2023 Conference Day 2
8:00 am Morning Networking Coffee
8:55 am Chair’s Opening Remarks
Streamlining the EU IVD Regulatory Process to Accelerate New CDx Approvals
9:00 am CDx Certifications Under IVDR: State of Play
Synopsis
- State of play IVDR with viewpoint on CDx
- Understanding interactions with EMA
- Lessons learnt and takeaways from first certification projects
9:30 am Session Reserved for Guardant Health
10:00 am Experiences & Challenges on the Co-Development of Personalised Medicines & CDx
Synopsis
- Update on the European regulatory framework
- Current experiences and challenges to streamline co-development
- Role of the CDx in pharmaceutical studies
10:30 am Morning Networking Break
11:00 am Session Reserved for Quest Diagnostics
11:30 am Panel Discussion: Taking Control of Your IVD Regulatory Submissions to Turbocharge the Future of CDx
Synopsis
- Addressing European frameworks and the need of industry collaboration
- Discussing how to best optimise regulatory process to avoid it being a barrier to finding new precision medicines in Oncology, NASH and Neurodegenerative disorders
12:00 pm Session Reserved for NeoGenomics
12:30 pm Lunch & Networking Break
TRACK A: Clinical Biomarker Development
Patient Enrichment & Stratification for Further Clinical Benefit
1:30 pm Patient-Derived Tissue Models to Support Personalised Safety
Synopsis
- Usage of micro-physiological systems in pre-clinical drug discovery and clinical development
- Case examples of precision medicine and personalised medicine: Cancer Immunotherapy and immune-related adverse events, paediatric drug development and support of trial design and clinical decision making
2:00 pm Enquire About Partnership Opportunities
Bioanalytical Assay Validation Approaches to Enhance Precision Medicine Clinical Trials
2:30 pm Standardisation of Biomarker Validation for Implementation in Clinical Trials: Oncology & NASH as Case Studies
Synopsis
- General guiding principles for biomarker development
- Best practices for the development and fit-for-purpose validation of biomarkers across a range of therapeutic areas, including NASH and oncology
- Addressing the challenges in developing and implementing biomarker use in clinical trials and clinical practice
- How are regulatory agencies addressing the need for validated biomarkers?
3:00 pm Aligning Biomarker Assay Validation Strategies for Successful Implementation in Clinical Trials
Synopsis
- Discussing the appropriate timing for validation
- Determining how to improve bioanalytical validity of a biomarker assay
- How to achieve more robust and comprehensive biomarker readouts
TRACK B: Drug-Diagnostics & Commercialisation
Opening the Way to a Better-Defined Commercialisation Pathway
1:30 pm New Era of Precision Medicine in Life-Threatening Diseases
Synopsis
- Why is there such a clinical need in the critical care space?
- Differences between marketplace payer and regulatory steps in different European countries
- Lessons learnt and how to apply to other non-oncology modalities
2:00 pm VUCA-N: Variable, Uncertain, Complex, Ambiguous, but Necessary: Discovering the Trials & Tribulations of Precision-based Diagnostics from a Pharma Perspective
Synopsis
- Addressing some of the inherent challenges facing a pharma company developing a global precision-based oncology therapeutic product and companion diagnostic portfolio
- From early clinical to post-commercialisation
Unravelling Reimbursement Challenges to Maximise Access to Precision Medicines
2:30 pm Precision Medicine in Cardiovascular & Metabolic Diseases
Synopsis
- Where are we today?
- Realisation of precision medicine outside of oncology: dream or reality
- Call to arms in CV space: what are the next steps?
3:00 pm Roundtable Discussion: CDx Market Strategies to Ensure Widespread Access to Approved Medicines
Synopsis
- Understanding the importance and value of the technology with payers
- How does reimbursement look like in different countries?
- Can the biomarker be separated from the treatment to which they are associated to?
3:30 pm Afternoon Networking Break
Shaping the Future of CDx to Ensure Precision Medicine Access for All
4:00 pm How to Handle IVDs in Clinical Trials: Sponsor Responsibilities According to the IVDR Requirements
Synopsis
- Addressing regulatory landscape changes and sponsor responsibilities
- Discovering IVDs used in drug clinical trials
- Deciphering clinical trial submission including IVDs
4:30 pm IVDR impact on Clinical Trials for Oncology & Non-Oncology Diseases
Synopsis
- Understanding CTR and IVDR interfaces
- How to apply for a performance study and strategies for market adoption
- Defining a better framework to ensure access to precision medicines