PSTC Japan Safety Biomarker Conference Session 1. Introduction John - - PowerPoint PPT Presentation

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PSTC Japan Safety Biomarker Conference Session 1. Introduction John - - PowerPoint PPT Presentation

Jun 12, 2023 203 likes •343 views

PSTC Japan Safety Biomarker Conference Session 1. Introduction John Michael Sauer, PhD Takayoshi Nishiya, PhD Executive Director, Predictive Safety Testing Consortium Senior Director, Daiichi Sankyo Chugai Nozomi Fujisawa NIHS Yoshiro Saito

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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

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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

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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
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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

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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
  • f 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

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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)

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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

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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

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PSTC Members and Partners

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Partners Consortium Members

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www.c-path.org

Thank you