Session topics and Invited Speakers at the 5th GBHI Conference

"2-stage, adaptive and replicate design: a regulatory update after the discussions at GBHI 2"

Wanjie Sun, US-FDA, USA, "Re-cap from last meeting and new evidence comparing EMA, HC, FDA approach for highly variable drugs and replicate design; consumer risk?"

Paulo Paixao, infarmed, Portugal, "News from EMA on requirements for highly variable drugs and replicate design"

Xiaojian Jiang, US-FDA, USA (TBC), "Adaptive design and alpha adjustment: FDA position"

Helmut Schütz, BEBAC, Austria, "Novel approaches in adaptive design and alpha adjustment, e.g. for parallel design studies, or integration of pilot into pivotal studies"

"Modeling & Simulation"

Paula Muniz,CTI, Model Informed Development, Spain, "Introduction and example(s) to illustrate the opportunities of modeling&simulation to support virtual BE"

Liang Zhao, US-FDA, USA, "Leveraging Model Integrated Evidence for Generic Drug Approval"

Michiel van den Heuvel, PK assessor in MEB, member of EMA MSWP and MWP, The Netherlands "EMA perspective on model based BE"

Sebastian Haertter, Boehringer Ingelheim, Germany, "IVIVC or PBPK, potential for waiver of in vivo BE studies from an innovator’s perspective"

"Introduction to Session II"

Jan Welink, MEB, The Netherlands, "Current regulatory thinking and where do we stand after GBHI-1 and GBHI-4?"

Mirko Koziolek, AbbVie, Germany, "Fasted vs. fed state: what are the most essential differences in GI physiology which may affect the in-vivo performance of immediate release solid oral dosage forms?"

Werner Weitschies, University Greifswald, Germany, "Comparability of different capsule types: In-vivo performance of capsule shells in fasted vs. fed stomach and consequences for BE assessment"

Christos Reppas, National and Kapodistrian University of Athens, Greece, "Biopharmaceutical and pharmacokinetic characteristics of the active drug ingredient: which properties may be critical for comparability in fasted vs. fed state?"

Clive Wilson, Strathclyde Institute of Pharmacy & Biomedical Sciences, UK "New food trends: possible impacts on gastrointestinal function"

Barbara Schug, SocraTec R&D GmbH, Germany, "Introduction: why the site of action matters also for topicals"

Wenlei Jiang, US Food and Drug Administration, Silver Spring MD USA "Which type of studies are needed for approval of generic topical products and in the case of major changes: Current position of FDA"

Evangelos Kotzagiorgis, EMA, The Netherlands, "Clinical endpoint studies, pharmacodynamic studies, cutanous PK studies and waiver option: EMAs current thinking and discussion process"

TBD, "Which type of studies are needed for approval of generic topical products and in the case of major changes: Current position of ANVISA"

Majella Lane, University College London - School of Pharmacy , UK, "Scientific background of appropriate comparative physicochemical characterisation, IVRT and IVPT of topical formulations"

Wenlei Jiang, US Food and Drug Administration, Silver Spring MD USA, "Requirements for a waiver of in-vivo studies based on qualitative, quantitative and structural similarity as well as IVRT and IVPT: example acyclovir topical cream"

Mehul Mehta, FDA, Rockville, "Promising technologies: Raman Spectroscopy and Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations"

Frank Sinner, Joanneum Research, Austria, "Promising technologies: microperfusion"

Jan Welink, MEB, Utrecht, The Netherlands, "Justification of the Current Regulatory Approach by EMA"

Wenlei Jiang, US-FDA, Silver Spring, US, "Justification of the Current Regulatory Approach by U.S. FDA"

Dr. Toru Yamaguchi, PMDA, Japan, "Justification of the Current Regulatory Approach by PMDA"

Dr. Shein-Chung Chow, Duke University, USA (TBC), "Statistical implication of divergent bioequivalence evaluation for NTI drugs"

Dr. Gerald Beuerle, Teva, Germany, "Challenges in global development of generic NTI drugs"

Paulo Paixao, University Lisbon, Potugal, "Alternative thinking regarding bioequivalence evaluation of NTI drugs"

Dr. Leslie Benet, University of California, USA (TBC), "Debate the merit of pharmacokinetic variability comparison"