CONFERENCE DAY THREE
7:00 am Light Breakfast
7:55 am Chair’s Opening Remarks
Optimizing Strategic Reimbursement Routes & Commercialization Strategies to Ensure Affordable & Accessible Companion Diagnostics Globally
8:00 am Precision Medicine Access Oncology & Beyond: A Bifocal Lens
Synopsis
- Assess the state of precision medicine access today
- Share a vision of precision medicine access in the future
8:20 am From Trial to Clinic: Accelerating Commercialization Through Biomarker Testing Adoption
Synopsis
- Solutions to support drug development from discovery to commercialization
- CDx and regulatory experience for NeoGenomics partners
- Leveraging NeoGenomics testing network to accelerate commercialization through sponsored testing program
8:50 am Fireside Chat: Integration of Responsibilities & Cross-Functional Cooperation for Precision Medicine & Companion Diagnostics in Pharma
Synopsis
- Recognizing Accountabilities: Defining and acknowledging functional responsibilities during CDx test development, approval, and launch
- Coordinating Activities: Streamlining processes and fostering cross-functional cooperation among teams involved in CDx test and therapeutic development
- Aligning with Therapeutic Development: Collaborating early on between diagnostic and therapeutic teams to optimize patient selection and treatment efficacy
9:10 am Precision Medicine at Scale: Innovation, Efficiency & Global Reach
Synopsis
- Setting high standards for genomic profiling and therapy selection
- Leveraging WGS to futurize clinical applications
- Enabling precision medicine in more places, for more patients
9:40 am Strategies to Implement Robust Validation of Clinical Biomarkers to Ensure Reimbursement of CDx & Accuracy of Clinical Studies
Synopsis
- Maximizing the analytic accuracy & precision for biomarkers in diverse patient populations to support reimbursement claims
- Establishing best practices for demonstrating the biological and clinical relevance of a biomarker in disease diagnosis and prognosis, & treatment paradigms to facilitate payer acceptance
- Defining the difference between the presence of data and establishing clinical utility to meet reimbursement criteria parameters
10:00 am Morning Networking Break – A Taste of Asia & Headshot Opportunity
Synopsis
- Come along to our morning break to celebrate the release of World CDx & LBx APAC, complete with Singaporean-inspired snacks! Or, come along to our Espresso Hour to keep your energy high on the final day.
- Our photographer will also be on hand to take your new headshot. Whether you need one for your next speaking opportunity or just for a refresh of your LinkedIn profile – this is available on a 'first come first serve' basis so don't miss out!
TRACK A: Biomarker Discovery & Translational Development
Harnessing Multi-Omics & Multiplexing to Improve Biomarker Identification for Revolutionized Treatment Potential
10:45 am Bridging Bioanalysis & Biomarker Analysis in Drug Development & Clinical Diagnosis: Regulatory Considerations & Technology Advancement
Synopsis
- The similarities and differences in regulatory requirements (1) for bioanalysis and biomarker analysis and (2) in drug development and clinical diagnosis
- The challenges and impact to biomarker testing resulted from the different concepts and practices of GCLP/BAV vs. CLIA-ISO/CLSI guidance for clinical biomarker analysis
- Advancement of immunoassay and chromatography-mass spectrometry assays for clinical biomarker analysis
11:05 am How a Simple Blood Draw & Multi-Omic Testing Can Optimize Cancer Treatment Strategies
Synopsis
- ddPCR™ testing drives progress in early cancer diagnosis, personalized therapy, and molecular residual disease detection
- Proteomic testing can identify a patient’s immune response to cancer; identifying those patients with an aggressive disease state that may benefit from enhanced surveillance, immunotherapy combinations or chemotherapy
11:35 am Optimizing the Novel Multiplexing Biomarker Paradigm to Support Clinical Studies
Synopsis
- Introduction of special based novel multiplexing paradigm to evaluate tumor and tumor microenvironment (apply both RNA and protein expression on one tissue slide if data available)
- Optimization of the testing panel including the multiplexing assay procedure and result assessment
- Selection of the multiplex paradigm to best support clinical studies
11:55 am Leveraging Computation Pathology for Target Identification & Biomarker R&D
Synopsis
- Novel multi-modal machine learning approaches for target ID and biomarker R&D
- The role of foundation models today vs. tomorrow
- Considerations for translating AI-powered biomarkers into clinical testing
12:25 pm Lunch & Networking Break
Unlocking the Potential of Digital Pathology & AI/ML to Revolutionize Accuracy in Biomarker Identification
1:25 pm Panel Discussion: Considering Digital Pathology & AI/ML from a Drug Development Pipeline Perspective
Synopsis
- What are the greatest barriers to routine digital pathology clinical use? What approaches can we take to overcome them?
