Advances in genomic research have significantly enhanced modern drug development. However, equita... more Advances in genomic research have significantly enhanced modern drug development. However, equitable benefit sharing of the results of scientific advancement has not always been achieved. This paper shows how molecular biology has modified medicines development while also leaving open significant challenges for benefit sharing. Presented here is a conceptual modeling describing the processes in genetic-related medicines development and how these are related to specific ethical considerations. The focus is on three important areas: 1) population genetics and the need for discrimination prevention; 2) pharmacogenomics and the need for inclusive governance; and 3) global health to be achieved in open science frameworks. Benefit sharing is taken as the ethical value that underlies all these aspects. The implementation of benefit sharing requires a value shift in which the outcomes of health science are not viewed simply as trade commodities but also as a “global public good”. This appro...
This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes ... more This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that• stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable.• research participants already receiving trial medication in such disruptive situations are to be considered highly vulnerable due to their medical dependency for ongoing treatment according to the approved clinical study protocol.• based on the present experience in Ukraine and Russia, we conclude that finishing ongoing trial treatments according to approved or amended protocols should be considered to be an ethical obligation of trial sponsors irrespective whether trial disruption is due to war, economic sanctions, or natural catastrophes.• it is important to devote more attention to the ethical challenges raised by such fundamentally disruptive situations to clinical trials generally in any region of the world.
Kaku igaku. The Japanese journal of nuclear medicine, 2015
OBJECTIVES To identify regulatory framework for approval of PET drugs in Korea. METHOD Interview ... more OBJECTIVES To identify regulatory framework for approval of PET drugs in Korea. METHOD Interview and literature survey. RESULTS In Korea Good Manufacturing Practice (GMP) regulation specific to radiopharmaceuticals, including PET (Positron Emission Tomography) drugs, under the Pharmaceutical Affairs Act was issued in August 2014, to be enforced on July 1, 2015, and its guidance was issued in December 2014. The new facilities to be established after July 1 of 2015 have to be compatible with this new regulation and already established facilities have two years grace period until June 30 of 2017. During this period, the regulatory authority will inspect all of the production sites which hold or submit approvals of radiopharmaceuticals. As of September 2015 in Korea, there are 7 commercial companies and 15 hospitals and institutes, which have approvals of PET drugs mainly FDG, and these companies and/or hospitals can supply PET drugs outside institutions. In this article we introduce th...
Phase IV clinical trials are postmarketing studies vital to establish longer term, additional cli... more Phase IV clinical trials are postmarketing studies vital to establish longer term, additional clinical evidence in the general population under regular usage conditions. They provide more pragmatic information on the safety and effectiveness of drugs than premarketing clinical trials involving
Background:The termregulatory sciencewas proposed in Japan by Uchiyama in 1987 and analytically r... more Background:The termregulatory sciencewas proposed in Japan by Uchiyama in 1987 and analytically reviewed in English literature in 1996. On the other hand, in the United States (US), one of the earliest uses of the term in analytical literature was by Jasanoff in 1990, in her book The Fifth Branch. Objectives:The objective of this interview is to clarify the beginning, history, and meaning of the term �regulatory sciencein the US as compared to Japan. Findings:Through this interview we found the following: (1) In US, Jasanoff first proposed the concept of regulatory science in an analytical way, though there may be some isolated mentions before; (2) to say Weinberg is the founder of this concept is wrong, as he proposed the concept oftrans-scienceto refer to the policy-relevant fields for which scientists have no answer, whereas the termregulatory sciencerefers to science generated to give answer to political questions; (3) in US, regulatory science is discussed in relation to all po...
In Korea the Bioethics and Safety Act was expanded in 2012 and in Taiwan the Human Subjects Resea... more In Korea the Bioethics and Safety Act was expanded in 2012 and in Taiwan the Human Subjects Research Act of 2011 and the Human Biobank Management Act of 2010 were established. In these countries a wide range of research involving human subjects and biobank projects have come to be regulated by legally-binding regulations, which cover research activities outside of pharmaceutical laws to regulate clinical trials aiming at new drug or new indication applications. In both countries leading research institutes are getting accreditation of AAHRPP (The Association for the Accreditation of Human Research Protection Programs, Inc.), the organization of the United States. Additionally in Korea, rebate taking of medical professionals became strictly prohibited. These developments are prerequisite lessons for the Japanese research community where recently many cases of scientific misconduct in clinical research have been uncovered and where people are discussing about establishment of laws to ...
