The 17th New Pharmaceutical Technology and Engineering Conference 2019
Shinagawa Intercity Hall (Tokyo, Japan)
Organized by: New Pharmaceutical Technology and Engineering Institute (NPTE)
Wed. July 17, 2019Thur. July 18, 2019
Christian Woelbeling
Senior Director Global Accounts, Werum IT Solutions GmbH
『From Industry 4.0 to the PHARMA 4.0 Operating Model – The Holistic ICH Control Strategy』

1

9:30～
10:20

Fumi Yamamoto
Director, Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health
10:00～
1
Bureau Ministry of Health, Labour and Welfare (MHLW)
10:50『Recent apdates for conditional early approval system etc,and regulatory policy and promoting
innovative drags』

2

Osamu Nagayama
10:20～
Chairman, Chugai Pharmaceutical Co., Ltd.
11:10
『Challenges and Trends for Japanese Pharmaceutical Industry』

Danieｌ Borginis
Senior Engineer, Solid Dosage Pilot Plant, Pharmaceutical Sciences
10:50～
2
Merck & Co., Inc., West Point, PA, USA
11:40『MSD continuous manufacturing strategy and the development of a custom continuous blendingsystem』

3

Carla Luciani
11:10～ Assoc Sr Engineer Advisor, Leader of Future Manufacturing Platforms
12:00
Small Molecule Design and Development – Eli Lily & Co
『The Future of Drug Substance Continuous Manufacturing』-12:00～
12:50

Youhei TakagiManager, API R&D Center, Process Technology Department, CMC R&D Division
12:30～
3
Shionogi & Co., Ltd.
13:20
『Designing for Peptide API Manufacturing～The process development for scale-up with highquality～』

4

Bertil SI. Abrahamsson
12:50～
Senior Principal Scientist, Pharmaceutical Technology & Development, Astrazeneca
13:40『Six years of progress in the oral biopharmaceutics area – the OrBiTo project』

Goldi Kaul
Director, Pharmaceutical Technology, Technical Operations
13:20～
4
Otsuka Pharmaceutical Development & Commercialization (OPDC). Princeton, NJ. USA
14:10『Abilify MyCite®- The world’s first approved digital medicine system with a tablet containing aningestible event marker (IEM) to track medication ingestion』

Satoshi Morino
Senior Manager, Kashima Quality Assurance, Japan Regional Quality, Global Quality HQs,
13:40～
5EisaiCo.,Ltd.
14:30『The Latest Global Regulatory Trends on Data Integrity and Issues to be Addressed by the
Pharmaceutical Industries』--

09:50〜Opening Remarks
10:00

11:40～
12:30

Lunch Time （ 50 mins ）14:10～
14:30

Coffee Break （ 20 mins ）14:30～
14:45

The New Pharmaceutical Technology and Engineering Foundation
Particle Design &Research Abroad Grant Awards Ceremony-Lunch Time （ 50 mins ）-14:30～
14:50

PD Award 2019 Commemorative Lecture
Hirokazu Sugiyama
14:45～
5
Associate Professor, Department of Chemical System Engineering, The University of Tokyo
15:35『Development of multiobjective and practical process design methodology
for drug product manufacturing』

6

Kikuko Harasawa
14:50～
CMC sciences Dept. Regulatory Affairs Division, R&D Division, Janssen
15:40『Janssen’s Experience to Introduce Innovative Continuous Manufacturing (CM)』

Masaru Yoshida
Researcher, Formulation Research & Development Laboratories
15:35～
6
Technology Research & Development, Sumitomo Dainippon Pharma Co.,Ltd
16:25『Introduction of a method for managing the granulation end point of spherical particles using anew PAT tool』

7Kenji Tsuchiya
15:40～Project Manager, Project Management Department, Shionogi. Co.,Ltd.
16:30『Global Development of Sakigake Product Xofluza』

Don Wetherhold
16:25～ Advisor to the Chairman and Senior Vice President, Aprecia Pharmaceuticals, LLC
17:15『3D Printing in Pharmaceutical Development and Manufacturing: Technological Requirements,
Critical Elements, and Process Controls in the Development of Novel Dosage Forms』-16:30～
Closing Remarks
16:40

7Coffee Break (20 mins ）