CONFERENCE DAY ONE
8:00 am Check-In & Light Breakfast
8:50 am Chair’s Opening Remarks
Successfully Navigating the Shifts in Companion Diagnostics Regulation to Maximize Stakeholders Influence & Patient Access
9:00 am Evaluating the Impact of Global Regulatory Bottlenecks on Patient Access to Companion Diagnostics
Synopsis
- How has the IVDR framework influenced the global regulatory landscape?
- Exploring strategies for diagnostics companies to manage and thrive amidst diverse regulatory requirements across different regions
- Overcoming critical difficulties with regulatory protocols to streamline patient access to safer, more effacacious drugs
9:20 am Placeholder for Quest Diagnostics
9:50 am
Panel Discussion: Shaping the Future of Laboratory Developed Tests During Significant Regulatory Shifts
Moderated by Veranex
Synopsis
- How will the reclassification of high-risk LDT’s accelerate innovation and accessibility in the development of clinical biomarkers and companion diagnostics?
- Exploring the impact of the new regulatory pathway conditions on the safety and efficacy of LDT’s
- How will different healthcare sectors respond to shifting regulations?
- How will the new LDT rule impact drug developers & IVD manufacturers?
10:20 am Exploring Opportunities to Advance Companion Diagnostic Co-Development in an Evolving Global Regulatory Environment
Synopsis
- Brief overview of current regulatory landscape for companion diagnostics
- Regulatory concepts and considerations that should be considered for biomarker testing in global therapeutic clinical trials
- Potential strategies for addressing upcoming regulatory challenges in companion diagnostic co-development
10:50 am Morning Networking Break
Leveraging the Latest Innovations in Precision Oncology & Companion Diagnostics to Deliver Effective & Targeted Therapies to Patients Faster
11:20 am Harnessing ctDNA to Unveil Early Signs of Drug Response in Cancer Drug Development
Synopsis
- Exploring the developments required for ctDNA to replace traditional tumor biopsies for monitoring treatment response and drug resistance in preclinical trials
- How can ctDNA be leveraged to identify promising drug candidates early in translational development, informing go/no-go decisions for new therapies?
- Considering the potential for ctDNA-guided patient stratification in translational studies, what are the ethical considerations and regulatory hurdles that need to be addressed?
11:40 am Confidence in Navigating Challenges to Biomarker Development & CDx Milestones
Synopsis
- How established, approved testing platforms can expand your biomarker population and accelerate timelines to CDx approval
- Learn how to validate innovative new biomarkers, such as HRDsig, MTAP loss, and detection of clonal hematopoiesis (CH) for inclusion in your clinical trials
- Review emerging CDx opportunities RNA, heme malignancies, and real-world data
12:10 pm Unlocking Unprecedented Insights with Urinal Biomarker Discovery for Revolutionary Patient Treatment
Synopsis
- Urine-based genomic analysis has the potential to become a standard liquid biopsy approach in early bladder cancer
- Urine enables convenient and reliable, non-invasive patient screening, addressing certain challenges of tissue and plasma-based testing
- The highly sensitive method detects a broad spectrum of genomic alterations, enhancing its clinical utility beyond treatment selection
12:30 pm Placeholder for Guardant
1:00 pm Lunch & Networking Break
The Future of Artificial Intelligence in Precision Medicine: Advancing Breakthroughs for Reliable Clinical Development & Companion Diagnostics
2:00 pm Unleashing the Power of Digital Pathology & AI to Accelerate Drug Development Across All Therapeutic Areas
Synopsis
- How can biopharma leverage AI and digital pathology to drive improvements along the continuum of drug R&D (target selection, MoA, PD, Endpoint analysis, Combination Strategies, Selection and Stratification)?
- What role do foundation models play in accelerating AI models development and expanding diagnostic capabilities?
- Highlighting the potential of AI and digital pathology in non-oncology areas
2:20 pm Placeholder for Roche
2:50 pm Harnessing Meta-Analysis & Multi-Modality Data to Build Robust CDx Development Beyond Disease Indication
Synopsis
- Illustrating the importance of metanalysis in identifying reliable biomarkers
- Demonstrating the integration of various data types, including genomic and transcriptomic data, to develop robust CDx models
- Exploring the capacity of AI/ML to move beyond disease indication
3:10 pm Placeholder for Tempus
3:40 pm Afternoon Networking Break
Expanding the Boundaries of Precision Medicine: Accelerating Companion Diagnostic Development in Non-Oncology Indications for Unmet Clinical Need
4:10 pm Going Global for Patient Care: The Importance of Incorporating a Decentralized CDx Strategy to Precision Medicine Programs for Global Market Access
Synopsis
- Technical and platform considerations when developing biomarker strategies
- Regulatory strategies in an evolving global landscape; an IVDR success story
- Commercial considerations for emerging market access
4:40 pm Bridging the Gap for Clinical Biomarkers Between Oncology & Non-Oncology Therapeutic Areas to Expedite Personalized Treatment
Synopsis
- What insights can be leveraged from the extensive experience with precision approaches in oncology as biopharmaceutical companies explore new therapeutic domains?
- How have recent advancements in genomic sequencing and bioinformatics contributed to new discoveries in diverse therapeutic areas?
- Unlocking the limitless potential of CDx in new areas: an evaluation of the promise of precision medicine
5:00 pm Advancing Precision Medicine Globally: From Gene Therapy to HLA CDx Commercialization
Synopsis
- Lessons from the first cell based CDx FDA approval in gene therapy
- Understand the dynamics of 3-way and 2-way partnerships models between pharma, IVD companies, and Labcorp with real world examples
- Strategic Considerations for Global Commercialization: from early development to trials, regulatory oversight, and post-commercialization support
5:30 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
5:50 pm Chair’s Closing Remarks & End of Conference Day One
6:00 pm Evening Thought Leadership Engager Hosted by Agilent
Synopsis
Register your interest to attend this learning and networking session with experts from Agilent and biopharma. Further details to be revealed!