- Translational studies – leveraging digital pathology to describe populations
- Leveraging digital pathology to define clinical endpoints
1:45 pm Digital Pathology & AI – from Drug Development to Clinical In Vitro Diagnostics
Synopsis
- How digital pathology, omics and access to quality data can pave the way for powerful and robust AI models and diagnostics
- How machine learning methodologies and approaches that combine the best of human and artificial intelligence are the key to closing the translational gap between complex biology and precision medicine – a look at the Owkin AI diagnostic portfolio
- How by partnering with others in the digital pathology ecosystem we can make our AI models more broadly accessible and support drug development in biomarker and diagnostic hotspots
2:15 pm Panel Discussion: AI and Digital Pathology – Enabling Next-Gen Treatments & Diagnostics
Synopsis
- What impact does artificial intelligence (AI) and digital pathology (DP) have on biomarker strategy and drug development?
- How novel treatment modalities are driving innovative assays and AI-powered scoring frameworks
- How AI-powered biomarkers can be deployed for trial enrollment and patient selection
2:40 pm H&E-Based Biomarker Profiling In Precision Medicine: Opportunities & Challenges
Synopsis
- Exploring opportunities, challenges and practical takeaways of H&E base biomarker
- Profiling across a variety of different applications (research, drug development, the clinic)
3:10 pm Afternoon Networking Break
TRACK B: Clinical Biomarker Development
Defining Clinical Endpoints with Robust Biomarkers with Regulatory Considerations for Improved Patient Survival in Therapeutic Trials
10:45 am Pioneering Bespoke Treatment Plans by Harnessing Prognostic Biomarkers to Forecast Disease Progression for Revolutionary Treatment for Patients in Need
Synopsis
- Delving into the transformative potential of using longitudinal data to develop prognostic biomarkers that forecast disease progression with unprecedented accuracy
- How can prognostic biomarkers be utilized to design personalized treatment plans that ensure patients receive the most effective therapies tailored specifically to their needs?
- Developing rigorous validation processes for prognostic biomarkers, ensuring they provide a solid foundation for robust, patient-specific treatment strategies
11:05 am Evaluating IVDR Compliance for EU Therapeutic Trials
Synopsis
- The European Union (EU) In Vitro Diagnostic Regulation (IVDR)
- IVDR and therapeutic trials in the EU
- Central lab solutions for IVDR compliance
11:35 am Panel Discussion: Novel Biomarkers to Stratify Populations for Pinpoint Accuracy in Clinical Trials
Synopsis
- Revolutionizing stratification with novel biomarkers
- How will biomarkers for patient stratification differ as biopharma approach non-oncology territories?
- Deciphering the necessary steps to accurately validate biomarkers
- Stratifying patients based on clinical benefit and survival consistent with outcomes observed in the clinic
- Facilitating decision making from preclinical candidate nomination to clinical trial design to sequencing and combination of interventions
12:00 pm Unravelling the Implications of NGS-based Solutions for Multiple Regional Clinical Trials in Oncology
Synopsis
- The value of NGS-Based solutions in clinical study on precision medicine has significant advantages on ctDNA biomarker detection and development
- In cases of using liquid biopsy and MRD solutions, the value of ctDNA detection has been widely confirmed for monitoring and evaluation of treatment plan, and providing prognostic information
- In this discussion, we would like to share our clinical level data on ctDNA detection, as well as our insight and opinions on the developing of liquid biopsy technology
12:30 pm Lunch & Networking Break
Revolutionizing Precision Healthcare with Prognostic Biomarkers to More Accurately Stratify Patients in Oncology & Beyond
1:25 pm Clinical Imaging Biomarkers in Drug Development
Synopsis
- Role of in vivo imaging biomarkers in clinical trials
- Leveraging imaging biomarkers for disease progression, patient selection and efficacy assessment
- Operational workflow and logistics of centralized imaging assessments
1:45 pm AI & Predictive Biomarkers from Histopathology
Synopsis
- Spatial distribution of TIL can predict efficacy of IO therapeutics and this can extend to other cell types
- Magnitude and subcellular localization of stains in IHC images are also linked to efficacy of therapeutics targeting the cell surface
- AI assessment of the above histopathology is currently deployed for clinical trials and is moving towards clinical use
2:15 pm Enhancing Patient Selection in Oncology: Clinical Validation of a Multi-Gene Expression Diagnostic
Synopsis
- Introduction to Allarity’s Drug Response Predictor (DRP)- a multi-gene expression diagnostic for selecting patients likely to benefit from cancer therapies
- Key findings from the phase II ddvanced, recurrent ovarian cancer study showcasing the impact of Allarity’s novel PARP/ Tankyrase inhibitor, Stenoparib
- A discussion of Stenoparib’s potential in advanced ovarian cancer using the Stenoparib DRP to select patients for therapeutic benefit
2:35 pm Integrated Immune Profiling of Peripheral Blood & Tumor Tissue for Rational Stratification of Patients in Immunotherapy Trials
Synopsis
- Identification of Immunological Signatures: Overlapping immunological signatures with putative treatment mechanisms of action (MOA) can significantly increase the probability of successful outcomes in immunotherapy trials
- Immune System Profiling: Profiling the immune system can identify a patient’s immune status, which may reveal resistance to various immune-based treatments. This information is crucial for tailoring personalized immunotherapy strategies
- Evaluation of Transcriptional Profiles: Assessing the transcriptional profiles of peripheral immune cells and circulating cell-free RNA can uncover dynamic prognostic biomarkers. These biomarkers are essential for predicting drug response and guiding treatment decisions in real-time
3:05 pm Afternoon Networking Break
TRACK C: CDx Development & Commercialization
Leveraging Efficient Partnerships to Optimize the Commercial Success of Companion Diagnostics Globally
10:45 am Fireside Chat: Navigating Regulatory Pathways & Commercial Strategies for Companion Diagnostics
Synopsis
- The evolving regulatory landscape for companion diagnostics and liquid biopsies, including key approval pathways and compliance requirements
- CDx Development to Adoption
11:05 am The role of Patient Centricity in CDx Development
Synopsis
- CDx development challenges for Pharma
- Role of CDx in the delivery of effective and targeted therapies to patients faster
- Biocartis strategies for CDx Co-development
11:35 am Panel Discussion: Establishing Partnerships to Develop, Commercialize, & Decentralize Companion Diagnostics for Unprecedented Global Impact
Synopsis
- When should partnerships be optimized to leverage approval of and access to biomarker information?
