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The Present Situation of PGx/PGt Study in Japan - JHSF Q uestionnaire Survey -. Daiichi Pharmaceutical Co., Ltd. Osamu Sato Ph.D. satooo7x@daiichipharm.co.jp. Tackling of JHSF.

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The present situation of pgx pgt study in japan jhsf q uestionnaire survey

The Present Situation of PGx/PGt Study in Japan- JHSF Questionnaire Survey -

Daiichi Pharmaceutical Co., Ltd.

Osamu Sato Ph.D.

satooo7x@daiichipharm.co.jp


Tackling of jhsf
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
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
Questionnaire Items

  • 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
1. Do you have any plans to conduct PGx/PGt study with developing drugs ?

Studies conducting or scheduled to be conducted in 2 or 3 years

: conducting: scheduled

Yes

37%

(n=10)

No

63%

(n=10)

(n=43)


2 do you have any plans to conduct pgx pgt study with post marketing drugs

Objectives

(n=5)

2. Do you have any plans to conduct PGx/PGt study with post-marketing drugs ?

Adverse Reaction

Respnder/Non-Responder

Exclusive Intention

Others

Yes

13%

Reason of “No”

0

10

20

30

Cost Effectiveness

2

Difficulty in Collaboration

with Institution

1

Difficulty in getting IC

2

No

87%

No Proper Drug

29

(n=33)

Others

2

(n=39)


3 what do you think about the necessity of guidelines for conducting pgx pgt studies

Replies

Necessary

35

85.4

Not necessary

2

4.9

Not familiar with this problem

4

9.8

Total

41

100.0

3. What do you think about the necessity of guidelines for conducting PGx/PGt studies ?

Not familiar

with this problem

Not necessary

10%

5%

Necessary

85%

(n=41)


4 are you concerned about decreases in the patients number by pgx pgt study
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.

14

58.3

Not familiar

with this problem

21%

(8)

Patients may prefer less effective drugs prescribed without gene testing.

8

33.3

No

13%

(5)

Yes

66%

(26)

Objection from the sales division.

14

58.3

Patients may not accept gene testing.

20

83.3

Other

2

8.3

(n=39)

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

(n=38)

1

0

5

10

15

20

25


Summary of the survey
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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