PSTC Japan Safety Biomarker Conference Session 6. Closing Akihiro Ishiguro, PhD – Pharmaceutical and Medical Device Agency John Michael Sauer, PhD – Critical Path Institute
Agenda – Day 1 Session Chairs Session Proposed Session Description / Theme Takayoshi Nishiya (Daiichi Sankyo) 2 Beyond protein biomarkers: small circulating RNA Nicholas King (C-Path) • miRNA safety biomarkers – Jiri Aubrecht (Takeda) • miRNA – Tsuyoshi Yokoi (Nagoya Univ.) • small circulating RNA – Takahiro Ochiya (Tokyo Medical Univ.) • miRNA represents an important type of biomarkers • miRNA can serve as safety biomarkers - Leakage biomarkers - Mechanistic biomarkers • miRNA biomarkers also can be used to evaluate disease activity and prediction • Analytical validation maybe much difficult than clinical validation 2
Agenda – Day 1 Session Chairs Session Proposed Session Description / Theme Piero Carninci (Riken) 3 Cluster/network analysis of genomics for disease grouping Jiri Aubrecht (Takeda) • 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) • There are many discovery activities, including genomics, that will lead to the discovery of novel biomarkers • Computational approaches will enable the discovery and application of biomarkers in the future • Qualification of in vitro biomarkers can have significant impact on the progression of drug development 3
Agenda – Day 2 Session Chairs Session Proposed Session Description / Theme Yoshiro Saito (NIHS) 4 Safety testing and disease diagnosis Tanja Zabka (Genentech) • GLDH clinical qualification – Jiri Aubrecht (Takeda) • Validation of drug-induced liver injury biomarkers in Japan – Noriaki Arakawa (NIHS) • Qualification of Clinical Skeletal Muscle Injury Biomarkers: An Innovative Approach – Tanja Zabka (Genentech) • Diagnostic test/tool standardization – Masato Maekawa (Hamamatsu Medical Univ.) • Novel safety biomarkers are need to accelerate drug development • The novel safety biomarkers discussed demonstrated significant improvement over the currently used biomarkers • The implementation of biomarkers and diagnostic tools requires significant effort to ensure the usability of the biomarker 4
Agenda – Day 2 Session Chairs Session Proposed Session Description / Theme Yasuto Otsubo (PMDA) 5 Biomarker qualification evidentiary considerations Masanori Hizue (Pfizer Japan) • 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) • Qualification is the process of obtaining regulatory approval for the regular use of a biomarker in drug development • The PMDA, EMA and FDA all have qualification programs but with different process and expectations • The two fundamental aspects of biomarker qualification are Analytical Validation and Clinical Validation • Proper analytical validation is required for successful clinical validation • However, there is no specific regulatory expectations on biomarker assay validation and more stakeholder education is required 5
Chugai Nozomi Fujisawa NIHS Yoshiro Saito RIKEN Piero Carninci Naoto Toyota Novartis Yumiko Tsujimura Masaaki Furuno C-Path Nicholas King Otsuka Yuichi Shimomura Linda Kostrencic John-Michael Sauer Masanori Hizue Todd Taylor Pfizer Daiichi Sankyo Ito Kazumi Chieko Muto Jiri Aubrecht Takeda Takayoshi Nishiya PMDA Akihiro Ishiguro Naomi Kamiguchi Mitsubishi Takuya Fujita Yasuto Otsubo Shingo Okubo Manami Miyake Taiki Sato Yusuke Sudo Toshinobu Shimuzi Thank you Planning Committee 6
Thank You to Our Co-Sponsors 7
Thank You to Our Host 8
Thank you www.c-path.org
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