DAY TWO | THURSDAY, NOVEMBER 14
2日目
第二天
Hari Kedua
8:30 am Light Breakfast
8:55 am Chair’s Opening Remarks
Establishing Gold Standard Regulatory Routes for Drug-Diagnostic Development to Overcome Inconsistencies in a Diverse Market
9:00 am CDx Regulation Navigation & Considerations in APAC from a Pharmaceutical Perspective
Synopsis
- Navigating CDx regulation in APAC with focus on China, Japan, South Korea and Australia, with rapidly evolving regulatory guidelines
- Challenges to develop CDx in APAC and implications to therapeutic products
- Insights into strategies
9:30 am Panel Discussion: Streamlining Regulatory Approaches to Optimize CDx Development, Reduce Complexities & Allow Patients Timely Access to Drug-Diagnostics Clinical Trials
Synopsis
- Given the fragmentation of regulatory requirements, will it be more beneficial to stakeholders to harmonise across APAC or will this create friction?
- Is there a future for there to be one solution that covers all regions to increase harmonisation and enable broader knowledge sharing between countries?
- Understanding different registration requirements across the region to increase commercialisation
- Aligning clinical practice with regulatory requirements: balancing the requirements of needing large panels in clinical trials to save the limited amount of tissue to get the maximum amount of information to make informed decisions vs the ease of getting a small focused panel approved
10:30 am Morning Networking Break
Gain Clarity on Emerging Technologies to Optimize Clinical Trials for Improved Personalized Healthcare
11:30 am Future of Liquid Biopsy from PARADIGM Study to Inform Patient Selection
Synopsis
- Overview of Liquid biopsy (ctDNA testing)
- Utility case of liquid biopsy based on PARADIGM study to describe validated and adequately sensitive plasma ctDNA assay may inform appropriate selection of patients for frontline metastatic colorectal cancer patients
- Limitation and future perspective of liquid biopsy in clinical practice
12:00 pm Addressing the Unmet Need for Early Diagnosis in HCC: The ELEGANCE Study
Synopsis
- Introduction of the ELEGANCE study, a whole-of-nation longitudinal, prospective study of 2000 at-risk patients of HCC from 6 local hospitals and 8 SingHealth polyclinics
- Uncovering miRNA, microbiome and imaging biomarkers in the evolution of chronic liver disease and liver cancer development with industrial support from MIRXES, Perspectum and AMILI
- Development of a more efficacious and convenient modality of surveillance of high-risk patients to diagnose HCC at an early stage
12:30 pm Facilitating Patient Selection for Solid Tumour Therapy with Artificial Intelligence-Based Digital Pathology
Synopsis
- Understanding how to fulfil compliance with regarding to patient management assay (for e.g., patient selection, patient monitoring for treatment decisions) and subsequent companion diagnostics (CDx) under different regional guidance
- Learn how an AI-powered digital pathology platform can provide a standardised, scalable, and reproducible method of characterising antigen positivity to support further patient selection in clinical study
- A Machine Learning-based model is poised to significantly enhance the success rate of pre-screening for clinical trials, leading to substantial savings in resources by minimising the need for unnecessary patient visits. This breakthrough has the potential to not only streamline the trial process but also improve patient experiences and outcomes
1:00 pm Lunch Break
1:45 pm Dedicated Networking Time
Utilising Biomarkers & Minimal Residual Disease as Surrogate Endpoints to Develop New Precision Oncology Therapies
2:15 pm Harnessing MRD for Optimal Patient Care
Synopsis
- MRD applications in clinical settings as a monitoring biomarker and surrogate endpoint
- How MRD has assisted clinical decision-making and helped with the success of clinical development in oncology
- Future outlook for how MRD can further advance cancer therapies
2:45 pm Harnessing Drug Target / Biomarker Identification to Accelerate Precision Therapies into the Clinic
Synopsis
- Genetic and metabolic changes in cancer cells present opportunities for targeted drug therapies that would preferentially block tumour cell growth with reduced side effects
- AI-powered systems that utilize genomics, transcriptomics, and clinical data can predict synthetic lethal gene pairs that can be developed as new drug targets and associated biomarkers
- This effort has led to identification of numerous genetic alterations in cancer cells that are being used as biomarkers for a development of new precision oncology therapies
3:15 pm Afternoon Break & Networking
Capitalising on Biomarker Innovation to More Accurately Stratify Patients for Improved Outcomes
3:45 pm Translating Biomarker Studies from Pre-Clinical to Clinical Development
Synopsis
- Identifying clinically meaningful biomarkers that impact the design of studies at different development stages
- Interpreting biomarker study results – key considerations
- Patient selection – Are there options other than CDx development?
4:15 pm Uncovering Biomarkers to Define Patient Populations
Synopsis
- Significance of biomarkers and CDx that enable precise patient selection and improves therapeutic outcomes
- Addressing and overcoming challenges and possible solutions in their development