2016/7/15

The 14th New Pharmaceutical Technology and Engineering Conference / Preliminary Program
Kyoto International Conference Center (ICC Kyoto), JAPAN
Organized by: New Pharmaceutical Technology and Engineering Institute (NPTE)
Thurs. July 21, 2016

Fri. July 22, 2016

10:00- 10:10 Opening Remarks

Larisa Wu, Ph.D
1

10:10- Senior Chemist and Special Assistant, Office of Pharmaceutical Quality, Center for Drug
10:55 Evaluation and Research, US Food and Drug Administration

Toru Kawanishi, Ph.D.

1

10:00Director General, National Institute of Health Sciences, Japan
10:45"Notification of Japanese Pharmacopoeia 17th Edition and its Impact on Drug Quality""Aggregates in Peptide Drug Products: Regulatory Considerations"Takeshi Omasa, Ph.D

Keiji Yoshimura, Ph.D

2

10:55Assistant Manager, Department of Regulatory Affairs, Japan Tissue Engineering Co., Ltd.
11:40

2"Perspective for Regenerative Medicine in Japanese Industry "10:45- Professor, Division of Advanced Science and Biotechnology, Graduate School of Engineering
11:30 Osaka University"Next Generation Biologics Production –Past and Future"
Lunch Time （60 min.）

11:40
～
12:40

11:30
～12:30Lunch Time （60 min.）Salvatore Mascia, Ph.D
12:403 13:25 Founder & CEO, CONTINUUS Pharmaceuticals"Integrated Continuous Manufacturing (ICM) of Pharmaceuticals"～Luncheon Seminar～No simultaneous interpretation available
Takuya Nagato, Manager, Research & Development Dept., Powrex Corporation"The Latest Technology of Continuous Process"Patrick Hunziker, M.D.
12:303 13:15 Presidnet for International Society of Nanomedicine, and University Hospital Basel, Switzerland"Personalized Medicine: Knowledge-Based Medicine enabled by Nano-Medicine"
Coffee Break (20 min.)Shawn Yin, Ph.D.

13:254
Senior Principal Scientist, Drug Product Science & Technology, Bristol-Myers Squibb Company
14:10"Characterization of Phase Separation from Amorphous Dispersion"

Akira Matsumoto

4

13:35Plant Manager, SATTE Plant, Production Division, TAKATA Pharmaceutical Co.,Ltd
14:20"Factory Specific for Oral Solid Dosage Forms with the Latest Facilities"

Coffee Break (20 min.)
14:30- The New Pharmaceutical Technology and Engineering Foundation
14:45 Particle Design & Research Abroad Grant Awards Ceremony 2016
Particle Design Award 2016 Commemorative Lecture (1)Kenji Nozawa
14:45- Senior Scientist, Formulation IV Group, Pharmaceutical Development Department
5 15:30 Sawai Pharmaceutical Co., Ltd.
"Effect of Surfactants or A Water Soluble Polymer on the Crystal Transition ofClarithromycin during A Wet Granulation Process"Michelle Bailey, Ph.D
14:205 15:05 Associate Director, Continuous Manufacturing & Automation Validation, Vertex Pharmaceuticals"Validation for Continuous Manufacturing & Inspection Readiness"

Coffee Break (20 min.)Particle Design Award 2016 Commemorative Lecture (1)15:30-

6 16:15

Nobuhiro Nishiyama, Ph.D
Professor, Laboratory for Chemistry and Life Science, Institute of Innovation Research, Tokyo
Institute of Technology"Development of Polymer Micelles for Targeting Intractable Cancers"

Xavier Luria, Ph.D.
Chair and Senior Consultant, Drug Development and Regulation

15:25(Former Head of Safety and Efficacy of Medicines, EMA)
616:10"Current Trends in Benefit/Risk Assessment of Medicines and Regulatory Impact from theEU Perspective"

Coffee Break (20 min.)Atsushi Sakurai, Ph.D.
Senior Researcher, Oral Formulation Development, Pharmaceutical Research and Technology

Michihiro Tsuchiya, Ph.D
16:35- Chairman of the Board & Director, Mitsubishi Tanabe Pharma Corporation
7 17:20"Future Outlook of Pharmaceutical Industry and Growth Strategies of Mitsubishi Tanabe

16:107 16:55 Labs., Technology, Astellas Pharma inc.

"Pharmaceutical technology can improve the patient adherence ---an example of Irribow ®
OD Tablet formulation development---"Pharma Corporation"-Break (20 min.)
16:55--17:4019:30

NETWORKING PARTY- 17:05 Closing Remarks*Simultaneous Interpretation will be available except luncheon seminars.