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The challenges faced by the life sciences industry are well documented – fall-off in NDA’s, more complex clinical trial programs, and overall increasing costs with diminishing successes. With such widelypublished, consistent depictions of these challenges, one would expect the industry to look for more opportunities to change their approach to drug development.

Life sciences informatics groups have expressed frustration in trying to determine how to best help their business counterparts. They have been reactive to information management requests over the last few years without necessarily solving the right problems or gettng out in front of the business needs. That leaves informatics groups wondering where the business is going and how to best support it.

There are many factors to consider for successful change. When planning for and implementing change, consider what should the change involve, how will the change impact workflow and technology, who will be impacted by the change, how fast should/can the change occur, what are the costs of change, how will the success of the change be measured, etc. These factors are all important to the process. However, none is more critical than those factors that surround the cultural and organizational change – those changes that impact each and every employee on a personal basis.

Over the last several years ResultWorks has been involved in developing numerous strategy roadmaps for diverse groups in Life Sciences from research to pre‐clinical and clinical development to manufacturing for traditional pharmaceutical, biopharmaceutical, and vaccines businesses.

In today’s environment of increasing competition, consolidation and drive toward operational effectiveness, having a clear picture of where an organization wants to go is essential to success. By necessity, Life Sciences organizations need to transform themselves in a way that integrates needed change associated with business process, technology, knowledge management, and organizational dynamics.

A Digital Transformation is reshaping healthcare. New technology, mobility, and advancements in computing are enabling innovation leaders to interact with patients at the touch of a button. Information collected from devices provides rapid insights and drives realtime decision making across organizations. Success in this space requires a shift in thinking and strategies to support these advancements.

The personalized nature of many cell therapies means organizations must be able to demonstrate to regulators that they have end to end visibility across the product supply chain to ensure chain of custody, identity and condition. Cell therapy manufacturing and supply chains need emerging information management approaches and solutions to support bringing these life changing treatments to market.