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 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?
- Bringing your drugs to markets outside of APAC: Identifying the right market strategy and managing local and global stakeholders to ensure success
- Strategies to achieve strategic partnerships earlier to avoid clinical trial delays
- Working towards a consortia in APAC to allow sharing of data therefore expediting approvals
- How to identify the best labs to perform testing
- What are optimal partnership designs, and what considerations should you have for partners?
With Guardant Health
12:30 pm Session Details to be Revealed
Synopsis
Session hosted by Genetron
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 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
2:45 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
3:15 pm Afternoon Break & Networking
Successfully Develop Best Practices for CDx Co-Development & Clinical Use for Approved Tests in APAC
4:15 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
4:45 pm Optimising Clinical Biomarkers & CDx Development for Improved Precision Therapies
Synopsis
- Session details to be revealed