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8:00 am Light Breakfast & Networking

8:55 am Chair’s Opening Remarks

Senior Director & Head of Global Clinical Delivery Unit & Oncology, Merck KGaA

Developing Effective Biomarker Strategies for Cell Therapies, ADCs & Bispecifics to Improve Patient Stratification & Enhance Treatment Efficacy

9:00 am Updates in Developing Effective Biomarker Strategies for CAR-T Therapies

Founder & CEO, Tikva Allocell
  • 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

9:30 am Session Reserved for BioIVT

Presentation Details to be Announced

10:00 am Organoid-Guided Precision: Advancing Indication Selection in ADC Development

Head of Biology Discovery Department, Senior Scientist, OBI Pharma Inc.
  • 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

10:30 am Panel Discussion: Establishing Scalable & Validated Digital Pathology to Support Patient Selection for ADC Therapies

Vyloy Global Medical Affairs Lead, International Markets, MA Global Brand Strategy, Astellas Pharma
Vice President, Oncology, AstraZeneca
  • Establishing robust validity for digital pathology platforms to ensure reproducibility and accuracy across different laboratories
  • What is the regulatory pathway for approving digital pathology based CDx approaches in APAC?
  • Designing digital pathology networks to address pathologist shortages and ensure equitable diagnostic access in geographically dispersed APAC regions

11:00 am Morning Networking Break

Navigating CDx Regulation, Reimbursement & Launch Planning Considerations to Accelerate Market & Patient Access in APAC

12:00 pm Navigating IVDR – Reviewing CDx & Critical Milestones

Senior Vice President, TÜV SÜD
  • Transitioning from IVDD to IVDR: current status
  • CDx: lessons learnt and looking ahead

12:30 pm Session Reserved for ARC Regulatory

Presentation Details to be Announced

12:40 pm Making Precision Medicine Research/Product Launch Quicker by Leveraging Local Regulatory Strategy

Founder, Asia Regulatory Professionals Association
  • Reviewing local regulatory strategy
  • Showcasing how to make product launch quicker by aligning regulatory knowledge and strategy

1:10 pm Lunch Break

1:55 pm Dedicated Networking Time

Shaping the Future of APAC Healthcare with Precision Therapies in Neurological, Chronic & Rare Disease to Expand Patient Access

2:40 pm Biomarker-Driven Translational & Precision Medicine in Oncology & Neuroscience

Associate Scientific Director, Research Innovation, Takeda Pharmaceutical
  • Reviewing clinically validated biomarkers of efficacy and their real-world expression in oncology
  • Spotlighting translational research to explore novel efficacy predictive biomarkers
  • Leveraging reverse translational approaches to facilitate early discovery

3:10 pm Precision Medicine in Global Health – Opportunities, Challenges & the Road Ahead

Director, Genomics and Diagnostic Technologies, FIND
  • 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

3:40 pm Chair’s Closing Remarks

3:45 pm End of the 2nd World Companion Diagnostics & Liquid Biopsy Summit APAC