The 18th New Pharmaceutical Technology and Engineering Conference 2021 Program
Kyoto International Conference Center (Japan) / Virtual Conference
Organized by: The New Pharmaceutical Technology and Engineering Institute (NPTE)
Tue. June 22, 2021

-Opening Remarks
09:50〜
Hirofumi Takeushi, Chairman, New Pharmaceutical Technology and Engineering Institute
10:00(Emeritus Professor, Gifu Pharmaceutical University)

Wed. June 23, 2021

1

9:30～
10:20

Remote Session 21:20 (MA/EST)<<Session Chair>> Makoto Miyajima (Daiichi Sankyo Co., Ltd)

Remote Session 21:00 (NJ/EST)Jose E. Tabora Sierra
10:00～ Research Fellow, Pharmaceutical Development/Chemical Synthetic Development
110:50Bristol Myers Squibb『The Evolution of Digital Data and Modeling in Pharmaceutical Development』<<Session Chair>> Yasuyuki Ikematsu (Eisai Co., Ltd.)
Remote Session 20:30 (MD/EST)Thomas O’Connor
Director of Division of Product Quality Research, CDER/Office of Pharmaceutical Quality
US Food and Drug Administration『FDA’s Advanced Manufacturing Journey』

Elçin Içten –Gençer
10:20～ Senior Scientist, Drug Product Technologies – Process Development, Amgen Inc.
2
11:10
『Virtual Plant for End-to-End Continuous Manufacturing of Synthetic Drug Substance andDevelopment of Advanced Process Control Strategy』<<Session Chair>> Yuji Tokunaga (SAWAI Pharmaceutical Co., Ltd.)

2

Masayuki Imagawa
10:50～Vice President, Head, Japan Vaccine Business Unit, Takeda Pharmaceutical Co., Ltd.
11:40
『Adaptive thinking and capacity in Japan against pandemic outbreak of infectious diseases』-11:40～
12:30

Lunch Time （ 50 mins ）<<Session Chair>> Katsuhide Terada (Takasaki University of Health and Welfare)Kenji Kuramochi
12:30～ Office Director, Office of Manufacturing Quality for Drugs
3
13:20
Pharmaceuticals and Medical Devices Agency (PMDA)『The situation of the recent GMP inspection - mainly on the revised GMP ordinance -』Yoshinori Nakajima
Executive Officer and Deputy General Manager, Formulation Manufacturing Division
11:10～
3
Daito Pharmaceutical Co., Ltd.
12:00
『Daito's strategy for development/ manufacturing of highly potent compounds and introduction ofthe 8th formulation plant~ The latest case of containment facility~』
12:00～
Lunch Time （ 50 mins ）12:50<<Session Chair>> Hirofumi Takeuchi (Gihu Pharmaceutical University)
4

Yoshihiko Hatanaka
12:50～
Representative Director, Chairman of the Board, Astellas Pharma Inc.
13:40
『Society by Future Healthcare』<<Session Chair>> Makoto Fukuta (SPERA PHARMA, Inc.)

Yasuhide Horiuchi
13:20～ General Manager, CMC Technical Dept., Toray Industies, Inc.
4
14:10
『Development of the OD coating film by use of RADIFILⓇ technology and the application to
REMITCHⓇ OD TABLET 2.5 μg』-

14:10～
14:30

Coffee Break （ 20 mins ）-14:30～
14:50

Commemoration Ceremony - Adress from the former chairman, Yoshiaki Kawashima
The New Pharmaceutical Technology and Engineering Foundation
The 8th Particle Design Award Ceremony<<Session Chair>> Hirofumi Takeuchi (Gihu Pharmaceutical University)
The 8th Particle Design Award Commemorative Lecture
Yu Hoshino
14:50～5Associate Professor, Department of Chemical Engineering, Kyushu University
15:40『Development of plastic antibodies: synthetic polymer nanoparticles that recognize, bind andneutralie target molecules in vivo』<<Session Chair>> Shigeo Yanai (Takeda Pharmaceutical Company Limited)
Goshi Murakami
15:40～ Director, Production Technology, Toyama Technology Center, Astellas Pharma Tech Co., Ltd.
6
16:30
『Apprication and Manufacturing process development and quality assurance of SAKIGAKE
Designation products, Xospata Tablets 40 mg』

Remote Session 09:30 (Germany)
Christoph Wabel
16:30～ Director / Team Leader, Process Management, Product and Process Development
7
17:20Pfizer Manufacturing Deutschland GmbH『Continuous Manufacturing of Solid Oral Dosage Forms – From Development to Production』-5

Yoshiyuki Yabe
13:40～ Scientist, Drug Metabolism and Pharmacokinetics Research Laboratories
14:30
Daiichi Sankyo Co., Ltd.
『Discovery and Development of Anti-drug Antibody Trastuzumab Deruxtecan (T-DXd, DS-8201a) 』-

14:30～
14:50

Coffee Break (20 mins ）<<Session Chair>> Etsuo Yonemochi (Hoshi University)

Rcording Session
Gavin Reynolds
14:50～
6
Professor, Pharmaceutical Technology & Development, AstraZeneca
15:40『Manufacturing Classification System (MCS): Data Gathering and Analysis from Regulatory Filings』

Kentaro Hayashi
15:40～ Manager, Formulation Development/Production Technology Department
7
16:30
Shionogi Pharma Co., Ltd.
『Adaption of Continuous Manufacturing in Shionogi Pharma』
Closing Remarks
16:30～ Etsuo Yonemochi, Steering Committee & Advisory Committee Members
New Pharmaceutical Technology and Engineering Institute
16:40(Hoshi University)*Program may be subject to change