With the coming introduction of QbD (ICH E8 R1) to the clinical development environment, sponsors need to examine what impact this will have on group resources. This session will provide an overview of the changes in ICH E8 R1 (moving away from sponsors “overreliance on retrospective document checking, monitoring, auditing or inspection” and towards QbD), a definition of what QbD is to Pharma, and impacts on resource planning in clinical development, both internally and externally with CROs.

Carlos will share useful insights into methodology and best practices to enable pipeline investment decision making based on his experience in developing an enterprise R&D investment decision making competency.  

This session will discuss agile methodology used to execute data collection at Kite. Explore how regional, national, and global expansion has led to simplification process of decision-making.  Understand the critical importance of energy/resource efficiency in an innovative therapeutic space like cell therapy and a highly collaborative cultural environment needed to deliver cell therapy to patients.

For the past 5 years, Amgen’s Process Development organization has installed and improved on a resource capacity management framework customized to our functional needs and delivering high quality insights. As we embark on the next phase of our journey, scaling to enterprise class as well as integrating with the broader research organization, we are uncovering both challenges and value. I will share the process and learnings to date.

Strategic resource management is critical in meeting business objectives, selecting and retaining the best talent and achieving financial effectiveness of an organization. Maintaining competitive edge in a resource constrained environment can be very challenging. We will share a new resource forecasting model we rolled out for forecasting and capacity planning; as well as change management and lessons learned during implementation.