DAY ONE | WEDNESDAY, NOVEMBER 13
初日
第一天
Hari Pertama
7:30 am Check In & Light Breakfast
8:20 am Chair’s Opening Remarks
Creating Robust Precision Medicine Strategies to Expand Market Access for Patients in Need
8:30 am Precision Medicine Strategic Considerations for Global Market Access: From Early CDx Development to Clinical Trials & Overcoming Regulatory Hurdles
Synopsis
- Understanding regulatory considerations for USA, EU and APAC to expedite approvals
- Creating a robust CDx strategy to expedite from clinical trials through to CDx launch
- Key considerations for diagnostic tests in clinical trials and using this data for global submissions
9:00 am Driving Global Change: Foundation Medicine’s Leadership in Companion Diagnostics & Impact on Patient Testing
Synopsis
- CDx Leadership: Nearly 60% of approved CDx indications for NGS testing in the US and Japan
- BioPharma Support: Expanding testing options for biopharma partners
- Japan Market Access: Enhancing patient testing and market access • Global Expansion: Insights into our expansion into China and HGRAC experiences
9:30 am Hands on Experience with Case Studies of Precision Medicine & CDx Co-Development in China
Synopsis
- Sharing the pharma perspective on the drug and CDx co-development in China
- Understanding CDx clinical validation data under drug clinical trial required by NMPA
- Deciphering the critical success factors to improve the possibility of success for CDx approval
10:00 am The Powerful Potential of Global, CDx-Driven Genomic Profiling
Synopsis
- Global trends towards IVD testing and CGP adoption
- Navigating the Asia and China markets as they drive localized CGP in the region
- A global approach to partnering, from CDx development to commercialisation
10:30 am Speed Networking & Morning Break
Synopsis
As the precision healthcare community meet in Singapore for the first time, this valuable session will ensure that you can connect with your peers to make new and lasting connections. All attendees will have the opportunity to meet and network with their industry peers.
Leveraging Partnerships & Collaborations to Streamline Reimbursement Routes for Affordable & Accessible Precision Therapies
11:30 am Development of a Public-Private Partnership to Expand Access to Precision Medicine for Advanced Oncology Patients
Synopsis
- How to create value for multiple stakeholders in a Public-Private partnership
- What additional access pathways can be created for patients in a precision medicine program?
- What is the impact on patient outcomes through broader access to precision medicine?
12:00 pm Navigating Global CDx Regulations & Emerging Technologies to Accelerate the Development of Clinical Trials
Synopsis
- Global Regulatory Landscape: Navigating CDx Approvals and Human Genetic Guidelines across China and the United States
- Liquid Biopsy Technologies: A Universal Catalyst for Advancing Drug Development within the Precision Medicine Paradigm
- Transforming the Global Pharma Arena with Cutting-Edge Precision Diagnostic Tools
With Guardant Health
12:30 pm Panel Discussion: Overcoming Barriers to Market Access with Strategic Partnership Selection to Expedite Global Development & Commercialization
Synopsis
- How to create an alignment between policy makers, pharma companies, and diagnostic providers to form strategic alliances empowered to tackle regional and global regulation and reimbursement differences to ensure patients equal access to testing and precision therapies
- How can key stakeholders strategically work together to bridge the gap between assays registered in the US and local solutions to overcome the need for increased samples and additional validation to avoid delays?
- Strategies to achieve strategic partnerships earlier to avoid clinical trial delays
- How to identify the best labs to perform testing
- What are optimal partnership designs, and what should be taken into consideration when selecting a partner?
1:00 pm Lunch Break
1:45 pm Dedicated Networking Time
Showcasing the Latest Innovations in Liquid Biopsy Testing for Earlier & More Accurate Patient Diagnosis & Effective Response Monitoring
2:15 pm Planning for Success when Developing & Validating Assays for Global Clinical Trials
Synopsis
- Key considerations for the development & analytical validation of assays for clinical stratification
- Regulatory compliance of Clinical Trial Assays across global jurisdictions (EU, US & China)
- Quality control & surveillance of assay performance
- Clinical trial monitoring across multiple clinical testing labs including APAC
2:25 pm A Case Study on Drug & CDx Co-Development for Cutaneous T-cell Lymphoma
Synopsis
- Developing drug and CDx for CTCL in the US and Japan
- After conversations with the FDA and PMDA, it was agreed that CDx was not required therefore the drug was submitted for approval without CD
- Sharing key discussions with the regulatory authorities in agreement and lessons learned to inform future pipelines
2:55 pm Panel Discussion: Streamlining CDx Development for Improved Precision Therapies
Synopsis
- Key considerations for genomic testing in clinical trials in APAC while targeting FDA submissions
- Strategies to use China clinical trial data in global CDx submissions
- The potential impacts the Biosecure act could have in choosing your CDx or testing partner in China
- Improving awareness of Liquid Biopsy in APAC. How can we work together for better options for patients
3:25 pm Global Reach, Rapid Results: Accessible Companion Diagnostic Solutions
Synopsis
- A decade of NGS CDx experience and results in advancing precision medicine
- Decentralized in-country CDx solutions with easy patient access to support therapy launches
- Accelerating time to treatment with NGS biomarker results available in as little as 24 hours from tissue and liquid biopsies
3:55 pm Afternoon Break & Networking
Successfully Develop Best Practices for CDx Co-Development & Clinical Use for Approved Tests in APAC
4:15 pm Liquid Biopsy Grows in Value in Oncology Clinical Application
Synopsis
- What are the benefits of liquid biopsies over tissue biopsies to accurately diagnose patients and ensure they receive the best treatments?
- Leveraging MRD assessment to provide comprehensive insights for clinical trials for sensitive and accurate treatment options
- Utilising liquid biopsy testing for early cancer detection and genetic profiling
- Beyond blood biomarkers: Utilizing fluid biomarkers from urine to bolster genetic profiling and early diagnosis
4:45 pm High-Dimensional ctDNA Analysis for Improving Sensitivity & Specificity of Liquid Biopsy Assays
Synopsis
- Circulating tumor signals are high-dimensional by nature. Analysing high-dimensional ctDNA will enhance the sensitivity and specificity of novel ctDNA profiling solutions to improve accuracy of disease diagnosis and monitoring
- Enabling cost-effective tumor-naive solutions for dynamic monitoring of cancer patients
- Optimising liquid biopsy testing for early cancer detection
5:15 pm Chair’s Closing Remarks & End of Conference Day One
Evening Networking Drinks Reception
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere and continue forging new and beneficial relationships.