D;, the faster you get to the clinic the better, without sacrificing quality, and at the lowest cost. Balancing these three parameters can become a "mission impossible," but a flexible CMO can definitely help.
Rosenblatt: There are two attributes that are commonly over- looked by companies. The first is the ability to retain personnel. The turnover rate of employees is often overlooked in favor of the overall industrial experience of the technical staff. It is a common misconception that overall experience is more important than experience in the current position or company. This can be prob- lematic, especially in cases where extensive technology transfer is required. There is nothing that cuts into productivity more than having to train new personnel.
The second attribute is the CMO's analytic capability. This is usually overlooked as it is frequently considered a lesser concern than production capabilities. Without sufficient analytic capability, in-process and lot-release testing can suffer delays and lapses in quality, resulting in potential loss of product.
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The CMO Leadership Awards 2012