Conference Day Two

Thursday - 25 April, 2024

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 Session Reserved for Roche

Synopsis

Talk Details TBA

9:30 am Comparative Analysis of Regulatory Landscapes: IVDs & Diagnostic Imaging Agents 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

  • Varun Pattani Senior Director, Diagnostic Development, Foundation Medicine

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 Fireside Chat: Diversity, Equity, & Inclusion: How to Ensure Successful Enrollment of Under- Represented Communities in Oncology & Non-Oncology Indications

  • Andrea Stevens Director - Precision Medicine Access Strategy, Johnson & Johnson Services, Inc
  • Kristina McGuire Executive Director and Head, Precision Medicine Laboratory Operations and Companion Diagnostics, Regeneron Pharmaceuticals Inc

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

Track A: Biomarker Discovery & Development

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

  • Karen Swales Senior Scientific Officer and Operational Manager, Clinical PD Biomarker Group, Institute of Cancer Research

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

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Track B: Companion Diagnostics & Commercialisation

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

  • Nitin Jain Director - Franchise Project Management, AstraZeneca

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

12:00 pm Session Reserved for Burning Rock Dx

  • Xinru Mao Vice President - Biomarker & Companion Diagnostics Services, Burning Rock Biotech

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

1:30 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?

2:00 pm Application of a Total Antibody (TAb) Assay as a Companion Diagnostic (CDx) for AAV5 Gene Therapy

  • Emanuela Izzo Director, CDx Program Development & Alliance Management, BioMarin Pharmaceutical

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 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 Afternoon Break & Networking

Accelerating Future Personalized Medicine Approaches with Development of Novel Biomarkers for Companion Diagnostics

3:30 pm Leveraging Differential mRNA Expression as Novel Companion Diagnostic Modality

  • Qian Chen Senior Scientist, Biomarkers & CDx, Monte Rosa Therapeutics

Synopsis

  • Compare biomarker expression on different modalities
  • Predict drug sensitivity based on mRNA expression
  • Discuss the value of using mRNA expression as companion diagnostics

4:00 pm Session Reserved for Neo Genomics

Synopsis

Talk Details TBA

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

5:30 pm Chair’s Closing Remarks & End of 14th Clinical Biomarkers & CDx Europe Summit 2024

  • Maciej Cabanski Senior Director Biomarkers and CDx, Monte Rosa Therapeutics