The central idea behind the “learn and confirm” paradigm is to emphasize the learning part of R&D and then intelligently apply what has been learned to the design of clinical trials. Modeling and simulation approaches have served as the means to that end, and certainly, M&S has played a significant role in the COVID pandemic.
Topics to be discussed:
- A holistic understanding of the needs of an R&D program
- Balancing the demand for fit-for-purpose modeling with the intuition to explore unexplained deviations of data from predictions that can lead to important insights
- Integrity & transparency required to explain the positive & negative implications of results to stakeholders
Our goal is to inspire conversation, with participation from the audience on how scientists at all levels of Pharma R&D can work more thoughtfully while increasing their impact on the delivery of innovation.
Presenter: Dr. Ted Grasela is Executive Vice President, of Cognigen. Ted has extensive experience in modeling and simulation, clinical pharmacology, and outcomes research.
Moderator: Dr. Ryan M. Franke has over 20 years of pharmacology experience, including 9 years of industry experience, with expertise in both pre-clinical research stages (in vitro and in vivo) and clinical studies: phase I, II, post-approval pediatric, and Human Abuse Potential.
Panelists:
Jill Fiedler-Kelly, M.S., FISoP, President of the Cognigen division and has over 25 years of CRO experience assisting companies with the strategic design and implementation of pharmacometric modeling and simulation approaches in new drug development programs. Jill is co-author of “Introduction to Population PK/PD Analysis with Nonlinear Mixed Effects Models.”
Elizabeth A. Ludwig, PharmD – Associate Vice President, Quantitative Clinical Pharmacology
Denise N. Morris, Ph.D. – Director of Learning Services
Julie A. Passarell, MA – Assistant Vice President, Statistics
Aksana Jones, MS – Associate Director