2023 Conference Day 1

7:30 am Registration & Welcome Coffee

8:20 am Chair’s Opening Remarks

  • Elizabeth Sheppard Global Pricing & Market Access Director, Oncology Diagnostics, AstraZeneca

Fast-Tracking Your Path to EU IVDR Compliance

8:30 am The MHRA & Medical Device Innovation

  • Penny Wilson Deputy Director, Innovative Devices, Medicines & Healthcare Products Regulatory Agency (MHRA)

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

  • Stephen Lee Director, Diagnostics Regulation, Association of British Healthcare Industries Ltd. - ABHI
  • Francesca Cipolli Associate Director, Precision Medicine & Digital Health, Global Regulatory Sciences, BMS
  • Patrick Fivey Director, Precision Medicine Policy, AstraZeneca
  • James Hewitt IVD Business Line Manager & Senior Specialist (CDx), TÜV SÜD

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

  • Ian Kavanagh Chief Operating Officer & Co-Founder, Apis Assay Technologies Ltd.

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

  • Julie Hart MHRA IVD Expert Advisory Group Member, Medicines & Healthcare Products Regulatory Agency (MHRA)
  • Michael Zaiac Head of Medical Affairs Oncology,
    Region Europe, Novartis AG
  • Geraldine Farjot VP, Translational Medicine, Samsara Therapeutics
  • Anna Reznichenko Senior Director, AstraZeneca

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

  • Pascal Forrer Diagnostic Sciences Director (DxSD) in Hematology & CAR T cells, GDD Precision Medicine, Novartis AG

Synopsis

  • Clinical diagnosis of AML
  • MRD in AML: challenges today
  • MRD in AML: future opportunities for surrogacy

TRACK B: Drug-Diagnostics & Commercialisation

  • Philippe Pinton Senior Vice President, Head, Global Translational and Clinical Research & Development, Ferring International Center SA

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

  • Elizabeth Sheppard Global Pricing & Market Access Director, Oncology Diagnostics, AstraZeneca

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

  • Lucian Visan Head of Biomarkers & Translational Medicine, Imcyse

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

  • Clare Balendran Vice President of Translational Development, Novo Nordisk
  • Michael Palmer Vice President - Translational Oncology, Bicycle Therapeutics
  • Brian Baker Senior Director - Regulatory Affairs & CDx, Regeneron Pharmaceuticals Inc
  • John Smeraglia VP Head of Global Integrated Bioanalysis, AstraZeneca

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

  • Michael Zaiac Head of Medical Affairs Oncology,
    Region Europe, Novartis AG

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

  • Philippe Pinton Senior Vice President, Head, Global Translational and Clinical Research & Development, Ferring International Center SA

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