- Maximizing market access through strategic partnerships with key stakeholders
- Understanding the value of consistent decentralized testing in the management of clinical trials
12:00 pm NGS Cutting-Edge Products Application & Companion Diagnostic in MRCTs
Synopsis
- How seq-MRD is revolutionizing blood cancer treatment
- How solid tumor MRD is transforming clinical oncology practices
- How to navigate the path of companion diagnostic China-US dual submissions in MRCT research
12:30 pm Lunch & Networking Break
Developing Robust CDx Models with Novel Technologies to Expedite Drug Development for Patients in Need
1:25 pm Use of Structured Dialogs to Navigate the CDx Consultation and Clinical Aspects of IVDR
Synopsis
- MDCG (2022-14) encourages IVD Manufacturers and Notified Bodies to have ‘structured dialogs’ between the partners to enhance the efficiency and predictability of the IVDR certification process.
- These dialogs, which can occur prior to and during the conformity assessment can be highly beneficial in:
- Identifying general clinical requirements of the IVDR
- Planning and ensuring clinical evidence is prepared adequately for the EMA CDx Consultation process
- Can help Manufacturers gain a better understanding of how they need to proceed for bringing a device (e.g., LDT) to market under the Regulation.
1:45 pm Bringing Multiplexed Immunofluorescence & Spatial Biology to The Clinic to Improve Patient Care
Synopsis
- Multiplex Immunofluorescence (mIF) and spatial biology biomarkers have demonstrated potential clinical utility in a multitude of translational studies
- Akoya is building a framework to build clinical tests with these biomarkers on our proprietary mIF platform
- Utilizing this framework, we are currently developing impactful tests like the OncoSignature and Immunoprint to improve patient care
2:15 pm Roundtable Discussion: Expanding the Use of Companion Diagnostics Beyond Oncology
Synopsis
- How can companion diagnostics be utilized to improve patient selection and outcomes in non-oncology indications?
- What are the potential opportunities for using companion diagnostics to enhance response rates in non-oncology therapeutic areas, and how can we identify the most promising biomarkers?
- When developing companion diagnostics outside of Oncology, how do we balance the need for innovative approaches and the practical challenges of development, approval, and implementation?
3:05 pm Afternoon Networking Break
Forging Strategic Partnerships to Accelerate Biomarker Development & Unleash the Potential of Precision Medicine
3:40 pm Leveraging Effective Communication Strategies to Enhance Stakeholder Engagement in Clinical Biomarker Development
Synopsis
- Diligently choosing diagnostic partners early to set up for clinical and commercial CDx success
- Advising clinical program development and engaging various stakeholders to optimize biomarker development
- Developing efficient strategies to support effective trial enrollment and commercialization
4:00 pm Companion Diagnostics for Immune Oncology with Episwitch® & 3D Genomics
Synopsis
• PD-(L)1 Checkpoint Inhibitors – Relevant Predictive & Prognostic Assays
• Targeted qPCR versus multi-variate assays on Agilent arrays
• EpiSwitch Data Knowledge: Prognosis for prevention of immune-related adverse events (irAE's)
4:30 pm Bringing the First Precision Medicine to Treat CNS Diseases using Innovative Biomarker Discovery Platforms
Synopsis
- Investigating the challenges of identifying and validating pharmacogenomic biomarkers for CNS drugs, such as placebo effects, model gaps, and diagnostic heterogeneity
- Leveraging a novel biomarker, DGM4, discovered through genome-wide screening of blood samples from a prior failed clinical study with liafensine, to predict treatment efficacy in TRD patients
- Launching a global phase 2b study utilizing the DGM4 biomarker to enrich potential responders to liafensine, achieving significant success and paving the way for precision medicine in CNS disorders