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

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 15 9 Opportunity Way | Newburyport, MA 01950 | Tel: (978) 462-5555 88 Jackson Road | Devens, MA 01434 | Tel. (978) 772-2111 Our clinical drug substance development and manufacturing team of more than 100 professionals at two Massachusetts based locations is ready to execute on your most challenging project. Whether your compound is a pre-clinical candidate or you need a partner for full scale commercial launch, PCI's unique mix of scale and capabilities are unmatched in the industry. Come see where problems get solved! VISIT PCISYNTHESIS.COM TO LEARN MORE ABOUT HOW WE CAN HELP YOU. Together. Moving Ideas Forward. 2014 edge database, they should be assessed against the above needs. Basic questions you should ask include: ▶ Can anyone look at this document and know what project it is for, why it was done, and what the key conclusions were? mented at the CDMO and with the sponsor interface. Clearly, a database of poor-quality documents is not knowledge manage- ment. We know a legacy perspective on the documentation of development activities is essential. Information and the assess- ment of that information must be captured in a manner that recognizes how people may use the information in the future, particularly in the absence of its creators. This is not just a minor issue of conve- nience and efficiency, avoiding the need to repeat studies. Miscommunication of results can have strategic consequences as well as tactical ones. For example, misunderstanding of stability results or processing conditions used in a study may lead to erroneous decisions on can- didate viability, the need for a specific process or presentation, or acceptability of a clinical formulation. It may lead to misjudging the value of an asset, the uniqueness of a formulation, or the prob- ability of success. CONSIDER ALL USERS To create legacy-value reports, both spon- sors and providers need to keep in mind all the potential users of the documents. As shown in Table 1, the accessibility of usable information impacts the company and the program over many years. The tertiary, or "forensic," reader is particularly challenged by poor knowl- edge management. Even in an electronic world, we still assume that the connectiv- ity between points of data will be made by the project guru, if you will. But proj- ect gurus disappear, and the value of the knowledge database is only measured by what can be retrieved — and understood — in their absence. Development documents that should meet the criteria discussed here include: process and product development reports (summaries of the work that is captured in notebooks and batch records), design-of- experiment studies, method-development reports, stability reports, and campaign reports. Documentation such as data anal- ysis and modeling — which use data from other reports to create new results, draw new conclusions, or communicate techni- cal progress and positions to a broader audience — should also be included. To ensure that documents have the quality to add legacy value to the knowl-

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