CONFERENCE DAY ONE
7:30 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 Managing Companion Diagnostics and Global Regulations within a Diverse Drug Development Portfolio
Synopsis
- Anticipating the needs of clinical programs as technologies are continuously evolving
- Balancing partnerships and vendors to enable growth and scalability
- Building global strategies to account for operational requirements, changing regulations and patient access
9:20 am Emerging Trends & Perspectives in Companion Diagnostics
Synopsis
• Evolution of Companion Diagnostics through key developmental milestones
• An analysis of the current CDx landscape
• Thoughts on future opportunities and challenges
9:50 am Panel Discussion: Harnessing the Benefits of Collaborative Partnerships to Pave the Way for Innovation during Significant Regulatory Shifts
Synopsis
- An Overview of the Final LDT Rule
- Exploring the impact of the new regulatory pathway conditions on the safety and efficacy of LDT’s
- Selecting the right partnership to expedite clinical trials during regulatory shifts
- Exploring how choosing the right partners can mitigate risks associated with regulatory shifts
- Clinical trial assay development versus commercial development dynamics
- Future considerations for partnerships with an ever-changing regulatory landscape
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 the Value of ctDNA 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 Advancing Precision Medicine in Early Bladder Cancer with Urine Assay Technology
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 Fireside Chat: Leveraging the Predictive Power of Liquid Biopsy for IO Treatment Response Monitoring
Synopsis
- Challenges with treatment response monitoring today
- Enhancing the predictive power of liquid biopsy with a methylation-based approach to treatment response monitoring
- Learn about Guardant / PICI’s new data, showcasing clinical evidence behind methylation-based tumor fraction for IO response monitoring
- Hear how response monitoring using liquid biopsy can accelerate drug development
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 Fireside Chat: Next Generation Digital Pathology Diagnostics… A Revolution in the Making
Synopsis
• Evolution of quantitative IHC including QCS
• Incorporating digital pathology including AI in the discovery phase
• Navigating the DP landscape
• Impact of digital pathology on patient care
2:50 pm Driving Computational Pathology in Oncology Drug Development
Synopsis
• Computational Pathology provides greater analytical precision and potentially greater clinical accuracy – enabling identification of best patient populations for clinical response to oncology therapies
• Quantitative Continuous Scoring (QCS) was developed to both quantify target expression in individual tumor's cells and to quantify spatial heterogeneity of expression
• Discussing how to leverage Computational Pathology approaches in oncology drug development
3:10 pm The Next Frontier in Diagnostics: From Regulatory Shifts to Novel Biomarkers
Synopsis
- Explore the latest in diagnostic development as we delve into evolving regulatory landscapes and pre-market pathways.
- Learn how novel biomarkers and AI-driven algorithms are shaping the future of Companion Diagnostics (CDx).
- Gain insights into innovative strategies to regulatory challenges and how industry leaders are advancing precision medicine through cutting-edge approaches.
3:40 pm Afternoon Networking Break
Expanding the Boundaries of Precision Medicine:
Accelerating Companion Diagnostic Development & Commercialization in Oncology & Beyond Indications for Patients with Unmet Clinical Need
Accelerating Companion Diagnostic Development & Commercialization in Oncology & Beyond Indications for Patients with 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 Catalyzing Global Breakthroughs with Strategic Partnerships & Patient-Centric Precision Medicine for a Healthier Future
Synopsis
- Underpinning the critical process of selecting the right partners across sectors to drive patient-centric innovations
- Overcoming barriers to market access with strategic partnership selection, ensuring that all patients have access to great medicine
- Fostering a culture of innovation and collaboration for continuous improvement to address emerging healthcare challenges and patient needs
5:50 pm Chair’s Closing Remarks & End of Conference Day One
6:00 pm - 8:45 pm | Challenges & Advances in CDx Development: A Case Study on the MAGE-A4 IHC IF9 pharmDx
6:00 pm Registration & Welcome
6:15 pm Guests to take seats
6:20 pm Opening Remarks
6:30 pm Starter Served
6:50 pm Panel Discussion: What challenges occurred during the co-development of the therapy with the companion diagnostic?
Synopsis
• Challenges to align timelines of clinical program and CDx program (fast transition from phase 1 study to registrations study, orphan drug designation with accelerated approval, etc.)
• Difficulty of sample procurement in the context of rare disease
• How does this launch impact the patients with synovial sarcoma?
• What are some of the considerations for commercializing a test for a rare disease?
7:30 pm Entrée Served
8:00 pm Dessert Served
8:30 pm Closing Remarks
8:45 pm End of Thought Leadership Engager with Agilent
