Explore the Agenda
议程 | 議題 | Agenda
8:00 am Check-In & Light Breakfast
8:50 am Chair’s Opening Remarks
Optimizing Regional & Global Biomarker-Driven Trial Design & Execution for Streamlined Approvals in APAC
9:00 am Dx Strategy: Strategic Planning to Enable China Joining Global Clinical Trials with Simultaneous Filing Intent
- Showcasing study kick off efforts and timeline in China including HGR related information
- Reviewing Dx development strategy to align with global and to support CN trial
- Discussing high level drug filing plan with Dx being a component
9:30 am Session Reserved for Thermo Fisher Scientific
Presentation Details to be Announced
10:00 am Optimizing Drug & CDx Development with Liquid CGP Under the Regulatory Requirements
- Interpretation of the accuracy for liquid-based assays as the follow-on CDx when the primary CDx is tissue-based
- What are the critical challenges trial sponsors face when designing and implementing global trials for efficient co-development of CDx?
- What are the challenges when developing CDx in rare cancers?
10:30 am Morning Break & Speed Networking
An opportunity to network, discuss and collaborate with like-minded leaders of the biomarker,
diagnostic and precision medicine community
Refining Vendor Screening & Co-Development Partnerships to Facilitate Harmonized Drug-Diagnostic Development & Complex Clinical Trials in APAC & Beyond
11:30 am Precision Medicine & Companion Diagnostics: Collaborating on the Precise Approach
- Discussing launch readiness in Precision Medicine
- Experience & learnings working with CDx partners
12:00 pm Innovative Ways to Democratize Precision Medicine Testing
- Learn how to optimize late-stage clinical development by designing and developing genomics solutions at scale
- Discover SOPHiA GENETICS’ market-leading lab network and regional strategic collaborations, particularly in the APAC region, democratizing genomics testing
- Gain insights into SOPHiA GENETICS’ regulatory and validation pathway for enabling broad and faster access to precision therapies.
- Explore how SOPHiA GENETICS’ unique hybrid deployment approach to liquid biopsy, combining centralized and decentralized testing, meets global regulatory requirements while paving the way for maximizing patient access to critical diagnostics
12:30 pm Advancing Patient Access to Treatment Options with Precision Dual-Sample Diagnostic Technology
- Determining a fit-for-purpose assay strategy based on dual sample types or multi platforms
- How can pharma and diagnostic developers collaboratively balance assay complexity, analytical sensitivity, and clinical relevance?
- Designing strategies for clinical trial management and sample acquisition to address logistical challenges
1:00 pm Session Reserved for Almac
Presentation Details to be Announced
1:10 pm Lunch Break
1:55 pm Dedicated Networking Time
Validating Novel Endpoints with ctDNA, CTCs & MRD to Advance Non-Invasive, Clinical Decision Making
2:25 pm SERENA-6: ctDNA-Guided Treatment Switch – A Potential New Paradigm in Cancer Management
- Traditional approach to treating solid tumors uses radiology images to determine clinical progression, to switch treatment to control the disease
- SERENA-6 challenges that paradigm, using ctDNA serial monitoring to detect the emergence of ESR1 mutations in hormone receptor positive metastatic breast cancer (HR+ mBC)
- An early switch to camizestrant plus a CDK4/6 inhibitor upon ctDNA detection of ESR1 mutations during first-line therapy, significantly prolonged progression-free survival (PFS) versus the conventional approach of switching therapy at clinical progression (median PFS 16.0 vs 9.2 months at first interim analysis)
2:55 pm Unlocking Clinical Insights: The Role of MRD as an Endpoint, Technologies, & Regulatory Perspectives
- How can MRD serve as a reliable surrogate endpoint to predict long-term clinical benefits in hematologic malignancies?
- What are the latest advancements in detection technologies that can enhance the sensitivity and reproducibility of MRD measurement?
- How are regulatory agencies evolving their frameworks to accept MRD as endpoint in clinical trials?
3:25 pm Afternoon Break & Networking
Best Practices in Genomics & Epigenetic Sequencing for CDx Development & Clinical Use with Approved Tests In APAC
3:55 pm Session Reserved for Guardant Health
Presentation Details to be Announced
4:10 pm Harnessing Next Generation Sequencing to Advance FGFR Inhibitor Development
- Overview of the development history of FGFR inhibitors
- Exploring the role of next generation sequencing in accelerating FGFR inhibitor discovery and development
- Showcasing a case study from the early-stage development of an FGFR inhibitor