Explore the Agenda
8:00 am Check In & Light Breakfast
8:25 am Chair’s Opening Remarks
Co-Development of Novel Drugs & CDx in Japan: Regulatory Pathways
8:30 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
9:00 am Designing Early-Phase Translational Medicine Studies for Success: Approaches to Accelerate Patient Enrolment
- This session will explore practical approaches to designing early-phase translational medicine studies that are both scientifically robust and operationally feasible
- Drawing on ARC Regulatory’s integrated capabilities across Dx CRO, Lab Services, and Pharma Tech, the discussion will highlight how combining regulatory strategy, clinical operations, and innovative technologies can streamline study design and execution.
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
Moderator:
Staci Kearney, Founder & Chief Executive Officer, Elevation Strategic Development
12:15 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 Session by: Ministry of Health, Labour and Welfare: 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