The 21st New Pharmaceutical Technology and Engineering Conference 2024 Program
Venue: Kyoto Internationl Conference Center (ICC Kyoto)
July 30th, 2024
Hirofumi Takeuchi
09:20～ Chairman, New Pharmaceutical Technology and Engineering Institute
09:30(Emeritus Professor, Gifu Pharmaceutical University) 『Opening Remarks』
Jennifer A. Maguire
09:30～
Director, CDER/OPQ/Office of Quality Surveillance, US Food and Drug Administration (FDA)
10:20『An Update on CDER’s Quality Management Maturity Program』
10:20～
10:40

Coffee Break (20 minutes)

July 31st, 2024
Hiroyuki Kojima
09:30～ Senior Vice President, Head of Pharmaceutical Research and Technology Labs, Pharmaceutical Research andTechnology Labs, CMC Development, Astellas Pharma Inc.
10:20
『Strategic History of Drug Product Development at Astellas～Past・Present・Coming Future～』

10:20～
10:40

Coffee Break (20 minutes)

Kazunori Kataoka
Daisuke Hirasawa
Vice Chairperson of KIIP, Center Director of iCONM, Kawasaki Institute of Industrial Promotion ・ Innovation
SeniorManager,
Manufacturing
Technology
Division/DigitalandEngineering
Department,
ChugaiPharma10:40～
10:40～
Center of NanoMedicine
Manufacturing Co., Ltd. 『Breaking new ground beyond the “Wall of 0.05μg/m3”～Honored as ISPE Facility of the 11:30
11:30『Nanotechnology for Future Medicine: Development of Molecular Technologies to Transport, Fabricate, andYear Awards Category Winner～』
Manipulate Drugs within the Body』
Stephen Timothy Buckley
11:30～
Vice President, Advanced Drug Delivery, Novo Nordisk
12;20『Discovery and development of an orally delivered GLP-1R agonist | From concept to reality and beyond』
12:20～
13:20

Lunch Time (60 minutes)

13:20～
13:40

The New Pharmaceutical Technology and Engineering Foundation
Particle Design & Research Abroad Grant Awards Ceremony

Yoshinori Ikeura
11:30～
Chief Executive Officer,Axcelead, Inc.
12:20
『Axcelead; Global Pharmaceutical Development Partner to create innovative medicine』

12:20～
13:20

Lunch Time (60 minutes)

The 11th Particle Design Award Commemorative Lecture
13:40～ Hidetaka Akita
14:30
Professor, Graduate Graduate School of Pharmaceutical Sciences, Tohoku University『Development of intracellular environment-responsive lipid-like material: ssPalm』

Rupesh Malhotra
13:20～
Associate Director, GMP Operational Quality Assurance, Vertex Pharmaceuticals
14:10『Exploring AI’s Role in Enhancing Quality and Efficiency in Continuous Manufacturing and Product Release』

Hirokazu Yokoyama
14:30～ Researcher, Formulation Research Group 1, Formulation Technology Research Laboratories, Pharmaceutical
15:20
Technology Division, Daiichi Sankyo Co., Ltd.
『Scale-up of lyophilization process using New monitoring tools.』

Biplob Mitra
14:10～
Associate Director, Drug Product Development, Bristol-Myers Squibb Company
15:00『A framework to development of micro-tablets and mini-tablets, an age-agnostic oral solid dosage form』

15:20～
15:40

15:00～
15:10

Coffee Break(20 minutes)

Coffee Break (10 minutes)

Jeremy A. Bartlett
15:40～ Research Fellow, Pharmaceutical Sciences/Drug Product Design, Pfizer Inc.
16:30
『Latest strategies and drug delivery technology advancements meeting the needs of pediatric to geriatricpatients』

Masato Gomi
15:10～
Manager, Formulation R&D Laboratory, Pharmaceutical Technology Research Division, SHIONOGI & CO.,LTD.
16:00『Product development of ensitrelvir fumaric acid tablet』

Hideki Fujiwara
Vice President, Head of Hikari Plant, Global Manufacturing & Supply Japan, Takeda Pharmaceutical Company
16:30～
Limited
17:20『Significant production increase using DX through the transparency of entire process and bottleneck process
improvement』

Daisuke Fujii
Deputy Director, Compliance and Narcotics Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour
16:00～ and Welfare
16:50『Current Situation of Japanese Pharmaceutical Inspection and Guidance, and Government Measures to Ensure
Quality of Medical Products』

17:40～
19:40

Katsuhide Terada
16:50～ Professor, Faculty of Pharmacy, Takasaki University of Health and Welfare
17:00『Closing Remarks』

Networking Party※Simultaneous interpretation is available for all the presentations