Conference Program
Wednesday, June 29
| 12:30pm –12:35pm | Opening Remarks |
| Toshinari Mitsuoka (Ministry of Health, Labour and Welfare, Japan) | |
| 12:35pm –13:00pm | Welcome, Introductions, and Symposium Overview |
| Vinod P. Shah, Ph.D. (International Pharmaceutical Federation, USA) | |
| 13:00pm -13:45pm | Keynote Address: New era in BA/BE world |
| Gordon L. Amidon, Ph.D. (University of Michigan, USA) | |
| 13:45pm -14:00pm | Break |
| Session 1: Predicting oral BA and DDI to select better compounds | |
| 14:00pm -14:40pm | Physiology-based biopharmaceutical modeling |
| Kiyohiko Sugano, Ph.D. (Pfizer, UK) | |
| 14:40pm -15:20pm | Drug absorption, first-pass extraction and bioavailability: Experience from human in vivo studies |
| Hans Lennernas, Ph.D. (Uppsala University, Sweden) | |
| 15:20pm -16:00pm | Role of absorptive transporter: Impact on oral BA and DDI |
| Ikumi Tamai, Ph.D. (Kanazawa University, Japan) | |
| 16:00pm -16:20pm | Break |
| 16:20pm -17:00pm | The challenge and strategy to study transporters in drug development |
| Noriko Okudaira, Ph.D. (Daiichi Sankyo Co., Ltd., Japan) | |
| 17:00pm -17:50pm | BDDCS for better understanding of DDI |
| Leslie Z. Benet, Ph.D. (University of California, San Francisco, USA) | |
| 17:50pm -18:10pm | Additional Discussion |
| 18:20pm -20:00pm | Welcome Reception |
Thursday, June 30
| Session 2: Improving oral BA of biopharmaceutical problem compounds | |
| 9:00am –9:35am | Physical chemistry of API and its implication for formulation strategy |
| Kohsaku Kawakami, Ph.D. (National Institute of Material Science, Japan) | |
| 9:35am –10:10am | Formulation design based on model and simulation |
| Ryusuke Takano, Ph.D. (Chugai Pharm. Co., Japan) | |
| 10:10am -10:50am | Design and development of conventional SEDDS and supersaturatable SEDDS formulations with improved oral absorption of poorly soluble drugs |
| Ping Gao, Ph.D. (Abbott Laboratories, Inc, USA) | |
| 10:50am -11:10am | Break |
| 11:10pm -11:50am | Release-controlling mechanism of water-soluble and water-insoluble drugs in oral delivery |
| Beom-Jin Lee, Ph.D. (Kangwon National University, Korea) | |
| 11:50am -12:30pm | Delivery strategies to diminish intestinal metabolism and enhance bioavailability |
| Peter R. Langguth, Ph.D. (Johannes Gutenberg University-Mainz, Germany) | |
| 12:30pm -12:45pm | Additional Discussion |
| 12:45pm -14:15pm | Lunch & Poster Presentation (Poster presentation 13:30-14:10) |
| Session 3-1: IVIVC and BCS for optimizing formulation and streamlining BE study | |
| 14:10pm -14:50pm | IVIVC consideration based on the analysis of in vivo oral absorption process in human |
| Shinji Yamashita, Ph.D. (Setsunan University, Japan) | |
| 14:50pm -15:30pm | Predicting bioequivalence from in vitro dissolution tests |
| Jennifer B. Dressman, Ph.D. (Goethe University Frankfurt, Germany) | |
| 15:30pm -16:10pm | Industrial perspective for evaluation of dissolution: Quality by Design |
| Bertil Abrahamsson, Ph.D. (AstraZeneca, Sweden) | |
| 16:10pm -16:25pm | Additional Discussion |
| 16:25pm -16:45pm | Break |
| 16:45pm -17:45pm | Special Lecture: Innovative strategies for drug development using microdose clinical study |
| Yuichi Sugiyama, Ph.D. (University of Tokyo, Japan) | |
| 17:45pm -18:30pm | Poster Presentation |
| 19:00pm -21:00pm | Banquet (at Kobe Portopia Hotel) |
Friday, July 1
| Session 3-2: IVIVC and BCS for optimizing formulation and streamlining BE study | |
| 9:20am -10:00am | Biowaivers for IR drug products - What have we learned since BCS? |
| Dirk Barends, Ph.D. (National Institute of Public Health and the Environment, Netherlands) | |
| 10:00am -10:40am | Future in BCS: Biowaiver Class 2 and Class 3 ? |
| James E. Polli, Ph.D. (University of Maryland, USA) | |
| 10:40am -11:00am | Break |
| 11:00am -11:40am | IVIVC and BE for combination drug: Experiences in Pfizer |
| Jack A. Cook, Ph.D. (Pfizer, USA) | |
| 11:40am -12:20pm | Quality by Design for modified release drug products |
| Andre Raw, Ph.D. (Food and Drug Administration, USA) | |
| 12:20pm -12:35pm | Additional Discussion |
| 12:35pm -13:30pm | Lunch |
| Session 4: World-wide standards for regulating oral drug products | |
| 13:30pm –14:10pm | BE guidelines in EU: current status and future |
| Jan Welink, Ph.D. (European Medicines Evaluation Board, Netherlands) | |
| 14:10pm –14:50pm | Japanese and global situations in regulating oral drug products |
| Chikako Yomota, Ph.D. (National Institute of Health Sciences, Japan) | |
| 14:50pm -15:15pm | Japanese draft guideline for BE studies for manufacturing changes |
| Noriyuki Muranushi, Ph.D. (Shionogi & Co. Ltd, Japan) | |
| 15:15pm -15:30pm | Short Break |
| 15:30pm -16:10pm | Panel Discussion for World wide standards of BE guideline |
| 16:10pm -16:20pm | Closing Remarks |
| Mitsuru Hashida, Ph.D. (Kyoto University, Japan) | |