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IVIVC: Current Perspectives on Models and Practices

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  • Masoud Jamei, Ph.D.

    Masoud Jamei, Ph.D., SMIEEE, is a Senior Scientific Advisor and head of Modelling and Simulation group at Simcyp (a Certara company). Since joining Simcyp in 2003, he together with a team of scientists are working on various aspects of Model-Based Drug Development (MBDD) including In Vitro - In Vivo Extrapolation techniques, Physiologically-Based PK/PD models and applying top-down PopPK data analysis to PBPK models in healthy volunteer, special, and patient populations. Jamei provides continuous support and advice to the Simcyp consortium members and associate members including regulatory agencies and he has led several Simcyp hands-on workshops on MBDD. He has been the author or co-author of over 120 abstracts, manuscripts and book chapters in the field of modelling and simulation. He currently serves as a vice-chair of the BPS Special Interest Group on PK/PD and Systems Pharmacology and a steering committee member of the AAPS Systems Pharmacology Focus Group. He earned a Ph.D. in Control Systems Engineering at the University of Sheffield, U.K. and is a visiting Senior Lecturer at the Manchester School of Pharmacy, U.K.

  • Sandra Suarez-Sharp, Ph.D.

    Dr. Sandra Suarez-Sharp graduated from UF with a Ph.D. in Pharmaceutical Sciences. She spent two years at UNC as a postdoctoral fellow in the area of drug delivery to the lungs. She joined the FDA in 1999. She worked as a Clinical Pharmacology and Biopharmaceutics reviewer in the Office of Clinical Pharmacology and the Office of Generic Drugs supporting several therapeutic areas. Currently, she works at the Office of New Drug Products/Division of Biopharmaceutics as a Master Biopharmaceutics Reviewer supporting all therapeutic areas. Her responsibilities in this office include the primary and secondary/tertiary review of submissions containing Biopharmaceutics information such as dissolution, biowaivers, IVIVCs, PBPK mechanistic absorption models in support of risk assessment/setting clinically relevant drug product specifications, dissolution models for RTRT, and mentoring new reviewers.

April 5, 2018
Thu 12:30 PM EDT

Duration 1H 30M

This live web event has ended.