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Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling
Session Chair(s)
Liang Zhao, PhD
Director, Division of Quantitative Methods and Modeling, OGD, CDER
FDA, United States
This forum will present examples of applications of quantitative modeling and methods to optimize strategic planning and discuss the developing trends in this area. A panel of experts will provide their insights for interpretation of those case examples and share the best practices.
Learning Objective : Discuss examples of applications of quantitative modeling and methods to strategic planning related to the timing of potential generic drug competition; Summarize best practices from the experiences of success and failure; Identify the developing trend in using quantitative methods and modeling for strategic planning.
Speaker(s)
Product Selection Drivers for Smaller Generic Drug Companies
Charles DiLiberti, MS
Montclair Bioequivalence Services, LLC, United States
President
FDA Perspective
Meng Hu, PhD
FDA, United States
Scientist, Division of Quantitative Methods and Modeling, ORS, OGD, CDER
Industry Perspective
Nicholas Cappuccino, PhD
Dr. Reddy's Laboratories, United States
Chair, IGBA Science Committee; Consultant, Compliance, Quality & Sci Affairs
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