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 notified bodies harmonising their interpretation of performance studies, from a technical and regulatory perspective?
- What is the expected interplay between IVDR and the enforced European AI act? And what is the regulatory pathway expected for the registration of an AI-driven diagnostic or medical device?
- How are US LDT regulations expected to impact the industry, and in what ways do they align with or differ from the IVDR framework?
9:00 am Beyond Biomarkers: Transforming Patient Journeys in Precision Medicine
Synopsis
Presentation Details to be Announced
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 Design Trials Focused on Population with High Unmet Need to Accelerate Access to Novel Therapies with ctDNA MRD
Synopsis
- Circulating tumor DNA (ctDNA) continues to transform clinical management of early-stage cancers
- Every month, Natera identifies thousands of patients with cancer who are ctDNA+ and at higher risk of progression, for whom standard treatments may be insufficient
- Increasing uptake of ctDNA surveillance in early-stage cancers has highlighted an unmet need in managing patients with molecular-only relapse and reinforces the need for more treat-on-molecular-relapse clinical studies
10:20 am
Morning Break & Networking
Dedicated One-on-One Partnering
TRACK A: Biomarker Discovery & Clinical Development
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 and 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 Session Reserved for Saga Diagnostics
Synopsis
Presentation Details to be Announced
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 vs diagnostic purposes
TRACK B: CDx Development & Commercialisation
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 like (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 Session Reserved for Biocartis: Decentralised Testing to Improve Patient Outcomes
Synopsis
Presentation Details to be Announced
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
2:10 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 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
2:10 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
2:30 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
3:00 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?
3:20 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 From Precision Medicine to Personalised Medicine in Oncology: Predicting Effective Treatments Based on Complex Tumour Gene Signatures Using a Novel In Vivo Screening Technology
Synopsis
- Genetic complexity: Tumours are driven by a network of oncogenic genetic alterations and tumour signatures are incredibly diverse across patient population
- Drosophila avatars: a rapid and cost-effective generation of in vivo models with genetically engineered complex tumour signatures for large-scale drug screening
- Utilising whole-exome sequencing and in vivo drug screening to uncover actionable insights into tumour-specific vulnerabilities: from standard of care ranking to novel combinations