US-JAPANHBD EAST Think Tank Meeting 2023

12 14https://www.pmda.go.jp/int-activities/int-harmony/hbd/0015.html)

US-JAPAN
HBD EAST Think Tank Meeting 2023
～ US-JAPAN Government-Academia-Industry Medical Device Regulatory
Harmonization Conference ～RegistrationneededSimultaneous（Thu）
Date：2023.
&interpretation
Free ofavailable
9:30～18:00
Charge

12.14

Venue: Ariake Central Tower Hall and Conference
Programme：Please see the following page

What is HBD???
 HBD (Harmonization By Doing) is a joint effort by Government-AcademiaIndustry in Japan and the US to harmonize medical device regulations inboth countries through "practical activity”. HBD has achieved significant
results such as the rapid approval of medical devices in thecardiovascular field in both countries.
 As one of the activities of HBD, a "Think Tank" is held once a year,
alternating between Japan and the US. The purpose of the Think Tank is
to inform medical device development companies and the general public
about HBD's latest activities.
(Ref: https://www.pmda.go.jp/int-activities/int-harmony/hbd/0015.html ) This year's Think Tank will be the first face-to-face meeting in Japan infour years, and since 2023 is the 20th anniversary of HBD, we have
prepared a full program to review the past achievements and discuss
future prospects. We look forward to your participation!

Please register via here (Deadline: 2023.11.21)
Contact: HBD East 2023 Secretariat Email: global*jfmda.gr.jp (replace * with @)US-JAPAN
HBD EAST Think Tank Meeting 2023
Date: Thursday, December 14th, 9:30 AM-6:00 PM (JP Time)
Venue: Ariake Central Tower Hall and Conference
Language: English & Japanese (simultaneous interpretation)
Moderator: Tomoyuki Miyasaka (MHLW) & Moe Ohashi (PMDA)
TimeSpeakers and Panelists
Agenda items (Draft)
Session A：Welcome Speeches (9:30~)
A-1
From MHLW
5A-2
From PMDA
5A-3
From FDA
5A-4
From JFMDA
5A-5
From AdvaMed
5
Session B：20th Anniversary Keynote Speeches (10:00~)
Chair
B-1
B-2

B-3

HBD history
Achievements of HBD activities andfuture expectations

15Q＆A

5

US

Yasunori Yoshida
Yasuhiro Fujiwara
Jeffrey Shuren
Toshiaki Takagi
Janet Trunzo
Neal Fearnot(MED Institute
Incorporated)
TBD

Q＆A

Mami Ho(Yumino Heart Clinic)
Yuka Suzuki(Clinical Research,Innovation and Education
Center,Tohoku University
Hospital(CRIETO))

15Coffee Break (15min)
Session C：Learning from HBD activity and recent update (10:50~)
Chair
Aaron Lottes(Purdue Univ.)
C-1
Update on HBD activities
10- Focusing on the last 5 yearsC-2
What we can say now based on our10
experience in obtaining approval inJapan and the U.S.
Case 1: Japanese industry’s view
C-3
What we can say now based on our10
Daiki Yasuhara
experience in obtaining approval in(Medtronic)
Japan and the U.S.
Case 2: U.S. industry’s view
C-4
Role of Academia in HBD Activities
10C-5

JPTBD
Hanako Morikawa(PMDA)
Kazuhisa Senshu(Terumo Corporation)

Hiroyoshi Yokoi(Fukuoka sanno Hospital)

5

Session D：Evaluating the efficacy and safety of medical devices from pre-market through post-market using
RWD (11:40~)
Chair
Misti Malone
Kensuke Ishii(FDA)(PMDA)
D-1
Basic Approach in utilizing RWD for
10
Misti Malone
regulatory decision-making(FDA)
1 / 3D-2
D-3
D-4

Challenges in establishing RWE forpre- and post-market clinicalevaluation
Challenges in developing devices
using RWD in Japan
Panel Discussion

10

Masato Nakamura(Toho Univ.)

10

Kazuo Kawahara(Boston Scientific Japan)
Speakers&
Takeshi Shiba(PMDA)

Speakers&
Theme: The efficient way of collecting
Eric Chen
RWD for regulatory decision-making(Abbott)in pre- and post-market to accelerate&device development
Chie Iwaishi(Edwards Lifesciences)&Aaron Lottes(Purdue Univ.)
Lunch Break (60 min)Session E：Approaches of HBD activity to promote the development of SaMD (13:40~)
Chair
Eric Chen(Abbott)
E-1
Regulation of SaMD in the U.S.
10
Nicole Ibrahim
(FDA)
E-2
Regulation of SaMD in Japan
10E-3
E-4

E-530

Learning from “CureApp” :how todevelop and get an approval of SaMD
Points to consider in the application ofAI for medical devices

10Panel Discussion

20

10Speakers&Fumiaki Ikeno(Stanford univ.)

Yuzuru Okazaki(PMDA)
Kentaro Kato(PMDA)
Tomoyuki Tanigawa(CureApp)Ryuji Hamamoto(Division of Medical AI
Research andDevelopment, NationalCancer Center ResearchInstitute)
Speakers

Theme: Strategies to promote thedevelopment of SaMD from thestandpoints of industry, government,and academia
Session F：Approaches of HBD activity to promote the development of pediatric devices (14:45~)
Chair
Nicole Gillette
Satoshi Yasukochi(FDA)(Aizawa hospital)
F-1
Progress and challenges in pediatric10
Takanari Fujii
medical device development(Showa Univ.)
F-2
U.S. Regulatory initiatives to promote
10
Nicole Gillette
pediatric medical device development
(FDA)
F-3
The road from development to10
Shintaro Nemoto
approval of pediatric medical devices(Osaka Med. Pharm.
and future approaches.
Univ.)
F-4
Utilization of RWD in pediatric10
Ryo Inuzuka
medical device development(Tokyo Univ.)
F-5
Panel Discussion
30Speakers
Speakers&&
Theme: Strategies to promote theTBD
Tohru Kobayashi
development of pediatric medical(Department of Data
devices from the standpoints ofScience, Center forindustry, government, and academia
Clinical Research,
National Center for Child2 / 3

Health and Development)&Koichi Aizawa(PMDA)
Coffee Break (15 min)Session G：What should be considered for global harmonization of medical device development through HBD
activity ? (16:10~)
Chair
TBD
Naoyuki Yabana(PMDA)
G-1
An overview of the global situation
10
Fumiaki Ikeno
surrounding medical devices(Stanford univ.)
G-2
Current situation of medical device
10
Kate Stohlman
regulations outside of Japan and the(Corvia Medical)
U.S.
G-3
Comparing clinical practices or
10
Robert Thatcher
consultation processes in the US vs(DIAXAMED)
Japan
G-4
Unique points of medical device
10
Koji Ikeda
development and advantages of global(Clinical Research,development.
Innovation and Education
Center,Tohoku University
Hospital(CRIETO))
G-5
Post-approval hurdles: Differences and10
Makoto Tamura
strategies between Japanese and the(Healthcare system
U.S. insurance systems
planning institute (HSPI))
G-6
Panel discussion
50Speakers
Speakers&&Theme: Future direction of HBD
Nicole Gillette
Kiyohito Nakai
activity(FDA)(MHLW)&&
Janet Trunzo
TBD(AdvaMed)
Session H：Closing Remarks (17:55~)
Tomonori Nakayama
H-1
Closing remarks
5(MHLW)3 / 3