The BioRAM Roadmap is an integrating systems strategy for patient-centric drug development that uses a therapy-based drug delivery framework. The BioRAM Scoring Grid provides the infrastructure for implementation of the BioRAM strategy. Together, they reflect an innovative strategy for optimizing clinical drug product development – using an integrated systems approach grounded in fundamental biopharmaceutics concepts, clinical insights and therapeutic drug delivery targets.
Illustrating BioRAM as an integrated drug development strategy, this dynamic, hands-on workshop follows the strategy and knowledge development stages in the BioRAM roadmap and concludes with recommendations for the Quality Target Product Profile (QTPP). Exploration will be facilitated by discussions, development and testing of critical questions and the related hypotheses. In addition, breakout sessions will allow attendees to obtain first-hand experience in applying BioRAM thinking and using the BioRAM Scoring Grid.