7:30 am Check-in & Morning Coffee
8:15 am Chair’s Opening Remarks
Bolstering Compliance of In-House Assays & IVDs to Enable Quicker Translation from Preclinic into Clinic & into Patients
8:30 am How the EU IVDR Impacts Both the Development & Access to the Pharmaceutical Industry’s Precision Medicines
Synopsis
- The EU IVDR introduces new impactful requirements for pharma’ for the use of IVDs both before and after the approval of precision medicines.
- Shortages of both CE marked and in-house IVDs , for use with precision medicines, may impact access to key treatments.
- The approval process for IVDs used within clinical trials of precision medicines may create impactful delays.
9:00 am The power of partnership…Past, Present and Future
Synopsis
- Zeroing in on early stage work and how it impacts downstream
- Exploring current digital pathology focus
- Discussing most recent partnerships
9:30 am IVDs & Diagnostic Radiopharmaceuticals in Clinical Trials
Synopsis
- Global and EU regulations of IVDS in clinical trials
- Global and EU regulations of diagnostic imaging agents in clinical trials
- Future developments and implications for drug development
10:00 am Approach IVDR, Global Trials & CDx with Confidence: How the Right Diagnostics Partner Can Make It Possible
Synopsis
- Learn about Foundation Medicine’s regulatory approach, and how existing platform validation data can accelerate timelines for CDx approval
- Gain insights and expectations on the study start-up process across different countries, such as China and Europe, with a focus on our experience through notification and authorization pathways under IVDR
- Look at what’s ahead, with new biomarkers like HRDsig and ctDNA tumor fraction, as well as possibilities for CDx milestones across RNA, heme malignancies, and real-world data
10:30 am Panel Discussion: Diversity, Equity, & Inclusion: How to Ensure Successful Enrollment of Under- Represented Communities in Oncology & Non-Oncology Indications
Synopsis
- What impact is the reduction in available assays in Europe having on clinical trials?
- What does this mean for patient representation?
- How are all stakeholders involved in promoting diversity, equity, and inclusion in the co-development of CDx and drugs for more patients?
11:00 am Morning Networking Break & Poster Session
Track A: Biomarker Discovery & Development
Track Chair
Unravelling Deeper Understanding of Mechanism of Action of Biomarkers to Create New Therapeutic Opportunity
12:00 pm Translating Biomarkers – From Bench to Bedside & Back Again
Synopsis
- Exploring examples of proof of mechanism and proof of concept biomarkers transferred from bench to bedside in phase I oncology trials
- Highlighting the need to robustly measure the right biomarker in the right sample at the right time
- Learnings from an academic translational research laboratory on the interface between drug discovery and clinical drug development
12:30 pm Navigating Lung Cancer Biomarkers & Assays: Insights into Performance Metrics for Assays
Synopsis
- An overview of preclinical and clinical space for lung cancer biomarkers with a 10 year retrospective analysis.
- A breakdown of the current lung cancer assays and their performance metrics using examples.
Track B: Companion Diagnostics & Commercialisation
Track Chair
Bolstering Market Access, Pricing & Alliance Management Strategy to Successfully Progress Your CDx & Medicine
12:00 pm Spotlighting Common Challenges in Co-development & Aligning Strategies for Advancing Precision Medicine Portfolio
Synopsis
- Highlighting key drivers of successful delivery and approval of diagnostics in parallel to drug approval
- Overcoming challenges in collaboration with diagnostic partners and understanding pharma ways of working
- Shaping the strategy and execution for oncology and rare diseases
12:30 pm Navigating MRCT Study & NGS-Based CDx Development Strategies: A Global View
Synopsis
- The Value of NGS-Based Solutions in Clinical Study on Precision Medicine has significant advantages.
- NGS-Based CDx Development in different countries require diverse strategies for development and registration.
