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Wednesday, June 27 • 2:00pm - 3:15pm
#368: Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-665-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000229; RN 1.25

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 Objectives

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.

Chair

Liang Zhao, PhD

Speaker

Product Selection Drivers for Smaller Generic Drug Companies
Charles DiLiberti, MS

FDA Perspective
Meng Hu, PhD

Industry Perspective
Nicholas Cappuccino, PhD, MBA


Speakers
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Nicholas Cappuccino

Consultant, Compliance, Quality and Scientific Affairs, Dr. Reddy's Laboratories
Dr. Cappuccino is currently a Consultant for Dr. Reddy’s Laboratories Inc., located in Princeton, NJ, USA. Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic and Biosimilar Medicines Association (IGBA) and represents IGBA on the ICH... Read More →
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Charles DiLiberti

President, Montclair Bioequivalence Services, LLC
Charlie DiLiberti is President of Montclair Bioequivalence Services, LLC, a consulting firm specializing in finding innovative solutions to difficult problems in formulation development, PK, biopharmaceutics, and clinical study design, particularly for difficult/complex drugs. Charlie... Read More →
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Meng Hu

Scientist, Division of Quantitative Methods and Modeling, ORS, OGD, CDER, FDA
Meng Hu received his Ph.D. degree in physics in 2008 from Zhejiang University, China. In 2009, he was a research fellow in Drexel University, Philadelphia, where his research included multivariate analysis, time series analysis, machine learning, etc. Since 2014, he joined the Office... Read More →
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Liang Zhao

Director, Division of Quantitative Methods and Modeling, OGD, CDER, FDA
Dr. Liang Zhao has been serving as Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS) in Office of Generic Drugs, CDER since 2015. He initially joined FDA as a clinical pharmacology reviewer in the Office of Clinical Pharmacology... Read More →

Wednesday June 27, 2018 2:00pm - 3:15pm
Room 153ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjMgt-StrategicPlanning, Forum