Explore the Agenda
8:00 am Check In & Light Breakfast
8:50 am Chair’s Opening Remarks
Co-Development of Novel Drugs & CDx in Japan: Regulatory Pathways
9:00 am Regulatory Submissions for Novel CDx: A Case Study of CDx & Drug Co-Development
- Traditional regulatory pathway for CDx co-development in Japan
- Companion vs. complementary diagnostics
- Libtayo approval lessons learned
9:30 am Navigating Japan’s Regulatory Challenges in CDx Development from A Pharmaceutical Company Perspective: Practical Solutions & Future Directions
- Current situation and challenges of Japan’s regulatory environment for CDx development compare to US/EU
- Case study of alternative diagnostic development based on these challenges
- Proposals for regulatory environment to advance future companion diagnostics development
10:00 am Refreshment Break
10:30 am Networking & 1:1 Meetings
Network with your peers during this session to exchange your ideas and generate meaningful industry connections and collaborations with other biomarker and CDx experts
CDx Regulatory Approval in Japan: Integrating Local Requirements with Global Development Strategies
11:00 am Navigating IVDR: Reviewing CDx, Critical Milestones & Suggested Changes to the Regulatory Framework
- Examining the current IVDR landscape for CDx, including key regulatory milestones, implementation challenges, and compliance expectations
- Exploring proposed and practical changes to the regulatory framework to improve clarity, timelines, and innovation while maintaining patient safety and clinical validity
11:30 am Panel Discussion: Discussing Decision Making by Regulatory Bodies & Aligning Development Strategy to Meet Regulatory Standards within Japan & Internationally
- Examining how PMDA decision-making processes compare with FDA and EMA expectations, and what this means for global CDx and therapeutic development planning
- Identifying practical strategies to align clinical evidence generation, submission timing, and stakeholder engagement to meet both Japanese and international regulatory standards
12:30 pm Lunch Break & Networking
Commercialization Strategies: Bringing the Right Therapies to the Right Patient Populations at the Right Time
1:30 pm Advancing NMIBC Precision Oncology: Dual Tissue–Urine Assay Strategies to Enhance Clinical Trial Screening & Patient Access
2:00 pm Reimbursement Pathways for Companion Diagnostics in Japan: SaMD, ctDNA, & Digital Biomarkers
- Demonstrating how laboratory testing services (including ctDNA, CGP, and digital biomarkers) are introduced as Software as a Medical Device (SaMD) in Japan
- Identifying critical reimbursement barriers limiting CDx implementation, including misalignment in current frameworks
2:30 pm Successfully Co-Launching a Novel CDx & Oncology Treatment to Enable Patient Access to Life-Changing Therapies
- Best practice examples of launching novel CDx and oncology therapies to ensure streamlined market access
- Considering the challenges and priorities of simultaneously commercialising CDx and precision therapies