DAY TWO
Thursday 10th April, 2025
7:30 am Morning Networking Coffee
8:20 am Chair’s Opening Remarks
Harmonising IVDR Compliance Across European Notified & Competent Bodies to Enhance Regulatory Clarity & Speed Towards Approval
8:30 am Panel Discussion: Strengthening the Interface between Competent & Notified Bodies to Define a Unified Path Towards IVDR Compliance for Streamlined Approvals
Synopsis
- What are the current and future expectations for CDx conformity? How closely are the new UK regulations expected to mirror or diverge from IVDR?
- How are stakeholders harmonizing the interpretation of performance studies, from a technical and regulatory perspective?
- How is the changing global landscape of laboratory developed tests expected to impact biomarker driven trials?
9:00 am Transforming Patient Access in Cancer Care: A New Collaborative Era
Synopsis
- Evolving Precision Medicine: Explore how patients are losing opportunities for targeted therapy at each step of the Precision Medicine pathway and the need for change
- Partnership and Collaboration: Understand the combined efforts of Roche and J&J to enhance patient access through early screening, diagnostic development, value propositions, and speeding up the adoption of innovative healthcare technologies
- Integration of Diagnostic & Treatment Pathways: Discuss comprehensive patient support programs, enhanced data sharing, ethical considerations, and educational resources to streamline patient access and improve outcomes
- Case Study on Lung Cancer: Address the challenges in the lung cancer patient pathway, including unequal diagnostic access, late-stage diagnoses, ineffective reimbursement strategies, and the commitment of Roche and J&J to bridge these gaps through multidisciplinary care and innovative solutions
9:30 am Navigating the Challenges of Changing Diagnostic Regulations in Clinical Trials
Synopsis
- Overview of the evolving diagnostic regulations and their impact on patient enrolment and recruitment
- Awareness of the complexities of diagnostic testing outside of oncology
- Importance of global alignment in the diagnostic regulations for clinical trial execution
- Strategies for the industry to align on intent, impact, and change for effective clinical trial execution
- Ensuring the availability of quality diagnostic tests for patients amidst regulatory changes
9:50 am Adapting Clinical Development to an MRD-Integrated Treatment Landscape
Synopsis
- Signatera™ MRD testing is transforming cancer care across tumour types in the US, with growing global adoption in clinical trials. Its impact on patient management is an increasingly important consideration for clinical development strategy
- Analyses from Phase 3 studies demonstrated that MRD-based patient selection can reveal treatment benefits not observed in unselected populations. Incorporating MRD may enable more efficient trial designs by enriching for high-risk patients, accelerating event-driven readouts, expanding development into earlier settings, and informing early go/no-go decisions
- Natera supports the integration of MRD into clinical development and offers additional multi-omic and real-world data (RWD) solutions to inform strategy across the drug development lifecycle
10:20 am
Morning Break & Networking
Dedicated One-on-One Partnering™
TRACK A: Biomarker Discovery & Clinical Development
Chair:
Strengthening Disease Management Through Biomarkers & Digital Innovations for Improved Autoimmune & Rare Disease Treatment Regimes
11:20 am Use of -Omics Data for Drug Development in Immune & Inflammatory Diseases
Synopsis
- Indication selection using pharmacological and transcriptomics data from preclinical disease model
- Transcriptomics and proteomics data from clinical studies provide insights on mechanism of action of new drugn candidates
- Correlation between transcriptomics data and clinical outcome
11:40 am Tumour-Informed & Tumour-Agnostic MRD Solutions for Clinical Drug Development
Synopsis
- Personalised MRD detection informed by baseline tissue, blood, or urine samples
- Tumour-agnostic MRD detection independent of baseline sample availability
- Integrated into clinical trials with high-impact publications in NEJM and Nature Medicine
11:50 am Next-Gen MRD: Increasing Access to Ultrasensitive ctDNA Assessment for Biomarker Discovery, Development, & CDx Programs
Synopsis
- The Pathlight MRD test is an ultrasensitive, cost-effective approach to MRD detection and quantification to <1 PPM using WGS proprietary dPCR methods to track structural variants
- Structural Variants (SVs) are highly prevalent across indications and are an ideal pan-cancer biomarker for determining MRD status
- Clinical studies in breast and ovarian cancers demonstrate improved detection of ctDNA at baseline, during neoadjuvant treatment, post-surgery, and during follow-up, with long lead times to clinical relapse
12:20 pm Addressing the Diagnostic Gap: The Need for Customised IVD Solutions for Rare Diseases
Synopsis
- Navigating the IVD landscape for rare diseases: Exploring strategies for addressing the challenges faced when IVDs are unavailable
- Market considerations: Discussing the implications of CE marking termination on IVD development.
