Session topics and Invited Speakers at the 5th GBHI Conference

Session co-chairs: Gerald Beuerle, Teva, Ulm, Germany and Nilufer Tampal, FDA Silver Spring MD, USA

"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, "Adaptive design and alpha adjustment: FDA position"

Helmut Schütz, BEBAC, Austria, "Novel approaches in adaptive designs and alpha adjustment, e.g., with futility criteria and for parallel design 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"

Session co-chairs: Henning Blume, SocraTec C&S, Oberursel Germany and Jan Welink, MEB, Utrecht, The Netherlands

"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"

Session co-chairs: Mehul Mehta, US Food and Drug Administration, Silver Spring MD USA and Barbara Schug, SocraTec R&D, Oberursel, Germany

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 "U.S. FDA Recommendation on Bioequivalence Demonstration of Topical Drug Products"

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

Taina Mendes Nunes, CETER/GGMED/ANVISA, Brazil, "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"

Markham Luke/Priyanka Ghosh, US Food and Drug Administration, Silver Spring MD USA, "Characterization based approaches for locally acting drug products applied to the skin"

Markham Luke/Priyanka Ghosh, FDA, Silver Spring MD USA, "Cutaneous PK based approaches for locally acting drug products applied to the skin"

Frank Sinner, Joanneum Research, Austria, "Promising technologies: Continous skin sampling methods for cutaneous PK-based bioequivalence assessment"

Session co-chairs: Wenlei Jiang, US-FDA, Silver Spring, USA  and Paulo Paxaio, University of Lisbon, Portugal

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, "A Proposed Approach for Determination of the BE Acceptance Range for NTI Drugs"

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

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

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