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 Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Trends of PI Trends of PI including PGx PGx information information including 250 25 Accum ulated Num bers Accum ulated % of PI N of PI 200 20 of Approval Drug % of PI incl. PGx including PGx 150 15 100 10 50 5 0 0 2002 2003 2004 2005 2006 2007 Fiscal Year EMEA/EFPIA Workshop Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Trends of PI Trends of PI including PGx PGx information information including 40 Accum ulated Num bers of PI 35 Metabolic Enzyme Metabolic Enzyme 30 including PGx 25 20 Virus/Bacterium Virus/Bacterium 15 10 Pharmacological Pharmacological 5 Target Target 0 2002 2003 2004 2005 2006 2007 Fiscal Year EMEA/EFPIA Workshop Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Guidances & Notifications related to & Notifications related to PGx PGx Guidances Title Date Notifier Points to consider on Clinical Trials using PGx September PFSB/ELD 2008 Points to consider for evaluating genotyping April 2008 PFSB/ELD platforms based on DNA chips Terminology in pharmacogenomics （ ICH-E15 ） January PFSB/ELD 2008 and PFSB/SD Request to cooperate in research regarding severe June 2006 PFSB/SD ** cutaneous adverse reactions Submission of information to regulatory authorities March PFSB/ELD for preparation of guidance on the use of 2005 Pharmacogenomics in clinical studies. Guidance on methods of drug interaction studies. June 2001 PFSB/ELD Guidance on clinical pharmacokinetics studies of June 2001 PFSB/ELD * Pharmaceuticals * 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 EMEA/EFPIA Workshop Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Points to Consider on Clinical Trial using Points to Consider on Clinical Trial using Pharmacogenomics Pharmacogenomics th , 2008) (Final Notification was published on Sep. 30 th , 2008) (Final Notification was published on Sep. 30 � This Q&A document describes basic principles on clinical This Q&A document describes basic principles on clinical � trials using PGx PGx. . trials using 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 � EMEA/EFPIA Workshop Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Major Reimbursable PGx PGx tests in Japan tests in Japan Major Reimbursable Genomic biomarker Target Date to be covered by NHI UGT1A1 Irinotecan-induced November 2008 Neutropenia Wilms tumor-1 mRNA Acute Myelocytic November 2007 Leukemia EGFR mutations Lung Cancer June 2007 KIT mutations Gastrointestinal June 2007 Stromal tumor Mutations in HIV HIV April 2006 Major bcr-abl mRNA (TMA) Chronic Myelogenous November 2004 Leukemia Mutations in HBV precore, Mutations HBV July 2003 in HBV core promoter (PCR) Her2/neu ( erbB2 ) (FISH) Breast Cancer April 2003 EMEA/EFPIA Workshop Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Biomarker & Ethnic Differences (1) Biomarker & Ethnic Differences (1) Irinotecan & UGT1A1 & UGT1A1 Irinotecan EMEA/EFPIA Workshop Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Ethnic difference in allele frequencies of Ethnic difference in allele frequencies of UGT1A1* 6 and and * 28 * 28 mutant genes mutant genes UGT1A1* 6 Caucasian * 6 : 0% * 28 : 44.6% African- Japanese American * 6 : 17.1% * 6 : 0% * 28 : 10% * 28 : 38.9% Kaniwa N et al. Drug Metab Dispos (2005) EMEA/EFPIA Workshop Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Examples of Package Insert including PGx Examples of Package Insert including PGx information information � Important Precautions Important Precautions � EMEA/EFPIA Workshop Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Biomarker & Ethnic Differences (2) Biomarker & Ethnic Differences (2) HLA- -B*1502 & SJS/TEN B*1502 & SJS/TEN HLA EMEA/EFPIA Workshop Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Han- -Chinese Chinese- -SJS/TEN and SJS/TEN and HLA* B1502 HLA* B1502 Han Dr Chang CF, APEC PRS, 2007 Chang CF, APEC PRS, 2007 Dr EMEA/EFPIA Workshop Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Ethnic differences in HLA- -B* 1502 B* 1502 Ethnic differences in HLA Ethnic group prevalence Ethnic group prevalence Han- -Chinese Chinese 1.9- -7.1 % 7.1 % Han 1.9 Thai 8.5 % Thai 8.5 % Singaporean 5.7 % Singaporean 5.7 % Korean 0.2 % Korean 0.2 % Japanese 0.1 % Japanese 0.1 % Caucasian 0- -1 % 1 % Caucasian 0 � Differences exist even among Asian populations Differences exist even among Asian populations � EMEA/EFPIA Workshop Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Framework of NIHS NIHS research regarding research regarding SCAR SCAR Framework of 3) cooperation Medical Doctors 3) sample 2) Requests for Adverse event research cooperation report 1) I nform SJS/ TEN cases (voluntary) I ndustries NI HS 2) Requests for research cooperation Adverse event Notification report support MHLW PMDA http://www.nihs.go.jp/mss/MSS%20folder/JSCAR/jscar_ronbun.html EMEA/EFPIA Workshop Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Japanese- -SJS/TEN and SJS/TEN and HLA* B HLA* B Japanese Kaniwa N et al, Pharmacogenomics, 9: 1617 N et al, Pharmacogenomics, 9: 1617- -1622, 2008 1622, 2008 Kaniwa EMEA/EFPIA Workshop Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
Biomarker Qualification Biomarker Qualification EMEA/EFPIA Workshop Pharmac Pharmaceutica uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
International Biomarker Qualification International Biomarker Qualification -Regulatory Collaborations Regulatory Collaborations- - - Joint meeting PMDA joined to JVXDS JVXDS PMDA joined to Since 2007 Since 2007 Confidential Confidential Confidential Confidential Agreement Agreement Agreement Agreement VGDS meeting PDG meeting Briefing Meeting Industry EMEA/EFPIA Workshop Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Pharmaceutica Pharmac uticals & Medi s & Medica cal Devices l Devices Agency Agency Dec 19, 2008, London, UK
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