Title: Approach to information management in an externalized business environment

Many BioPharmaceutical companies are anxiously expanding partnerships with a variety of contract research and specialty organizations in order to cut costs, share risk, and streamline the business. Companies have been using partners (e.g., central labs, CRO's, specialty labs, CMO's) for many years in a wide variety of situations. However, as companies transition to a new paradigm for drug development, one that is less reliant on their own internal resources, the use of and the dependency on external partners is accelerating and broadening. So what happens with the information associated with externalized work? Who needs it? Who owns it? Where is it stored? How accessible is it for immediate and long-term use to inform future investments? Organizations self-optimize based on their own business objectives, processes, and systems. Contract organizations strive to be more cost effective by performing similar functions and providing similar deliverables for all of their customers. Information generated and transferred by partners is optimized for decisions that need to be taken in the present by members of a given project team. Without a clear long-term informatics vision in this mixed environment, that information is no more likely to be available and useful in the future than it is today within the vertical structure of a Pharmaceutical company. If anything it will be more challenging because information governance across co-operating companies is often an afterthought. This presentation explores information issues created by business externalization strategies and outlines an approach for an information management framework based on a variety of work with several major BioPharmaceutical companies.