DIA/FDA/PhRMA Conference To Expand The Role Of Modeling And Simulation In Clinical Drug Development

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The Drug Information Association (DIA), in collaboration with FDA and PhRMA, will host Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making from October 28-29 in Bethesda, MD.

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Although mechanistic and stochastic modeling and/or simulation have long been used for the design and analysis of clinical trials by different stakeholders within drug development, the recent trend is to expand the joint understanding of how M&S can be better integrated and utilized into the drug development process

The Drug Information Association (DIA), in collaboration with FDA and PhRMA, will host Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making from October 28-29 in Bethesda, MD.

This two-day conference will provide an opportunity for different stakeholders to learn, create greater awareness, share good and bad experiences, identify gaps and opportunities, and clarify terminology and understanding of modeling and simulation and its role in clinical drug development. Three breakout sessions will discuss missing data, modeling and simulation in the learn-and-confirm paradigm, and model development using accumulating data. Additional session topics will include:

  •     Taxonomy of Modeling and Simulation0
  •     Modeling and Simulation in Early Development
  •     Modeling and Simulation to Inform Design and Analysis of Confirmatory Trials
  •     From Early to Full Development: Strategy and Efficiency
  •     Modeling and Pharmacogenomics
  •     Product Differentiation
  •     Modeling Safety and Epidemiology
  •     Path Forward and Next Steps

The FDA Critical Path Initiative has stimulated interest in new tools and ways to improve the efficiency and success rates of drug development programs, including their planning and analysis. Among the opportunities being explored is the increased use of quantitative modeling and computer simulation tools and approaches.

"Although mechanistic and stochastic modeling and/or simulation have long been used for the design and analysis of clinical trials by different stakeholders within drug development, the recent trend is to expand the joint understanding of how M&S can be better integrated and utilized into the drug development process," says Program Co-chair Rajesh Krishna, PhD, Director, Clinical Pharmacology and Head, Quantitative Clinical Pharmacology, Merck and Company, Inc. "This trend has been associated with some level of confusion in terminology and understanding of the role and scope of M&S. There is, however, broad consensus that M&S has an enormous potential, in many cases already realized, to greatly improve drug development through better clinical study and program design, more effective approaches to dose selection and regimen optimization, as well as better assessment of the risk/benefit of new and existing treatments."

Robert O'Neill, PhD, Director, Office of Biostatistics, CDER, FDA, and Donald R. Stanski, MD, Vice President and Global Head, PH, Modeling and Simulation, Novartis Pharmaceuticals Corporation, will deliver the keynote address.

Click here to register.

About the Drug Information Association (DIA)
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.

Contact: Joe Krasowski
DIA
+1-215-293-5812

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