- Assay validation considerations: Examining the complexities of cross-validation of assays across regions and the difference between validating biomarker assays used for exploratory versus diagnostic purposes
TRACK B: CDx Development & Commercialisation
Chair:
Optimising Regulatory & Commercialisation Priorities within the Clinic to Expedite Approvals
11:20 am Panel Discussion: Navigating IVDR: Biomarker Test Compliance in Clinical Trials
Synopsis
- How patient recruitment can be impacted by IVDR
- What strategies are pharma/labs using to overcome IVDR challenges?
- How biomarker testing will look (centralised vs decentralised) in the future
11:50 am Planning for Success When Developing & Validating Assays for Global Clinical Trials
Synopsis
- Key considerations for the development and analytical validation of assays for clinical stratification
- Regulatory compliance of clinical trial assays across global jurisdictions (EU, US and China)
- Quality control, surveillance of assay performance and clinical trial monitoring
12:20 pm Decentralised Testing to Improve Patient Outcomes
Synopsis
- Many cancer patients still lack timely access to molecular results needed to guide targeted therapy decisions
- Local rapid testing is a cost and sample effective triage tool to help physicians make fast treatment decisions
- Fast, decentralised testing can accelerate clinical trial enrollment by quick identification of eligible patients
12:50 pm
Lunch & Break & Networking
Dedicated One-on-One Partnering™
Integrating Blood-Based & Neuroinflammation Biomarkers for Better Outcomes in Neurological Diseases to Improve Quality of Life
1:50 pm Roundtable Discussion: Identifying & Developing Biomarkers for Patients with Neurological Disorders to Deliver Treatment Sooner & Improve Long-Term Patient Outcomes
Synopsis
- Why do neurological biomarkers face higher rates of failure in clinical validation compared to oncology, and what lessons from successful oncology biomarkers can be adapted to address these bottlenecks?
- How to ensure the scalability and reproducibility of biomarker assays for neurological conditions in the transition from research settings to routine clinical practice
- How to address the variability in biomarker expression across different stages of neurological diseases and incorporate dynamic biomarkers for longitudinal patient monitoring
2:20 pm Bringing Precision to Psychiatry: Pioneering Genetic CDx-Use in Major Depressive Disorder
Synopsis
- The Unmet Need in Psychiatry: Psychiatry has lagged behind oncology and immunology in adopting CDx, despite the clear potential to address the biological heterogeneity of disorders like MDD
- Our Innovative CDx Platform anticify™: Using statistical genetics, we’ve developed tools to stratify MDD patients into biologically distinct subtypes, enabling personalised treatment strategies
- Clinical Validation of CDx in Psychiatry: Post-hoc analysis shows our CDx candidate accurately predict responses to CRHR1 antagonists, breathing new life into previously shelved treatments
- IVDR’s impact on a small EU biotech company codeveloping Rx + CDx: Change of study design to dodge IVDR requirements (pivoting to a prospective-retrospective approach); Choosing UK over EU as study location
- The Future Vision: With ongoing clinical programs for Cortibon and Nelivabon, our work sets the stage for applying CDx across psychiatry
Bolstering Access & Synchronising Commercialisation for Precision Medicines Across Oncology & Non-Oncology
1:50 pm Leveraging AI & Digital Pathology to Advance Biomarker Diagnostics in Clinical Trials & Routine Practice
Synopsis
- How AI-driven diagnostics can deliver transformative value to patients and pharma by improving patient identification in clinical routine and clinical trials
- Case study: Accelerating gBRCA genetic testing for high-risk patients with BRACAnalysis – Key learnings and progress
- Strategies to increase digital pathology adoption
2:20 pm Genomics & Diagnostic Data for Disease Population Sequencing Using Secondary Health Data
Synopsis
- Purpose-built repositories for real-world data use
- Linking between registries for granular analysis of health data
- Use cases of integration of genomic and diagnostics into RWE study designs
2:40 pm
Afternoon Networking Break
Dedicated One-on-One Partnering™
From Tumour-Specific Models to AI-Enabled Tools: Enabling the Future of Precision Medicine Through Novel Technologies
3:10 pm EpiSwitch® 3D Genomic Liquid Biopsy: Diagnostic, Prognostic & Predictive Clinical Biomarkers
Synopsis
- EpiSwitch PSE: accurate detection of prostate cancer
- EpiSwitch CiRT: prediction of response to immune checkpoint inhibitors
- EpiSwitch Data Knowledge
3:50 pm Challenges in AI Application Development for Clinical Use to Progress Precision Medicines
Synopsis
- 80% of development cycle time is spent on preparing the data algorithm ready
- How to address the lack of high-quality, annotated clinical datasets for training AI models in precision medicine while ensuring patient privacy and data security
- What is the best approach for clinical validation and integrating AI-based tools into existing clinical workflows?