2018.7.13

The 16th New Pharmaceutical Technology and Engineering Conference 2018
Kyoto Internatioal Conference Center (ICC Kyoto, Japan)
Organized by: New Pharmaceutical Technology and Engineering Institute (NPTE)
Wed. July 18, 2018

Thur. July 19, 2018

RemoteArwa El Hagrasy
Quality Assessment Lead (Acting), Office of Process and Facilities, OPQ/FDA『Process Development and Control Strategy Implementation for Continuous PharmaceuticalManufacturing』-09:50〜
Opening Remarks
10:00

1

9:30～
10:15

1

Isao Teshirogi
10:00〜
President and CEO, Shionogi & Co., Ltd.
11:00
『Management Practices for Sustained Increase of Corporate Value』

2Osamu Hiruta10:15～ Manager, Senior QA Advisor, Quality assurance Department, Reliability & Quality assurance Division
11:00
Meiji Seika Pharma Co., Ltd.
『A recent topics about the data integrity: What should we do as a pharmaceutical company?』

3

Thomas Wozniewski
11:00～
Global Manufacturing & Supply Officer, Takeda Pharmaceuticals International AG
11:45『Transforming into a new Takeda』-11:45～
12:45

Kazunori Kataoka
11:00〜 Director General, Kawasaki Institute of Industrial Promotion, Innovation Center of NanoMedicine
2『Self-Assembled Supramolecular Nanosystems for Smart Diagnosis and Target Therapy of11:45
Intractable Diseasese』-11:45〜
12:45

Lunch Time （60 mins）

Lunch Time （60分）

Eun Young Yang
12:45〜 Senior Director, Head of CDO Business Development Team
3Contract, Compliance & Communication Center, Samsung BioLogics
13:30『Most Qualified CDMO Chosen by Clients - Customized, Cost-effective, and Comprehensive』

Tadashi Tsunoda
12:45～ IMP Management, Pharmaceutical R&D, CMC & Production HQs
4
13:30
ONO PHARMACEUTICAL CO., LTD.
『ONO’s Efforts toward Continuous Manufacturing for Solid Dosage Form』

Atsushi Maeda
Research Fellow, Drug Delivery, Pharmaceutical Research and Technology Labs.
13:30〜4
Pharmaceutical Technology, Astellas Pharma, Inc.
14:15
『Design of orally disintegrating tablets employing phase transition of water-insoluble polymer byhigh-pressure carbon dioxide gas』

Hiroaki Kikuoka
Pharmaceutical Development Department Formulation I Group
13:30～
5
Sawai Pharmaceutical Co., Ltd.
14:15
『Development of ESUEEWAN® Combination OD tablet (Film Coating OD Tablet) produced by
Sawai』

14:15〜
14:40
14:40〜
15:00--Coffee Break （25 mins）
The New Pharmaceutical Technology and Engineering Foundation
Particle Design &Research Abroad Grant Awards Ceremony

14:15～
14:45

Coffee Break （30 mins）

PD Award 2018 Commemorative Lecture
Ahmad Almaya
Hitoshi Sasaki
Director, Small Molecule Design and Development; Lilly Research Labs
14:45～
15:00〜65
Professor and Director, Department of Hospital Pharmacy, Nagasaki University Hospital
Eli Lilly and Company
15:30
15:45
『Design of self-assembly nano-particles of nucleic acid medicine with anionic surface for cellular『Lilly: The First to Design and Implement a Network of Continuous Oral Solid Dose (OSD)targeting and organ targeting』
Manufacturing Facilities』
Jae D. Yoo
Masatoshi Karashima
15:30～
15:45〜 Senior Scientific Investigator, Advanced Manufacturing Technologies, R&D Platform Technology
67
Associate Director, Analytical Development, Takeda Pharmaceutical Company
16:15& Science, GlaxoSmithKline
16:30『Latest trend of crystal engineering-based pharmaceutics research』『Pharmaceutical Applications of Three Dimensional Printing (3DP) and Additive Manufacturing』

7

Shingo Sakurai
16:30〜 Associate Director of PMDA, Office of Manufacturing/Quality and CompliancePharmaceutical Medical Device Agency (PMDA)
17:15『Draft Revision of Ministerial Ordinance of GMP』-

17:30〜
Networking Party
19:30-16:15～Closing Remarks
16:20*Program may be subject to change