2019 PSTC Japan Safety Biomarker Conference
Summary
With the cooperation and support of RIKEN, NIHS, JSOT and JPMA, the Predictive Safety Testing Consortium (PSTC) of the Critical Path Institute hosted the 2nd PSTC Japan Safety Biomarker Conference from April 17-18, 2019 in Yokohama, Japan.
The utilization of biomarkers in guiding drug development decisions through clinical trials and post marketing studies is increasing. This conference explored “the areas of cooperation in the clinical application of biomarkers and drug development tools and their qualification” and shared knowledge about safety biomarkers in drug development via speaker presentations, panel sessions, and a poster exhibition. Representatives from academia, government and industry participated.
Presentations
Day 1: April 17, 2019 |
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| Title | Presenter | Presentation |
| Session 1. Introduction | Dr. John-Michael Sauer (C-Path) Dr. Takayoshi Nishiya (Daiichi Sankyo) |
Acknowledgments Session I |
| Session 2. Beyond protein biomarkers: small circulating RNA |
Session Chairs: Dr. Takayoshi Nishiya (Daiichi Sankyo) |
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| 2.1 Profiles of circulating miRNAs as non-invasive liquid biopsies for investigating hepatotoxicity in human subjects | Dr. Jiri Aubrecht (Takeda) | Tsuyoshi Yokoi |
| 2.2 MicroRNA as a Biomarker for Drug-induced Adverse Effects | Dr. Tsuyoshi Yokoi (Nagoya University) | |
| 2.3 small circulating RNA | Dr. Takahiro Ochiya (Tokyo Medical University) | |
| Session 3. Cluster/network analysis of genomics for disease grouping |
Session Chairs: Dr. Piero Carninci (Riken) |
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| 3.1 New diagnostic examination (biomarkers) and treatment for mental disorders using genomics, epigenetics and metabolomics technologies | Dr. Atsushi Takata (Yokohama City University) | Atsushi Takata Jay Shin Roland Frötschl |
| 3.2 Modeling of the transcriptional response to multidrug treatment for prediction of positive and negative effects of combinatorial drug therapy | Dr. Erik Arner (RIKEN) | |
| 3.3 Building the Human Cell Atlas towards Medical Innovations | Dr. Jay Shin (RIKEN) | |
| 3.4 Transcriptomic biomarker panel as assessed by RT-qPCR and microarray | Dr. Roland Frötschl (BfArM) | |
Day 2: April 18, 2019 |
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| Title | Presenter | Presentation |
| Session 4. Safety testing and disease diagnosis | Session Chairs: Dr. Yoshiro Saito (NIHS) Dr. Tanja Zabka (Genentech) |
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| 4.1 GLDH Clinical Qualification Project | Dr. Jiri Aubrecht (Takeda) | Masato Maekawa |
| 4.2 Validation of drug-induced liver injury biomarkers in Japan | Dr. Noriaki Arakawa (NIHS) | |
| 4.3 Qualification of clinical muscle injury biomarkers | Dr. Tanja Zabka (Genentech) | |
| 4.4 Diagnostic test/tool standardization | Dr. Masato Maekawa (Hamamatsu Medical University) | |
| Session 5. Biomarker qualification evidentiary considerations |
Session Chairs: Dr. Yasuto Otsubo (PMDA) |
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| 5.1 Current evidentiary considerations progress across PMDA, FDA, and EMA | Mr. Nicholas King (C-Path) | Nicholas King John-Michael Sauer Yoshiro Saito Mineo Matsumoto |
| 5.2 Case study: clinical and analytical validation of safety biomarkers | Dr. John-Michael Sauer (C-Path) | |
| 5.3 Survey results and perspectives on analytical validation in Japan | Dr. Yoshiro Saito (NIHS) | |
| 5.4 Qualification at PMDA | Dr. Mineo Matsumoto (PMDA) | |
| Session 6. Closing |
Session Chairs: Dr. Akihiro Ishiguro (PMDA) |
Closing |
| 6.1 Introduction | Session Chairs | |
| 6.2 Panel Session | Session chairs from all sessions | |
| 6.3 Closing | Dr. Akihiro Ishiguro (PMDA) Dr. John-Michael Sauer (C-Path |
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