Life Science Leader Magazine Supplements

CMO 2017

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 14 By S. Wollowitz AN OUTSOURCING CHALLENGE: CREATING A KNOWLEDGE BASE WITH LEGACY VALUE KNOWLEDGE MANAGEMENT Documentation and controls) professionals internally. These new members must quickly catch up to learn what has been done at the CDMO and identify new service providers to do preformulation work, solid state characterization, and/or Phase 1 drug product manufacture. After a year of activity, with funds again running low, the startup tightens its belt, the project is put on hold, and these recently hired CMC experts move on to other companies. Another year later, the project is reactivated, or being reviewed for outlicensing/partnering. The internal people who oversaw the develop- ment work are gone. Contracts with the CDMOs have expired, and workers there have changed positions. What remains is a pile of development reports from multiple sources, gathering e-dust. New employees must decide how long it will take to be Phase 2 or 3 ready, whether the formulation or test method is truly robust, if they can support a process change without more work, why the yields are so variable, etc. Or how about this one? A CDMO is asked to quote on a project that has already been in a Phase 1 study. It is given summa- ries of the process, formulation, test methods, etc. in a technical package, perhaps taken right out of the IND (investigational new drug) application. After taking on the project, the CDMO finds that the test method has insufficient resolution or the process cannot be replicated, and has to invest more time (and money) in the project than in its quotation, frustrating both service provider and client. When they finally do complete their work, their reports are subject to numerous rewrites by the client. Two years later, when they are no longer working with the client, the CDMO is asked to provide additional supporting data that has long been archived. If you have been in our business for a while, you may have found yourself in situations like these, frustrated by the way development activities have been docu- t risk of speaking about an overdiscussed topic, knowledge management continues to be a challenge at the interface between sponsors and CDMOs. We know that regu- latory agencies see knowledge management as a major component of quality risk assessment, and under- standing of the design space, as quoted in ICH Q10: Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinu- ation. For example, development activities using scientific approaches provide knowledge for prod- uct and process understanding. Knowledge man- agement is a systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components. Sources of knowledge include, but are not limited to, prior knowledge (public domain or internally documented); pharmaceutical develop- ment studies; technology transfer activities; pro- cess validation studies over the product life cycle; manufacturing experience; innovation; continual improvement; and change management activities. However, when outsourcing development activities, documentation of the development history can become particularly challenging because the sponsor does not have 100 percent access to the primary data or the envi- ronment in which it was gathered. In addition, changing dynamics at the sponsor company can place additional demands on the documentation of development activi- ties. Here is an example of the complications that can arise particularly for the small companies that depend on CDMOs for a majority of their development activities: A small startup with limited funds identifies a development candidate and a possible synthesis route in-house. It contracts a CDMO to initially provide GLP and Phase 1 material, and to do early analytical development and stability. Subsequently with some new funding sources, the startup then hires additional CMC (chemistry, manufacturing, A An Outsourcing Challenge: Creating A Knowledge Base With Legacy Value S U E W O L L O W I T Z

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