Applications of PGx in PK at PMDA experience and expectations - - PowerPoint PPT Presentation

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Applications of PGx in PK at PMDA experience and expectations - - PowerPoint PPT Presentation

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Applications of PGx in PK at PMDA experience and expectations Yoshiaki Uyama Uyama, , Ph.D Ph.D Yoshiaki Pharmaceuticals & Medical Devices Agency Pharmaceuticals & Medical Devices Agency (PMDA) (PMDA) EMEA/EFPIA Workshop Pharmac

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Applications of PGx in PK at PMDA experience and expectations

Yoshiaki Yoshiaki Uyama Uyama, , Ph.D Ph.D Pharmaceuticals & Medical Devices Agency Pharmaceuticals & Medical Devices Agency (PMDA) (PMDA)

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Trends of PI Trends of PI including including PGx PGx information information

N of PI % of PI incl. PGx

50 100 150 200 250 2002 2003 2004 2005 2006 2007

Fiscal Year Accum ulated Num bers

  • f Approval Drug

5 10 15 20 25

Accum ulated % of PI including PGx

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

5 10 15 20 25 30 35 40 2002 2003 2004 2005 2006 2007 Fiscal Year Accum ulated Num bers of PI including PGx

Trends of PI Trends of PI including including PGx PGx information information

Metabolic Enzyme Metabolic Enzyme Virus/Bacterium Virus/Bacterium Pharmacological Pharmacological Target Target

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Guidances Guidances & Notifications related to & Notifications related to PGx PGx

PFSB/ELD September 2008 Points to consider on Clinical Trials using PGx PFSB/ELD * June 2001 Guidance on clinical pharmacokinetics studies of Pharmaceuticals PFSB/ELD June 2001 Guidance on methods of drug interaction studies. PFSB/ELD March 2005 Submission of information to regulatory authorities for preparation of guidance on the use of Pharmacogenomics in clinical studies. PFSB/SD ** June 2006 Request to cooperate in research regarding severe cutaneous adverse reactions PFSB/ELD and PFSB/SD January 2008 Terminology in pharmacogenomics（ICH-E15） PFSB/ELD April 2008 Points to consider for evaluating genotyping platforms based on DNA chips Notifier Date Title

* PFSB/ELD: Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) ** PFSB/SD: Safety Division, Pharmaceutical and Food Safety Bureau, MHLW

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Points to Consider on Clinical Trial using Points to Consider on Clinical Trial using Pharmacogenomics Pharmacogenomics

  • This Q&A document describes basic principles on clinical

This Q&A document describes basic principles on clinical trials using trials using PGx PGx. . Key Points Key Points

  • Encourage to examine genetic effects in drug response

Encourage to examine genetic effects in drug response

  • Clarify a role of IRB on clinical study using

Clarify a role of IRB on clinical study using PGx PGx

  • Clarify issues to be described in study protocol

Clarify issues to be described in study protocol

  • Clarify basic principles for information feed back to a

Clarify basic principles for information feed back to a subject subject

  • Encourage to discuss with PMDA

Encourage to discuss with PMDA (Final Notification was published on Sep. 30 (Final Notification was published on Sep. 30th

th, 2008)

, 2008)

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Major Reimbursable Major Reimbursable PGx PGx tests in Japan tests in Japan

November 2008 Irinotecan-induced Neutropenia UGT1A1 November 2007 Acute Myelocytic Leukemia Wilms tumor-1 mRNA April 2003 Breast Cancer Her2/neu (erbB2) (FISH) July 2003 HBV Mutations in HBV precore, Mutations in HBV core promoter (PCR) November 2004 Chronic Myelogenous Leukemia Major bcr-abl mRNA (TMA) April 2006 HIV Mutations in HIV June 2007 Gastrointestinal Stromal tumor KIT mutations June 2007 Lung Cancer EGFR mutations Date to be covered by NHI Target Genomic biomarker

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Biomarker & Ethnic Differences (1) Biomarker & Ethnic Differences (1) Irinotecan Irinotecan & UGT1A1 & UGT1A1

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Ethnic difference in allele frequencies of Ethnic difference in allele frequencies of UGT1A1* 6 UGT1A1* 6 and and * 28 * 28 mutant genes mutant genes