United States (U.S.) Food and Drug Administration (FDA) issued the report on the Clitical Path In... more United States (U.S.) Food and Drug Administration (FDA) issued the report on the Clitical Path Initiative in 2004 in which they mentioned imaging technology as one of the tools for assessment of biomarkers of drug efficacy, which should facilitate clinical development. Additionally the FDA issued several guidances to facilitate development of imaging diagnostic drugs and regulations for PET (Positron Emission Tomography) drug specific Good Manufacturing Practice (PET drug GMP). Actually in the U.S., medical/research institutions and companies have been developing various PET drugs aiming at regulatory approval and public health reimbursement coverage. This article reports such situations in the U.S., considering related situations in Japan.
In the U.S. (United States), there are various activities to develop diagnostic PET drugs toward ... more In the U.S. (United States), there are various activities to develop diagnostic PET drugs toward the use in medical practice being covered by healthcare insurance and also to make use of PET drugs for assessment of biomarkers for therapeutic drug development. In this second report of 3-part series, we introduce some of the strategic initiatives to promote multi-center clinical research and clinical trial network being facilitated by collaboration among academia, industry, and regulators.
Clinical development of regenerative medicine using somatic stem cells is making steady progress ... more Clinical development of regenerative medicine using somatic stem cells is making steady progress toward practical application all over the world. Needless to say, clinical trials of cellular-based products are regarded as being in the experimental stage in the world and mostly have been conducted under the Pharmaceutical Affairs Law (PAL). Therefore, their efficacy and safety are rigorously evaluated by regulatory authorities based on quality-assured preclinical and clinical data, aiming at the goal of marketing authorization. Currently in Japan, several investigator-initiated regenerative medicine clinical trials under the PAL have steadily achieved planned progress. On the other hand, �clinical research of iPSCs (induced pluripotent stem cells)� outside the control of PAL has been rapidly accelerated toward clinical application. Considering this situation, we reviewed Japanese regulations related to preclinical assessment of cellular-based products, comparing with the regulatory p...
Advances in genomic research have significantly enhanced modern drug development. However, equita... more Advances in genomic research have significantly enhanced modern drug development. However, equitable benefit sharing of the results of scientific advancement has not always been achieved. This paper shows how molecular biology has modified medicines development while also leaving open significant challenges for benefit sharing. Presented here is a conceptual modeling describing the processes in genetic-related medicines development and how these are related to specific ethical considerations. The focus is on three important areas: 1) population genetics and the need for discrimination prevention; 2) pharmacogenomics and the need for inclusive governance; and 3) global health to be achieved in open science frameworks. Benefit sharing is taken as the ethical value that underlies all these aspects. The implementation of benefit sharing requires a value shift in which the outcomes of health science are not viewed simply as trade commodities but also as a “global public good”. This appro...
This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes ... more This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that• stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable.• research participants already receiving trial medication in such disruptive situations are to be considered highly vulnerable due to their medical dependency for ongoing treatment according to the approved clinical study protocol.• based on the present experience in Ukraine and Russia, we conclude that finishing ongoing trial treatments according to approved or amended protocols should be considered to be an ethical obligation of trial sponsors irrespective whether trial disruption is due to war, economic sanctions, or natural catastrophes.• it is important to devote more attention to the ethical challenges raised by such fundamentally disruptive situations to clinical trials generally in any region of the world.
Kaku igaku. The Japanese journal of nuclear medicine, 2015
OBJECTIVES To identify regulatory framework for approval of PET drugs in Korea. METHOD Interview ... more OBJECTIVES To identify regulatory framework for approval of PET drugs in Korea. METHOD Interview and literature survey. RESULTS In Korea Good Manufacturing Practice (GMP) regulation specific to radiopharmaceuticals, including PET (Positron Emission Tomography) drugs, under the Pharmaceutical Affairs Act was issued in August 2014, to be enforced on July 1, 2015, and its guidance was issued in December 2014. The new facilities to be established after July 1 of 2015 have to be compatible with this new regulation and already established facilities have two years grace period until June 30 of 2017. During this period, the regulatory authority will inspect all of the production sites which hold or submit approvals of radiopharmaceuticals. As of September 2015 in Korea, there are 7 commercial companies and 15 hospitals and institutes, which have approvals of PET drugs mainly FDG, and these companies and/or hospitals can supply PET drugs outside institutions. In this article we introduce th...
