Explore the Agenda
议程 | 議題 | Agenda
8:00 am Light Breakfast & Networking
8:55 am Chair’s Opening Remarks
Developing Effective Biomarker Strategies for Next Generation Therapies to Improve Patient Stratification & Enhance Treatment Efficacy
9:00 am Organoid-Guided Precision: Advancing Indication Selection in ADC Development
- Physiologically relevant screening platform: Patient-derived organoids (PDOs) retain tumor complexity, offering more predictive ADC response than 2D or animal models
- Integrated target validation and cytotoxicity assessment: Concurrently evaluate antigen expression and ADC potency across cancer types
- Biomarker-driven patient stratification: Link PDOs response with molecular data to identify predictive markers and guide patient selection
9:30 am The Critical Role of High-Quality Human Biological Specimens (HBS) in Advancing Research & Personalized Medicine
- High-quality HBS are essential for reliable research and form the foundation of precision medicine, making them a necessity rather than a luxury
- Poor specimen quality causes severe financial and scientific setbacks, leading to questioning of findings and limiting the scope of critical work
- Selecting a reliable HBS provider requires rigorous quality control, ethical practices, and robust infrastructure, which also supports rapid advancements in future personalized medicine strategies
10:00 am Panel Discussion: Developing Effective CDx Strategies for ADCs to Improve Patient Stratification & Enhance Treatment Efficacy
- What are the most critical biomarkers for ADC target selection and patient stratification today?
- How can digital pathology, IHC, and genomics platforms elevate ADC trials?
- What are the best practices for navigating diagnostic regulatory pathways?
- How to design testing networks to ensure equitable diagnostic access
10:30 am Partnering with a Global Leader in IVD Diagnostics: Your Gateway to Japan & Beyond
- Global Leadership in IVD Diagnostics: Proven expertise in developing and launching IVD products worldwide, with a track record of successful global regulatory approvals and market entries
- Japan as a Strategic Hub: Leveraging our strong presence and experience in the Japanese market to accelerate product introduction and ensure regulatory success in Japan
- Your Partner for Global Expansion: Supporting partners not only in entering the Japanese market, but also in expanding IVD business to global markets through our extensive network and know-how
10:50 am Morning Networking Break
Navigating CDx Regulation, Reimbursement & Launch Planning Considerations to Accelerate Market & Patient Access in APAC
11:50 am Navigating IVDR – Reviewing CDx & Critical Milestones
- Transitioning from IVDD to IVDR: current status
- CDx: lessons learnt and looking ahead
12:20 pm Designing for Success: Navigating Early Phase Translational Medicine Studies to Expedite Patient Inclusion
- Practical strategies for successful IVD and CDx regulatory submissions and clinical studies
- How the EU IVDR Article 5(5) Health Institution Exemption can provide speed and flexibility for pharma-led precision medicine programmes
- Lessons learned and case studies from ARC’s collaborations in translational and precision medicine trials
12:30 pm Making Precision Medicine Research/Product Launch Quicker by Leveraging Local Regulatory Strategy
- Reviewing local regulatory strategy
- Showcasing how to make product launch quicker by aligning regulatory knowledge and strategy
1:00 pm Lunch Break
1:45 pm Dedicated Networking Time
Shaping the Future of APAC Healthcare with Innovative Biomarker-Driven Strategies & Precision Therapies to Expand Patient Access
2:30 pm Updates in Developing Effective Biomarker Strategies for CAR-T Therapies
- Showcasing progress in CAR-T for hematologic malignancies
- Reviewing updates and innovation in CAR-T for solid tumors
- Exploring updates on prognostic and predictive biomarkers
3:00 pm Precision Medicine in Global Health – Opportunities, Challenges & the Road Ahead
- From evidence to policy – genomics for AMR diagnosis and treatment guidance
- Precision medicine for infectious disease: A case for companion diagnostics?
- Partnering to strengthen sequencing capacity and clinical utility in LMICs