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?
9:30 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
10:00 am Morning Break & Networking
TRACK A: Biomarker Discovery & Clinical Development
Strengthening Disease Management Through Biomarkers & Digital Innovations for Improved Autoimmune & Rare Disease Treatment Regimes
11:00 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
11:30 am Session Reserved for Saga Diagnostics
Synopsis
Presentation Details to be Announced
12:00 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
11:00 am Panel Discussion: Advancing IVDR-Adherence within the Clinic to Bolster Strengthened Filings
Synopsis
- What are the main hurdles faced in the clinical development phase for CDx? Does this differ between oncology and nononcology indications?
- With regards to data collections and performance studies, what are the main hurdles faced for CE-Marked certification?
11:30 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
12:00 pm Session Reserved for Biocartis
Synopsis
Presentation Details to be Announced
12:30 pm Lunch & Break & Networking
Integrating Blood-Based & Neuroinflammation Biomarkers for Better Outcomes in Neurological Diseases to Improve Quality of Life
1:30 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
2:00 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
Synchronising Commercial & Launch Planning for Precision Medicine & CDx Across Oncology & Non-Oncology to Expedite Patient Access
1:30 pm Roundtable Discussion: Advancing Streamlined Commercialisation for Precision Oncology Therapies for Faster Access to Life Saving Treatments
Synopsis
- How can you commercialise products across Europe? Considering panel size and level of centralisation
- How can we bolster reimbursement through bridging medicinal guidelines and advocacy groups?
- What is the reimbursement approach for pan-tumour therapies? Are comparisons between single agents needed?
2:00 pm Unlocking Commercial Pathways for Non-Oncology Precision Medicines & Diagnostics to Accelerate Market Entry
Synopsis
- What steps are essential for analytical and clinical validation in non-oncology diagnostics?
- Optimising commercial and launch planning outside oncology to corroborate timely medicinal product and CDx approvals
- How can labs optimise processes for non-oncology diagnostics in areas like sample acquisition, network setup, turnaround time, and reliable result delivery?
2:30 pm Afternoon Networking Break
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?
3:30 pm Session Reserved for Oxford BioDynamics
Synopsis
Session Details to be Announced
4:00 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