Dheeraj Rupani: No financial relationships to disclose
Objectives: In the evolving landscape of pharmacometrics, the urgent need to rapidly deliver high-quality pharmacokinetic (PK) insights demand a robust and innovative approach. This poster delves into the challenges of accelerating delivery timelines while ensuring PK data quality at the source through finalizing the report. Key obstacles include the timely availability of data , persistent communication barriers due to lack of processes and SOPs, dependencies across cross-functional teams and various delivery models.
Methods: To address these challenges, we have implemented a suite of strategic solutions: Harmonization of Raw PK Data Standards: Establishing uniform standards to ensure consistent data quality and integrity from the outset. Streamlined Workstreams: Developing dedicated communication channels and workstreams to overcome communication challenges. Standardization Tools: Introducing tools for data specification standardization to align diverse inputs and outputs more effectively. Programming and Reporting Templates: Utilizing structured programming frameworks and templates to streamline analysis and reporting processes. Early Access to Unblinded PK Data and SOPs/Charters: Facilitating early access to critical data required for analysis and guidelines to expedite analysis and decision-making. Training and Change Management: Establishing training programs and change management strategies to ensure all team members are proficient with new tools and processes.
These initiatives are supported through close collaboration among integrated Bio-analysis, data management, Biometrics, Pharmacometric Programming, Pharmacometrics, and the Project Management Office,. Our comprehensive framework ensures that speed and quality are balanced with innovation, enabling more dynamic responses to the intricacies of Pharmacometric research and development allowing our scientists to focus on the science rather than operational hurdles.
Results: : The above methods have been successfully implemented in several submissions at AstraZeneca rapidly to deliver high-quality population PK and exposure response reports accelerating delivery timelines.
Conclusions: This poster provides an overview of the current pharmacometrics landscape and the need for rapid delivery of high-quality submissions/decision-making. It identifies the key obstacles, such as data availability, communication gaps, and cross-functional dependencies and provides strategic solutions, including standardized PK data & data specifications, automated reporting, and structured programming. Additionally, it overs methods for early access to unblinded data and guidelines for faster analysis. Emphasis is placed on training and change management to ensure effective implementation. Anyone reviewing the poster will gain an appreciation for balancing speed, quality, and innovation in pharmacometric research and development.
