2023 Conference Day 1
7:30 am Registration & Welcome Coffee
8:20 am Chair’s Opening Remarks
Fast-Tracking Your Path to EU IVDR Compliance
8:30 am The MHRA & Medical Device Innovation
Synopsis
Session Details TBC
9:00 am Session Reserved for Illumina
9:30 am Panel Discussion: How to Navigate the IVD Regulatory Landscape in Different European Countries to Accelerate Your Companion Diagnostics Approval
Synopsis
- Discovering the differences between European countries when it comes to the new IVD regulatory process
- Evaluating the impact of IVDR to patients’ access to precision medicines in Oncology, as well as NASH and CNS disorders
10:00 am HER2 Stratification with a Novel Diagnostic Test
Synopsis
- Discovering the potential of the Apis Breast Cancer Subtyping Kit for faster HER2 result turnaround without the need for reflex testing to ISH
- Learning how to significantly reduce time for results interpretation with automatic results via validated software
- The detection ability of lowly expressed ERBB2 levels aligns the IVD test as a CDx to HER2 targeted therapies, such as Trastuzumab deruxtecan
10:30 am Panel Discussion: Equity, Diversity & Inclusion: How to Ensure Succesful Enrollment of Under- Represented Communities in Oncology & Non-Oncology Indications
Synopsis
- Best practices to engage with patient communities and ensure successful enrollment of under-represented groups in multiple disease indications
- Analysing different ways and parameters to measure success in precision medicine clinical trial enrolment
- What role do regulatory agencies play in advancing diversity?
11:00 am Morning Break & Speed Networking
Synopsis
An opportunity to network, discuss and collaborate with precision medicine leaders passionate about advancing patient-centric progress within the field
TRACK A: Clinical Biomarker Development
Non-Oncology Biomarker Development to Advance Precision Medicine
12:00 pm Multiplexing Translational Research Applied to the Development of Autophagy Inducers to Treat Neurodegenerative Diseases
Synopsis
- Developing autophagy inducers to treat neurodegenerative diseases
- Challenges in biomarker development for first-in-class therapies
- Highlighting the power of multiplexing when evaluating clinical utility of compounds
12:30 pm Session Reserved for Mission Bio
1:00 pm AML MRD: Where We Are Today & Where We Want to Be in the Future
Synopsis
- Clinical diagnosis of AML
- MRD in AML: challenges today
- MRD in AML: future opportunities for surrogacy
TRACK B: Drug-Diagnostics & Commercialisation
Clinical Validity to Accelerate Approval for a Precision Drug
12:00 pm Biomarker Readiness for Drug Development in NASH Including CDx
Synopsis
- Impact on IVD and/or DDT approval of a biomarker
- Study considerations related to precision medicine approaches in NASH
- Current status and expected future qualification need of NASH markers
12:30 pm Session Reserved for Almac Diagnostic Services
1:00 pm Roundtable Discussion: Learnings from Companion Diagnostics in Oncology Care to Enable More Informed Decision Making
Synopsis
- What advances in assay sensitivity and specificity have we seen to improve diagnostic journey for patients?
- Translatable takeaways from oncology to enable better decision making for enhanced patient outcomes in NASH, CNS and cardiovascular diseases
1:30 pm Lunch & Networking Break
Developing Biomarkers to Improve Clinical Development
2:30 pm Panel Discussion: Pre-Analytical Sample Preparation & Handling: What can We do Better?
Synopsis
- Addressing the impact of sampling methods on the assay outcome
- Real-life examples of succesful trainings to ensure sample viability
- Discussing the importance of analysing the tissue and its different applications
- Future steps in study and sample collection design
3:00 pm Enquire About Partnership Opportunities
3:30 pm Interim Analysis of Single Cell Transcriptomics Data from Type I Diabetes (TID) Phase 2 IMPACT Trial
Synopsis
- Methodology to detect signal in peripheral blood single cell transcriptomic data developed and used in TID clinical trial patients
- Evidence of induction of insulin specific CD4+ cells of a cytolytic nature
- Evidence of a treatment impact on Th17 (presumed) pathogenic cells
- Potential biomarkers identified to help guide further Imotope™ technology development
Accelerating Your Companion Diagnostic Approval with Early Planning
2:30 pm Panel Discussion: Advancing Confidently Your Precision Medicine Launches
Synopsis
- Fostering closer collaboration between pharma and diagnostic developers to support an optimal CDx launch
- Addressing different strategies to accelerate agreements with CDx partners
- Determining the right time to partner to successfully bring innovative therapies into the clinic
3:00 pm Session Reserved for Foundation Medicine
3:30 pm Maximising Chances of Success for New Non- Oncology CDx Clinical Programmes
Synopsis
- Precision medicine platform of evidence for increased confidence in development
- Selecting the right diagnostic partner: considerations relevant for a non-oncology CDx collaboration
- Regulatory Expertise
- Global Footprint
- Preparations for launch and marketing
4:00 pm Afternoon Networking Break
Digital Pathology & Artificial Intelligence to Remain at the Forefront of Precision Medicine
4:30 pm AI-Driven Patient Stratification towards Precision Medicine in CKD
Synopsis
- Capturing biological heterogeneity of disease through individual patient-level molecular profile analysis
- Uncovering novel patient subgroups with specific molecular profiles through unbiased stratification approaches
- Analysing molecular data patterns in large cohorts of patients to enable molecular re-classification of CKD towards precision medicine
5:00 pm Use of Advanced Analytics to Predict Risk: Relying on Existing Biomarkers to Advance Treatment
Synopsis
- Highlight the opportunities of digital pathology in uncovering valuable information for patient selection
- Use existing laboratory and clinical parameters and apply machine learning to predict risk of events and initiate potential counter actioncounteraction
- Look towards the future integration of novel and established markers to optimise patient selection in a variety of cancers
Game-Changing Advancements for the Future of CDx
4:30 pm Pan-Disease CDx – From Oncology to NASH & Beyond, Precision Medicine Matters
Synopsis
- The present what and how in Oncology
- From Oncology to NASH, and beyond
- Shaping precision medicine with pan-disease CDx
5:00 pm Delivering Genomic Medicine for Cancer Patients
Synopsis
- Highlighting the gaps between vision and delivery in genomic medicine
- Exploring mechanisms to accelerate and democratise access to genomic medicine for patients diagnosed with cancer
5:30 pm CLOSING REMARKS & END OF DAY 1
6:00 pm Thought Leadership Engager in Partnership with Illumina
Synopsis
Join us to discuss From Discovery to CDx: Illumina as the Genomics Partner for Pharma