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ICH M9: Harmonization of Biopharmaceutics Classification System (BCS)-Based Biowaivers

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  • Jack Cook, Ph.D.

    Jack Cook, Ph.D. is a Vice President in the Clinical Pharmacology Department of the Global Product Development unit at Pfizer, Inc. Dr. Cook holds adjunct faculty positions at the Universities of Michigan and Florida Colleges of Pharmacy. He received B.S. degrees in Applied Mathematics and Pharmacy from Ferris State College, and his Ph.D. in Pharmaceutics from the University of Michigan. He has authored/co-authored over 70 peer-reviewed publications. He is a fellow of the AAPS. His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs

  • Sebastian Haertter, Ph.D.

    Dr. Haertter is currently Clinical Pharmacology Expert at Boehringer Ingelheim (BI). He is further member of Cardiometabolism Therapeutic Area leading bodies at BI (Clin Expert Committee, Ther Area Leading Committee). He is also representative of Translational Science and Clinical Pharmacology in the BI Clinical Pediatric Expert Group, the Global Labeling and Risk/Benefit Committee, and Inlicensing expert groups.

    Dr. Haertter is member of the IQ-Clin Pharm LG (CPLG) and chair of the IQ-CPLG Pediatrics WG and the Exploratory Trial Design WG. He is pharmacist by training, received his PhD in pharm chemistry and a lecturing degree (German Habilitation) in Pharmacology&Toxicology. He was in the past assistant professor at the University of Mainz (Germany), Adjunct Professor at the Universities of Ulm (Germany), Connecticut and Albany, NY and is author or co-author of > 100 peer reviewed publications. He served as PhRMA deputy topic lead for ICH M9-Working Group, is currently EFPIA topic lead in the ICH M13 (Bioequivalence) Working Group and member of the EFPIA expert group in support of ICH M12 – DDI.

  • James Polli, Ph.D.

    Dr. James E. Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption. He has served as advisor to 21 Ph.D. graduates. He is co-Director of the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI) and the recently initiated Center for Research on Complex Generics, each an FDA-funded collaborative agreement with the Agency. He is Director of the online MS in Regulatory Science program.  He is an Editor of Pharmaceutical Research and an AAPS fellow.

  • Hans Lennernäs, Ph.D.

    Dr. Hans Lennernäs is a professor of Biopharmaceutics at Uppsala University since 2000, Sweden and he has been an adjunct professor of Biopharmaceutics at Copenhagen University, Denmark 2000-2012. His research objectives has been and are to develop novel strategies of tissue drug targeting and delivery that is expected to improve the clinical use and efficacy of drugs in various diseases, such as metabolic and cancer diseases. He has been the Principal Investigator in an extensive collaboration with Food Drug & Administration, USA, University of Michigan, USA, and Medical Product Agency, Sweden during 1992-2000 to develop the novel FDA regulatory guideline named the Biopharmaceutics Classification System. He has established an extensive human pharmacokinetic database with jejunal permeability values for 45 drug compounds that today is widely used in academia and pharmaceutical industry. His work had led to more 230 peer-reviewed publications, 300 invited lectures and more than 350 submitted presentations at scientific meetings. He is well-cited author and his research is currently supported by the Swedish Research Council and Swedish Cancer Society.

September 3, 2020
Thu 12:30 PM EDT

Duration 2H 0M

This live web event has ended.