Phase IV clinical trials are postmarketing studies vital to establish longer term, additional cli... more Phase IV clinical trials are postmarketing studies vital to establish longer term, additional clinical evidence in the general population under regular usage conditions. They provide more pragmatic information on the safety and effectiveness of drugs than premarketing clinical trials involving
Background:The termregulatory sciencewas proposed in Japan by Uchiyama in 1987 and analytically r... more Background:The termregulatory sciencewas proposed in Japan by Uchiyama in 1987 and analytically reviewed in English literature in 1996. On the other hand, in the United States (US), one of the earliest uses of the term in analytical literature was by Jasanoff in 1990, in her book The Fifth Branch. Objectives:The objective of this interview is to clarify the beginning, history, and meaning of the term �regulatory sciencein the US as compared to Japan. Findings:Through this interview we found the following: (1) In US, Jasanoff first proposed the concept of regulatory science in an analytical way, though there may be some isolated mentions before; (2) to say Weinberg is the founder of this concept is wrong, as he proposed the concept oftrans-scienceto refer to the policy-relevant fields for which scientists have no answer, whereas the termregulatory sciencerefers to science generated to give answer to political questions; (3) in US, regulatory science is discussed in relation to all po...
In Korea the Bioethics and Safety Act was expanded in 2012 and in Taiwan the Human Subjects Resea... more In Korea the Bioethics and Safety Act was expanded in 2012 and in Taiwan the Human Subjects Research Act of 2011 and the Human Biobank Management Act of 2010 were established. In these countries a wide range of research involving human subjects and biobank projects have come to be regulated by legally-binding regulations, which cover research activities outside of pharmaceutical laws to regulate clinical trials aiming at new drug or new indication applications. In both countries leading research institutes are getting accreditation of AAHRPP (The Association for the Accreditation of Human Research Protection Programs, Inc.), the organization of the United States. Additionally in Korea, rebate taking of medical professionals became strictly prohibited. These developments are prerequisite lessons for the Japanese research community where recently many cases of scientific misconduct in clinical research have been uncovered and where people are discussing about establishment of laws to ...
United States (U.S.) Food and Drug Administration (FDA) issued the report on the Clitical Path In... more United States (U.S.) Food and Drug Administration (FDA) issued the report on the Clitical Path Initiative in 2004 in which they mentioned imaging technology as one of the tools for assessment of biomarkers of drug efficacy, which should facilitate clinical development. Additionally the FDA issued several guidances to facilitate development of imaging diagnostic drugs and regulations for PET (Positron Emission Tomography) drug specific Good Manufacturing Practice (PET drug GMP). Actually in the U.S., medical/research institutions and companies have been developing various PET drugs aiming at regulatory approval and public health reimbursement coverage. This article reports such situations in the U.S., considering related situations in Japan.
In the U.S. (United States), there are various activities to develop diagnostic PET drugs toward ... more In the U.S. (United States), there are various activities to develop diagnostic PET drugs toward the use in medical practice being covered by healthcare insurance and also to make use of PET drugs for assessment of biomarkers for therapeutic drug development. In this second report of 3-part series, we introduce some of the strategic initiatives to promote multi-center clinical research and clinical trial network being facilitated by collaboration among academia, industry, and regulators.
Clinical development of regenerative medicine using somatic stem cells is making steady progress ... more Clinical development of regenerative medicine using somatic stem cells is making steady progress toward practical application all over the world. Needless to say, clinical trials of cellular-based products are regarded as being in the experimental stage in the world and mostly have been conducted under the Pharmaceutical Affairs Law (PAL). Therefore, their efficacy and safety are rigorously evaluated by regulatory authorities based on quality-assured preclinical and clinical data, aiming at the goal of marketing authorization. Currently in Japan, several investigator-initiated regenerative medicine clinical trials under the PAL have steadily achieved planned progress. On the other hand, �clinical research of iPSCs (induced pluripotent stem cells)� outside the control of PAL has been rapidly accelerated toward clinical application. Considering this situation, we reviewed Japanese regulations related to preclinical assessment of cellular-based products, comparing with the regulatory p...
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