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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 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 -

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

  2. 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

  3. 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

  4. 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.

  5. 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）

  6. 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）

  7. 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）

  8. 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

  9. 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

  10. 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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