Japanese Caucasian African- American

Kaniwa N et al. Drug Metab Dispos (2005)

* 6 : 17.1% * 28 : 10% * 6 : 0% * 28 : 38.9% * 6 : 0% * 28 : 44.6%

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Examples of Package Insert including Examples of Package Insert including PGx PGx information information

  • Important Precautions

Important Precautions

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Biomarker & Ethnic Differences (2) Biomarker & Ethnic Differences (2) HLA HLA-

  • B*1502 & SJS/TEN

B*1502 & SJS/TEN

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Han Han-

  • Chinese

Chinese-

  • SJS/TEN and

SJS/TEN and HLA* B1502 HLA* B1502

Dr Dr Chang CF, APEC PRS, 2007 Chang CF, APEC PRS, 2007

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Ethnic differences in HLA Ethnic differences in HLA-

  • B* 1502

B* 1502

0.2 % 0.2 % Korean Korean 8.5 % 8.5 % Thai Thai 5.7 % 5.7 % Singaporean Singaporean 0-

  • 1 %

1 % Caucasian Caucasian 0.1 % 0.1 % Japanese Japanese 1.9 1.9-

  • 7.1 %

7.1 % Han Han-

  • Chinese

Chinese prevalence prevalence Ethnic group Ethnic group

  • Differences exist even among Asian populations

Differences exist even among Asian populations

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Framework of Framework of NIHS NIHS research regarding research regarding SCAR SCAR

MHLW PMDA NI HS I ndustries Medical Doctors 1) I nform SJS/ TEN cases (voluntary)

3) sample support 3) cooperation

Adverse event report 2) Requests for research cooperation Notification

http://www.nihs.go.jp/mss/MSS%20folder/JSCAR/jscar_ronbun.html

2) Requests for research cooperation Adverse event report

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Japanese Japanese-

  • SJS/TEN and

SJS/TEN and HLA* B HLA* B

Kaniwa Kaniwa N et al, Pharmacogenomics, 9: 1617 N et al, Pharmacogenomics, 9: 1617-

  • 1622, 2008

1622, 2008

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Biomarker Qualification Biomarker Qualification

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

International Biomarker Qualification International Biomarker Qualification

  • Regulatory Collaborations

Regulatory Collaborations-

  • VGDS meeting

Industry Briefing Meeting

Confidential Confidential Agreement Agreement

PDG meeting

Confidential Confidential Agreement Agreement Joint meeting

PMDA joined to PMDA joined to JVXDS JVXDS Since 2007 Since 2007

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Future Tasks in Future Tasks in PGx PGx

  • General principles on

General principles on PGx PGx clinical trials clinical trials

  • Genomic biomarker qualification

Genomic biomarker qualification

  • Clinical trial designs using

Clinical trial designs using PGx PGx

  • PGx

PGx test availability (co test availability (co-

  • development)

development)

  • PGx

PGx data handling in approval process data handling in approval process Q&A was published in Sep 2008 Q&A was published in Sep 2008 ICH E16 is drafting ICH E16 is drafting draft will be available by next summer draft will be available by next summer

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Near Future Near Future

Healthcare Insurance Card:

001279541235 2015/01/01 Name: ??????? Address: XXXXXXXX Sex: Male Race: Japanese Birthl: 1950/01/01

Electric Medical Record (History, Genetic Inf. etc) Diagnosis Administer a right drug at a right dose in a right timing A selection of Drugs and Doses

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EMEA/EFPIA Workshop Dec 19, 2008, London, UK

Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency

Information Information

  • PMDA HOMEPAGE

PMDA HOMEPAGE http:// http://www.pmda.go.jp/english/index.html www.pmda.go.jp/english/index.html

  • PMDA DRUG Information Search

PMDA DRUG Information Search http:// http://www.info.pmda.go.jp/ www.info.pmda.go.jp/info/search.html info/search.html

  • E

E-

  • mail:

mail: uyama uyama-

  • yoshiaki@pmda.go.jp

yoshiaki@pmda.go.jp

Thank you for your Thank you for your attention ttention