Final

The 15th New Pharmaceutical Technology and Engineering Conference 2017
Shinagawa Intercity Hall (Tokyo, Japan)
Organized by: New Pharmaceutical Technology and Engineering Institute (NPTE)
Wed. July 19, 2017
10:00～
Opening Remarks
10:10-Kazunobu Oyama
10:10～ Principal Reviewer, Office of Cellular and Tissue-based Products, Pharmaceutical Medical Device Agency
1『Quality issues and CMC Development Strategy of Regenerative Medical Products Assigned for Forerunner
10:55
Review Assignment System “SAKIGAKE”』
2

Niklas Sandler
10:55～
Professor, Pharmaceutical Sciences Laboratory, Åbo Akademi Univeristy
11:40『2D/3D printing as an emerging technology in drug manufacturing and product tailoring』-11:40～Lunch Time （50 mins）
12:30
Lawrence De Belder

12:30～ Senior Principal Engineer, Technical Operations, Janssen Supply Chain
3
Johnson and Johnson
13:15『Considerations for Implementation of Drug Product Continuous Manufacturing in Legacy Products and new
Product Introductions』

4

Hayato Ishimoto
13:15～
Principal Scientist, Formulation Research. PST CFU. Medicine Development Center
14:00『Continuous Manufacturing – Eisai’s Way』

-14:00～Coffee Break
14:20

Thurs. July 20, 201712

Yoshinori Oie
10:35～
Assistant Professor, Department of Ophthalmology, Osaka University11:20『Regenerative medicine for corneal epithelium』

3

11:20～ Don Barbieri
Technical Product Manager, Marketing, SPI Pharma, Inc.
12:05
『Designing Patient Friendly Dosage Forms to Meet Specific Dosing Needs』

Teleconference

12:05～Lunch Time （50 mins）
12:55
Christine M. V. Moore
12:55～ Executive Director and Global Head, CMC Policy4
13:40
Merck, Sharp and Dohme Corp.
『Global Regulatory Trends for Breakthrough Therapies / Accelerated Approval Pathways』

5

13:40～ Sinya Taguma
President, Chugai Pharma Manufacturing Co., Ltd.
14:25
『Development and production of antibody medicinal products in Chugai Pharmaceutical』-14:25～14:45（20 mins）

14:20～ The New Pharmaceutical Technology and Engineering Foundation/Research Abroad Grant Awards
14:40
Ceremony 2017 / The 15th Anniversary Presentation Ceremony

9:50～
10:35

Sharmista Chatterjee
Division Director, Process Assessment II
Office of Process & Facilities (OPF), U.S. Food and Drug Administration『Switching from Batch to Continuous Manufacturing (CM): An FDA Perspective』

Coffee Break (20 mins)

Gordon L. Amidon
14:40～ Professor, Department of Pharmaceutical Sciences, College of Pharmacy, The University of Michigan
5『BCS Class and Subclass: Approach to in vivo Predictive Dissolution (iPD): A GastroIntestinal Simulator
15:25(GIS)』

Yoshinobu Sato
14:45～ Associate Director, Formulation Development, Pharmaceutical Science
6
Takeda Pharmaceutical Co.,Ltd.
15:30『Technical studies for implementation of continuous manufacturing for oral dosage form』

Ken Tojo
15:25～ Section Manager, Production Planning Dept. Odawara Central Factory6
Nippon Shinyaku Co., Ltd.
16:10
『Practice of risk management at the design of containment factory』

Hiroyuki Kojima
Senior Director, Oral Formulation Development, Pharmaceutical Research and Technology Labs
15:30～
Pharmaceutical Technology, Astellas Pharma inc.
7
16:15
『Tackling to Develop Pediatric Formulations from Pharmaceutical Industry Perspectives~ Deliver the Medicine to African Children by Use of Pharmaceutical Technology ~』Thorsten Poehl
Representative Director and President
16:10～
Boehringer Ingelheim Japan, Ltd.
7
16:55
『Competitive Strategy in times of change across the value chain of a multinational Pharmaceutical Company
in the Japanese market』--

17:25～
Networking Party
19:25

16:15～
Closing Remarks
16:20*Program may be subject to change