企業の視点から捉えた PGt/PGx Study -

The Present Situation of
PGx/PGt Study in Japan
- JHSF Questionnaire Survey -
Daiichi Pharmaceutical Co., Ltd.
Osamu Sato Ph.D.
[email protected]
Tackling of JHSF
JHSF (Japan Health Sciences Foundation) was
established by 128 companies in April, 1986, under
the support of the MHLW (MHW at that time)
 The mission of JHSF is promoting of basic and
advanced technologies related to medicine, drugs and
of contributing to human health and welfare
 Since 1998, JHSF has continuously performed the
investigation of the tendencies and future views of
genome sciences and has offered reports every year
 In the report for 2002 JHSF performed a questionnaire
survey in order to know the present situation of
PGx/PGt in Japan

JHSF Questionnaire Survey
Purpose: Grasp of the PGx/PGt Present
Situation in Japan
 Term: September 27 to November 1,
2002
 Target: 91 JHSF Member Companies
 Method: Questionnaire Survey by Mail
 Recovery: 53 Companies(44 valid)
 Breakdown of the 44 companies:
37 Pharmaceuticals and 7 Others

Questionnaire Items
1.
2.
3.
4.
5.
6.
Study of a relationship between developing
drugs and gene polymorphism
Problems related to ethics in PGx/PGt
studies
Problems related to the method of PGx/PGt
study
Problems on application using the results of
PGx/PGt studies
Post-marketing PGx/PGt study
Problems related to the marketing of
PGx/PGt-related drugs
etc.
1. Do you have any plans to conduct PGx/PGt
study with developing drugs ?
Replies
16
27
43
Yes
No
Total
％
37.2
62.8
100.0
Yes
37％
No
63％
（n=43）
Studies conducting or scheduled
to be conducted in 2 or 3 years
: conducting
0
: scheduled
5
Relating to
drug
metabolism
4
10
6
（n=10）
Relating to
drug
reactivity
（n=10）
3
7
2. Do you have any plans to conduct PGx/PGt
study with post-marketing drugs ?
Replies
5
34
39
Yes
No
Total
Objectives
％
12.8
87.2
100.0
No
87％
（n=39）
1
特定の副作用発現との関連を明ら
Adverse Reaction
かにする
2
3
4
5
2
レスポンダー／ノンレスポンダー
Respnder/Non-Responder
を明らかにする
4
Exclusive
Intention
競合品との差別化を図る
0
Others
Yes
13％
0
その他 0
Reason of “No”
（n=5）
0
10
Cost Effectiveness
2
Difficulty in Collaboration
with Institution
1
Difficulty in getting IC
2
No Proper Drug
Others
20
30
29
2
（n=33）
3. What do you think about the necessity of
guidelines for conducting PGx/PGt studies ?
Not familiar
with this problem
Necessary
Replies
35
％
Not necessary
10%
85.4
5%
4.9
Not
necessary
2
Not familiar
with this
problem
4
9.8
41
100.0
Total
Necessary
85%
（n=41）
4. Are you concerned about decreases in the
patients number by PGx/PGt study ?
Replies
A higher price, which
compensate the
decrease in the
number of patients,
may not be accepted.
Not familiar
with this problem
21%
(8)
No
13％
(5)
（n=39）
Yes
66％
(26)
％
14
58.3
8
33.3
Objection from the
sales division.
14
58.3
Patients may not
accept gene testing.
20
83.3
2
8.3
Patients may prefer
less effective drugs
prescribed without
gene testing.
Other
Replies from 24 companies
5. What do you expect for MHLW if you will
develop drugs for the non-responders ?
Orphan-development
24
Financial support
10
Registration
without Phase III
6
Premium NHI price
14
No idea
4
Others
1
0
（n=38）
5
10
15
20
25
Summary of the Survey
Difficulties in finding appropriate
methodologies
 Not clear relationship between GCP and
“Common Ethical Guideline”
 Decreased number of patients

Preparation of new ethical guideline for
PGx/PGt
 Establishment of system to conduct
retrospective PGx/PGt study
 Premium addition on regular NHI price


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