PSTC Japan Safety Biomarker Conference Session 1. Introduction John Michael Sauer, PhD Executive Director, Predictive Safety Testing Consortium Takayoshi Nishiya, PhD Senior Director, Daiichi Sankyo
PSTC Japan Safety Biomarker Conference Session 1. Introduction
John Michael Sauer, PhDExecutive Director, Predictive Safety Testing Consortium
Takayoshi Nishiya, PhDSenior Director, Daiichi Sankyo
Thank you Planning Committee
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Chugai Nozomi Fujisawa
Naoto Toyota
C-Path Nicholas King
John-Michael Sauer
Daiichi Sankyo Ito Kazumi
Takayoshi Nishiya
Mitsubishi Takuya Fujita
Manami Miyake
Toshinobu Shimuzi
NIHS Yoshiro Saito
Novartis Yumiko Tsujimura
Otsuka Yuichi Shimomura
Pfizer Masanori Hizue
Chieko Muto
PMDA Akihiro Ishiguro
Yasuto Otsubo
Taiki Sato
RIKEN Piero Carninci
Masaaki Furuno
Linda Kostrencic
Todd Taylor
Takeda Jiri Aubrecht
Naomi Kamiguchi
Shingo Okubo
Yusuke Sudo
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Thank You to Our Host
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Thank You to Our Co-Sponsors
PSTC Japan Safety Biomarker Conference
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Why are we here today?
The objectives of the conference:
• Bring together biomarker stakeholders in order to share
scientific discoveries and approaches around safety biomarkers
• Identify collaborative opportunities across stakeholder groups
• To teach and to learn
PSTC Japan Safety Biomarker Conference
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Why are we here today?
The objectives of the conference:• International alignment around the implementation of safety
biomarkers in drug development
• Alignment on the regulatory qualification of biomarkers in general across the three major government agencies – FDA, EMA, and PMDA
Agenda – Day 1
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Time Session Proposed Session Description / Theme Session Chairs
10:30 – 11:00 1 Introduction John Michael-Sauer (C-Path)Takayoshi Nishiya (Daiichi Sankyo)
11:00 – 13:00 Lunch (poster session)
13:00 – 15:00 2 Beyond protein biomarkers: small circulating RNA• miRNA safety biomarkers – Jiri Aubrecht (Takeda)• miRNA – Tsuyoshi Yokoi (Nagoya Univ.)• small circulating RNA – Takahiro Ochiya (Tokyo Medical Univ.)
Takayoshi Nishiya (Daiichi Sankyo)Nicholas King (C-Path)
15:00 – 15:15 Break
15:00 – 17:30 3 Cluster/network analysis of genomics for disease grouping• New diagnostic examination (biomarkers) and treatment for mental disorders by
using of genomics, epigenetics and metabolomics technologies – Atsushi Takata(Yokohama City Univ.)
• Modeling of the transcriptional response to multidrug treatment for prediction of positive and negative effects of combinatorial drug therapy – Erik Arner(RIKEN)
• Building the Human Cell Atlas towards Medical Innovations – Jay Shin (RIKEN)• TGx-DDI – Qualification of a Preclinical Biomarker – Roland Frötschl (BfArM)
Piero Carninci (Riken) Jiri Aubrecht (Takeda)
18:00 Banquet
Agenda – Day 2
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Time Session Proposed Session Description / Theme Session Chairs
09:00 – 10:30 4 Safety testing and disease diagnosis• GLDH clinical qualification – Jiri Aubrecht (Takeda) • Validation of drug-induced liver injury biomarkers in Japan – Noriaki Arakawa (NIHS)
Yoshiro Saito (NIHS)Tanja Zabka (Genentech)
10:30 – 10:45 Break
10:45 – 12:00 4 Safety testing and disease diagnosis• Qualification of Clinical Skeletal Muscle Injury Biomarkers: An Innovative Approach –
Tanja Zabka (Genentech)• Diagnostic test/tool standardization – Masato Maekawa (Hamamatsu Medical Univ.)
Yoshiro Saito (NIHS)Tanja Zabka (Genentech)
12:00 – 13:00 Lunch
13:00 – 15:30 5 Biomarker qualification evidentiary considerations • Current evidentiary considerations progress across PMDA, FDA, and EMA – Nicholas King
(C-Path)• Case study: clinical and analytical validation of safety biomarkers – John-Michael Sauer
(C-Path)• Survey results and perspectives on analytical validation in Japan – Yoshiro Saito (NIHS)• Qualification at PMDA – Mineo Matsumoto (PMDA)
Yasuto Otsubo (PMDA)Masanori Hizue (Pfizer Japan)
15:30-15:45 Break
15:45 – 16:30 6 Closing • Conclusions and next steps• Include all session chairs for panel discussion to summarize the conference
Akihiro Ishiguro (PMDA)John Michael Sauer (C-Path)
PSTC Japan Safety Biomarker Conference
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Since the 2017 Safety Biomarker Conference…
• PSTC has initiated formal interactions with PMDA to qualify the kidney safety biomarkers for clinical use in Japan
• FDA qualified the kidney safety biomarker for clinical use as a composite measure
• PSTC has advance the qualification of GLDH with FDA and EMA
• PSTC has initiated the qualification of clinical skeletal muscle safety biomarkers with the FDA
Translational Safety Biomarkers
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Fluid-Based Safety Biomarkers: Can be used to accurately predict drug-induced tissue injury, similar to a routine clinical pathology measure.
Monitorability of Drug-Induced Tissue Injury
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Gaps:The Need for Better Safety Biomarkers
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Current biomarker standards do not exist or they have significant limitations
PSTC Members and Partners
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Partners
Consortium Members
www.c-path.org
Thank you