- Challenges and solutions we are facing during the CDx development and our strategies
1:00 pm Networking Lunch
Expanding into Indications Beyond Oncology for Novel Biomarker Discovery Using AI / Machine Learning
2:00 pm Circulating Histones as Robust Liquid Biopsies for Cardiovascular Diseases & Cancer
Synopsis
- Increasing evidence suggests that circulating histones and histone complexes, originating from cell death or immune cell activation, could act as promising biomarkers for cancer detection and management
- Leveraging circulating histones as a powerful liquid biopsy approach and methods for their detection. Hghlighting current knowledge on circulating histones in hematologic malignancies and solid cancer, as well as in cardiovascular disease
- Describing potential artificial intelligence (AI)-based strategies to identify histone identity and cancer tissue-of-origin in blood plasma based on nucleosome positioning
2:30 pm Regulatory Ingredients in Pharmaceutical Development in Pharma 4.0 Age (“BANI environment”)
Synopsis
- Unearthing the latest AI concepts and evolving momentum for use in precision medicine
- Spearheading new biomarkers concepts, current stage and outlook for the future
- Harnessing insights from a start-up for CDx development
3:00 pm AI Driven Biomarkers for Mental Health – Advances & Pitfalls in Speech Analysis
Synopsis
- Speech (paralinguistic acoustic modelling) offers a solid foundation for biomarkers in mental health; good progress in the recent years both in academia and industry using AI
- What are relevant quality metrics and what quality to expect or not to expect
- How can speech biomarkers adopted in the market
- Some challenges and pitfalls in developing speech AI biomarkers for mental health are of broader interest and learnings are applicable for any AI biomarkers
Bolstering Start-Up Strategy Before Committing to Biomarker Development or Collaborating with Large Pharma
2:00 pm Panel Discussion: How are Small to Mid-Size Biotechs Navigating the Current IVD Landscape?
Synopsis
- What impact on biomarker discovery have the new regulations had?
- Have they hindered clinical development?
- What do you need to see from the regulators?
- How can diagnostics companies assist development?
2:30 pm Application of a Total Antibody (TAb) Assay as a Companion Diagnostic (CDx) for AAV5 Gene Therapy
Synopsis
- Rationale for the selection of a Companion Diagnostic (CDx) for AAV5-based gene therapy for the treatment of Hemophilia A
- Validation of the AAV5 TAb assay as a companion diagnostic according to international standard and regulatory requirements
- AAV5 TAb CDx commercialization effort to ensure patients access to the validated and approved test
3:00 pm Fireside Chat: Market Strategy – What is the Current State of Play for Reimbursement Across Europe?
Synopsis
- How has IVDR impacted payer behaviours?
- What is the interplay between companion diagnostic providers, the drug in development, and reimbursement?
- How can drug developers begin thinking about reimbursement earlier in the drug diagnostic development process?
3:30 pm Afternoon Break & Networking
Accelerating Future Personalized Medicine Approaches with Development of Novel Biomarkers for Companion Diagnostics
4:00 pm Leveraging Differential mRNA Expression as Novel Companion Diagnostic Modality
Synopsis
- Compare biomarker expression on different modalities
- Predict drug sensitivity based on mRNA expression
- Discuss the value of using mRNA expression as companion diagnostics
4:30 pm Liquid Biopsy Testing in Oncology, Perspectives on Comprehensive Genomic Profiling Testing
Synopsis
- The era of liquid biopsy as an alternative to, or supportive of the genomic profiling using solid tissue biopsy has arrived
- In this presentation we will review the strengths and challenges of liquid biopsy testing, particularly with the push towards larger, more comprehensive panels
- We will review NeoGenomics' experience over the past 9 years with the development and application of plasma-based liquid biopsy testing
5:00 pm Allergen-Specific Immunotherapy: Development & Validation of Biomarkers for Monitoring of Clinical Efficacy, Patients’ Stratification & Prognosis
Synopsis
- Unravelling the pathogenesis of type I IgE-mediated hypersensitivity (asthma, allergic rhinoconjunctivitis) and allergen immunotherapy treatment modalities
- Updating the current status for surrogate biomarkers of clinical efficacy endpoints and unmet needs in biomarkers of clinical response and prognosis
- Uncovering challenges in transition from analytical biomarker assay development andvalidation phase into clinical validation